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New FDA Drug Approvals - January 2023

sodium phenylbutyrate and taurursodiol

Albrioza (Canadian), Relyvrio

Pharmaceutical company: Amylyx

Pharmacologic classification:Histone deacetylase inhibitor, hydrophilic bile acid

Therapeutic classification:Miscellaneous CNS drug

AVAILABLE FORMS

Oral suspension: 3 g sodium phenylbutyrate and 1 g taurursodiol in single-dose packet

INDICATIONS AND DOSAGES

Amyotrophic lateral sclerosis

Adults: Initially, one packet PO daily for 3 weeks. Then, increase to the maintenance dose of one packet b.i.d.

CONTRAINDICATIONS AND CAUTIONS

  • Avoid 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-REPRODUCTION

  • There 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.

INTERACTIONS

Drug-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 REACTIONS

CNS: Fatigue, dizziness.
EENT: Salivary hypersecretion.

GI: Diarrhea, abdominal pain, nausea.

Respiratory: URI.

Reactions in bold italics are life-threatening.

Released: January 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

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New FDA Drug Approvals Archive

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 
New FDA Drug Approvals - August 2022
mavacamtenCamzyosPharmaceutical company: Bristol-Myers SquibbPharmacologic classification:Cardiac myosin inhibitorTherapeutic classification:Heart failure drugAVAILABLE FORMSCapsules: 2.5 mg, 5 mg, 10 mg, 15 mgINDICATIONS AND DOSAGESSymptomatic New York Heart Association class II to III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptomsAdults: Initially, 5 mg PO daily. Dosage must be individualized based on clinical status and echocardiographic assessment of patient response. Subsequent doses after titration may be 2.5, 5, 10, or 15 mg once daily. See the manufacturer’s instructions for initiation and maintenance dose algorithms based on left ventricular ejection fraction (LVEF) and Valsalva left ventricular outflow tract assessments.Adjust-a-dose: For patients who are on stable therapy with a weak CYP2C19 or moderate CYP3A4 inhibitor, initiate mavacamten therapy with 5 mg PO once daily. For patients who initiate a weak CYP2C19 or a moderate CYP3A4 inhibitor during mavacamten therapy, reduce mavacamten dose by one level (15 mg to 10 mg; 10 mg to 5 mg; or 5 mg to 2.5 mg). Avoid initiation of concomitant weak CYP2C19 or moderate CYP3A4 inhibitors in patients stable on mavacamten 2.5 mg daily because a lower mavacamten dose isn’t available.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to mavacamten or its components.Black Box Warning: This drug is contraindicated with concomitant use of moderate to strong CYP2C19 inhibitors, strong CYP3A4 inhibitors, moderate-to-strong CYP2C19 inducers, or moderate-to-strong CYP3A4 inducers.Black Box Warning: This drug can cause heart failure due to systolic dysfunction.Black Box Warning: Echocardiogram assessments of LVEF are required before and during use of mavacamten.Black Box Warning: Initiation in patients with LVEF less than 55% isn’t recommended. Interrupt therapy if LVEF drops below 50% or if there is a worsening of clinical status.Consider interruption of the drug in patients with intercurrent illness as an exacerbation of cardiac symptoms may result.This drug hasn’t been studied in pediatric patients.Use cautiously in older adults.Black Box Warning: Because of the risk of heart failure due to systolic dysfunction, mavacamten is available only through a restricted program under the Camzyos REMS program.Dialyzable drug: Unlikely.Overdose S&S: Vasovagal reaction, hypotension, asystole, systolic dysfunction symptoms (shortness of breath, edema, fatigue, dizziness, cough, or wheezing).PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal toxicity based on animal studies.Females of reproductive potential must use effective contraception during therapy and for 4 months after the last dose.This drug may reduce the effectiveness of combined hormonal contraceptives (CHCs). If patient is on a CHC, use an alternative contraceptive method or add nonhormonal contraception.Report pregnancies to Bristol-Myers Squibb pregnancy outcomes study at 1-800-721-5072 or www.bms.com.It’s unknown if this drug is present in human milk. Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for the drug and risks to the breastfed child from the drug or from the underlying maternal condition.INTERACTIONSDrug-drug. Cimetidine: May increase mavacamten level. Use together cautiously.CYP2C8 (repaglinide), CYP2C9 (tolbutamide), CYP2C19 (omeprazole), and CYP3A4 (midazolam, repaglinide) substrates: May reduce levels of substrate drugs. Monitor levels of substrate drugs when decreased levels may reduce their activity.Disopyramide, ranolazine, verapamil with a beta blocker, diltiazem with a beta blocker: Use with mavacamten hasn’t been studied. Avoid use together.Disopyramide with verapamil or diltiazem: May cause left ventricular dysfunction and heart failure in patients with obstructive hypertrophic cardiomyopathy. Avoid use together.Hormonal contraceptives (progestin, ethinyl estradiol): May decrease ethinyl estradiol and progestin levels leading to contraceptive failure or breakthrough bleeding. Use a contraceptive method not affected by CYP450 enzyme induction (intrauterine system) or add nonhormonal contraception (condoms) during concomitant use and for 4 months after its last dose.Black Box Warning: Moderate to strong CYP2C19 or CYP3A4 inducers (rifampin):May decrease mavacamten level and reduce efficacy. Concomitant use is contraindicated.Black Box Warning: Moderate to strong CYP2C19 inhibitors: May increase mavacamten level and the risk of heart failure. Concomitant use contraindicated.Negative inotropes (beta blockers, diltiazem, verapamil): May have additive effects. When concomitant use can’t be avoided, monitor LVEF closely when initiating or increasing the negative inotrope dose until stable doses and clinical response have been achieved.Black Box Warning: Strong CYP3A4 inhibitors (ketoconazole): May increase mavacamten level and increase the risk of heart failure due to systolic dysfunction. Concomitant use contraindicated.Weak CYP2C19 inhibitors (esomeprazole, omeprazole) or moderate CYP3A4 inhibitors (ciprofloxacin, cyclosporine): May increase mavacamten level. Adjust mavacamten dose.Drug-herb. St. John’s wort: May decrease mavacamten level and efficacy. Don’t use together.Drug-food. Grapefruit juice: May increase mavacamten level and increase drug adverse effects. Discourage use together.ADVERSE REACTIONSCNS: dizziness, syncope.CV: Heart failure, LVEF reduction.Reactions in bold italics are life-threatening.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New FDA Drug Approvals - July 2022
ganaxoloneZtalmyPharmaceutical company: Marinus PharmaceuticalsPharmacologic classification:Neuroactive steroid GABA type A receptor positive modulatorTherapeutic classification:AnticonvulsantControlled substance schedule: PendingAVAILABLE FORMSOral suspension: 50 mgINDICATIONS AND DOSAGESSeizures associated with cyclin-dependent kinase-like 5 deficiency disorderPatients age 2 and older weighing over 28 kg: Initially, 150 mg t.i.d. (450 mg daily). Titrate to 300 mg t.i.d., then 450 mg t.i.d. to the maximum dosage of 600 mg t.i.d. (1,800 mg daily) based on tolerability. Titrate no more frequently than every 7 days.Patients age 2 and older weighing 28 kg or less: Initially, 6 mg/kg t.i.d. (18 mg/kg/day). Titrate to 11 mg/kg t.i.d., then 16 mg/kg t.i.d. to the maximum dosage of 21 mg/kg t.i.d. (63 mg/kg/daily) based on tolerability.Adjust-a-dose: When discontinuing ganaxolone, decrease the dose gradually, when possible, to minimize the risk of increased seizure frequency and status epilepticus. For those with hepatic impairment, monitor for adverse reactions; reduce dose as needed.CONTRAINDICATIONS AND CAUTIONSUse cautiously in those with hepatic impairment, or with depression.Alert: Anticonvulsant drugs may increase the risk of suicidality as soon as the first week of treatment.This drug has the potential for abuse. Physical dependence risk hasn’t been determined, but abrupt discontinuation of anticonvulsant drugs isn’t recommended because of the risk of seizures.Safety and effectiveness in children under age 2 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONEnroll patients in pregnancy exposure registry at 1-888-233-2334 or https://www.aedpregnancyregistry.org/. There are no adequate and well-controlled studies during pregnancy.This drug is excreted in human milk. The effects on milk production and the breastfed infant are unknown. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. CNS depressants (opioids, antidepressants): may cause somnolence and sedation. Use cautiously together when driving or operating machinery.Strong or moderate CYP450 inducers (anticonvulsant drugs [carbamazepine, phenytoin, phenobarbital, primidone], rifampin): May decrease ganaxolone levels. Avoid use together. If use together is unavoidable, consider increased ganaxolone dosage; don’t exceed maximum daily dose. In patients on a stable ganaxolone dosage who are initiating or increasing the dosages of enzyme-inducing anticonvulsant drugs, ganaxolone dosage may need to be increased; don’t exceed maximum daily dose.Drug-lifestyle. Alcohol use: May increase somnolence and sedation. Use caution when driving or operating machinery.ADVERSE REACTIONSCNS: seizures, somnolence, pyrexia, sedation.EENT: nasal congestion.GI: salivary hypersecretion.Musculoskeletal: gait disturbance.Respiratory: upper respiratory infection, bronchitis.Other: seasonal allergy, flulike syndrome.