asciminib
Scemblix
Pharmaceutical company: Novartis
Pharmacologic classification:Kinase inhibitor
Therapeutic classification:Antineoplastic
AVAILABLE FORMS
Tablets: 20 mg, 40 mg
INDICATIONS AND DOSAGES
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitors
Adults: 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 mutation
Adults: 200 mg PO every 12 hours.
Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.
CONTRAINDICATIONS AND CAUTIONS
- This 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.
PREGNANCY-LACTATION-REPRODUCTION
- This 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.
INTERACTIONS
Drug-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 REACTIONS
CNS: 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 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer
maribavir
Livtencity
Pharmaceutical company: Takeda Pharmaceuticals
Pharmacologic classification:Kinase inhibitor
Therapeutic classification:Antiviral
AVAILABLE FORMS
Tablets: 200 mg
INDICATIONS AND DOSAGES
Post-transplant cytomegalovirus (CMV) infection or disease that is refractory to treatment with ganciclovir, valgaciclovir, cidofovir or foscarnet
Adults 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 CAUTIONS
- Virologic 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-REPRODUCTION
- No 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.
INTERACTIONS
Drug-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 REACTIONS
CNS: 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 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer
vosoritide
Voxzogo
Pharmaceutical company: BioMarin Medical
Pharmacologic classification:Human C type natriuretic peptide analog
Therapeutic classification:Growth factor
AVAILABLE FORMS
Injection: 0.4 mg, 0.56 mg, 1.2 mg single-dose vial
INDICATIONS AND DOSAGES
Increase linear growth in patients with achondroplasia with open epiphyses
Children 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 CAUTIONS
- Use 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.
PREGNANCY-LACTATION-REPRODUCTION
- There 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.
INTERACTIONS
Drug-drug. Antihypertensives: May increase hypotensive effect. Use cautiously together.
ADVERSE REACTIONS
CNS: 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 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer