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New FDA Drug Approvals - August 2025

atrasentan

Vanrafia

Pharmaceutical company: Novartis Pharmaceuticals

Pharmacologic classification: Endothelin receptor antagonists

Therapeutic classification: Miscellaneous GU drugs


AVAILABLE FORMS

Tablets: 0.75 mg


INDICATIONS AND DOSAGES

To reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, a urine protein-to-creatinine ratio greater than or equal to 1.5 g/g

Adults: 0.75 mg PO daily.


ADVERSE REACTIONS

CV: decreased BP, peripheral edema.
Hematologic: anemia.
Hepatic: increased transaminase levels.

INTERACTIONS

Drug-drug. Moderate or strong CYP3A inducers (carbamazepine, phenytoin, rifampin): May decrease atrasentan level and efficacy. Avoid use together.
OATP1B1/1B3 inhibitors (lopinavir, lovastatin, ritonavir, simvastatin): May increase atrasentan level and risk of adverse reactions. Avoid use together.

Drug-herb. St. John's wort: May decrease atrasentan level. Discourage use together.


CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with a history of hypersensitivity to drug or its components.
  • Contraindicated in patients with Child-Pugh class C liver impairment. Drug increases risk of liver toxicity.
  • Use cautiously in patients with HF. Drug may cause fluid retention.
  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unlikely.


PREGNANCY-LACTATION-REPRODUCTION

  • Boxed Warning: Contraindicated in pregnancy. Drug may cause major birth defects. Effective contraception should be used before, during therapy, and for 2 weeks after final dose.
  • It's unknown whether drug is present in human milk. Due to risk for adverse effects, breastfeeding isn't recommended during therapy.
  • Drug may decrease spermatogenesis.
Reactions in bold italics are life-threatening.

Released: August 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer

 

fitusiran

Qfitlia

Pharmaceutical company: Genzyme Corporation

Pharmacologic classification: Antithrombin-directed small interfering RNA agent

Therapeutic classification: Miscellaneous hematologic drugs


AVAILABLE FORMS

Injection: 20 mg/0.2 mL single-dose vials; 50 mg/0.5 mL single-dose prefilled pens


INDICATIONS AND DOSAGES

Routine prophylaxis for the prevention or reduction of bleeding episodes from hemophilia A or B, with or without factor VIII or factor IX inhibitors

Adults and children age 12 and older: Initially, 50 mg subcut once every 2 months. Adjust dose or dosing interval as needed to maintain antithrombin (AT) activity at 15 to 35%.

Adjust-a-dose: If AT activity is less than 15%, reduce dosage 3 months after the prior dose; if AT activity is greater than 35% after 6 months or bleed control hasn't been achieved, consider dosage increase. Refer to manufacturer's instructions for dose modifications based on AT activity levels and breakthrough bleed management.


ADVERSE REACTIONS

CNS: headache.
CV: thrombotic event.
EENT: nasopharyngitis.
GI: abdominal pain, gall bladder disease, dyspepsia.
Hepatic: liver toxicity.
Musculoskeletal: arthralgia.
Respiratory: cough.
Skin: injection site reaction.
Other: viral or bacterial infection.

INTERACTIONS

Drug-drug. Clotting factor concentrates (CFC) (activated prothrombin complex concentrate), bypassing agents (BPA) (anti-inhibitor coagulant complex): May cause an increased risk of thrombosis. Use cautiously together for breakthrough bleeding. Discontinue prophylaxis with CFC or BPA no later than 7 days after starting fitusiran.
Hormonal contraceptives: May increase risk of thrombotic events. Encourage non-hormonal contraceptive use prior to starting fitusiran and during therapy.


CONTRAINDICATIONS AND CAUTIONS

  • Boxed Warning: Serious thrombotic events have occurred in patients treated with fitusiran with risk factors including persistent AT activity less than 15%, fitusiran 80 mg once monthly dosing, an indwelling venous catheter, and the post-operative setting when bleed management guidelines were not followed.
  • Boxed Warning: Acute and recurrent gallbladder disease has occurred in patients treated with fitusiran, some requiring cholecystectomy or developing complications (pancreatitis). Consider alternative treatment for hemophilia if patient has a history of symptomatic gallbladder disease.
  • Avoid use in patients with any level of liver impairment.
  • Safety and effectiveness haven't been established in children younger than 12.
  • Dialyzable drug: Unknown.


PREGNANCY-LACTATION-REPRODUCTION

  • Studies during pregnancy are inadequate. Use only if potential benefit outweighs fetal risk.
  • It's unknown if drug is present in human. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are life-threatening.

Released: August 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer

 

gepotidacin

Blujepa

Pharmaceutical company: GlaxoSmithKline

Pharmacologic classification: Triazacenaphthylenes

Therapeutic classification: Antibiotic


AVAILABLE FORMS

Tablets: 750 mg


INDICATIONS AND DOSAGES

Uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis

Female adults and children age 12 and older weighing at least 40 kg: 1500 mg PO twice daily approximately 12 hours apart for 5 days.


ADVERSE REACTIONS

CNS: headache, dizziness.
GI: abdominal pain, diarrhea, flatulence, nausea, soft feces, vomiting.
GU: vulvovaginal candidiasis.

INTERACTIONS

Drug-drug. Acetylcholinesterase inhibitors (aricept, donepezil): May increase the effect of inhibitors. Monitor for excessive cholinergic effects.
Anticholinergics (benztropine, oxybutynin): May decrease effects of anticholinergic agents. Monitor for therapeutic effect.
CYP3A4 Substrates with a narrow therapeutic index (quinidine, cyclosporine): May increase substrate level. Avoid use together.
Depolarizing neuromuscular blocking agents (succinylcholine): May increase effect of neuromuscular blocking agent. Monitor for exaggerated neuromuscular blockade.
Digoxin: May increase digoxin level. Monitor digoxin level.
Non-depolarizing neuromuscular blocking agents (rocuronium, pancuronium): May decrease effect of neuromuscular blocking agent. Monitor for effectiveness.
QT-prolonging agents (antiarrhythmics, haloperidol): May further increase risk of QTc prolongation. Avoid use together.
Strong CYP3A4 Inducers (phenobarbital, carbamazepine, phenytoin rifampin): May decrease level of gepotidacin. Avoid use together.
Strong CYP3A4 Inhibitors (clarithromycin, itraconazole, nelfinavir ritonavir): May increase level of gepotidacin. Avoid use together.

Drug-Herb. St. John's Wort: May decrease drug level. Discourage use together.

Drug-Food. Grapefruit juice: May increase gepotidacin level. Discourage use together.


CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with a severe hypersensitivity to gepotidacin.
  • Drug may cause QTc prolongation. Avoid use in patients with a history of QTc interval prolongation, relevant pre-existing cardiac disease, or currently taking antiarrhythmic agents or other medications that may prolong the QTc interval.
  • Use cautiously in patients with medical conditions that may be exacerbated by acetylcholinesterase inhibition (bradycardia, heart block, arrhythmias, hypotension, gastric ulcers).
  • Drug may cause CDAD, ranging in severity from mild diarrhea to fatal colitis, which may occur more than 2 months after administration.
  • Avoid use in patients with CrCl less than 30 mL/minute or Child-Pugh class C liver impairment.
  • Safety and effectiveness haven't been established in children less than 12 years or weighing less than 40 kg.
  • Dialyzable drug: Unknown.


PREGNANCY-LACTATION-REPRODUCTION

  • Studies during pregnancy are inadequate to evaluate risk.
  • Enrollment in a pregnancy exposure registry is encouraged (GlaxoSmithKline 1-888-825-5249).
  • Based on animal study, drug is likely present in human milk. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are life-threatening.

Released: August 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer

 

isatuximab-irfc

Sarclisa

Pharmaceutical company: Sanofi-Aventis U.S. LLC

Pharmacologic classification: Monoclonal antibodies

Therapeutic classification: Antineoplastics


AVAILABLE FORMS

Injection: 100 mg/5 ml, 500 mg/25 ml single-dose vial


INDICATIONS AND DOSAGES

Adjust-a-dose (all indications): Interrupt isatuximab for grade 2 or 3 infusion-related reactions. If symptoms resolve or improve to grade 1, restart isatuximab infusion at half of the initial infusion rate. If after 30 minutes symptoms do not recur, the infusion rate may be increased to the initial rate, and then further increased incrementally as recommended. Permanently discontinue for grade 4 infusion-related reactions or anaphylactic reaction. For patients who need recovery of blood counts in the event of hematological toxicity, delay dose if needed. Dose reductions of isatuximab aren't recommended. Refer to manufacturer's instructions for doing information and toxicity-related dosage adjustments for drugs used in combination.

Multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
Adults: 10 mg/kg by IV infusion. Cycle 1 (28-day cycle), give weekly on days 1, 8, 15, 22; then cycle 2 and beyond give days 1, 15. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 40 mg PO or IV (or 20 mg PO or IV for patients age 75 years and older).

