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New FDA Drug Approvals - November 2022


vutrisiran

Amvuttra

Pharmaceutical company: Alnylam Pharmaceuticals

Pharmacologic classification:Anti-transthyretin small interfering RNA agent

Therapeutic classification:Protein inhibitor

AVAILABLE FORMS

Injection: 25 mg/0.5 mL prefilled syringe

INDICATIONS AND DOSAGES

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Adults: 25 mg subcut every three months.

CONTRAINDICATIONS AND CAUTIONS

  • This 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-REPRODUCTION

  • There 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.

INTERACTIONS

None reported.

ADVERSE REACTIONS

CV: 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 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

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New FDA Drug Approvals Archive


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 - 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
New FDA Drug Approvals - March 2022
asciminibScemblixPharmaceutical company: NovartisPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 20 mg, 40 mgINDICATIONS AND DOSAGESPhiladelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitorsAdults: 80 mg PO once daily or 40 mg PO every 12 hours as long as clinical benefit is observed or until unacceptable toxicity.Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutationAdults: 200 mg PO every 12 hours.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSThis drug may increase risk for hypersensitivity reactions, severe thrombocytopenia and neutropenia events, pancreatic toxicity, and hypertension.Cardiovascular toxicity, including arrhythmias, QT prolongation, ischemic cardiac and CNS conditions, arterial thrombotic and embolic events, and cardiac failure may occur. Patients with prior exposure to multiple tyrosine kinase inhibitors, preexisting cardiac conditions or CV risk factors are at increased risk.Safety and effectiveness in children haven’t been determined.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of asciminib or its metabolites in human milk, the effects on the breastfed child, or milk production. Advise women not to breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility in females of reproductive potential. The reversibility of the effect is unknown.INTERACTIONSDrug-drug. Certain P-glycoprotein (P-gp) substrates: May increase plasma levels of P-gp substrates. Closely monitor patients treated with concomitant P-gp substrates where minimal changes in substrate level may lead to serious toxicities.CYP2C9 substrates (warfarin): May increase risk of adverse reactions of the substrate. Avoid coadministration of asciminib 80 mg total daily with CYP2C9 substrates where minimal changes in substrate level may lead to serious adverse reactions. If coadministration is unavoidable, reduce the substrate dose as recommended in its prescribing information. Avoid coadministration of asciminib 200 mg b.i.d. with sensitive substrates and substrates where minimal changes in substrate level may lead to serious adverse reactions. If coadministration is unavoidable, consider alternative therapy with a non-CYP2C9 substrate.CYP3A4 substrates (midazolam): May increase level of substrate and risk of adverse reactions. Closely monitor patients treated with asciminib 80 mg daily with concomitant use of CYP3A4 substrates where minimal changes in substrate level may lead to serious adverse reactions. Avoid coadministration of asciminib 200 mg b.i.d. with substrates where minimal changes in substrate level may lead to serious adverse reactions.Itraconazole oral solution containing hydroxypropyl-β-cyclodextrin: May reduce asciminib level, which may reduce its efficacy. Avoid concomitant use.Strong CYP3A4 inhibitors (clarithromycin): May increase asciminib level and increase the risk of adverse reactions. Closely monitor patients treated with asciminib at 200 mg b.i.d.ADVERSE REACTIONSCNS: fatigue, fever, headache, dizziness, peripheral neuropathy.CV: heart failure, hypertension,edema, hemorrhage, QT interval prolongation, arrhythmia, palpitations.EENT: blurred vision, dry eye.GI: nausea, diarrhea, abdominal pain, vomiting, constipation, pancreatitis, increased lipase and amylase.GU: UTI, increased creatinine.Hematologic: thrombocytopenia, neutropenia, febrile neutropenia, lymphopenia, anemia.Hepatic: increased ALT, increased AST, hyperbilirubinemia.Metabolic: increased triglycerides, dyslipidemia, hypothyroidism, increased creatine kinase, hypophosphatemia, hypocalcemia, hypercholesterolemia, hypokalemia, hyperuricemia.Musculoskeletal: musculoskeletal pain, arthralgia.Respiratory: upper respiratory infection, cough, dyspnea, pleural effusion, pneumonia.Skin: rash, pruritis, hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwermaribavirLivtencityPharmaceutical company: Takeda PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:AntiviralAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESPost-transplant cytomegalovirus (CMV) infection or disease that is refractory to treatment with ganciclovir, valgaciclovir, cidofovir or foscarnetAdults and children age 12 and older and weighing at least 35 kg: 400 mg PO b.i.d.Adjust-a-dose: If coadministered with carbamazepine, increase maribavir to 800 mg PO b.i.d.; if coadministered with phenytoin or phenobarbital, increase maribavir to 1,200 mg PO b.i.d.CONTRAINDICATIONS AND CAUTIONSVirologic failure due to resistance can occur during and after treatment, usually within 4 to 8 weeks after treatment discontinuation.Safety and effectiveness in children younger than 12 and weighing less than 35 kg haven’t been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONNo adequate human data are available to establish whether this drug poses a risk in pregnancy.It’s unknown if this drug has any effects on nursing; consider clinical need for the drug and any potential adverse effects to the breastfed child.INTERACTIONSDrug-drug. Carbamazepine, phenytoin, phenobarbital: May decrease maribavir levels; increase maribavir dosage if taking concurrently.Cyclosporine, everolimus, sirolimus, tacrolimus: May increase concentrations of immunosuppressant; monitor for increased drug levels and adverse effects. Adjust immunosuppressant dose as needed.Digoxin: May increase digoxin levels; monitor digoxin level and adjust digoxin as needed.Ganciclovir, valganciclovir: May decrease viral activity of these drugs; don’t give together.Rifabutin, rifampin: May decrease maribavir efficacy; don’t give together. Rosuvastatin: May increase statin concentrations; monitor patient closely for adverse effects, especially myopathy and rhabdomyolysis. Strong CYP3A4 inducers (except for carbamazepine, phenytoin, and phenobarbital): May decrease maribavir levels; avoid concurrent use.Substrates of CYP3A, P-glycoprotein and BCRP (midazolam, fexofenadine, glyburide, cimetidine): May cause clinically relevant increase in plasma concentrations of substrate; avoid concurrent use.Drug-herb. St. John’s wort: May decrease maribavir efficacy; don’t give together.ADVERSE REACTIONSCNS: fatigue, taste disturbance.GI: nausea, diarrhea, vomiting.GU: acute kidney injury.Hematologic: neutropenia, anemia.Other: recurrence of underlying CMV infection or CMV disease.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwervosoritideVoxzogoPharmaceutical company: BioMarin MedicalPharmacologic classification:Human C type natriuretic peptide analogTherapeutic classification:Growth factorAVAILABLE FORMSInjection: 0.4 mg, 0.56 mg, 1.2 mg single-dose vialINDICATIONS AND DOSAGESIncrease linear growth in patients with achondroplasia with open epiphysesChildren age 5 and older: 0.24 to 0.8 mg subcut once daily, based on actual body weight. See prescribing information for dosing table.Adjust-a-dose: Adjust dose every 3 to 6 months, according to actual body weight. Permanently discontinue upon confirmation of no further growth potential, indicated by closure of epiphyses.CONTRAINDICATIONS AND CAUTIONSUse in those with significant cardiac or vascular disease hasn’t been studied.Avoid use in those with eGFR less than 60 mL/min/1.73 m2.Some dosage forms may contain polysorbate 80.Safety and effectiveness in children younger than age 5 haven’t been established.This drug isn’t indicated for use in adults.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in pregnant women.There are no data on the safety of breast-feeding. Consider benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant. There are no data on fertility.INTERACTIONSDrug-drug. Antihypertensives: May increase hypotensive effect. Use cautiously together.ADVERSE REACTIONSCNS: dizziness, fatigue.CV: hypotension.EENT: ear pain.GI: vomiting, diarrhea, gastroenteritis.Musculoskeletal: arthralgia.Skin: dry skin, injection site erythema, swelling, urticaria, pain, bruising, pruritus, hemorrhage, discoloration, or induration.Other: flulike symptoms, seasonal allergy.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - January 2022