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwermitapivatPyrukyndPharmaceutical company: Agios PharmaceuticalsPharmacologic classification:Pyruvate kinase activatorTherapeutic classification:Hemolysis inhibitorAVAILABLE FORMSTablets: 5 mg, 20 mg, 50 mgINDICATIONS AND DOSAGESHemolytic anemia in those with pyruvate kinase (PK) deficiencyAdults: Initially, 5 mg PO b.i.d. for 4 weeks. If hemoglobin remains below normal range or the patient required a transfusion within the last 8 weeks, increase to 20 mg b.i.d. for 4 weeks. If hemoglobin remains below normal range or patient required a transfusion within the last 8 weeks, increase to 50 mg b.i.d. If hemoglobin decreases during maintenance therapy of 5 mg or 20 mg b.i.d., consider titrating up to maximum of 50 mg b.i.d. Discontinue if there is no benefit by 24 weeks.Adjust-a-dose: If used with moderate CYP3A inhibitors, maximum mitapivat dose is 20 mg b.i.d. If use with moderate CYP3A inducers is unavoidable, titrate mitapivat beyond 50 mg b.i.d., but don’t exceed a maximum of 100 mg b.i.d.For those with adverse reaction, intolerability, or for hemoglobin above normal, reduce dose to the next lower dose level, 20 mg b.i.d. or 5 mg b.i.d. Taper the dose gradually to discontinue the drug. If the risk to the patient is greater than the risk of acute hemolysis because of sudden withdrawal of the drug, stop the drug without tapering.CONTRAINDICATIONS AND CAUTIONSAvoid use in those with moderate or severe hepatic impairment.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies during pregnancy. Use cautiously during pregnancy.Untreated PK deficiency during pregnancy may precipitate acute hemolysis, preterm labor, miscarriage, and severe anemia requiring frequent transfusion. Additionally, preeclampsia and severe hypertension have been reported.Patients using hormonal contraception should use an alternative nonhormonal method or add a barrier method during treatment.There are no data on the safety of breastfeeding. Consider the benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSDrug-drug. CYP3A substrates (midazolam, hormonal contraceptives like ethinyl estradiol), CYP2B6 substrates, CYP2C substrates, UGT1A1 substrates): May decrease substrate level. Monitor for loss of therapeutic effect of substrates with narrow therapeutic index. Use of alternative nonhormonal contraceptive or adding a barrier method of contraception is recommended.Moderate CYP3A inducers (efavirenz): May decrease mitapivat levels. Consider alternative therapy. If use together is unavoidable, monitor hemoglobin and titrate beyond 50 mg b.i.d., if necessary, but don’t exceed a maximum recommended dose of 100 mg b.i.d.Moderate CYP3A inhibitors (fluconazole): May increase mitapivat levels, and risk of adverse reactions. Monitor hemoglobin. Don’t titrate mitapivat beyond 20 mg b.i.d.P-glycoprotein (P-gp) substrates: May increase levels of drugs that are P-gp substrates. Monitor for adverse reactions of P-gp substrates with narrow therapeutic index.Strong CYP3A inducers (rifampin): May decrease mitapivat levels. Avoid use together.Strong CYP3A inhibitors (itraconazole): May increase mitapivat levels and risk of adverse reactions. Avoid use together.ADVERSE REACTIONSCNS: paresthesia.CV: hot flush, flushing, hypertension, arrhythmia.EENT: oropharyngeal pain, dry mouth.GI: gastroenteritis, constipation.Hematologic: acute hemolysis.Metabolic: hypertriglyceridemia, increased urate level, estrone and estradiol decreases in males, testosterone increases in males.Musculoskeletal: back pain, arthralgia, musculoskeletal pain.Other: breast discomfort.