Relapsed or refractory multiple myeloma in combination with carfilzomib and dexamethasone in patients who have received 1 to 3 prior lines of therapy
Adults: 10 mg/kg by IV infusion. Cycle 1 (28-day cycle), give weekly on days 1, 8, 15, 22; then cycle 2 and beyond give days 1, 15 of every 28-day cycle. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 20 mg IV on infusion days, PO on day 22 in cycle 2 and beyond, and PO on day 23 in all cycles).

Newly diagnosed multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in patients who aren't eligible for autologous stem cell transplant (ASCT)
Adults: 10 mg/kg by IV infusion. Cycle 1 (42-day cycle) give days 1, 8, 15, 22, 29; then cycles 2 to 4 give days 1, 15, 29. Cycles 5 to 17 (28-day cycles) give every 2 weeks on days 1, 15. Cycles 18 and beyond (28-day cycles) give every 4 weeks on day 1. Continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone 20 mg (IV on the days of isatuximab infusions, PO on other days).


ADVERSE REACTIONS

CNS: fatigue, asthenia, peripheral sensory neuropathy, insomnia.
CV: HF, HTN, peripheral edema.
EENT: cataract.
GI: diarrhea, nausea, vomiting, constipation.
Hematologic: anemia, febrile neutropenia, lymphopenia, thrombocytopenia.
Musculoskeletal: back pain, pain.
Respiratory: URI, pneumonia, bronchitis, dyspnea, cough.
Other: infusion-related reactions, infections, second primary malignancies.

INTERACTIONS

None reported by the manufacturer.


CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in those with severe hypersensitivity to isatuximab, or to any of its components.
  • Alert: Drug may cause serious infusion-related reactions, including life-threatening anaphylactic reactions or cytokine release syndrome; and life-threatening infections.
  • May increase the incidence of second primary malignancies during and after treatment.
  • Older patients may have greater sensitivity to isatuximab, including neutropenia.
  • Safety and effectiveness in children have not been established.
  • Dialyzable drug: Unknown.


PREGNANCY-LACTATION-REPRODUCTION

  • Drug can cause fetal harm. Fetal immune cell depletion and decreased bone density can occur.
  • Patients of childbearing potential should use effective contraception during treatment and for 5 months after the last dose of isatuximab. The combination pomalidomide and lenalidomide are contraindicated during pregnancy because they may cause birth defects or death of the fetus.
  • It's unknown if isatuximab is present in human milk. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding isn't recommended during treatment.
Reactions in bold italics are life-threatening.

Released: August 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer

 

Download these updates as a PDF

New FDA Drug Approvals Archive

New FDA Drug Approvals - January 2022
atogepantQuliptaPharmaceutical company: AbbViePharmacologic classification:Calcitonin gene-related peptide receptor antagonistTherapeutic classification:Antimigraine drugAVAILABLE FORMSTablets: 10 mg; 30 mg; 60 mgINDICATIONS AND DOSAGESPrevention of episodic migraine headachesAdults: 1 tablet PO once daily.Adjust-a-dose: If taking with a strong CYP3A4 inhibitor, the recommended dose is 10 mg PO once daily. If taking with a strong or moderate CYP3A4 inducer, the recommended dose is 30 mg or 60 mg PO once daily. If taking with an OATP inhibitor, the recommended dose is 10 mg or 30 mg PO once daily. If severe renal impairment or end-stage renal disease (creatinine clearance less than 30 mL/min), the recommended dose is 10 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSAvoid use in patients with severe hepatic impairment (Child-Pugh class C).Use cautiously in older adults. Initiate therapy at lowest dose.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONIt isn’t known if this drug causes fetal harm. Use during pregnancy only if clearly indicated and the benefit outweighs the fetal risk. Women with migraine headaches may be at increased risk for preeclampsia and gestational hypertension.It isn’t known if this drug appears in human milk. Use cautiously in women who are breastfeeding.INTERACTIONSDrug-drug. OATP inhibitors (cyclosporine, rifampin): May increase level of atogepant. Adjust atogepant dose.Strong or moderate CYP3A4 inducers (carbamazepine, efavirenz, etravirine, rifampin, phenytoin): May decrease level of atogepant. Adjust atogepant dose.Strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole): May increase level of atogepant. Adjust atogepant dose.Drug-herb. St. John’s wort: May decrease level of atogepant. Adjust atogepant dose.ADVERSE REACTIONSCNS: fatigue, somnolence.GI: nausea, constipation, decreased appetite.Hepatic: increased transaminase levels.Metabolic: weight loss.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer avacopanTavneosPharmaceutical company: ChemoCentryx, Inc.Pharmacologic classification:Complement inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSCapsules: 10 mgINDICATIONS AND DOSAGESAdjunctive treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoidsAdults: 30 mg PO b.i.d. with food.Adjust-a-dose: When used with strong CYP3A4 inhibitors, reduce dose to 30 mg once daily. If AST or ALT increase to greater than 3 times the upper limit of normal (ULN), consider pausing avacopan. If AST or ALT increases to greater than 5 times ULN, or AST or ALT increases to 3 times ULN with elevation of bilirubin to more than 2 times ULN, discontinue drug until avacopan-induced liver injury is ruled out.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with serious hypersensitivity reaction to avacopan or to any of its components.May cause serious liver injury, transaminase elevations and hepatobiliary events, including serious and life-threatening events.Not recommended for use in patients with active, untreated, or uncontrolled chronic liver disease (hepatitis B, hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis.Reactivation of latent hepatitis B infection and hypersensitivity reactions, including angioedema can occur.Serious and fatal infections have been reported. Avoid use in patients with an active, serious infection.Use cautiously in patients with chronic or recurrent infection, tuberculosis (TB) exposure, history of serious or opportunistic infections, underlying conditions that predispose them to infection, or who have lived or traveled in areas of endemic TB or mycoses.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate data to inform the use of avacopan during pregnancy or breastfeeding; use only if the benefits outweigh the fetal risk.INTERACTIONSDrug-drug. CYP3A4 substrates (midazolam): May increase adverse reactions. Monitor patient closely and consider dose reduction of sensitive CYP3A4 substrates with narrow therapeutic window.Strong and moderate CYP3A4 inducers (rifampin): May decrease level of avacopan. Avoid use together.Strong CYP3A4 inhibitors (itraconazole): May increase level of avacopan. Reduce avacopan dose to 30 mg PO once daily.Drug-herb. St. John’s wort: May decrease level of avacopan. Avoid use together.ADVERSE REACTIONSCNS: headache, fatigue, dizziness, paresthesia.CV: hypertension.GI: nausea, diarrhea, vomiting, upper abdominal pain.GU: increase in creatinine.Hepatic: liver enzyme abnormalities.Skin: rash.Other: angioedema.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer mobocertinibExkivityPharmaceutical company: Takeda Pharmaceuticals AmericaPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSCapsules: 40 mgINDICATIONS AND DOSAGESLocally advanced or metastatic non–small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with progression on or after platinum-based chemotherapyAdults:160 mg PO daily, until disease progression or unacceptable toxicity.Adjust-a-dose: See the manufacturer’s information for toxicity-related dose reductions. If use with a concomitant moderate CYP3A inhibitor can’t be avoided, reduce mobocertinib dose by approximately 50% and monitor QTc interval more frequently. After moderate CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the drug at the dose prior to CYP3A initiation.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug can cause life-threatening heart rate-corrected QT (QTc) prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation.Black Box Warning: Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors, as these may further prolong the QTc.Black Box Warning: Withhold, dose reduce, or permanently discontinue this drug based on the severity of QTc prolongation.This drug can increase the risk of interstitial lung disease/pneumonitis, which can be fatal.This drug increases the risk of cardiac toxicity, including decreased ejection fraction, cardiomyopathy, and heart failure.This drug may cause diarrhea, leading to dehydration or electrolyte imbalance, with or without renal impairment.Safety and effectiveness of this drug in children haven’t been established.Use cautiously in older adults as there may be a higher incidence and severity of adverse reactions.Recommended dosage hasn’t been determined for patients with severe renal or hepatic impairment.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Females of reproductive potential must use effective nonhormonal contraception during treatment and for 1 month after the last dose, and males with female partners of reproductive potential must use effective contraception during treatment with and for 1 week after the last dose.Due to the potential for adverse reactions in a child who is breastfed, women should not breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. CYP3A substrates (midazolam): May decrease level of substrate; consider increasing substrate dosage if possible.Black Box Warning: Drugs that prolong the QTc interval (haloperidol, thioridazine, amiodarone, procainamide, lithium, ciprofloxacin, methadone, SSRIs, tricyclic antidepressants): May significantly increase risk of QTc prolongation; avoid use together. If use together is unavoidable, monitor QTc carefully.Hormonal contraceptives: May decrease level of contraceptive and cause therapeutic failure. Avoid use together.Strong and moderate CYP3A inducers (rifampin, efavirenz): May decrease mobocertinib level and antitumor activity; avoid concomitant use.Black Box Warning: Strong or moderate CYP3A inhibitors (itraconazole, ketoconazole): May increase mobocertinib level; avoid use together. If concomitant use can’t be avoided, reduce mobocertinib dose, monitor the QTc interval more frequently with ECGs, and monitor patients for increased risk of adverse reactions.Drug-herb. St. John’s wort: May decrease mobocertinib level; discourage use together.Drug-food. Grapefruit, grapefruit juice: May increase drug level; discourage intake during treatment.ADVERSE REACTIONSCNS: headache, fever, fatigue, peripheral neuropathy.CV: QTc prolongation, atrial fibrillation, hypertension, heart failure, edema.EENT: ocular toxicity.GI: diarrhea, stomatitis, vomiting, decreased appetite, nausea, abdominal pain, gastroesophageal reflux disease, dyspepsia.GU: acute kidney injury.Hematologic: leukocytopenia, anemia.Metabolic: weight loss, increased amylase, increased lipase, hypokalemia, increased creatinine, hypomagnesemia.Musculoskeletal: pain.Respiratory: interstitial lung disease, pneumonitis, cough, upper respiratory infection, dyspnea, rhinorrhea, pleural effusion.Skin: rash, paronychia, dry skin, pruritus, alopecia, hand-foot syndrome.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - December 2021
difelikefalinKorsuvaPharmaceutical company: Vifor, Inc.Pharmacologic classification:Kappa opioid receptor agonistTherapeutic classification:Miscellaneous CNS agentAVAILABLE FORMSInjection: 65 mcg/1.3 mL (50 mcg/mL)INDICATIONS AND DOSAGESModerate-to-severe pruritus associated with chronic kidney disease in those undergoing hemodialysisAdults: 0.5 mcg/kg IV bolus injection into venous line of dialysis circuit at the end of each hemodialysis treatment.CONTRAINDICATIONS AND CAUTIONSThis drug isn’t recommended for use in those on peritoneal dialysis or in those with severe hepatic impairment.Safety and effectiveness in children haven’t been established.Dialyzable drug: Yes.Overdose S&S: Dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, vomiting.PREGNANCY-LACTATION-REPRODUCTIONThere are limited human data on use in women who are pregnant. Use only if clearly needed.There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Consider the benefits to the mother versus the risks to the infant from the drug or the underlying maternal condition.INTERACTIONSDrug-drug. CNS depressants, sedating antihistamines, opioids: May increase the risk of CNS adverse reactions. Use cautiously together.ADVERSE REACTIONSCNS: dizziness, gait disturbances, headache, somnolence, mental status change.GI: diarrhea, nausea.Metabolic: hyperkalemia.Reactions in bold italics are life-threatening.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwer  maralixibatLivmarliPharmaceutical company: Mirum Pharmaceuticals, Inc.Pharmacologic classification:Ileal bile acid transporter (IBAT) inhibitorTherapeutic classification:Miscellaneous GI drugAVAILABLE FORMSOral solution: 9.5 mg/mLINDICATIONS AND DOSAGESCholestatic pruritus in patients with Alagille syndrome (ALGS)Adults and children age 1 and older: Initially 190 mcg/kg PO once daily. After one week, increase dose to 380 mcg/kg once daily, as tolerated. Maximum dose is 28.5 mg (3 mL) daily in patients weighing 70 kg or more.Adjust-a-dose: Decrease dose or interrupt therapy for liver function study abnormalities or GI adverse reactions. Once the liver study abnormalities either return to baseline or stabilize at a new baseline value, consider restarting at 190 mcg/kg, and increase as tolerated. If liver function study abnormalities or GI reactions recur, or symptoms consistent with clinical hepatitis, portal hypertension, or hepatic decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy.CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in patients with ALGS with clinically significant portal hypertension or decompensated cirrhosis haven’t been established.Safety and effectiveness in patients age 65 and older and children less than age 1 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONPatients with ALGS can have fat-soluble vitamin (FSV) deficiency as part of their disease and maralixibat may reduce absorption of FSV. Increased maternal supplementation of FSVs during pregnancy and lactation may be needed.Maternal use at the recommended dose is not expected to result in measurable fetal exposure because systemic absorption is low, but it may decrease fetal absorption of FSV.There are no data on the presence of this drug in human milk, its effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the infant to maralixibat at the recommended dose.INTERACTIONSDrug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind to maralixibat in the GI tract. Give bile acid binding resin at least 4 hours before or 4 hours after maralixibat.OATP2B1 substrates (statins): May decrease absorption of the OATP2B1 substrate. Monitor effect of the substrate.ADVERSE REACTIONSGI: diarrhea, vomiting, nausea, GI bleeding, abdominal pain.Hepatic: increased liver function studies.Metabolic: FSV deficiency.Musculoskeletal: bone fracture.Reactions in bold italics are life-threatening.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - November 2021