atogepantQuliptaPharmaceutical company: AbbViePharmacologic classification:Calcitonin gene-related peptide receptor antagonistTherapeutic classification:Antimigraine drugAVAILABLE FORMSTablets: 10 mg; 30 mg; 60 mgINDICATIONS AND DOSAGESPrevention of episodic migraine headachesAdults: 1 tablet PO once daily.Adjust-a-dose: If taking with a strong CYP3A4 inhibitor, the recommended dose is 10 mg PO once daily. If taking with a strong or moderate CYP3A4 inducer, the recommended dose is 30 mg or 60 mg PO once daily. If taking with an OATP inhibitor, the recommended dose is 10 mg or 30 mg PO once daily. If severe renal impairment or end-stage renal disease (creatinine clearance less than 30 mL/min), the recommended dose is 10 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSAvoid use in patients with severe hepatic impairment (Child-Pugh class C).Use cautiously in older adults. Initiate therapy at lowest dose.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONIt isn’t known if this drug causes fetal harm. Use during pregnancy only if clearly indicated and the benefit outweighs the fetal risk. Women with migraine headaches may be at increased risk for preeclampsia and gestational hypertension.It isn’t known if this drug appears in human milk. Use cautiously in women who are breastfeeding.INTERACTIONSDrug-drug. OATP inhibitors (cyclosporine, rifampin): May increase level of atogepant. Adjust atogepant dose.Strong or moderate CYP3A4 inducers (carbamazepine, efavirenz, etravirine, rifampin, phenytoin): May decrease level of atogepant. Adjust atogepant dose.Strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole): May increase level of atogepant. Adjust atogepant dose.Drug-herb. St. John’s wort: May decrease level of atogepant. Adjust atogepant dose.ADVERSE REACTIONSCNS: fatigue, somnolence.GI: nausea, constipation, decreased appetite.Hepatic: increased transaminase levels.Metabolic: weight loss.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer avacopanTavneosPharmaceutical company: ChemoCentryx, Inc.Pharmacologic classification:Complement inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSCapsules: 10 mgINDICATIONS AND DOSAGESAdjunctive treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoidsAdults: 30 mg PO b.i.d. with food.Adjust-a-dose: When used with strong CYP3A4 inhibitors, reduce dose to 30 mg once daily. If AST or ALT increase to greater than 3 times the upper limit of normal (ULN), consider pausing avacopan. If AST or ALT increases to greater than 5 times ULN, or AST or ALT increases to 3 times ULN with elevation of bilirubin to more than 2 times ULN, discontinue drug until avacopan-induced liver injury is ruled out.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with serious hypersensitivity reaction to avacopan or to any of its components.May cause serious liver injury, transaminase elevations and hepatobiliary events, including serious and life-threatening events.Not recommended for use in patients with active, untreated, or uncontrolled chronic liver disease (hepatitis B, hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis.Reactivation of latent hepatitis B infection and hypersensitivity reactions, including angioedema can occur.Serious and fatal infections have been reported. Avoid use in patients with an active, serious infection.Use cautiously in patients with chronic or recurrent infection, tuberculosis (TB) exposure, history of serious or opportunistic infections, underlying conditions that predispose them to infection, or who have lived or traveled in areas of endemic TB or mycoses.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate data to inform the use of avacopan during pregnancy or breastfeeding; use only if the benefits outweigh the fetal risk.INTERACTIONSDrug-drug. CYP3A4 substrates (midazolam): May increase adverse reactions. Monitor patient closely and consider dose reduction of sensitive CYP3A4 substrates with narrow therapeutic window.Strong and moderate CYP3A4 inducers (rifampin): May decrease level of avacopan. Avoid use together.Strong CYP3A4 inhibitors (itraconazole): May increase level of avacopan. Reduce avacopan dose to 30 mg PO once daily.Drug-herb. St. John’s wort: May decrease level of avacopan. Avoid use together.ADVERSE REACTIONSCNS: headache, fatigue, dizziness, paresthesia.CV: hypertension.GI: nausea, diarrhea, vomiting, upper abdominal pain.GU: increase in creatinine.Hepatic: liver enzyme abnormalities.Skin: rash.Other: angioedema.