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New FDA Drug Approvals - April 2024

berdazimer

Zelsuvmi

Pharmaceutical company: LNHC, Inc.

Pharmacologic classification: Nitric oxide-releasing agent

Therapeutic classification: Antiviral

AVAILABLE FORMS

Gel: 10.3% berdazimer supplied as two tubes (Tube A contains 14 g berdazimer and Tube B contains 17 g hydrogel)

INDICATIONS AND DOSAGES

Molluscum contagiosum

Adults and children age 1 and older: Mix 0.5-mL gel from Tube A and 0.5-mL gel from Tube B on the manufacturer-provided dosing guide. Immediately apply as an even, thin layer once daily to each molluscum contagiosum lesion for up to 12 weeks.

CONTRAINDICATIONS AND CAUTIONS

  • Application site reactions, including allergic contact dermatitis, have occurred.
  • Safety and effectiveness in children younger than 1 year haven't been established.
  • Dialyzable drug: Unknown

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Fetal risk is unknown.
  • It isn't known whether drug appears in human milk. Before use during breastfeeding, consider the patient's need for therapy and the potential effects on the infant.

INTERACTIONS

None reported by the manufacturer.

ADVERSE REACTIONS

CNS: fever.
GI: vomiting.
Respiratory: upper respiratory infection.
Skin: application site pain, erythema, stinging, burning, pruritis, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, infection.

Reactions in bold italics are life-threatening.
 

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

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New FDA Drug Approvals Archive

New FDA Drug Approvals - June 2023
omaveloxoloneSkyclarysPharmaceutical company: Reata PharmaceuticalsPharmacologic classification:Nuclear factor(erythroid-derived 2) activatorTherapeutic classification:Miscellaneous CNS drugAVAILABLE FORMSCapsules: 50 mgINDICATIONS AND DOSAGESFriedreich ataxiaAdults and adolescents age 16 and older: 150 mg PO once daily on an empty stomach at least 1 hour before a meal.Adjust-a-dose: If use with a strong CYP3A4 inhibitor can't be avoided, reduce omaveloxolone to 50 mg once daily. If use with a moderate CYP3A4 inhibitor can't be avoided, or for patients with Child-Pugh class B liver impairment, reduce omaveloxolone to 100 mg once daily. If adverse reactions develop, further decrease dose to 50 mg once daily. Discontinue if adverse reactions occur at 50 mg dose.CONTRAINDICATIONS AND CAUTIONSMay worsen cardiac function. Use cautiously in patients with heart failure or cardiac disease.Avoid use in Child-Pugh class C liver impairment.Safety and effectiveness have not been established in children younger than age 16.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONBased on animal data, this drug may cause fetal harm.There are no data on presence of this drug in human milk. Effects on milk production and the breastfed infant are unknown. Use only if the benefit to the patient outweighs the risk to the infant.May decrease efficacy of hormonal contraceptives. Patients of childbearing potential should use an alternative contraceptive method or additional nonhormonal contraceptive (condoms) during concomitant use and for 28 days after discontinuation of omaveloxolone.INTERACTIONSDrug-drug. CYP3A4 substrates (midazolam), CYP2C8 substrates (repaglinide),BCRP and OATP1B1 substrates (rosuvastatin): May decrease level of substrate drug. Monitor for lack of efficacy.Hormonal contraceptives (pill, patch, ring, implant, and progestin-only pill): May decrease contraceptive effectiveness. Avoid concomitant use.Strong or moderate CYP3A4 inducers: May decrease omaveloxolone level and its effectiveness. Avoid concomitant use.Strong or moderate CYP3A4 inhibitors: May increase omaveloxolone level. Avoid concomitant use. If use can't be avoided, reduce omaveloxolone dose.Drug-herb. St. John's wort: May decrease omaveloxolone level. Avoid concomitant use.Drug-food. Grapefruit, grapefruit juice: May increase omaveloxolone level. Discourage concomitant use.  ADVERSE REACTIONSCNS: headache, fatigue.CV: increased B-type natriuretic peptide.EENT: oropharyngeal pain.GI: nausea, diarrhea, vomiting, abdominal pain, decreased appetite.Hepatic: increased liver enzymes.Metabolic: increased LDL-cholesterol, decreased HDL-cholesterol.Musculoskeletal: musculoskeletal pain, spasms, back pain.Skin: rash.Other: flulike syndrome.Reactions in bold italics are life-threatening.Released: June 2023Nursing Drug Handbook© 2023 Wolters KluwersparsentanFilspariPharmaceutical company: Travere TherapeuticsPharmacologic classification: Endothelin and angiotensin II receptor antagonistTherapeutic classification: Miscellaneous GU drugAVAILABLE FORMSTablets: 200 mg, 400 mgINDICATIONS AND DOSAGESReduce proteinuria in patients with primary immunoglobulin A nephropathy at risk for rapid disease progressionAdults: 200 mg PO once daily. After 14 days, increase to 400 mg PO once daily, as tolerated. Consider repeating titration when resuming drug after an interruption.Adjust-a-dose: Refer to the manufacturer's instructions for dosage adjustment and monitoring in patients developing transaminase elevations of more than 3 times the upper limit of normal (ULN). If treatment is withheld, don't resume in patients with symptoms of liver toxicity or liver enzyme levels and bilirubin that have not returned to pretreatment levels. Stop the drug permanently if ALT or AST is greater than 8 x ULN and no other cause is found.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Prescribers, patients, and pharmacies must enroll in a REMS program due to risks of elevation in aminotransferases, hepatotoxicity and liver failure, and major birth defects.Alert: Avoid use in patients with any degree of liver impairment, including those with aminotransferase levels greater than 3 x ULN at baseline.This drug inhibits the renin-angiotensin-aldosterone system (RAAS) and may increase the risk of acute kidney injury.Use cautiously in those at risk for hypotension, in those with fluid retention, and in patients with advanced kidney disease, due to the risk of hyperkalemia. Use hasn't been evaluated in patients with heart failure.Safety and effectiveness in children haven't been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONBlack Box Warning: Use during pregnancy is contraindicated. This drug can cause major birth defects and fetal death if used during pregnancy. Initiate in patients of childbearing potential only after confirmation of a negative pregnancy test. Pregnancy testing is also required monthly during treatment, and one month after discontinuation.Patients who can become pregnant must use effective contraception before initiation, monthly during treatment, and for one month after discontinuation.Breastfeeding isn't recommended during treatment due to the risk of adverse reactions, such as hypotension, in breastfed infants.INTERACTIONSDrug-drug. Antacids and acid-reducing agents (histamine-2 [H2] antagonists, PPI): May decrease sparsentan level. Administer sparsentan 2 hours before or after antacids. Avoid concomitant use with H2 antagonists and PPIs.CYP2B6, 2C9, 2C19 substrates (bupropion): May decrease substrate level.Drugs that increase serum potassium (potassium-sparing diuretics, potassium supplements): May increase risk of hyperkalemia. Monitor potassium level. Monitor for substrate efficacy and consider dosage adjustment.Moderate CYP3A inhibitors (cyclosporine): May increase sparsentan level and the risk of adverse reactions. Monitor blood pressure, edema, potassium, and kidney function.NSAIDs (cyclooxygenase-2 inhibitors): May worsen kidney function. Monitor for signs of worsening kidney function.P-gp substrates (fexofenadine, digoxin) and BCRP substrates (glyburide, cimetidine, rosuvastatin): May increase substrate level and substrate-related adverse reactions. Avoid concomitant use of sensitive substrates.Alert: RAAS inhibitors (angiotensin receptor blockers, ACE inhibitors), endothelin receptor antagonists (bosentan, ambrisentan), aliskiren: May increase risk of hypotension, syncope, hyperkalemia, and decreased kidney function. Use together is contraindicated.Strong CYP3A inducers (rifampin): May decrease sparsentan level. Avoid use together.Strong CYP3A inhibitors (itraconazole): May increase sparsentan level. Avoid use together. If not possible, interrupt sparsentan.Drug-food. Potassium-containing salt substitutes: May cause hyperkalemia. Monitor potassium level.ADVERSE REACTIONSCNS: dizziness.CV: peripheral edema, hypotension, orthostatic hypotension.GU: acute kidney injury.Hematologic: anemia.Hepatic: transaminase elevations.Metabolic: hyperkalemia.Reactions in bold italics are life-threatening.Released: June 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - May 2023
daprodustatJesduvroqPharmaceutical company: GlaxoSmithKlinePharmacologic classification:Hypoxia-inducible factor prolyl hydroxylase inhibitorTherapeutic classification:HematopoieticAVAILABLE FORMSTablets: 1 mg; 2 mg; 4 mg; 6 mg; 8 mgINDICATIONS AND DOSAGESAnemia due to chronic kidney disease in patients who have been receiving dialysis for at least 4 monthsAdults not being treated with an erythropoiesis stimulating agent (ESA): If the pretreatment hemoglobin is less than 9 g/dL, give 4 mg PO once daily; if the pretreatment hemoglobin is 9 to 10 g/dL, give 2 mg PO once daily; if the pretreatment hemoglobin is greater than 10 to 11 g/dL, give 1 mg PO once daily.Adults being switched from an ESA: For patients switching from epoetin alfa, darbepoetin alfa, or ethoxy PEG-epoetin beta, refer to the manufacturer's instructions for daprodustat dosing instructions based on current ESA drug and dosage.Adjust-a-dose: Increase or decrease dose by one dose level at a time. Dose levels are 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 12 mg, 16 mg, and 24 mg. Decrease dose if hemoglobin increases rapidly by more than 1 g/dL over 2 weeks or 2 g/dL over 4 weeks, or if hemoglobin exceeds 11 g/dL. Don't increase the dose more frequently than every 4 weeks. If hemoglobin exceeds 12 g/dL, interrupt treatment. Restart at one dose level lower when hemoglobin drops to within the target range. Maximum dose is 24 mg once daily. Reduce daprodustat starting dose by half in patients on clopidogrel or a moderate CYP2C8 inhibitor, or with moderate hepatic impairment (Child-Pugh class B), except in patients whose starting dose is already 1 mg. Discontinue therapy if a clinically meaningful hemoglobin increase isn't achieved by 24 weeks.  CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Daprodustat increases the risk of thrombotic vascular events (MI, stroke, venous thromboembolism, and vascular access thrombosis), that may be fatal.Alert: Patients with CV or cerebrovascular disease are at increased risk. Avoid use in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within 3 months prior to starting. A hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.Black Box Warning: Targeting hemoglobin greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with ESAs, which also increase erythropoietin levels. No trial has identified a hemoglobin target, daprodustat dose or dosing strategy that does not increase these risks. Use the lowest dose sufficient to reduce the need for RBC transfusion.Alert: Contraindicated in patients with uncontrolled hypertension. Hypertensive crises, including hypertensive encephalopathy and seizures, have been reported.This drug isn't indicated for use in patients not on dialysis as they may be at greater risk for CV mortality, stroke, thromboembolism, serious acute kidney injury, hospitalization for heart failure, and serious GI erosions.Use in severe hepatic impairment (Child-Pugh class C) isn't recommended.Patients with a preexisting history of heart failure are at increased risk of hospitalization for heart failure.Gastric or esophageal erosions, including GI bleeding and need for RBC transfusion, may occur. Use cautiously in patients at increased risk, including patients with a history of GI erosion or peptic ulcer disease, concomitant medications that increase the risk of GI erosion, current tobacco smoking, and current alcohol use.Use isn't recommended in patients with active malignancies. Increased hypoxia inducible factor-1 levels may be associated with unfavorable effects on cancer growth.This drug has not been shown to improve quality of life, fatigue, or patient well-being.Daprodustat is not a substitute for transfusion in patients requiring immediate correction of anemia.Safety and effectiveness in children haven't been established.Intentional drug abuse for its rewarding psychological or physiologic effects may be seen in athletes for the effects on erythropoiesis.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug is associated with adverse fetal outcomes in animal studies. Advise patients who are pregnant of the fetal risk.There are no data on the presence of daprodustat in human milk, the effects on the breastfed child, or effects on milk production. Due to serious adverse reactions of the drug, patients should not breastfeed during treatment and for 1 week after the final dose.INTERACTIONSDrug-drug. CYP2C8 inducers (rifampin): May decrease daprodustat level and decrease its efficacy. Monitor hemoglobin and adjust daprodustat dose when initiating or discontinuing CYP2C8 inducers.Moderate CYP2C8 inhibitors (clopidogrel): May increase daprodustat level. Reduce daprodustat starting dose when initiating treatment unless starting dose is already 1 mg. Monitor hemoglobin and adjust daprodustat dose when initiating or stopping CYP2C8 inhibitors.Strong CYP2C8 inhibitors (gemfibrozil): May increase level of daprodustat. Concomitant use in contraindicated.Drug-lifestyle. Tobacco smoking, alcohol use: May increase risk of gastric or esophageal erosions. Discourage use together.ADVERSE REACTIONSCNS: stroke, dizziness.CV: thrombotic vascular events (MI, deep vein thrombosis, pulmonary embolism, vascular access thrombosis), heart failure, hypertension..GI: GI erosion, abdominal pain.Other: hypersensitivity.Reactions in bold italics are life-threatening.Released: May 2023Nursing Drug Handbook© 2023 Wolters Kluwerlecanemab-irmbLeqembiPharmaceutical company: Eisai Inc. and BiogenPharmacologic classification: Amyloid beta-directed antibodyTherapeutic classification: Anti-Alzheimer drugAVAILABLE FORMSInjection: 200 mg/2 mL; 500 mg/5 mL single-use vialsINDICATIONS AND DOSAGESMild cognitive impairment or mild dementia stage of Alzheimer diseaseAdults: 10 mg/kg administered IV infusion over approximately one hour once every two weeks.Adjust-a-dose: See the manufacturer's instructions for dose reductions in the settings of amyloid-related imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H) based on symptom severity and magnetic resonance imaging findings.CONTRAINDICATIONS AND CAUTIONSAlert: ARIA may develop; monitor closely during the first 14 weeks of treatment. ARIA-E appears as brain edema or sulcal effusions. ARIA-H includes microhemorrhage and superficial siderosis, and usually occurs with ARIA-E. ARIA is usually asymptomatic but can rarely include seizure and status epilepticus.Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 homozygotes compared to heterozygotes and noncarriers. Consider testing for APOE ε4 status prior to treatment.Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E.Alert: Intracerebral hemorrhage may rarely occur; use cautiously in patients with prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, evidence of cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, or severe small vessel or white matter disease.Safety and effectiveness in children haven't been established. Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate data on use in pregnancy.There are no data on use during lactation. Weigh risks versus benefits.INTERACTIONSDrug-drug. Antithrombotics, thrombolytic agents, antiplatelets, anticoagulants: May increase risk of bleeding; use together cautiously. Consider withholding lecanemab-irmb temporarily if anticoagulant must be used for 4 weeks or less.ADVERSE REACTIONSCNS: headache, ARIA-E.CV: atrial fibrillation.EENT: cough.GI: diarrhea.Hematologic: lymphopenia.Other: infusion-related reactions.Reactions in bold italics are life-threatening.Released: May 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - April 2023
bexagliflozinBrenzavvyPharmaceutical company: TheracosBioPharmacologic classification:Sodium-glucose cotransporter 2 (SGLT2) inhibitorTherapeutic classification:AntidiabeticAVAILABLE FORMSTablets: 20 mgINDICATIONS AND DOSAGESAs adjunct to diet and exercise to improve glycemic control in type 2 diabetesAdults: 20 mg PO once daily in the morning.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to this drug or any of its components and in patients on dialysis.This drug isn’t recommended in patients with eGFR less than 30 mL/min/1.73 m2 or type 1 diabetes mellitus. This drug has not been studied in severe hepatic impairment and isn’t recommended for use in this population.This drug may increase the risk of ketoacidosis. Use cautiously in patients with pancreatic insulin deficiency, caloric restriction, and alcohol use.Use cautiously in patients predisposed to need for amputation, including those with prior amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers. This drug may increase the risk of lower limb amputation due to infection, gangrene, ischemia, or osteomyelitis.This drug may cause a decrease in intravascular volume and cause symptomatic hypotension or acute transient changes in creatinine. Older adults, those with impaired kidney function (eGFR less than 60 mL/min/1.73 m2), low systolic blood pressure, or taking loop diuretics may be at increased risk. Acute kidney injury, some requiring hospitalization and dialysis, has been reported in patients receiving SGLT2 inhibitors.SGLT2 inhibitors (including bexagliflozin) may increase the risk of UTI, including urosepsis and pyelonephritis.Necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare, serious, life-threatening necrotizing infection requiring urgent surgical intervention, has been reported in patients receiving SGLT2 inhibitors.This drug may increase the risk of genital mycotic infection. Patients with a history of genital mycotic infection or who are uncircumcised are at greater risk.The safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.Use of this drug isn’t recommended during the second and third trimesters of pregnancy based on animal data.There is no information regarding the presence of this drug in human milk, effects on the breastfed infant or on milk production. This drug may increase the risk of adverse reactions in a breastfed infant. Use isn’t recommended while breastfeeding.INTERACTIONSDrug-drug. Insulin and insulin secretagogues (glimepiride, glyburide, sulfonylurea agents): Increases the risk of hypoglycemia. When used together, decrease the insulin or insulin secretagogue dose as needed.Lithium: May decrease lithium level. Monitor lithium level more frequently upon initiation and discontinuation of bexagliflozin.UGT enzyme inducers (rifampicin, phenobarbital): May decrease bexagliflozin level and its efficacy. Consider adding another antihyperglycemic agent if necessary.ADVERSE REACTIONSGI: thirst.GU: increased urination,genital mycotic infection, UTI, vaginal pruritus, increased serum creatinine, decreased eGFR.Metabolic: volume depletion, hypoglycemia.Musculoskeletal: lower limb amputation.Skin: rash.Other: sepsis.