belumosudilRezurockPharmaceutical company: Kadmon PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESChronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapyAdults and children age 12 and older: 200 mg PO daily with food until progression of chronic GVHD requires new systemic therapy.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. When coadministered with strong CYP3A inducers or proton pump inhibitors, increase dosage of belumosudil to 200 mg b.i.d.CONTRAINDICATIONS AND CAUTIONSUse in patients with preexisting severe renal or hepatic impairment hasn’t been studied.The safety and effectiveness in children younger than age 12 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Advise pregnant females of fetal risk.No data are available on the presence of this drug in human milk or its effects on breastfed children or milk production. Because of the potential for serious adverse reactions, breastfeeding during treatment and for at least one week after the last dose isn’t recommended.Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for at least one week after the last dose.This drug may cause reversible impairment of fertility in females and males.INTERACTIONSDrug-drug. Proton pump inhibitors (rabeprazole, omeprazole): May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.Strong CYP3A inducers (rifampin):May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.ADVERSE REACTIONSCNS: asthenia, fever, headache.CV: edema, hypertension, hypotension, hemorrhage.EENT: nasal congestion.GI: nausea, diarrhea, abdominal pain, dysphagia, decreased appetite.GU: elevated creatinine, renal failure.Hematologic: lymphocytopenia, anemia, thrombocytopenia, neutropenia.Hepatic: increased GGT, increased alkaline phosphatase, increased ALT.Metabolic: hypophosphatemia, hypocalcemia, hyperkalemia.Musculoskeletal: musculoskeletal pain, muscle spasm, arthralgia.Respiratory: dyspnea, cough.Skin: rash, pruritus.Other: infection (including bacterial and viral).Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  finerenoneKerendiaPharmaceutical company: Bayer PharmaceuticalsPharmacologic classification:Mineralocorticoid receptor antagonistTherapeutic classification:Miscellaneous renal drugAVAILABLE FORMSTablets: 10 mg, 20 mgINDICATIONS AND DOSAGESTo reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, nonfatal MI, and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetesAdults: Initially,10 mg or 20 mg PO once daily based on eGFR and serum potassium thresholds. Don’t initiate treatment if serum potassium is more than 5.0 mEq/L. If eGFR is 60 mL/min/1.73 m2 or more, start at 20 mg once daily; if eGFR is 25 to less than 60 mL/min/1.73 m2, start at 10 mg once daily. If starting with 10 mg, increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds.Adjust-a-dose: Adjust dosage as needed based on every 4-week potassium and eGFR level results. If current serum potassium is 4.8 mEq/L or less and patient is on 10 mg daily, increase to 20 mg daily, except if eGFR has decreased by more than 30% compared to previous measurement; if so, maintain 10 mg dose. If on 20 mg dose already, stay at 20 mg daily.If current serum potassium is more than 4.8 to 5.5 mEq/L and patient is on 10 mg daily, stay at 10 mg daily; if on 20 mg dose already, stay at 20 mg daily.If current serum potassium is more than 5.5 mEq/L and patient is on 10 mg daily, hold and consider restarting at 10 mg once daily when serum potassium is 5.0 mEq/L or less; if on 20-mg dose already, hold and restart at 10 mg once daily when serum potassium is 5.0 mEq/L or less.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with adrenal insufficiency.This drug is not recommended if eGFR is less than 25 mL/min/1.73 m2.This drug increases the risk of hyperkalemia, especially in patients with decreased kidney function and those with higher baseline potassium and risk factors for hyperkalemia (concomitant drugs that increase serum potassium or impair its excretion). If serum potassium levels are more than 4.8 to 5.0 mEq/L, initiation may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgement and serum potassium levels.Avoid use in patients with severe hepatic impairment (Child Pugh C), and consider additional potassium monitoring in patients with moderate hepatic impairment (Child Pugh B).This drug is not approved for use in pediatric patients.Use cautiously in older adults.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug has not been studied in patients who are pregnant.Breastfeeding is not recommended during treatment and for at least 1 day after the last dose of the drug.INTERACTIONSDrug-drug. Drugs that may increase potassium (ACE inhibitors, angiotensin-receptor blockers, potassium sparing diuretics): May increase retention of potassium; monitor potassium levels frequently.Moderate (erythromycin) and weak (amiodarone) CYP3A inhibitors: May increase finerenone level and risk of adverse reactions; use cautiously together and monitor potassium.Strong (rifampicin) or moderate (efavirenz) CYP3A inducers: May decrease finerenone level; avoid concurrent use.Strong CYP3A inhibitors (itraconazole): May significantly increase finerenone level; use together is contraindicated.Drug-herb. St. John’s wort:May decrease finerenone level; use together cautiously.Drug-food. Grapefruit or grapefruit juice: May increase finerenone level; discourage use together.ADVERSE REACTIONSCV: hypotension.Metabolic: hyperkalemia, hyponatremia.Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  odevixibatBylvayPharmaceutical company: Albireo PharmaPharmacologic classification:Bile acid transporter inhibitorTherapeutic classification:Miscellaneous GI drugAVAILABLE FORMSCapsules: 400 mcg, 1,200 mcgOral pellets: 200 mcg, 600 mcgINDICATIONS AND DOSAGESPruritus in patients with progressive familial intrahepatic cholestasisAdults and children age 3 months and older:40 mcg/kg PO daily with morning meal. If there is no improvement in pruritus after 3 months, increase dose in 40 mcg/kg increments up to 120 mcg/kg PO daily. Maximum total daily dose is 6 mg.Adjust-a-dose: Interrupt the drug if new onset liver function test (LFT) abnormalities or symptoms of clinical hepatitis are observed. Once LFTs return to baseline or stabilize at a new baseline, restart at 40 mcg/kg/day and increase dose as tolerated and appropriate. Consider permanent discontinuation if LFT abnormalities recur. Interrupt drug if persistent diarrhea occurs. Restart at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated and appropriate. If diarrhea persists and no alternate etiology is identified, discontinue treatment.CONTRAINDICATIONS AND CAUTIONSPatients who are exclusively on liquid food should not use odevixibat, including children who only take liquids (human milk, formula).This drug may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3).Efficacy and safety in patients with clinically significant portal hypertension and in patients with decompensated cirrhosis haven’t been established.Fat-soluble vitamin deficiency may develop or worsen. Monitor vitamin levels (A, D, E) and INR (for vitamin K activity) and supplement as indicated.The safety and effectiveness of this drug in patients less than 3 months or greater than 65 years of age have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no human data on use in pregnant women. Based on data from animal reproduction studies, in utero exposure may cause fetal harm, including cardiac malformations. Use only if clearly needed.There are no data on the presence of this drug in human milk or its effects on breastfed infants or on milk production. This drug has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant at recommended doses.Monitor fat-soluble vitamin levels and increase fat-soluble vitamin intake if deficiency is observed during lactation.INTERACTIONSDrug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind odevixibat in the gut and reduce efficacy. Administer binding resin at least 4 hours before or 4 hours after odevixibat.ADVERSE REACTIONSGI: diarrhea, vomiting, abdominal pain.Hepatic: increased transaminases, hyperbilirubinemia, cholelithiasis.Metabolic: fat-soluble vitamin deficiency, dehydration.Musculoskeletal: fracture.Other: splenomegaly.Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2021
relugolix–estradiol–norethindrone acetateMyfembreePharmaceutical company: Myovant Sciences GmbH and PfizerPharmacologic classification: Gonadotropin-releasing hormone receptor antagonist/estrogen/ progestinTherapeutic classification: Hormonal agentAVAILABLE FORMSTablets: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mgINDICATIONS AND DOSAGESManagement of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal womenAdults: One tablet PO daily for up to 24 months.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug increases the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and MI, especially in women at increased risk for these events.Black Box Warning: This drug is contraindicated in women with current or a history of thrombotic or thromboembolic disorders, and in women at increased risk for these events, including women over age 35 who smoke, or women with uncontrolled hypertension, dyslipidemia, vascular disease, or obesity.Contraindicated in women at high risk for arterial, venous thrombotic, or thromboembolic disorder (cerebrovascular disease, coronary artery disease, peripheral vascular disease, thrombogenic valvular or thrombogenic rhythm diseases of the heart, inherited or acquired hypercoagulopathies, or headaches with focal neurologic symptoms or migraine headaches with aura if over age 35).Contraindicated for use in patients with known osteoporosis, current or history of breast cancer or other hormone-sensitive malignancies, increased risk for hormone-sensitive malignancies, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, or hypersensitivity to any of the drugs in the product.Discontinue the drug immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs, or if a hormone-sensitive malignancy is diagnosed.Stop the drug if sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions occurs, and evaluate for retinal vein thrombosis immediately.Treatment duration is limited to 24 months. This drug may cause decreases in bone mineral density (BMD) that may not be completely reversible. Baseline and periodic BMD assessments are recommended. Assess risk-benefit for women with additional risk factors for bone loss.This drug may contribute to depression, mood disorders, or suicidal ideation.Use cautiously in women with well-controlled hypertension; continue to monitor blood pressure and stop the drug if blood pressure rises significantly.Use cautiously in women with a history of cholestatic jaundice related to past estrogen use or pregnancy.Use cautiously in patients with prediabetes, diabetes, and hypertriglyceridemia. This drug may decrease glucose tolerance and increase cholesterol and triglyceride levels.This drug may cause uterine fibroid prolapse or expulsion; advise patients to seek medical attention for severe uterine bleeding.This drug may cause alopecia; discontinue the drug if hair loss becomes a concern.