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluweroteseconazoleVivjoaPharmaceutical company: Mycovia PharmaceuticalsPharmacologic classification:Azole antifungalTherapeutic classification:AntifungalAVAILABLE FORMSCapsules: 150 mgINDICATIONS AND DOSAGESReduce incidence of recurrent vulvovaginal candidiasis (RVVC) in patients with a history of RVVC who are not of reproductive potentialAdult: 600 mg PO as a single dose on day 1, then 450 mg as a single dose on day 2, then beginning day 14, give 150 mg every 7 days for 11 weeks (weeks 2 through 12). Or, if given in combination with fluconazole; on day 1, day 4, and day 7, give fluconazole 150 mg PO; then on days 14 through 20, give oteseconazole 150 mg once daily; then beginning day 28, give oteseconazole 150 mg PO every 7 days for 11 weeks (weeks 4 through 14).CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or its components.Safety and efficacy have not been established in females who are premenarchal.This drug is not recommended for use in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) or in patients with severe renal impairment or end-stage renal disease with or without dialysis.Use cautiously in older adults.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm based on animal studies. The drug’s exposure window is about 690 days (5 half-lives).This drug is contraindicated in patients of reproductive potential (biological females who are not postmenopausal or who don’t have another reason for permanent infertility [tubal ligation, hysterectomy, salpingo-oophorectomy]) and during pregnancy.This drug is contraindicated during breastfeeding.INTERACTIONSDrug-drug. Breast cancer resistance protein substrates (rosuvastatin): May increase level and adverse effects of substrate. Use the lowest possible starting dose of the substrate or consider reducing the dose of the substrate drug. Monitor for adverse effects.ADVERSE REACTIONSCNS: headache.GI: nausea, dyspepsia.GU: dysuria, menorrhagia, metrorrhagia, vulvovaginal burning, discomfort, or pain.Other: hot flush.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - May 2022
abrocitinibCibinqoPharmaceutical company: Pfizer, Inc.Pharmacologic classification:Janus kinase (JAK) inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSTablets: 50 mg, 100 mg, and 200 mgINDICATIONS AND DOSAGESRefractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisableAdults: 100 mg PO once daily. If inadequate response after 12 weeks, may increase to 200 mg once daily. Discontinue if there is an inadequate response after increasing to 200 mg once daily.Adjust-a-dose: For patients with moderate renal impairment (eGFR 30 to 59 mL/min) or patients who are known or suspected CYP2C19 poor metabolizers, reduce dosage to 50 mg once daily; if inadequate response after 12 weeks, may double the dose. Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug may increase the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. The most frequently reported serious infections were herpes simplex, herpes zoster, and pneumonia. Avoid use in those with active, serious infection, including localized infections. Consider the risk and benefits of use in those with chronic or recurrent infection.Don’t give to patients with active tuberculosis (TB). Consider anti-TB treatment in patients with previously untreated latent TB, history of active TB if an adequate course of treatment can’t be confirmed, and in patients with a negative latent TB test but who have risk factors for TB infection.Black Box Warning: Patients age 50 and older with rheumatoid arthritis (RA) and at least one CV risk factor treated with a JAK inhibitor have an increased risk of major adverse CV events, including all-cause mortality. A higher rate of major adverse CV events (MACE) (CV death, MI, stroke) and thrombosis (pulmonary embolism, venous, arterial) have occurred with JAK inhibitors compared with TNF blockers in patients with RA. Patients who are current or past smokers are at additional risk. Discontinue the drug in patients who have MI, stroke, or symptoms of thrombosis. Abrocitinib isn’t approved for use in RA patients.Black Box Warning: Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Patients with RA treated with JAK inhibitors have a higher rate of malignancies (excluding nonmelanoma skin cancer) compared with TNF blockers. Patients who are current or past smokers are at increased risk.Black Box Warning: Serious and sometimes fatal thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors. Use cautiously in patients at increased risk for thrombosis after first carefully considering the risks and benefits.Use isn’t recommended for patients with active hepatitis B or hepatitis C.Avoid use in patients with severe (Child Pugh C) hepatic impairment.Use cautiously in patients with moderate renal impairment.Use not recommended in patients with severe renal impairment (eGFR 15 to 29 mL/min) or end-stage renal disease, platelet count less than 150,000/mm3, absolute lymphocyte count less than 500/mm3, ANC less than 1,000/mm3 or hemoglobin less than 8 g/dL.Use cautiously in older adults and patients who are CYP2C19 poor metabolizers.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in pregnant women. Enroll women exposed to this drug during pregnancy in the pregnancy exposure registry at 1-877-311-3770.There are no data on the safety of breastfeeding. Advise against breastfeeding during treatment with abrocitinib and for one day after the last dose (approximately 5 to 6 elimination half-lives).This drug may impair female fertility.INTERACTIONSDrug-drug. Antiplatelet drugs (clopidogrel, prasugrel, ticagrelor [excluding low-dose aspirin]): May increase risk of bleeding with thrombocytopenia. Contraindicated during the first 3 months of treatment.Moderate to strong CYP2C19 and CYP2C9 inhibitors (fluconazole): May increase abrocitinib levels. Avoid use with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9.Other JAK inhibitors, biologic immunomodulators, or immunosuppressants: May enhance immunosuppressant effect. Avoid use together.P-glycoprotein (P-gp) substrates (digoxin, dabigatran): May increase P-gp substrate levels and risk of adverse reactions of the substrate where small increases may lead to serious or life-threatening toxicities. Monitor closely or dose titrate P-gp substrate.Strong CYP2C19 and CYP2C9 inducers (rifampin): May decrease abrocitinib levels. Avoid use together.Strong CYP2C19 inhibitors (fluvoxamine): May increase abrocitinib levels. Reduce dosage of abrocitinib.Vaccines: May diminish therapeutic effect of inactivated vaccines and increase risk of infection from live vaccines. Complete immunizations, including herpes zoster, following current guidelines prior to start of therapy. Avoid live vaccines immediately prior to, during, and immediately after therapy.Drug-lifestyle. Smoking:Increased risk of malignancies and CV events. Discourage smoking.Sun Exposure: Increased risk of malignancies. Limit exposure to sunlight and UV light.ADVERSE REACTIONSCNS: headache, dizziness, fatigue.CV: hypertension.EENT: nasopharyngitis, oropharyngeal pain.GI: nausea, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort.GU: UTI.Hematologic: thrombocytopenia.Metabolic: increased creatine kinase.Skin: acne, impetigo, contact dermatitis.Other: herpes simplex, herpes zoster, flulike symptoms, infections.Reactions in bold italics are life-threatening.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - April 2022
cabotegravirApretude, VocabriaPharmaceutical company: ViiV HealthcarePharmacologic classification:HIV-1 integrase strand transfer inhibitorTherapeutic classification:AntiretroviralAVAILABLE FORMSInjection (extended-release): 600 mg/3 mL single-dose vialTablets: 30 mgINDICATIONS AND DOSAGESShort-term treatment of HIV-1 infection in combination with rilpivirine in patients who are virologically suppressed (HIV­1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirineAdults (lead-in therapy): 30 mg PO daily in combination with oral rilpivirine for at least 28 days as oral lead-in therapy to assess tolerability of cabotegravir prior to starting cabotegravir and rilpivirine extended-release injections. Take last oral dose on the same day cabotegravir and rilpivirine injections are started.Adults (bridging therapy): 30 mg PO daily in combination with oral rilpivirine for up to 2 months as oral bridging therapy for patients who plan to miss a scheduled injection visit by more than 7 days. The first dose of oral bridging therapy should begin about 1 month after the last cabotegravir and rilpivirine injection for patients on the monthly dosing schedule, and about 2 months after the last injections for patients on the every-2-month dosing schedule. Continue oral dosing until the day the injections are restarted.Short-term preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk patientsAdults and adolescents age 12 and older weighing at least 35 kg (lead-in therapy): One tablet PO daily for 1 month (at least 28 days) as oral lead-in therapy prior to starting cabotegravir extended-release injections. Take last oral dose on the same day cabotegravir injections are started or within 3 days.Adults and adolescents age 12 and older weighing at least 35 kg (bridging therapy): One tablet PO daily to replace one every 2-month injection as oral bridging therapy for patients who plan to miss cabotegravir injection by more than 7 days. The first dose of oral bridging therapy should begin about 2 months after the last cabotegravir injection and continued until injections are restarted or within 3 days. An alternate oral PrEP regimen is recommended for duration of more than 2 months.PrEP to reduce the risk of sexually acquired HIV-1 infection in at-risk patients with or without an oral lead-in with oral cabotegravirAdults and adolescents age 12 and older weighing at least 35 kg: Initially, 600 mg IM on the last day of or within 3 days after oral lead-in therapy, if used, followed by a second injection one month later. Continue with injections every 2 months thereafter.