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerelacestrantOrserduPharmaceutical company: Stemline Therapeutics, Inc.Pharmacologic classification:Estrogen receptor antagonistTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 86 mg, 345 mgINDICATIONS AND DOSAGESEstrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapyPostmenopausal females and adult males: 345 mg PO once daily until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. Reduce the dose to 258 mg once daily for patients with moderate hepatic impairment (Child-Pugh B). Avoid use in patients with severe hepatic impairment (Child-Pugh C). Avoid concomitant use with strong or moderate CYP3A4 inducers and inhibitors.CONTRAINDICATIONS AND CAUTIONSAvoid use in severe hepatic impairment (Child-Pugh C).Safety and effectiveness have not been established in children.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONBased on findings in animals and its mechanism of action, this drug can cause fetal harm.Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of this drug in human milk, its effects on milk production, or the breastfed child. Patients shouldn’t breastfeed during treatment and for 1 week after the last dose.Based on findings from animal studies, this drug may impair fertility.INTERACTIONSDrug-drug. BCRP substrates (rosuvastatin), p-glycoprotein substrates (digoxin): May increase the substrate level and the risk of adverse reactions. Reduce the dosage of the substrate per its product labeling.Strong and moderate CYP3A4 inducers (rifampin, efavirenz): May decrease elacestrant level and its effectiveness. Avoid use together.Strong and moderate CYP3A4 inhibitors (itraconazole, fluconazole): May increase elacestrant level and the risk of adverse reactions. Avoid use together.ADVERSE REACTIONSCNS: fatigue, headache, insomnia, dizziness.EENT: stomatitis.GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, decreased appetite, gastroesophageal reflux disease.Hepatic: abnormal liver function tests.Musculoskeletal: musculoskeletal pain.Metabolic: increased cholesterol, increased triglycerides, hyponatremia, increased creatinine.Hematologic: decreased hemoglobin.Respiratory: cough, dyspnea.Skin: rash.Other: hot flush.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerlenacapavirSunlencaPharmaceutical company: Gilead Sciences, Inc.Pharmacologic classification:Capsid inhibitorTherapeutic classification:AntiretroviralAVAILABLE FORMSInjection: 463.5 mg/1.5 mL single-dose vialTablets: 300 mgINDICATIONS AND DOSAGESHIV-1 infection in combination with other antiretrovirals, in heavily treatment-experienced patients with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerationsInitiation option 1Adults: 927 mg subcut and 600 mg PO once on day 1. Then 600 mg PO once on day 2. Then begin maintenance regimen.Initiation option 2Adults: 600 mg PO once daily on days 1 and 2. Then 300 mg PO once on day 8.Then 927 mg subcut once on day 15. Then begin maintenance regimen.Maintenance regimenAdults: 927 mg subcut every 6 months (26 weeks) from the date of last injection. May give within 2 weeks before or after the 6 month target date.CONTRAINDICATIONS AND CAUTIONSUse cautiously in patients with severe hepatic impairment or kidney failure with replacement therapy.Immune reconstitution syndrome may occur in patients treated with combination antiretroviral therapy. Autoimmune disorders (Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) may occur with immune reconstitution syndrome.Nonadherence to the medication regimen could lead to loss of virologic response and development of resistance.Safety and effectiveness in children have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONInsufficient data on use in pregnancy is available to determine risk.Health care providers are encouraged to register patients in the Antiretroviral Pregnancy Registry at 1-800-258- 4263.The Centers for Disease Control and Prevention recommends those with HIV-1 infection not to breastfeed. It’s unknown whether this drug is present in breast milk.INTERACTIONSAlert:Lenacapavir has the potential for significant interactions with many drugs. Consult a drug interactions resource for additional information.Drug-drug. Alert: Anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): May decrease lenacapavir levels and increase risk for resistance. Use with carbamazepine or phenytoin is contraindicated. Use with oxcarbazepine or phenobarbital isn’t recommended. Consider use of alternative anticonvulsants.Alert: Antimycobacterials (rifabutin, rifampin, rifapentine): May decrease lenacapavir levels and increase risk for resistance. Use with rifampin is contraindicated. Use with rifabutin or rifapentine isn’t recommended.Antiretroviral agents (atazanavir–cobicistat, atazanavir–ritonavir, efavirenz, nevirapine, tipranavir–ritonavir): May alter lenacapavir level.Use of efavirenz, nevirapine, or tipranavir–ritonavir may decrease lenacapavir levels and increase risk for resistance. Use with atazanavir–cobicistat or atazanavir–ritonavir may increase lenacapavir levels. Concomitant administration with any of these agents isn’t recommended.Combined P-glycoprotein (P-gp), UGT1A1, and strong CYP3A inhibitors (cobicistat, atazanavir): May significantly increase lenacapavir levels. Use together isn’t recommended.Corticosteroids, systemic (dexamethasone, hydrocortisone/cortisone): may increase systemic corticosteroid levels and increase risk of Cushing syndrome and adrenal suppression. Initiate with lowest starting dose and titrate carefully while monitoring for safety.CYP3A substrates: Lenacapavir may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last subcut dose of lenacapavir, increasing the risk of adverse reactions. See prescribing information of sensitive CYP3A substrate for dosing with moderate inhibitors of CYP3A.Digoxin: May increase digoxin levels. Use cautiously and monitor digoxin therapeutic concentration.Direct oral anticoagulants (rivaroxaban, dabigatran, edoxaban): May increase direct oral anticoagulants. Refer to the anticoagulant prescribing information for administration with combined moderate CYP3A and P-gp inhibitors.Ergot derivatives (dihydroergotamine, ergotamine, methylergonovine): May increase levels of ergot derivatives. Use together isn’t recommended.HMG-CoA reductase inhibitors (lovastatin, simvastatin): May increase levels of these statins. Initiate statins at lowest starting dose and titrate carefully while monitoring for safety.Midazolam (oral), triazolam: May increase levels of these drugs. Use cautiously together.Moderate CYP3A inducers (efavirenz): May significantly decrease lenacapavir levels and increase risk of resistance to lenacapavir. Use together isn’t recommended.Naloxegol: May increase naloxegol level. Avoid use together; if unavoidable, decrease dosage of naloxegol and monitor for adverse reactions.Narcotic analgesic for treatment of opioid dependence (buprenorphine, methadone): Effects of coadministration are unknown. Carefully titrate the dose of buprenorphine or methadone to desired effect; use the lowest possible initial or maintenance dose. In patients currently taking buprenorphine or methadone, a dose adjustment may be needed when lenacapavir is started. Monitor clinical signs and symptoms.Narcotic analgesics metabolized by CYP3A (fentanyl, oxycodone): May increase levels of these narcotics. Monitor closely for effects and adverse reactions.PDE-5 inhibitors (sildenafil, tadalafil, vardenafil): When used for pulmonary arterial hypertension, use with lenacapavir and tadalafil isn’t recommended. When used for erectile dysfunction, refer to the prescribing information of PDE5 inhibitors for dose recommendations.Strong CYP3A inducers (rifampin): May significantly decrease lenacapavir levels and increase risk of resistance to lenacapavir. Use together is contraindicated.Tramadol: May increase tramadol levels. Consider a decrease in tramadol dose.Drug-herb. St. John’s wort: May decrease lenacapavir levels. Use together is contraindicated.ADVERSE REACTIONSGI: nausea.GU: elevated creatinine levels, glycosuria, proteinuria.Hepatic: increased AST, ALT, and direct bilirubin levels.Metabolic: hyperglycemia.Skin: injection site reactions (swelling, pain, discomfort, erythema, nodule, induration, pruritus, extravasation, mass, hematoma, edema, ulcer).Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerpirtobrutinibJaypircaPharmaceutical company: Eli Lilly and CompanyPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 50 mg, 100 mgINDICATIONS AND DOSAGESRelapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitorAdults: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose:Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. If severely reduced GFR (eGFR 15 to 29 mL/min) and the current dose is 200 mg once daily, reduce the dose to 100 mg once daily; otherwise reduce the dose by 50 mg. If the current dosage is 50 mg once daily, discontinue the drug. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the pirtobrutinib dose by 50 mg. If the current dosage is 50 mg once daily, interrupt pirtobrutinib treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the pirtobrutinib dose taken prior to initiating the inhibitor. If concomitant use with a moderate CYP3A inducer is unavoidable and the current dosage of pirtobrutinib is 200 mg once daily, increase the dose to 300 mg. If the current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg.CONTRAINDICATIONS AND CAUTIONSFatal and serious bacterial, viral, fungal, and opportunistic infections have occurred. Consider prophylaxis (vaccinations, antimicrobials) in patients at increased risk for infections.Fatal and serious hemorrhage has occurred. Consider withholding the drug for 3 to 7 days pre- and post-surgery depending upon the type of surgery and risk of bleeding.Use cautiously in patients with cardiac risk factors (hypertension, previous arrhythmias); this drug may increase the risk of development of atrial fibrillation or flutter.Use cautiously in older adults.Safety and effectiveness of this drug have not been established in children.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies, this drug can cause fetal harm.Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of this drug in human milk or the effects on the breastfed child or milk production. Patients shouldn’t breastfeed during treatment and for 1 week after the last dose.INTERACTIONSDrug-drug. Antithrombotic agents (heparin, warfarin, apixaban): May increase risk of bleeding. Use cautiously together.CYP2C8 (repaglinide), CYP2C19 (omeprazole), CYP3A (midazolam), P-glycoprotein (digoxin), or BCRP (rosuvastatin) substrates: May increase level of sensitive substrates and the risk of substrate-related adverse reactions. Follow recommendations for sensitive substrates provided in their product labeling.Strong CYP3A inhibitors (itraconazole): May increase pirtobrutinib level and risk of adverse reactions. Avoid use together. If unavoidable, reduce the pirtobrutinib dose.Strong or moderate CYP3A inducers (rifampin, bosentan, efavirenz): May decrease pirtobrutinib level and efficacy. Avoid use together. If concomitant use is unavoidable, increase the dose of pirtobrutinib.Drug-lifestyle. Sunlight: May increase risk of new skin cancer or other cancers. Use sun protection.ADVERSE REACTIONSCNS: fatigue, fever, peripheral neuropathy, dizziness.CV: edema, hemorrhage, atrial fibrillation, atrial flutter.GI: diarrhea, constipation, abdominal pain, nausea.GU: increased creatinine level,Hematologic: bruising, anemia, neutropenia, thrombocytopenia, lymphocytopenia, transient lymphocytosis.Hepatic: increased transaminases, increased alkaline phosphatase.Metabolic: hypocalcemia, hypokalemia, hyponatremia, hyperkalemia, increased lipase.Musculoskeletal: musculoskeletal pain, arthritis, arthralgia.Respiratory: dyspnea, cough, pneumonia, upper respiratory infection, pleural effusion.Skin: rash.Other: sepsis, infection, second primary malignancy.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - March 2023
adagrasibKrazatiPharmaceutical company: Mirati TherapeuticsPharmacologic classification: KRAS inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESKRAS G12C-mutated locally advanced or metastatic non–small-cell lung cancer in patients who have received at least one prior systemic therapyAdults: 600 mg PO b.i.d. until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. First dose reduction for adverse reactions is to 400 mg PO b.i.d.; second dose reduction is to 600 mg PO daily. Permanently discontinue drug if patients can’t tolerate 600 mg per day.CONTRAINDICATIONS AND CAUTIONSThis drug may increase the risk of QTc interval prolongation and risk for tachyarrhythmias, torsades de pointes, and sudden death. Avoid use in patients with congenital QT syndrome.Use cautiously in patients with heart failure, bradyarrhythmias, electrolyte abnormalities, and patients unable to avoid taking medication known to prolong the Qt interval.Safety and effectiveness haven’t been established in children.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on the use of this drug during pregnancy.Because of the potential for adverse reactions in a breastfed child, patients shouldn’t breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. Drugs that prolong QT interval (amiodarone, levofloxacin, fluoxetine, haloperidol, methadone): May prolong the QT interval. Avoid use together.Sensitive CYP2C9 or CYP2D6 substrates or P-glycoprotein substrates (warfarin, dextromethorphan, digoxin): May increase substrate level. Avoid use together where minimal concentration changes may lead to serious adverse reactions.Sensitive CYP3A4 substrates (midazolam): May increase CYP3A substrate level. Avoid use together.Strong CYP3A4 inducers (rifampin): May reduce adagrasib level. Avoid use together.Strong CYP3A4 inhibitors (itraconazole): May increase adagrasib level. Avoid concomitant use until adagrasib concentrations have reached steady state (after approximately 8 days).Drug-herb. St. John’s wort: May reduce adagrasib concentrations. Avoid use together.ADVERSE REACTIONSCNS: fatigue, dizziness, fever, mental status changes.CV: edema, QT prolongation, heart failure, hypotension, pulmonary embolism.GI: diarrhea, nausea, vomiting, constipation, abdominal pain, decreased appetite, GI bleeding, GI obstruction.GU: abnormal kidney function.Hematologic: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia.Hepatic: hepatotoxicity, increased liver enzymes, decreased albumin.Metabolic: hyponatremia, hypokalemia, increased lipase, increased amylase, hypomagnesemia, dehydration, decreased weight.Musculoskeletal: musculoskeletal pain, muscular weakness.Respiratory: dyspnea, cough, pneumonia, interstitial lung disease, interstitial pneumonitis, hypoxia, pleural effusion, respiratory failure, pulmonary hemorrhage.Other: sepsis, sudden death.  Reactions in bold italics are life-threatening.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer olutasidenibRezlidhiaPharmaceutical company: Rigel Pharmaceuticals, Inc.Pharmacologic classification: Isocitrate dehydrogenase-1 (IDH1) inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSCapsules: 150 mgINDICATIONS AND DOSAGESRelapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutationAdults: 150 mg PO b.i.d. until disease progression or unacceptable toxicity. If there is no disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.Adjust-a-dose: Refer to the manufacturer’s instruction for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Differentiation syndrome, which can be fatal, can occur. If differentiation syndrome is suspected, withhold drug and initiate corticosteroids and hemodynamic monitoring until symptoms resolve.This drug may increase the risk of hepatotoxicity. Use cautiously in patients with mild or moderate hepatic impairment. Use in patients with severe hepatic impairment hasn’t been established. Safety and effectiveness in children haven’t been established.Older adults have an increased risk of hepatotoxicity and hypertension compared to younger individuals.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.It’s unknown if this drug is excreted in human milk. Patients shouldn’t breastfeed during and for 2 weeks after treatment.INTERACTIONSDrug-drug. Moderate or strong CYP3A inducers (phenytoin, dexamethasone, rifampin): May decrease olutasidenib levels. Avoid use together.Sensitive CYP3A substrates (digoxin, sirolimus): May decrease levels of substrates. Avoid concomitant use; if unavoidable, monitor for loss of therapeutic effects of these drugs.ADVERSE REACTIONSCNS: fatigue, malaise, fever, headache.CV: edema, hypertension.GI: nausea, constipation, mucositis, diarrhea, abdominal pain, vomiting, decreased appetite, gallbladder disorders.GU: increased creatinine.Hematologic: leukocytosis, increased lymphocytes.Hepatic: hepatotoxicity, elevated transaminases, increased bilirubin, increased alkaline phosphatase.Metabolic: hypokalemia, hypophosphatemia, increased lipase, increased uric acid, hyponatremia.Musculoskeletal: arthralgia.Respiratory: dyspnea, cough.Skin: rash.Other: differentiation syndrome. Reactions in bold italics are life-threatening.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - January 2023