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.Overdose S&S: Nausea, vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding.PREGNANCY-LACTATION-REPRODUCTIONThis drug is contraindicated in pregnancy. Females who are pregnant and exposed to the drug are encouraged to call the Myfembree Pregnancy Exposure Registry at 1-(855)-428-0707.This drug can cause early pregnancy loss; exclude pregnancy before initiating treatment.This drug may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue the drug if pregnancy is confirmed.Advise women of reproductive potential to use effective non-hormonal contraception during treatment with the drug and for 1 week after the final dose. Avoid concomitant use of hormonal contraceptives.This drug is likely to be present in human milk. Weigh the benefits against the risk of adverse effects to the breastfed child.INTERACTIONSDrug-drug. Combined P-glycoprotein (P-gp) and strong CYP3A inducers (rifampin): May decrease concentrations of relugolix, estradiol, or norethindrone; avoid concurrent use.Estrogen-containing contraception: May increase estrogen levels, risk of estrogen-associated adverse events, and decrease efficacy of relugolix, estradiol, and norethrindrone. Avoid concurrent use.P-gp inhibitors (erythromycin): May increase relugolix concentrations; avoid concurrent use or if cannot discontinue P-gp inhibitor, separate doses by 6 hours and monitor for adverse reactions.Drug-herb. St. John’s wort: May decrease concentrations of relugolix, estradiol, or norethindrone. Discourage use together.Drug-lifestyle. Black Box Warning: Smoking: Smoking increases the risk of thromboembolic disorders and vascular events, especially in those over age 35. Discourage smoking.ADVERSE REACTIONSCNS: depression, mood disorders, irritability, anxiety.CV: hypertension, hot flush.GI: dyspepsia.GU: abnormal uterine bleeding, loss of libido.Musculoskeletal: bone loss.Skin: alopecia, hyperhidrosis or night sweats.Other: hypersensitivity, breast cyst.Reactions in bold italics are life-threatening.Released: October 2021 Nursing Drug Handbook© 2021 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - September 2021
ibrexafungerpBrexafemmePharmaceutical company: Scynexis, Inc.Pharmacologic classification:Triterpenoid antifungalTherapeutic classification:AntifungalAVAILABLE FORMSTablets: 150 mgINDICATIONS AND DOSAGESTreatment of patients with vulvovaginal candidiasisAdults and postmenarchal pediatric females: 300 mg (two 150-mg tablets) PO administered approximately 12 hours apart (in the morning and in the evening) for one day, for a total daily dosage of 600 mg (total of 4 tablets for one course of therapy).Adjust-a-dose: If taking a concomitant strong CYP3A inhibitor, administer one 150-mg tablet approximately 12 hours apart (in the morning and in the evening) for 1 day (total of 2 tablets for one course of therapy).CONTRAINDICATIONS AND CAUTIONSContraindicated in pregnancy or in patients hypersensitive to the drug or its components.Safety has not been established in premenarchal pediatric females.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm; use is contraindicated in pregnancy.Verify the pregnancy status in females of reproductive potential prior to initiating treatment.If this drug is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after a patient receives the drug, pregnant women exposed to the drug and health care providers should report pregnancies to Scynexis, Inc. at 1-888-982-SCYX (7299).There is no information regarding this drug’s presence in human breast milk; weigh the risk to the breastfed child.Advise females of reproductive potential to use effective contraception during treatment and for 4 days after the last dose.INTERACTIONSDrug-drug. Strong CYP3A inhibitors (ketoconazole, itraconazole): May significantly increase ibrexafungerp level; reduce ibrexafungerp dosage.Strong/moderate CYP3A inducers (rifampin, carbamazepine, phenytoin, long-acting barbiturates, bosentan, efavirenz, or etravirine): May significantly reduce ibrexafungerp level; avoid use together.Drug-herb. St. John’s wort: May significantly reduce ibrexafungerp level; discourage use together.ADVERSE REACTIONSCNS: dizziness.GI: diarrhea, nausea, abdominal pain, vomiting, flatulence.GU: dysmenorrhea, vaginal bleeding.Hepatic: elevated transaminases.Musculoskeletal: back pain.Skin: rash.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: September 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - August 2021
pegcetacoplanEmpaveliPharmaceutical company: Apellis PharmaceuticalsPharmacologic classification:Complement inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSTablets: 1,080 mg/20 mL (54 mg/mL) single-dose vialINDICATIONS AND DOSAGESParoxysmal nocturnal hemoglobinuria (PNH)Adults: 1,080 mg subcut infusion twice weekly via infusion pump.Adjust-a-dose: For LDH greater than twice the upper limit of normal, infuse 1,080 mg subcut every three days and monitor LDH twice weekly for at least 4 weeks. To reduce the risk of hemolysis with abrupt treatment discontinuation when switching from eculizumab, initiate pegcetacoplan while continuing eculizumab at its current dose; after 4 weeks, discontinue eculizumab and continue pegcetacoplan. When switching from ravulizumab, initiate pegcetacoplan no more than 4 weeks after the last dose of ravulizumab.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Meningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use predisposes patients to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae type B.Black Box Warning: Contraindicated in patients not currently vaccinated against encapsulated bacteria (including S. pneumoniae, N. meningitidis types A, C, W, Y, and B, and H. influenzae type B) unless the risk of delaying treatment outweighs the risk of developing such a bacterial infection.Alert:Contraindicated in patients with serious infection caused by encapsulated bacteria, including S. pneumoniae, N. meningitidis, and H. influenzae.Black Box Warning: Pegcetacoplan is available only through a REMS program. Prescribers must enroll in the program by phone (888-343-7073) or at www.empavelirems.com.Contraindicated in patients with hypersensitivity to pegcetacoplan or excipients.Hypersensitivity reactions (facial swelling, rash, urticaria) may occur. If a severe hypersensitivity reaction (including anaphylaxis) occurs, immediately discontinue infusion, treat per standard of care, and monitor until signs and symptoms resolve.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause embryo-fetal harm. There are risks to the mother and fetus associated with untreated PNH in pregnancy. Consider use during pregnancy only if benefits outweigh risk.It is unknown whether this drug is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, discontinue breastfeeding during treatment and for 40 days after the last dose.Pregnancy testing is recommended for females of reproductive potential prior to treatment.Female patients of reproductive potential should use effective contraception during treatment and for 40 days after the last dose.INTERACTIONSNone reported.ADVERSE REACTIONSCNS: fatigue, headache.CV: chest pain, hypertension.GI: abdominal pain, diarrhea, intestinal ischemia, biliary sepsis.Musculoskeletal: back pain.Respiratory: respiratory tract infection, hypersensitivity pneumonitis.Skin: injection site reaction.Other: infection, viral infection.Reactions in bold italics are life-threatening.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - July 2021
drospirenone and estetrolNextstellisPharmaceutical company: Mayne PharmaPharmacologic classification:Estrogen-progestin combinationTherapeutic classification:Endocrine-metabolic agentsREAD MORE...AVAILABLE FORMSTablets: 3 mg drospirenone and 14.2 mg estetrol as 24 active tablets, and 4 inert tablets per packINDICATIONS AND DOSAGESTo prevent pregnancy in females of reproductive potentialWomen with no current use of hormonal contraception: One active tablet PO daily for 24 days beginning on day 1 of menstrual cycle. Then one inert tablet PO daily for 4 days. Begin each subsequent 28-day pack on the same day of the week as the first cycle pack; restart active tablets the next day after last inert tablet.Women switching from another contraceptive method: One active tablet PO daily for 24 days beginning on the day when previous combined oral contraceptive would have started; or on the day when a new transdermal system, vaginal insert, or injection would have been scheduled; or on the day after removal of intrauterine system or implant; or on the day after the last progestin-only pill was taken. Then one inert tablet PO daily for 4 days. Begin each subsequent 28-day pack on the same day of the week as the first cycle pack; restart active tablets the next day after the last inert tablet.Women starting after delivery of more than 20 weeks’ gestation or abortion or miscarriage after more than 14 weeks’ to 20 weeks’ or less gestation: Beginning no earlier than 4 weeks after delivery, follow directions for women with no current use of hormonal contraception if menses have resumed. If menses have not resume and the woman is not pregnant, use additional nonhormonal contraception for the first 7 days of use.Women starting after abortion or miscarriage after 14 weeks’ or less gestation: Followdirections for women with no current use of hormonal contraception. If within the first 7 days after abortion or miscarriage, use additional nonhormonal contraception for the next 7 days.CONTRAINDICATIONS AND CAUTIONSContraindicated in females with a high risk of arterial or venous thrombotic diseases; evaluate patient for any past personal or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy before starting medication. Risk factors for venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism) include smoking, obesity, family history of VTE and prolonged immobilization.Contraindicated in females with current or history of a hormonally-sensitive malignancy (breast cancer), hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or decompensated cirrhosis.Contraindicated in women with uterine bleeding of undiagnosed etiology.Contraindicated in females predisposed to hyperkalemia (renal