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer mobocertinibExkivityPharmaceutical company: Takeda Pharmaceuticals AmericaPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSCapsules: 40 mgINDICATIONS AND DOSAGESLocally advanced or metastatic non–small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with progression on or after platinum-based chemotherapyAdults:160 mg PO daily, until disease progression or unacceptable toxicity.Adjust-a-dose: See the manufacturer’s information for toxicity-related dose reductions. If use with a concomitant moderate CYP3A inhibitor can’t be avoided, reduce mobocertinib dose by approximately 50% and monitor QTc interval more frequently. After moderate CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the drug at the dose prior to CYP3A initiation.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug can cause life-threatening heart rate-corrected QT (QTc) prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation.Black Box Warning: Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors, as these may further prolong the QTc.Black Box Warning: Withhold, dose reduce, or permanently discontinue this drug based on the severity of QTc prolongation.This drug can increase the risk of interstitial lung disease/pneumonitis, which can be fatal.This drug increases the risk of cardiac toxicity, including decreased ejection fraction, cardiomyopathy, and heart failure.This drug may cause diarrhea, leading to dehydration or electrolyte imbalance, with or without renal impairment.Safety and effectiveness of this drug in children haven’t been established.Use cautiously in older adults as there may be a higher incidence and severity of adverse reactions.Recommended dosage hasn’t been determined for patients with severe renal or hepatic impairment.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Females of reproductive potential must use effective nonhormonal contraception during treatment and for 1 month after the last dose, and males with female partners of reproductive potential must use effective contraception during treatment with and for 1 week after the last dose.Due to the potential for adverse reactions in a child who is breastfed, women should not breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. CYP3A substrates (midazolam): May decrease level of substrate; consider increasing substrate dosage if possible.Black Box Warning: Drugs that prolong the QTc interval (haloperidol, thioridazine, amiodarone, procainamide, lithium, ciprofloxacin, methadone, SSRIs, tricyclic antidepressants): May significantly increase risk of QTc prolongation; avoid use together. If use together is unavoidable, monitor QTc carefully.Hormonal contraceptives: May decrease level of contraceptive and cause therapeutic failure. Avoid use together.Strong and moderate CYP3A inducers (rifampin, efavirenz): May decrease mobocertinib level and antitumor activity; avoid concomitant use.Black Box Warning: Strong or moderate CYP3A inhibitors (itraconazole, ketoconazole): May increase mobocertinib level; avoid use together. If concomitant use can’t be avoided, reduce mobocertinib dose, monitor the QTc interval more frequently with ECGs, and monitor patients for increased risk of adverse reactions.Drug-herb. St. John’s wort: May decrease mobocertinib level; discourage use together.Drug-food. Grapefruit, grapefruit juice: May increase drug level; discourage intake during treatment.ADVERSE REACTIONSCNS: headache, fever, fatigue, peripheral neuropathy.CV: QTc prolongation, atrial fibrillation, hypertension, heart failure, edema.EENT: ocular toxicity.GI: diarrhea, stomatitis, vomiting, decreased appetite, nausea, abdominal pain, gastroesophageal reflux disease, dyspepsia.GU: acute kidney injury.Hematologic: leukocytopenia, anemia.Metabolic: weight loss, increased amylase, increased lipase, hypokalemia, increased creatinine, hypomagnesemia.Musculoskeletal: pain.Respiratory: interstitial lung disease, pneumonitis, cough, upper respiratory infection, dyspnea, rhinorrhea, pleural effusion.Skin: rash, paronychia, dry skin, pruritus, alopecia, hand-foot syndrome.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters KluwerDownload these updates as a PDF
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