sodium phenylbutyrate and taurursodiolAlbrioza (Canadian), RelyvrioPharmaceutical company: AmylyxPharmacologic classification:Histone deacetylase inhibitor, hydrophilic bile acidTherapeutic classification:Miscellaneous CNS drugAVAILABLE FORMSOral suspension: 3 g sodium phenylbutyrate and 1 g taurursodiol in single-dose packetINDICATIONS AND DOSAGESAmyotrophic lateral sclerosisAdults: Initially, one packet PO daily for 3 weeks. Then, increase to the maintenance dose of one packet b.i.d.CONTRAINDICATIONS AND CAUTIONSAvoid use in those with moderate or severe hepatic impairment and abnormal kidney function.Use cautiously in those with disorders that interfere with bile acid circulation, disorders of enterohepatic circulation (biliary infection, active cholecystitis), severe pancreatic disorders (pancreatitis), and intestinal disorders that may alter concentrations of bile acids (ileal resection, regional ileitis).Use cautiously in patient’s sensitive to salt intake such as those with HF, abnormal kidney function, or other conditions associated with sodium retention because of the high sodium content of this drug.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no data on the use in pregnant patients.It’s unknown if this drug is present in human milk. The risks and benefits should be considered.INTERACTIONSDrug-drug. Aluminum-based antacids: May interfere with taurursodiol absorption. Avoid use together; consider other acid-lowering agents.Bile acid sequestering agents (cholestyramine, colestipol, colesevelam): May decrease taurursodiol absorption. Avoid use together. Consider alternative cholesterol-lowering agents.CYP1A2, CYP2B6, CYP3A4 substrates (ramelteon, bupropion, aminophylline): May decrease level of these isoenzymes. Avoid use to together when a small change in substrate plasma level may lead to serious toxicities or loss of efficacy.CYP2C8 and CYP2B6 substrates (repaglinide): May increase level of these substrates. Avoid use together when a small change in substrate plasma level may lead to serious toxicities or loss of efficacy.Histone deacetylace (HDAC) inhibitor (phenylbutyrate): May increase risk of adverse effects as this drug contains phenylbutyrate. Avoid use of other HDAC inhibitors, because of additive effects.Inhibitors of bile acid transporters (cyclosporine): May exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. Avoid use together; if concomitant use with strong inhibitor is necessary, use caution and monitor serum transaminases and bilirubin.OATP1B3 inhibitors (rifampicin, pioglitazone): May increase level of taurursodiol. Avoid use together.OAT1 substrates (adefovir, tenofovir, statins): May increase levels of OAT1 substrates. Avoid use of together.P-glycoprotein and BCRP substrates (digoxin, methotrexate, rosuvastatin): May increase levels of these substrates. Avoid use together when a small change in substrate levels may lead to serious toxicities or loss of efficacy with this drug.Probenecid: May affect kidney excretion of sodium phenylbutyrate metabolites. Avoid use together.Strong CYP3A4 inducers (phenytoin, rifampin): May decrease taurursodiol level. Monitor use together.ADVERSE REACTIONSCNS: Fatigue, dizziness.EENT: Salivary hypersecretion.GI: Diarrhea, abdominal pain, nausea.Respiratory: URI.Reactions in bold italics are life-threatening.Released: January 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - December 2022
deucravacitinibSotyktuPharmaceutical company: Bristol-Myers SquibbPharmacologic classification:Janus kinase inhibitorTherapeutic classification:AntipsoriaticAVAILABLE FORMSTablets: 6 mgINDICATIONS AND DOSAGESModerate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapyAdults:6 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or its components. Hypersensitivity reactions, including angioedema, have been reported.Use cautiously in patients with known or suspected liver disease. This drug isn’t recommended in patients with severe hepatic impairment (Child-Pugh C).This drug isn’t recommended for use in patients with active hepatitis B or hepatitis C.This drug may increase risk of infection. Avoid use in patients with active or serious infection.Use cautiously in patients with chronic or recurrent infection, exposure to tuberculosis (TB), history of serious or opportunistic infection, with underlying conditions that predispose them to infection.Evaluate for active or latent TB prior to initiating treatment. Don’t administer to patients with active TB. This drug may reactivate latent TB. Initiate treatment of latent TB prior to administering the drug. Consider anti-TB therapy in patients with a history of latent or active TB when an adequate course of treatment can’t be confirmed.Malignancies, including lymphomas, were observed in clinical trials. Use cautiously in patients with known malignancy and patients who develop malignancy during treatment.Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding nonmelanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis patients; this drug isn’t approved for use in rheumatoid arthritis.Safety and effectiveness in children haven’t been established.Use cautiously in older adults as the incidence of adverse reactions may be higher in this population.Dialyzable drug: 5.4%.PREGNANCY-LACTATION-REPRODUCTIONIt’s unknown if this drug causes harm to a fetus. Report pregnancies to Bristol-Myers Squibb’s Adverse Event reporting line (1-800-721-5072).There is no data on the appearance of this drug in human milk, its effects on the breastfed infant, or on milk production. This drug is excreted in rat milk. Weigh the risk to the infant versus the benefit to the patient.INTERACTIONSDrug-drug. Live vaccines: May increase risk of infection. Avoid use during deucravacitinib therapy.Potent immunosuppressants: May increase immunosuppression. Use together isn’t recommended.ADVERSE REACTIONSEENT: mouth ulcers.Hepatic: increased liver enzymes.Metabolic: increased CK level.Musculoskeletal: rhabdomyolysis.Respiratory: upper respiratory infection.Skin: folliculitis, acne.Other: infection (bacterial and viral), malignancy.Reactions in bold italics are life-threatening.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluweromidenepag isopropylOmlontiPharmaceutical company: Santen Pharmaceutical and UBE CorporationPharmacologic classification:Selective prostaglandin E2 receptor agonistTherapeutic classification:Antiglaucoma drug–antihypertensiveAVAILABLE FORMSOphthalmic solution: 0.002% (0.02 mg/mL)INDICATIONS AND DOSAGESReduction of elevated intraocular pressure in patient with open-angle glaucoma or ocular hypertensionAdults:Instill one drop in the affected eye(s) once daily in the evening.CONTRAINDICATIONS AND CAUTIONSIrreversible increase in brown pigmentation of the iris may occur and may not be noticeable for months to years.This drug may gradually increase pigment of the periorbital tissues and increase length, thickness, and number of lashes or hairs of the treated eye. These are usually reversible upon discontinuation.Ocular inflammation has been reported. Use caution in patients with active ocular inflammation, including iritis or uveitis.Macular edema has been reported. Use caution in patients with aphakic or pseudophakic glaucoma, or in patients with risk factors for macular edema.Dialyzable drug: Not likely.PREGNANCY-LACTATION-REPRODUCTIONThere are no data on the use of this drug in pregnant women. Use cautiously during pregnancy.There are no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to omidenepag following topical ocular administration is low.INTERACTIONSNone reported.ADVERSE REACTIONSCNS: headache.EENT: conjunctival hyperemia, photophobia, blurred vision, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, eye irritation, visual impairment.Reactions in bold italics are life-threatening.Released: December 2022Nursing Drug Handbook© 2022 Wolters KluwerterlipressinTerlivazPharmaceutical company: Mallinckrodt PharmaceuticalsPharmacologic classification:Posterior pituitary hormoneTherapeutic classification:VasoconstrictorAVAILABLE FORMSPowder for injection: 0.85-mg single-dose vialINDICATIONS AND DOSAGESTo improve kidney function in patients with hepatorenal syndrome with rapid reduction in kidney functionAdults: 0.85 mg (1 vial) IV bolus over 2 minutes every 6 hours on days 1 to 3.On day 4, compare serum creatinine (SCr) to baseline. If SCr has decreased by 30% or more, continue 0.85 mg IV bolus every 6 hours. If SCr has decreased by less than 30%, increase dose to 1.7 mg (2 vials) IV bolus every 6 hours. If SCr is at or above baseline, discontinue the drug. Continue for 24 hours after two consecutive SCr values at least 2 hours apart of less than 1.5 mg/dL have been achieved or for a maximum of 14 days. CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) grade 3 are at increased risk.Use is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in patients with ongoing coronary, peripheral, or mesenteric ischemia.Avoid use in ACLF grade 3.Terlipressin-related adverse reactions may make a patient ineligible for liver transplantation. The benefits of the drug in patients with high priority for liver transplantation may not outweigh its risks.This drug is a vasoconstrictor and can cause ischemic events (cardiac, cerebrovascular, peripheral, or mesenteric). Avoid use in patients with a history of severe CV conditions, cerebrovascular, and ischemic disease. Discontinue in patients who experience signs or symptoms suggestive of ischemia.Patients with SCr greater than 5 mg/dL are unlikely to benefit from this drug.Safety and effectiveness in children haven’t been established.Use cautiously in older adults who may be more sensitive to the drug’s effects.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm as it induces uterine contractions and endometrial ischemia. Advise patients of the risk to the fetus.There are no data on the presence of this drug in human or animal milk or on its effects on the breastfed infant or milk production. Evaluate the risk to the infant versus the benefit to the patient.INTERACTIONSNone reported.ADVERSE REACTIONSCV: bradycardia.GI: abdominal pain, nausea, diarrhea.Metabolic: fluid overload.Respiratory: respiratory failure, dyspnea, pleural effusion.Other: sepsis, ischemia-related events.Reactions in bold italics are life-threatening.Released: December 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - November 2022