impairment, hepatic impairment, adrenal insufficiency).Contraindicated in patients with uncontrolled hypertension (HTN) or HTN with vascular disease.Contraindicated in females who have migraines with aura; discontinue medication in females who develop new migraines that are recurrent, persistent, or severe, or who have an increase in frequency or severity of migraines with medication use.Avoid use in females with hereditary angioedema; medication may induce or exacerbate symptoms.Avoid use in females with a history of chloasma gravidarum or increased sensitivity to sun or ultraviolet exposure.This drug may be less effective in females with a BMI of 30 kg/m2 or greater. Safety and efficacy in females with a BMI 35 kg/m2 or greater have not been established.Use of combined hormonal contraceptives may increase risk of CV events and is greatest in females over age 40, those with HTN, dyslipidemia, diabetes, or obesity, and those who use nicotine-containing products.Use cautiously in females with prediabetes or diabetes; medication may decrease glucose tolerance.Consider an alternate contraceptive method in females with personal or family history of hypertriglyceridemia; medication may increase triglyceride level and the risk for pancreatitis.Medication may increase the risk of developing or worsening existing gallbladder disease. Consider discontinuing use in females with symptomatic gallbladder or cholestatic disease.Dialyzable drug: Unknown.Overdose S&S: Nausea, vomiting, severe headache, thromboembolic complications, vaginal bleeding.PREGNANCY-LACTATION-REPRODUCTIONDiscontinue hormonal contraceptives if pregnancy occurs.Hormonal contraceptives are present in human breast milk and may decrease milk production. Advise women who are breastfeeding to switch to an alternative form of birth control, if possible, taking into consideration the benefits of breastfeeding and the mother’s clinical need for contraception.INTERACTIONSDrug-drug. Antibiotics: May reduce contraceptive effectiveness. Advise use of backup contraception during coadministration.Antidiabetic drugs: May reduce the blood glucose lowering effect of antidiabetic drugs. Increase frequency of glucose monitoring and increase antidiabetic drug dosage, as needed, based on glucose levels.Bile acid sequestrants (cholestyramine, colesevelam, colestipol): May decrease absorption of contraceptive and lead to contraceptive failure or increase in breakthrough bleeding. Separate time of administration and refer to the sequestrants prescribing information for additional information.Drugs that may increase serum potassium level (ACE inhibitors, ARBs, NSAIDs spironolactone, potassium supplements):Mayincrease serum potassium level. Monitor serum potassium level.Hepatitis C drug combinations containing ombitasvir–paritaprevir–ritonavir, with or without dasabuvir: May increase liver enzymes. Use together is contraindicated. May start drospirenone and estetrol 2 weeks after completion of hepatitis C combination drug regimen.Lamotrigine:May decrease lamotrigine efficacy. Adjust lamotrigine dosage as recommended in prescribing information.Moderate and weak CYP3A4 inducers (dabrafenib, dexamethasone, modafinil, nafcillin): May lead to contraceptive failure. Use an alternative or backup contraceptive method during coadministration and up to 28 days after discontinuation of the CYP3A inducer, unless the prescribing information of the inducer indicates no clinically significant interaction.Strong CYP3A inducers (phenytoin, phenobarbital, dexamethasone, rifamycin, rifampin): May lead to contraceptive failure. Avoid concomitant use. If concomitant use is unavoidable, use an alternative contraceptive method or backup nonhormonal contraceptive method during coadministration and up to 28 days after discontinuation of the inducer.Strong CYP3A inhibitors (ketoconazole, saquinavir, loperamide, diltiazem): May increase risk of adverse drug reactions. Monitor serum potassium level in patients taking concomitantly long term.Systemic corticosteroids:May increase the risk of corticosteroid-related adverse reactions. Monitor patient closely. Follow the recommendation for the corticosteroid in accordance with its prescribing information.Thyroid hormone replacement therapy: May increase thyroid-binding globulin level. Monitor thyroid-stimulating hormone level and follow the recommendation for thyroid hormone replacement in accordance with its prescribing information.Drug-herb. St. John’s wort:May reduce contraceptive effectiveness or increase breakthrough bleeding. Discourage use together or recommend alternative method of birth control.Drug-lifestyle. Black Box Warning: Smoking: Cigarette smoking increases the risk of serious CV events from combined hormonal contraceptive use. Use together is contraindicated in females over age 35.Sun and ultraviolet light:Drug may increase risk of chloasma. Limit exposure and wear sunscreen while taking this medication.ADVERSE REACTIONSCNS: headache, mood disturbance.CV: thromboembolic disorders.GU: libido decrease, bleeding irregularities.Metabolic: dysmenorrhea, weight increase.Skin: acne.Other: breast symptoms.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwertivozanibFotivdaPharmaceutical company: AVEO PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticREAD MORE...AVAILABLE FORMSCapsules: 0.89 mg, 1.34 mgINDICATIONS AND DOSAGESTreatment of relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapiesAdults: 1.34 mg PO once daily for 21 days followed by 7 days off treatment for a 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.Adjust-a-dose: If moderate hepatic impairment (total bilirubin greater than 1.5 to 3 times the upper limit of normal [ULN] with any AST), decrease dosage to 0.89 mg. Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSThis drug may cause severe hypertension and hypertensive crisis. Control blood pressure prior to initiating therapy and monitor the patient closely.This drug may cause serious or fatal cardiac failure, cardiac ischemia, arterial or venous thromboembolic events (MI, stroke), or hemorrhagic events. Closely monitor patients at risk for these events or those with a history of these events. Discontinue the drug if severe or life-threatening events occur.This drug may increase the risk of impaired wound healing; withhold therapy for at least 24 days before elective surgery and for at least 2 weeks following major surgery until adequate wound healing has occurred.This drug may cause reversible posterior leukoencephalopathy syndrome (RPLS). Evaluate patients with seizures, headaches, visual disturbances, confusion, or altered mental function with magnetic resonance imaging. Discontinue the drug in patients who develop RPLS.The 0.89-mg capsule contains FD&C Yellow No.5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in susceptible patients.Safety and effectiveness have not been established in pediatric patients, or in patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times ULN with any AST).Dialyzable drug: Unknown.Overdose S&S: Hypertension and hypertensive crisis.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies and mechanism of action, this drug can cause fetal harm. Advise women who are pregnant of the risk.Verify pregnancy status of females of reproductive potential prior to start of treatment.Females of reproductive potential and male patients with female partners of reproductive potential should use effective contraception during treatment and for one month after the last dose.There are no data on the presence of this drug in human milk, or the effects of this drug on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise a woman who is lactating not to breastfeed during treatment or for one month after the last dose.This drug can impair fertility in males and females of reproductive potential.INTERACTIONSDrug-drug. Strong CYP3A inducers (rifampin, carbamazepine, phenytoin): May decrease tivozanib levels. Avoid use together.ADVERSE REACTIONSCNS: fatigue, delirium.CV: bleeding, cardiac failure, cardiac ischemia, venous thromboembolism, arterial thromboembolism, hypertension.EENT: dysphonia.GI: diarrhea, nausea, stomatitis, vomiting, decreased appetite.GU: acute kidney injury, proteinuria, increased creatinine.Hematologic: decreased lymphocytes, decreased platelets, prolonged activated partial thromboplastin time, increased or decreased hemoglobin.Hepatic: hepatobiliary disorders.Metabolic: hypothyroidism, decreased weight.Musculoskeletal: back pain, osteonecrosis.Respiratory: pneumonia, respiratory failure, cough, dyspnea.Skin: rash, palmar-plantar erythrodysesthesia syndrome.Other: hypothyroidism.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerviloxazineQelbreePharmaceutical company: Supernus PharmaceuticalsPharmacologic classification:Selective norepinephrine reuptake inhibitorTherapeutic classification:ADHD drugREAD MORE...AVAILABLE FORMSCapsules (extended-release): 100 mg, 150 mg, 200 mgINDICATIONS AND DOSAGESTreatment of attention-deficit hyperactivity disorder (ADHD)Children ages 6 to 11 years: Initially, 100 mg PO once daily. May titrate by increments of 100 mg weekly to the maximum dose of 400 mg daily, depending on response and tolerability.Children ages 12 to 17 years: Initially,200 mg PO once daily. After one week, may titrate by increments of 200 mg to the maximum dose of 400 mg daily, depending on response and tolerability.Adjust-a-dose: For severe renal impairment (eGFR less than 30 mL/min/1.73 m2), the recommended starting dose is 100 mg once daily. May titrate weekly by increments of 50 to 100 mg once daily, to a maximum dose of 200 mg once daily.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Suicidal thoughts and behavior may increase when treated with this drug; monitor patients closely.This drug may induce manic or mixed episodes in patients with bipolar disorder. Screen patients prior to therapy for risk of bipolar disorder, including a detailed psychiatric history with personal and family history of suicide, bipolar disorder, and depression.Use cautiously in those with severe renal impairment.Use is not recommended in those with hepatic impairment.Safety and effectiveness have not been established in children younger than age 6.Dialyzable drug: Unknown.Overdose S&S: Drowsiness, impaired consciousness, diminished reflexes, and increased heart rate.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies, this drug may cause maternal and fetal harm when used during pregnancy. Discontinue when pregnancy is recognized, unless benefits to mother outweigh the risk.Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or online at www.womensmentalhealth.org/preg.This drug may be present in breast milk. Consider the benefits of breastfeeding along with the mother’s need for the drug, and the risk to the child.INTERACTIONSDrug-drug. CYP2D6 substrates (atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone); CYP3A4 substrates (atiplfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, lurasidone): May increase levels of these substrates and risk for adverse reactions. Monitor patient closely and adjust dose of the substrates as clinically indicated.Drugs that are moderately sensitive CYP1A2 substrates (clozapine, pirfenidone): May increase levels of sensitive substrates and risk for adverse reactions. Use together is not recommended. If coadministered, substrate dose reduction may be warranted.Drugs that are sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline): May increase levels of sensitive substrates and risk for adverse reactions. Use together is contraindicated.MAO inhibitors: (selegiline, isocarboxazid, phenelzine, tranylcypromine, safinamide, rasagiline):May increase the risk of hypertensive crisis with concomitant treatment or within 14 days after discontinuing MAO inhibitor. Use during this timeframe is contraindicated.ADVERSE REACTIONSCNS: somnolence, fatigue, insomnia, lethargy, sedation, irritability, headache, pyrexia.CV: increased diastolic blood pressure, tachycardia.EENT: upper respiratory infection.GI: decreased appetite,nausea, vomiting, abdominal discomfort or pain.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - June 2021