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or its components.Cabotegravir is contraindicated for PrEP in patients with unknown or positive HIV-1 status. Monotherapy with cabotegravir isn’t a complete regimen for HIV-1 treatment.Black Box Warning: There is a risk of drug resistance with use for HIV PrEP in patients with undiagnosed HIV-1 infection. Drug-resistant variants have been identified in patients with undiagnosed HIV-1 infections with use of cabotegravir injections. Black Box Warning: Prior to starting cabotegravir (oral or IM) for PrEP and prior to each subsequent injection, test for HIV-1 infections using an FDA approved or cleared test for the diagnosis of acute primary HIV-1 infections. Patients who become infected with HIV-1 while receiving injections for PrEP must transition to a complete HIV-w treatment regimen.Black Box Warning: Don’t initiate this drug for PrEP unless negative infections status in confirmed.The time from initiation of HIV-1 PrEP to maximal protection is unknown.Use of this drug for PrEP is part of a comprehensive prevention strategy, including adherence to the drug schedule and safer sex practices.Serious or severe hypersensitivity reactions have occurred with other integrase inhibitors and may occur with cabotegravir. Treatment should be discontinued if signs or symptoms of hypersensitivity reactions develop.Use cautiously in patients with underlying liver disease or marked elevations in transaminases prior to treatment. Hepatoxicity has been reported in patients with or without known preexisting hepatic disease or other risk factors.Residual extended-release formulation of this drug may remain in circulation for up to 12 months or longer.Use cautiously in older adults and patients with severe or end-stage renal disease. Use in severe hepatic impairment hasn’t been studied.The safety and efficacy of cabotegravir for the treatment of HIV-1 infection in children, and for HIV-1 PrEP in children younger than age 12 or weighing less than 35 kg hasn’t been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONUse of cabotegravir during pregnancy hasn’t been evaluated. Use of cabotegravir injections isn’t recommended for use in patients planning to become pregnant. Risks and benefits of treatment should be discussed with individuals of childbearing potential or who are pregnant.Enroll pregnant women exposed to this drug during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263).Women with HIV-1 infection shouldn’t breastfeed due to the potential risk of HIV-1 transmission to the infant.For uninfected women taking cabotegravir for PrEP, assess the risks and benefits of treatment while breastfeeding. Extended-release formulation may be found in human milk 12 months or more after discontinuing the drug.INTERACTIONSDrug-drug. Antacids containing aluminum, magnesium, or calcium carbonate: Concomitant use may decrease the absorption of oral cabotegravir. Administer antacid products at least 2 hours before or 4 hours after taking cabotegravir.Methadone: May decrease methadone level. Monitor patient and adjust methadone dose as needed.Other antiretroviral drugs:Other antiretrovirals shouldn’t be used with cabotegravir when used as monotherapy for PrEP or in combination with rilpivirine for treatment of HIV-1.Rifabutin: May decrease cabotegravir level when given with extended-release injection. When used together, the second injection of extended-release cabotegravir should be given 2 weeks after the initial dose, and maintenance doses given monthly while on rifabutin.Strong inducers of UGT1A1 or 1A9 (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine): May significantly decrease cabotegravir levels and cause loss of virologic response. Use together is contraindicated.ADVERSE REACTIONSCNS: asthenia, depression, depressed mood, mood swings, headache, fever, sleep disorders, dizziness, somnolence, fatigue, abnormal dreams.GI: diarrhea, nausea, abdominal pain, flatulence, vomiting, decreased appetite.Hepatic: hepatoxicity.Musculoskeletal: myalgia, back pain.Respiratory: upper respiratory infection.Other: suicidality, injection site reactions.Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerdaridorexantQuviviqPharmaceutical company: Idorsia PharmaceuticalsPharmacologic classification:Orexin receptor antagonistTherapeutic classification:HypnoticControlled substance schedule: PendingAVAILABLE FORMSTablets: 25 mg, 50 mgINDICATIONS AND DOSAGESInsomnia characterized by difficulties with sleep onset or sleep maintenanceAdults: 25 to 50 mg PO no more than once per night 30 minutes before going to bed and at least 7 hours until planned awakening.Adjust-a-dose: For moderate hepatic impairment (Child Pugh 7 to 9) or coadministered with moderate CYP3A4 inhibitor, maximum dosage is 25 mg once per night.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with narcolepsy.Use in severe hepatic impairment isn’t recommended.Use cautiously in patients with psychiatric disorders; hypnotics may worsen depression, or suicidal ideation or behavior.Use cautiously in patients with a history of abuse or addiction to alcohol or other drugs.Use cautiously in patients with compromised respiratory function.Evaluate patients for comorbid diseases as cause of insomnia prior to starting daridorexant or if insomnia persists after 7 to 10 days.Use cautiously in older adults as they are more prone to CNS effects and falls.Safety and effectiveness haven’t been established in children.Sleep paralysis, hallucinations, and cataplexy-like symptoms (periods of leg weakness lasting from seconds to a few minutes and may not be associated with an identified triggering event [laughter or surprise]) may occur.Complex sleep behaviors (sleepwalking, sleep-driving, engaging in activities while not fully awake, including preparing and eating food, making phone calls, or having sex) may occur. If these occur, discontinue daridorexant immediately.Dialyzable drug: Unlikely.Overdose S&S: Somnolence, muscle weakness, cataplexy-like symptoms, sleep paralysis, disturbance in attention, fatigue, headache, constipation.PREGNANCY-LACTATION-REPRODUCTIONThere are no data available on safety of use during pregnancy. Health care providers are encouraged to register patients who are pregnant in a pregnancy exposure registry at 1-833-400-9611.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 was present in animal milk and is likely to be present in human milk. Consider the mother’s need against the risk to the breastfed infant. Monitor breastfed infants for excessive sedation.INTERACTIONSDrug-drug. CNS depressants: May increase risk of CNS depression. Use with caution and consider dose decrease of daridorexant or CNS depressant.Strong and moderate CYP3A4 inducers: May reduce efficacy level of daridorexant. Avoid concomitant use together.Strong or moderate CYP3A4 inhibitors: May increase daridorexant level and risk of adverse reactions. Avoid concomitant use with strong CYP3A4 inhibitors. Decrease daridorexant dose to 25 mg once nightly with moderate CYP3A4 inhibitors.Drug-food. High-fat and high-calorie meal: May delay sleep onset if meal is consumed 30 minutes prior to taking daridorexant.Drug-lifestyle. Alcohol: May increase risk of CNS depression. Discourage use together.ADVERSE REACTIONSCNS: headache, somnolence or fatigue, dizziness.GI: nausea.Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerinclisiranLeqvioPharmaceutical company: NovartisPharmacologic classification:Proprotein convertase subtilisin kexin type 9 mRNA inhibitorTherapeutic classification:AntilipemicAVAILABLE FORMSInjection: 284 mg/1.5 mL (189 mg/mL) prefilled syringeINDICATIONS AND DOSAGESAdjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or clinical atherosclerotic CV disease, in patients who require additional lowering of LDL cholesterolAdults: 284 mg subcut for one dose. Repeat dose at 3 months, then every 6 months thereafter.CONTRAINDICATIONS AND CAUTIONSUse of this drug hasn’t been studied in those with end-stage renal disease or severe hepatic impairment.The effect of this drug on CV morbidity and mortality hasn’t been determined.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in women who are pregnant. This drug may cause fetal harm based on the mechanism of action.Discontinue the drug when pregnancy is recognized; consideration may be given to the therapeutic needs of the individual patient. Treatment of hyperlipidemia isn’t generally necessary during pregnancy.There are no data on the safety of this drug while breastfeeding. Consider the benefits of breastfeeding, the clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSNone reported.ADVERSE REACTIONSGI: diarrhea.GU: UTI.Musculoskeletal: arthralgia, extremity pain.Respiratory: bronchitis, dyspnea.Skin: injection site reaction (pain, erythema, rash).Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
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