vutrisiranAmvuttraPharmaceutical company: Alnylam PharmaceuticalsPharmacologic classification:Anti-transthyretin small interfering RNA agentTherapeutic classification:Protein inhibitorAVAILABLE FORMSInjection: 25 mg/0.5 mL prefilled syringeINDICATIONS AND DOSAGESPolyneuropathy of hereditary transthyretin-mediated amyloidosisAdults: 25 mg subcut every three months.CONTRAINDICATIONS AND CAUTIONSThis drug hasn’t been studied in those with severe renal impairment, end-stage renal disease, or moderate to severe hepatic impairment.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on use during pregnancy. Use in pregnancy only if the benefit clearly outweighs the fetal risk.There is no information regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Use cautiously during breastfeeding.INTERACTIONSNone reported.ADVERSE REACTIONSCV: AV block.Metabolic: decreased vitamin A.Musculoskeletal: arthralgia.Respiratory: dyspnea.Skin: injection site reactions (bruising, erythema, pain, pruritus, warmth).Other: anti-drug antibody development.Reactions in bold italics are life-threatening.Released: November 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2022
tirzepatideMounjaroPharmaceutical company: LillyPharmacologic classification:Glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonistTherapeutic classification:Antidiabetics AVAILABLE FORMSInjection: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/mL, 15 mg/mL single-dose penINDICATIONS AND DOSAGESAdjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusAdults: Initially, 2.5 mg subcut once weekly. After 4 weeks, increase to 5 mg subcut once weekly. If additional glycemic control is needed, increase in 2.5-mg increments after at least 4 weeks on the current dose, up to a maximum of 15 mg subcut once weekly.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) and in patients with multiple endocrine neoplasia syndrome type 2.Black Box Warning: Thyroid C-cell adenomas and carcinomas occurred in animal studies. It’s not known if tirzepatide causes thyroid C-cell tumors, including MTC, in humans.Contraindicated in patients with known serious hypersensitivity to tirzepatide or any of its components.Monitor renal function in patients with renal impairment reporting severe adverse GI reactions, especially if dehydration occurs.This drug is associated with GI adverse reactions, sometimes severe. Use in patients with severe GI disease isn’t recommended.Rapid improvement in glycemic control has been associated with temporary worsening of diabetic retinopathy. Monitor patients with a history of diabetic retinopathy for disease progression.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm based on animal reproduction studies. Use during pregnancy only if the potential benefit justifies the risk to the fetus.There are no data on the presence of this drug in animal or human milk, the effects on the breastfed infant, or the effects on milk production. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. Insulin, insulin secretagogues (sulfonylureas): May increase the risk of hypoglycemia. Monitor blood glucose level and adjust the dose of insulin or insulin secretagogues accordingly.Oral hormonal contraceptives: May reduce efficacy of oral contraceptive due to delayed gastric emptying. Switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after tirzepatide initiation and for 4 weeks after each dose escalation.Oral medications: Tizepatide delays gastric emptying and may affect absorption of concomitantly administered oral medications. Use cautiously together.ADVERSE REACTIONSCV: sinus tachycardia.GI: nausea, diarrhea, vomiting, constipation, dyspepsia, abdominal pain, decreased appetite, eructation, flatulence, gastroesophageal reflux disease, abdominal distension.Metabolic: increased amylase, increased lipase.Skin: injection site reaction.Other: hypersensitivity, anti-tirzepatide antibody development.Reactions in bold italics are life-threatening.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwervonoprazan and amoxicillinVoquenza Dual PakPharmaceutical company: Phathom PharmaceuticalsPharmacologic classification:Potassium-competitive acid blocker and antibacterialTherapeutic classification:Antacid and anti-infective AVAILABLE FORMSCopackage containing:Capsules: amoxicillin 500 mgTablets: vonoprazan 20 mgINDICATIONS AND DOSAGESHelicobacter pylori infectionAdults: Vonoprazan 20 mg PO b.i.d. (morning and evening) plus amoxicillin 1,000 mg PO t.i.d. (morning, midday, and evening) for 14 days.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to vonoprazan, amoxicillin, or other beta-lactams (penicillins or cephalosporins).Avoid use in severe renal impairment (eGFR less than 30 mL/minute) or moderate-to-severe hepatic impairment (Child-Pugh B or C).Avoid use of this drug in patients with mononucleosis, because this drug may increase the risk of erythematous skin rash.Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported.Severe cutaneous adverse reactions (SCARs) have occurred. Discontinue at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.Clostridioides difficile-associated disease has been reported with use of acid-suppressing therapies and nearly all antibacterial agents, including amoxicillin.Safety and effectiveness in children haven’t been established.Use cautiously in older adults.Dialyzable drug: Vonoprazan, no; amoxicillin, yes.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies during pregnancy. Use with caution.There are no data regarding the presence of vonoprazan or amoxicillin in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential risk of adverse liver effects, patients who are breastfeeding should pump and discard milk for the duration of therapy and for 2 days after therapy ends, and feed the infant stored human milk (collected prior to therapy) or formula.A pregnancy exposure registry is available at Phathom Pharmaceuticals, Inc. at 1-800-775-PHAT (7428).INTERACTIONSDrug-drug. Allopurinol: May increase incidence of rash. Discontinue allopurinol at first sign of skin rash.Atazanavir: May alter absorption of atazanavir. Avoid use together.Clopidogrel: May reduce clopidogrel level and platelet inhibition. Carefully monitor efficacy of clopidogrel or use alternative antiplatelet therapy.CYP2C19 substrates (citalopram, cilostazol): May increase substrate level. Monitor for adverse reactions.CYP3A4 substrates (tacrolimus, cyclosporine): May increase risk of adverse reactions of substrate. Frequent monitoring of substrate drug level or for adverse effects may be required.Drugs dependent on gastric pH for absorption (antiretrovirals, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole): Vonoprazan reduces intragastric acidity which may decrease the absorption of these drugs and their effectiveness. Refer to prescribing information for the individual drugs for dosing information if used together.Nelfinavir: May alter absorption of nelfinavir. Avoid concomitant use.Oral anticoagulants: May increase PT and INR. Monitor closely and adjust dose of oral anticoagulants as necessary.Probenecid: May increase amoxicillin exposure resulting in adverse reactions. Monitor for adverse reactions.Rilpivirine: May alter absorption of rilpivirine. Concomitant use is contraindicated.Strong or moderate CYP3A inducers: May decrease vonoprazan effectiveness. Avoid use together.ADVERSE REACTIONSCNS: dysgeusia, headache.CV: hypertension.EENT: nasopharyngitis.GI: diarrhea, abdominal pain.GU: vulvovaginal candidiasis.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer vonoprazan–amoxicillin–clarithromycinVoquenza Triple PakPharmaceutical company: Phathom PharmaceuticalsPharmacologic classification:Potassium-competitive acid blocker, antibacterial, and antimicrobialTherapeutic classification:Antacid and antibiotic AVAILABLE FORMSCopackage containing:Capsules: amoxicillin 500 mgTablets: vonoprazan 20 mg and clarithromycin 500 mgINDICATIONS AND DOSAGESHelicobacter pylori infectionAdults: Vonoprazan 20 mg PO plus amoxicillin 1,000 mg PO plus clarithromycin 500 mg PO b.i.d. for 14 days.CONTRAINDICATIONS AND CAUTIONSKnown hypersensitivity to vonoprazan, amoxicillin or other beta-lactams, (penicillins or cephalosporins), or clarithromycin or other macrolide antibacterials.Use in patients with a history of cholestatic jaundice or hepatic dysfunction associated with clarithromycin is contraindicated.Serious and occasionally fatal reactions, including anaphylaxis, have been reported. If hypersensitivity reactions occur, discontinue therapy and institute immediate supportive care.Severe cutaneous adverse reactions (SCARs) have occurred. Discontinue at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.Clostridiodes difficile-associated disease has been reported with use of acid-suppressing therapies and nearly all antibacterial agents.Clarithromycin may increase the risk of QT prolongation and arrhythmias, including torsades de pointes. Avoid use in patients with known QT prolongation, ventricular cardiac arrhythmia, patients on drugs known to prolong the QT interval, patients with proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, or significant bradycardia.Avoid use in patients with mononucleosis due to amoxicillin content since many of these patients develop an erythematous skin rash.Avoid use in patients with severe renal impairment (eGFR less than 30 mL/min) or moderate-to-severe hepatic impairment (Child-Pugh B or C).Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome related to clarithromycin may occur.Safety and effectiveness in children haven’t been established.Use cautiously in older adults.Dialyzable drug: Vonoprazan, no; amoxicillin, yes; clarithromycin, no.Overdose S&S: Amoxicillin: interstitial nephritis, crystalluria, reversible renal impairment; clarithromycin: GI symptoms.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in pregnant women to evaluate for vonoprazan-associated risks. Clarithromycin may cause adverse fetal and pregnancy effects, including miscarriage. Use isn’t recommended in women who are pregnant unless there are no appropriate alternative therapies.There are no data regarding the presence of vonoprazan in human milk, the effects on the breastfed infant or the effects on milk production. Because of the potential for adverse liver effects, women who are breastfeeding should pump and discard milk for the duration of therapy and for 2 days after therapy ends, and feed the infant stored human milk (collected prior to therapy) or formula.Advise patients who are exposed to vonoprazan–amoxicillin–clarithromycin during pregnancy to contact Phathom Pharmaceuticals, Inc. at 1-800-775-PHAT (7428).Based on animal fertility study findings, clarithromycin may impair fertility in males of reproductive potential.INTERACTIONSDrug-drug. Allopurinol: May increase incidence of rash. Discontinue allopurinol at first sign of skin rash.Antiarrhythmics: (amiodarone, dofetilide, procainamide, sotalol, quinidine): May increase risk of adverse reactions, including QT prolongation and cardiac arrhythmias. Avoid concomitant use. If concomitant use is unavoidable, monitor patients for QTc prolongation.Atazanavir, nelfinavir: May alter absorption of these drugs. Avoid concomitant use.Atorvastatin: May increase level of statin. Avoid use together. If use can’t be avoided, limit atorvastatin dose to 20 mg daily.Benzodiazepines (alprazolam, midazolam, triazolam): May increase benzodiazepine level. Closely monitor patients for increased or prolonged central nervous system effects, and refer to the benzodiazepine prescribing information for dosage recommendations.Calcium channel blockers (amlodipine, diltiazem, nifedipine, verapamil): May increase calcium channel blocker level and risk of adverse reactions. Use cautiously together.Clopidogrel: May reduce the clopidogrel level and platelet inhibition. Carefully monitor efficacy of clopidogrel or use alternative antiplatelet therapy.Colchicine: May increase colchicine level and risk of adverse reactions. Concomitant use is contraindicated in patients with renal or hepatic impairment. If coadministration is necessary in patients with normal renal or hepatic function, carefully monitor patients for colchicine toxicity.CYP2C19 substrates (citalopram, cilostazol): May increase substrate level. Carefully monitor patients for adverse reactions associated with substrate. See the prescribing information of substrate for dosage adjustments if used together.CYP3A substrates (alfentanil, bromocriptine, cilostazol, methylprednisolone, phenobarbital, vinblastine): Clarithromycin may increase substrate level. Use cautiously together.CYP3A4 substrates (tacrolimus, cyclosporine): May increase level of these substrates. Monitor substrate level frequently, monitor for adverse effects and decrease substate level if needed.CYP450 substrates (hexobarbital, phenytoin, valproate): May increase substrate level and risk of adverse reactions. Use together with caution.Digoxin: Clarithromycin may increase digoxin level and risk of adverse reactions. Monitor digoxin level.Disopyramide: May increase risk of adverse reactions, including cardiac arrhythmias and hypoglycemia. Avoid concomitant use. If unavoidable, monitor for QTc prolongation and changes in blood glucose level.Drugs dependent on gastric pH for absorption (antiretrovirals, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole): Vonoprazan reduces intragastric acidity which may decrease the absorption of these drugs and their effectiveness.See the prescribing information for other drugs dependent on gastric pH for absorption.Ergot alkaloids (ergotamine, dihydroergotamine): May increase ergot alkaloid level. Concomitant use is contraindicated.Etravirine: Clarithromycin may increase risk of adverse reactions or loss of effectiveness of both agents. Avoid use together.Fluvastatin: May increase fluvastatin level. Avoid use together. If use together can’t be avoided, give at the lowest dose.Hypoglycemic agents (insulin, nateglinide, pioglitazone, repaglinide, rosiglitazone): May increase hypoglycemic agent level and risk of hypoglycemia.Itraconazole: Clarithromycin may increase risk of adverse effect of both agents. Monitor for adverse effects.Lovastatin, simvastatin: May increase statin level. Use with these statins is contraindicated.Maraviroc: Clarithromycinmay increase maraviroc level. Use together with caution. See maraviroc prescribing information for coadministration with clarithromycin.Omeprazole: May increase clarithromycin level. Avoid concomitant use.Oral anticoagulants: May increase PT and INR. Monitor closely and adjust dose of oral anticoagulants as necessary.Phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil): Clarithromycin may increase phosphodiesterase inhibitor level and risk of adverse reactions. Avoid concomitant use. If use can’t be avoided, refer to inhibitor prescribing information for dosage adjustment when given with strong CYP3A inhibitor.Pimozide: May increase pimozide level, somnolence, neuroleptic malignant syndrome, and risk of QT prolongation and arrhythmias. Concomitant use is contraindicated.Pravastatin: May increase statin level. Avoid use together. If use can’t be avoided, limit pravastatin dose to 40 mg daily.Probenecid: May increase amoxicillin exposure resulting in adverse reactions. Monitor for adverse reactions associated with amoxicillin.Quetiapine: May increase quetiapine level and risk of adverse reactions. Refer to quetiapine prescribing information for recommendations on coadministration with clarithromycin.Rilpivirine-containing products: May alter absorption of rilpivirine. Concomitant use is contraindicated.Ritonavir: Clarithromycin may increase risk of adverse reactions or loss of effectiveness of both agents. Concomitant administration is not recommended in patients with decreased renal function.Saquinavir: May increase risk of adverse reactions or loss of effectiveness of saquinavir and clarithromycin. See saquinavir prescribing information for instructions on coadministration.Strong or moderate CYP3A inducers (rifampicin, efavirenz): May decrease vonoprazan and clarithromycin effectiveness. Avoid concomitant use.Theophylline: Clarithromycin may increase theophylline level. Closely monitor serum theophylline level in patients receiving high dosages of theophylline or with baseline concentrations in the upper therapeutic range.Tolterodine: May increase tolterodine level and risk of adverse reactions. Tolterodine 1 mg b.i.d. is recommended in patients deficient in CYP2D6 poor metabolizers activity when coadministered with clarithromycin.Zidovudine: May increase level of zidovudine and clarithromycin. Separate drug administration by at least 2 hours.Drug-herb. St. John’s wort: May decrease clarithromycin level. Use together with caution.ADVERSE REACTIONSCNS: dysgeusia, headache.CV: hypertension.EENT: nasopharyngitis.GI: diarrhea, abdominal pain.GU: vulvovaginal candidiasis.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: October 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - September 2022
tapinarofVtamaPharmaceutical company: Dermavant Sciences, Inc.Pharmacologic classification:AntipsoriaticTherapeutic classification:Aryl hydrocarbon receptor agonistAVAILABLE FORMSCream: 1%INDICATIONS AND DOSAGESPlaque psoriasisAdults: Apply a thin layer to psoriatic skin lesions once daily.CONTRAINDICATIONS AND CAUTIONSSafety and efficacy in children haven’t been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use during pregnancy only if the potential benefit justifies the fetal risk.It isn’t known if this drug appears in human milk. Use during breastfeeding only if the potential benefit justifies the infant risk.INTERACTIONSNone reported.ADVERSE REACTIONSCNS: headache.EENT: nasopharyngitis.Skin: folliculitis, contact dermatitis, pruritis.Other: flulike syndrome.Reactions in bold italics are life-threatening.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
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