dasiglucagonZegaloguePharmaceutical company: Zealand PharmaPharmacologic classification:Glucagon receptor agonistTherapeutic classification:AntihypoglycemicREAD MORE...AVAILABLE FORMSInjection: 0.6 mg/0.6 mL single-dose autoinjector; 0.6 mg/0.6 mL single-dose prefilled syringeINDICATIONS AND DOSAGESTreatment of severe hypoglycemia in patients with diabetesAdults and children age 6 and older: 0.6-mg subcut injection. If no response after 15 minutes, may repeat with an additional 0.6 mg subcut.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with pheochromocytoma. If a patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, consider giving 5 to 10 mg of phentolamine mesylate IV.Contraindicated in patients with insulinoma. This drug may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of dasiglucagon, give PO or IV glucose.Allergic reactions have been reported with glucagon products.This drug is effective in treating hypoglycemia only if sufficient hepatic glycogen stores are present. Patients in a starvation state, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for the drug to be effective. Treat these patients with glucose.The safety and effectiveness of this drug have not been established in patients younger than age 6.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on dasiglucagon use in pregnant females. However, untreated hypoglycemia in pregnancy can cause complications and may be fatal.There is no information on the presence of this drug in human milk, its effects on the breastfed infant, or milk production. Dasiglucagon would be expected to be broken down to amino acids in the infant's digestive tract and is therefore unlikely to cause harm to an exposed infant.INTERACTIONSDrug-drug. Beta-blockers: May transiently increase pulse and blood pressure. Monitor patient’s vital signs.Indomethacin: May decrease antihypoglycemic effect of dasiglucagon or may produce hypoglycemia. Use together cautiously.Warfarin: May increase anticoagulant effect of warfarin. Monitor patient closely.ADVERSE REACTIONSCNS: headache.CV: hypertension, hypotension, bradycardia, presyncope, palpitations, orthostatic intolerance.GI: nausea, vomiting, diarrhea.Skin: injection site pain.Other: hypersensitivity reactions.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwermelphalan flufenamidePepaxtoPharmaceutical company: Oncopeptides Inc.Pharmacologic classification:Nitrogen mustardTherapeutic classification:AntineoplasticREAD MORE...AVAILABLE FORMSInjection: 20-mg single-dose vialINDICATIONS AND DOSAGESRelapsed or refractory multiple myeloma, in combination with dexamethasone, in those who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibodyAdults: 40-mg IV infusion over 30 minutes on day 1 of each 28-day cycle in combination with dexamethasone 40 mg PO or IV on days 1, 8, 15 and 22 of each cycle until disease progression or until unacceptable toxicity.Adjust-a-dose: For patients age 75 or older, reduce dose of dexamethasone to 20 mg. Refer to the manufacturer’s instruction for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to melphalan flufenamide or melphalan.Dosages exceeding the recommended dose for relapsed and refractory multiple myeloma are associated with mortality.This drug may increase the risk of secondary malignancies, such as myelodysplastic syndromes or acute leukemia. Monitor patients long-term for secondary malignancies.This drug is not indicated or recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.This drug has not been studied in patients with creatinine clearance 15 to 44 mL/min.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the risk to a fetus.Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.Verify pregnancy status in females of reproductive potential prior to initiating this drug.Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.There is potential for serious adverse reactions in a breastfed child; advise women not to breastfeed during treatment and for 1 week after the last dose.This drug can cause amenorrhea and result in infertility.This drug may impair male fertility and irreversible testicular suppression.INTERACTIONSNone reported.ADVERSE REACTIONSCNS: pyrexia, fatigue, asthenia, headache, dizziness, insomnia.CV: peripheral edema, hemorrhage.GI: nausea, diarrhea, constipation, vomiting, decreased appetite.Hematologic: thrombocytopenia, neutropenia, febrile neutropenia, leukopenia, hemorrhages, anemia.Metabolic: hypokalemia, hypocalcemia.Musculoskeletal: bone pain, back pain, arthralgia, extremity pain.Respiratory: pneumonia, respiratory tract infection, respiratory failure, cough, dyspnea, exertional dyspnea.Other: sepsis, general physical health deterioration, hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwer ponesimodPonvoryPharmaceutical company: Janssen PharmaceuticalsPharmacologic classification:Sphingosine 1-phosphate receptor modulatorTherapeutic classification:Multiple sclerosis drugREAD MORE...AVAILABLE FORMSTablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mgINDICATIONS AND DOSAGESRelapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive diseaseAdults: Initially, one tablet PO daily from starter pack for days 1 to 14: days 1 and 2, 2 mg; days 3 and 4, 3 mg; days 5 and 6, 4 mg; day 7, 5 mg; day 8, 6 mg; day 9, 7 mg; day 10, 8 mg; day 11, 9 mg; days 12 to 14, 10 mg;then begin maintenance dose of 20 mg PO once daily starting on day 15.CONTRAINDICATIONS AND CAUTIONSContraindicated in those with a history of MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III or IV heart failure within the last 6 months.Contraindicated in those with Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker.Use in those with moderate or severe hepatic impairment (Child-Pugh class B and C) is not recommended.Use cautiously in patients with preexisting heart and cerebrovascular conditions, hypertension, arrhythmias, prolonged QTc interval, risk for prolonged QTc interval; or concurrent drug therapy that slows the heart rate or AV conduction, or prolongs the QTc interval after consultation with a cardiologist on a monitoring strategy.Use cautiously in those with severe respiratory disease (pulmonary fibrosis, asthma, chronic obstructive pulmonary disease). Dose-dependent reductions in respiratory function were seen in patients treated with this drug.Use cautiously in patients with a history of uveitis or diabetes; this drug may increase the risk of macular edema. Regular follow-up examinations of the fundus should be obtained in these patients. This drug may increase the risk of infections, including life-threatening and rare fatal infections.This drug may cause severe exacerbation of MS, including disease rebound, after discontinuation. Monitor patient closely and treat as clinically indicated.Safety and effectiveness in children have not been established.Use cautiously in elderly patients because of the potential for decreased hepatic, renal, or cardiac function, concomitant disease, or other drug therapy.Dialyzable drug: No.Overdose S&S: bradycardia, AV conduction block.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Advise women of childbearing potential of the risk prior to the start of treatment.Women of childbearing potential should use effective contraception during and for 1 week after the end of therapy.There are no data on the safety of breastfeeding, effects on the breastfed infant or the production of human milk. Consider benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSDrug-drug. Alemtuzumab: Alemtuzumab effects are prolonged and may have additive immune suppressive effects. Initiating treatment with ponesimod after alemtuzumab is not recommended.Antineoplastic, immunosuppressive, or immune-modulating therapies: Use together cautiously due to additive immunosuppressive effects. When switching from drugs with prolonged immune effects, consider half-life and mode of action of these drugs.Beta-blockers (atenolol, metoprolol, carvedilol, labetalol): May have additive heart rate lowering effects. Use cautiously together; dose interruption of beta-blocker may be necessary. Beta-blocker can be initiated in those receiving stable doses of ponesimod.Beta interferon or glatiramer acetate: May have additive immunosuppressive effects, but ponesimod can generally be started immediately after discontinuation of these drugs.Alert: Drugs that prolong QT interval (class Ia [quinidine, procainamide] and class III [amiodarone, sotalol] antiarrhythmics, verapamil, diltiazem, or other drugs that may decrease heart rate [digoxin]):May have additive effects on heart rate. Consult cardiologist prior to use together.Drugs that slow heart rate or AV conduction:May have additive effects.Monitor patient closely and consult a cardiologist as appropriate.Live-attenuated vaccine immunizations: May increase risk of infection. Administer live-attenuated vaccine at least 1 month prior to initiation of ponesimod and avoid during and from 1 to 2 weeks after treatment with ponesimod.Strong CYP3A4 and UGT1A1 inducers (rifampin, phenytoin, carbamazepine): May decrease ponesimod levels. Use together is not recommended.Vaccines: Drug may decrease effectiveness of vaccine during treatment and for up to 1 to 2 weeks after discontinuations. Avoid giving vaccines until 2 weeks after end of treatment.Drug-lifestyle. Sun exposure: May cause an increase in cutaneous malignancies. Limit exposure to sunlight and ultraviolet light.ADVERSE REACTIONSCNS: dizziness, somnolence, pyrexia, vertigo, fatigue, migraine, insomnia, depression, seizures.CV: bradycardia,AV conduction delay, hypertension, chest discomfort, peripheral edema.EENT: rhinitis, dry mouth, sinusitis, macular edema.GI: dyspepsia.GU: UTI.Hepatic: increased liver function tests.Metabolic: hypercholesterolemia.Musculoskeletal: joint swelling, back pain.Respiratory: upper respiratory infection,dyspnea, cough, pneumonia.Other: extremity pain, increased C-reactive protein, infections.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - May 2021
Download these updates as a PDFserdexmethylphenidate–dexmethylphenidateAzstarysPharmaceutical company: Corium, Inc.Pharmacologic classification:Norepinephrine and dopamine reuptake inhibitorsTherapeutic classification:CNS stimulantsControlled substance schedule: CII AVAILABLE FORMSCapsules: serdexmethylphenidate–dexmethylphenidate: 26.1 mg/5.2 mg; 39.2 mg/7.8 mg; 52.3 mg/10.4 mgINDICATIONS AND DOSAGESAttention deficit hyperactivity disorder (ADHD)Adults and children age 13 and older: Initially, serdexmethylphenidate–dexmethylphenidate 39.2 mg/7.8 mg PO once daily in the morning. Increase after 1 week to the maximum recommended dosage of serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO daily.Children ages 6 to 12 years: Initially, serdexmethylphenidate–dexmethylphenidate 39.2 mg/7.8 mg PO once daily in the morning. Dose may be increased after 1 week to serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO once daily or decreased to serdexmethylphenidate–dexmethylphenidate 26.1 mg/5.2 mg PO daily depending on response and tolerability. Maximum dosage is serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO daily.Adjust-a-dose: Reduce the dose or discontinue the drug if paradoxical aggravation of ADHD symptoms or other adverse reactions occur. Periodically discontinue the drug to assess a pediatric patient’s condition. If improvement is not observed after appropriate dosage adjustment over 1 month, discontinue the drug.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This product and other CNS stimulants (methylphenidate-containing products, amphetamines) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.Contraindicated in patients with hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of this product. Bronchospasm, rash, and pruritus have been reported. Hypersensitivity reactions (angioedema, anaphylactic reactions) have been reported in patients treated with other methylphenidate products.Avoid use in patients with structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Assess for cardiac disease (cardiac history, family history of sudden death or ventricular arrhythmia, and physical exam). Sudden death, stroke, and MI have been reported with CNS stimulants at recommended doses. Evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment.CNS stimulants cause an increase in blood pressure and heart rate. Monitor for hypertension and tachycardia.CNS stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon. Signs and symptoms generally improve after dose reduction or drug discontinuation.CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.CNS stimulants may induce a manic or mixed mood episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).In patients without a prior history of psychotic illness or mania, CNS stimulants at recommended doses, may cause psychotic or manic symptoms (hallucinations, delusional thinking, or mania). If such symptoms occur, consider discontinuing the stimulant.Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products. Priapism developed after some time on the drug, often during a drug holiday, or after a dosage increase or drug discontinuation.CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth in children. Pediatric patients not growing or gaining weight as expected may need to have therapy interrupted or discontinued.Do not substitute this product for other methylphenidate products on a mg-per-mg basis since these have different pharmacokinetic profiles and may have different methylphenidate base composition.The long-term efficacy of methylphenidate in pediatric patients has not been established.The safety and effectiveness of the product in patients younger than age 6 have not been established.Use in patients age 65 and older has not been studied.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.The use of CNS stimulants during pregnancy can cause vasoconstriction and decrease placental perfusion. No fetal or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low-birth-weight infants have been reported in amphetamine-dependent mothers.Health care providers are encouraged to register female patients in the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.There are no available data on the presence of serdexmethylphenidate in human milk, effects on the breastfed infant, or effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the product and any potential adverse effects on the breastfed infant or from the underlying maternal condition.Monitor breastfeeding infants for adverse reactions (agitation, anorexia, and reduced weight gain).INTERACTIONSDrug-drug. MAO inhibitors (selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue): May cause hypertensive crisis. Do not administer concomitantly with or within 14 days of discontinuing MAO inhibitor.Antihypertensive drugs (potassium-sparing and thiazide diuretics, calcium channel blockers, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists): May decrease effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.Halogenated anesthetics (halothane, isoflurane, enflurane, desflurane, sevoflurane): May increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid concomitant use on the day of surgery.Risperidone: May increase the risk of extrapyramidal symptoms (EPS) when there is an increase or decrease in dosage of either or both medications. Monitor for signs of EPS.Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, opioids): May increase risk of serotonin syndrome. Use cautiously together.ADVERSE REACTIONSCNS: insomnia, anxiety, affect lability, irritability, dizziness, fever, seizure, dyskinesia, serotonin syndrome, nervousness, headache, tremor, drowsiness, vertigo, disorientation, hallucination, auditory hallucination, visual hallucination, logorrhea, mania, restlessness, agitation.CV: increased blood pressure, tachycardia, angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate, chest pain, chest discomfort, Raynaud phenomenon.EENT: diplopia, mydriasis, visual impairment, blurred vision, dry mouth.GI: nausea, abdominal pain, dyspepsia, vomiting, decreased appetite.GU: change in libido, priapism.Hematologic: pancytopenia, thrombocytopenia, thrombocytopenic purpura.Hepatic: hepatocellular injury, acute hepatic failure.Metabolic: decreased weight.Musculoskeletal: arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps.Skin: alopecia, erythema, hyperhidrosis.Other: hypersensitivity reactions (angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus necrotizing enterocolitis [NEC], rashes, eruptions, and exanthems NEC).Reactions in bold italics are life-threatening.Released: May 2021© 2021 Wolters Kluwer tepotinibTepmetkoPharmaceutical company: EMD Serono, Inc.Pharmacologic classification:Kinase inhibitorTherapeutic classification:Antineoplastic AVAILABLE FORMSTablets: 225 mgINDICATIONS AND DOSAGESMetastatic non–small-cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterationsAdults: 450 mg PO daily until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. Permanently discontinue the drug in those who are unable to tolerate 225 mg orally once daily.CONTRAINDICATIONS AND CAUTIONSUse cautiously in those with severe renal or hepatic impairment.This drug may cause interstitial lung disease (ILD)/pneumonitis. Immediately withhold therapy in patients with suspected ILD/pneumonitis. Permanently discontinue therapy in patients with a confirmed diagnosed with ILD/pneumonitis of any severity.This drug may cause hepatotoxicity. Monitor liver function tests. Withhold, reduce dose, or permanently discontinue therapy based on severity.Safety and effectiveness in children have not been established.Use in patients with severe renal impairment (creatinine clearance greater than 30 mL/min) and severe hepatic impairment (Child Pugh C) have not been studied.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the potential harm to a fetus.Verify pregnancy status in females of reproductive potential prior to initiating.Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the final dose.Advise women not to breastfeed during treatment and for 1 week after the final dose.INTERACTIONSDrug-drug. P-glycoprotein (P-gp) substrates (dabigatran, digoxin, morphine, cyclosporine, sirolimus): May increase the concentration of P-gp substrate levels and increase the incidence and severity of adverse reactions. Avoid concomitant use where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.Strong CYP3A inducers (phenytoin, rifampin): May decrease tepotinib level. Avoid concomitant use.Strong CYP3A inhibitors (ketoconazole, nefazodone, ritonavir) and P-gp inhibitors: May increase tepotinib level and the incidence and severity of adverse reactions. Avoid concomitant use.ADVERSE REACTIONSCNS: fatigue, asthenia, fever, dizziness, headache.CV: edema, pulmonary embolism.GI: nausea, diarrhea, abdominal pain, constipation, vomiting, decreased appetite.Hematologic: lymphocytopenia, decreased albumin, decreased hemoglobin.Hepatic: hepatotoxicity, hepatic pain.Metabolic: decreasedsodium, increased liver function tests.Musculoskeletal: musculoskeletal pain.Respiratory: ILD/pneumonitis, pleural effusion, pneumonia, dyspnea, cough.Skin: rash, pruritus.Other: general health deterioration.Reactions in bold italics are life-threatening.Released: May 2021 © 2021 Wolters Kluwer trilaciclibCoselaPharmaceutical company: G1 TherapeuticsPharmacologic classification:Kinase inhibitorTherapeutic classification:Antineoplastic AVAILABLE FORMSInjection: 300-mg single-dose vialINDICATIONS AND DOSAGESDecrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small-cell lung cancerAdults: 240 mg/m2-IV infusion over 30 minutes completed within 4 hours prior to start of chemotherapy on each day of chemotherapy. If given on sequential days, the interval between doses of trilaciclib should not be greater than 28 hours.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reactions to this drug. Reactions have included anaphylaxis.Use is not recommended in patients with moderate or severe hepatic impairment (total bilirubin greater than 1.5 times the upper limit of normal, irrespective of AST)Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the risk.For females of reproductive potential, a pregnancy test is recommended prior to treatment.There are no data on the presence of this drug in human milk, effects on the breastfed child, or effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise lactating females to not breastfeed while taking this drug and for at least 3 weeks after the last dose.Females of reproductive potential should use an effective method of contraception during treatment with this drug and for at least 3 weeks after the last dose.This drug may impair female fertility.INTERACTIONSDrug-drug. Cisplatin: May increase risk of cisplatin-related nephrotoxicity. Closely monitor renal function.Dalfampridine: May increase dalfampridine blood levels and the risk of seizures. Use together cautiously.Dofetilide: May increase dofetilide blood levels and the risk of serious ventricular arrhythmias associated with QT interval prolongation, including torsades de pointes. Use cautiously together.OCT2, MATE1, and MATE-2K substrates (metformin):May increase substrate level. Avoid concomitant use with certain substrates where minimal concentration changes may lead to serious or life-threatening toxicities.ADVERSE REACTIONSCNS: asthenia, fatigue, headache.CV: thrombosis, hemorrhage, peripheral edema.GI: upper abdominal pain.Hematologic: neutropenia, febrile neutropenia, anemia, thrombocytopenia, leukopenia.Hepatic: increased AST.Metabolic: hypocalcemia, hypokalemia, hypophosphatemia, hyperglycemia.Respiratory: respiratory failure, pneumonia.Skin: injection-site reaction, rash.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: May 2021© 2021 Wolters Kluwer
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