deuruxolitinib
Leqselvi
Pharmaceutical company: Sun Pharmaceutical Industries
Pharmacologic classification: Janus kinase (JAK) inhibitor
Therapeutic classification: Immunomodulator
AVAILABLE FORMS
Tablets: 8 mg
INDICATIONS AND DOSAGES
Severe alopecia areata
Adults: 8 mg PO b.i.d.
Adjust-a-dose: Avoid or interrupt treatment for an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1,000 cells/mm3, hemoglobin less than 8 g/dL, or if the patient develops a serious or opportunistic infection. Begin or resume treatment when the absolute lymphocyte count is at least 500 cells/mm3, ANC is at least 1,000 cells/mm3, hemoglobin is at least 8 g/dL, or the infection is controlled.
CONTRAINDICATIONS AND CAUTIONS
- This drug is contraindicated for use in patients who are CYP2C9 poor metabolizers.
- Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Use isn't recommended in patients with active TB.
- Use cautiously in patients with a chronic or recurrent infection, a history of serious or opportunistic infections, or underlying conditions that may predispose to infection; or in patients who have been exposed to TB or who have resided or traveled in areas of endemic TB or endemic mycoses. Avoid use in patients with active, serious infections, including localized infections.
- Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, was observed with another JAK inhibitor compared to tumor necrosis factor (TNF) blockers in the treatment of rheumatoid arthritis (RA). Deuruxolitinib isn't approved for use in RA.
- Boxed Warning: Malignancies have been reported with deuruxolitinib. Higher rates of lymphomas and lung cancers occurred with another JAK inhibitor versus TNF blockers in RA patients.
- Use cautiously in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer), or in patients who develop a malignancy. Nonmelanoma skin cancers have been reported.
- Boxed Warning: Higher rates of major adverse CV events (CV death, MI, stroke) were observed with another JAK inhibitor compared to TNF blockers in patients with RA. Discontinue the drug if MI or stroke occurs.
- Use cautiously in patients with CV risk factors, and in current or past smokers.
- Boxed Warning: Thrombosis has occurred in patients treated with deuruxolitinib. Increased incidence of pulmonary embolism, and venous and arterial thrombosis has occurred with another JAK inhibitor versus TNF blockers. Avoid the drug in patients at increased risk for thrombosis.
- Use isn't recommended in patients with active hepatitis B or C virus.
- This drug isn't recommended for use in patients with an eGFR less than 30 mL/minute or Child-Pugh class C liver impairment.
- Safety and effectiveness in children haven't been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause fetal harm. Pregnancy prevention is recommended. Report pregnancy to the manufacturer at 1-800-818-4555.
- It's unknown if this drug is present in human milk, or if the drug affects milk production or infants who are breastfed. Breastfeeding isn't recommended during treatment and for 1 day after the last dose.
INTERACTIONS
Drug-drug. Live vaccines: May enhance adverse effects and decrease therapeutic effect of live vaccines. Avoid live vaccines immediately before and during treatment.
Moderate or strong CYP2C9 inhibitors (fluconazole, gemfibrozil): May increase deuruxolitinib level and risk of adverse effects. Use together is contra indicated.
Potent immunosuppressants (other JAK inhibitors, biologic immunomodulators, cyclosporine): May increase immunosuppressive effects and risk for infection. Use together isn't recommended.
Strong CYP3A, moderate or strong CYP2C9 inducers (rifampin, phenobarbital, dexamethasone): May decrease deuruxolitinib level and therapeutic effect. Avoid use together.
Drug-herb. St. John's wort: May decrease drug level. Discourage use together.
ADVERSE REACTIONS
CNS: headache, fatigue.
EENT: nasopharyngitis.
Hematologic: anemia, neutropenia, lymphopenia, thrombocytosis.
Metabolic: increased creatine kinase level, hyperlipidemia, weight gain.
Skin: acne, skin and soft tissue infection.
Other: herpes infection.
Reactions in bold italics are life-threatening.
Released: December 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
vorasidenib
Voranigo
Pharmaceutical company: Servier Pharmaceuticals
Pharmacologic classification: Isocitrate dehydrogenase (IDH)-1 and IDH-2 inhibitors
Therapeutic classification: Antineoplastic
AVAILABLE FORMS
Tablets: 10 mg; 40 mg
INDICATIONS AND DOSAGES
Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, subtotal resection, or gross total resection
Adults and children ages 12 and older weighing 40 kg or more: 40 mg PO once daily until disease progression or unacceptable toxicity occurs.
Children age 12 and older weighing less than 40 kg: 20 mg PO once daily until disease progression or unacceptable toxicity occurs.
Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Permanently discontinue vorasidenib if the patient is unable to tolerate 10 mg once daily.
CONTRAINDICATIONS AND CAUTIONS
- This drug may cause elevations in liver transaminase levels and lead to liver failure, liver necrosis, and autoimmune hepatitis.
- Use cautiously in patients with creatine clearance of 40 mL/minute or less, patients on dialysis, or patients with Child-Pugh class C liver impairment; safety and effectiveness haven't been studied.
- Safety and effectiveness in children younger than age 12 haven't been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause fetal harm.
- Females of reproductive potential and males with female partners of reproductive potential should use effective nonhormonal contraception during treatment and for 3 months after the last dose.
- It isn't known whether this drug appears in human milk or how the drug affects milk production or infants who are breastfed. Because of the risk of adverse reactions in the breastfed child, breastfeeding isn't recommended during treatment and for 2 months after the last dose.
- This drug may impair fertility. Effects weren't reversible in animal studies.
INTERACTIONS
Drug-drug. CYP3A substrates (amiodarone, sirolimus, warfarin): May decrease level of CYP3A substrate. Avoid use together where a minimal change in substrate level may lead to decreased therapeutic effect.
Hormonal contraceptives: May decrease level of contraceptive and lead to contraceptive failure or increased breakthrough bleeding. If use together can't be avoided, use additional nonhormonal contraceptive methods.
Moderate CYP1A2 inducers (phenytoin, rifampicin): May decrease vorasidenib level and antitumor activity. Avoid use together.
Moderate or strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine): May increase vorasidenib level. Avoid use together. If use together can't be avoided, monitor for adverse reactions and adjust vorasidenib dose per manufacturer's instructions.
Drug-lifestyle. Smoking (tobacco): May decrease vorasidenib level and antitumor activity. Discourage use together.
ADVERSE REACTIONS
CNS: fatigue, headache, seizures.
GI: diarrhea, nausea, constipation, abdominal pain, decreased appetite.
GU: increased creatinine.
Hematologic: increased hemoglobin, decreased lymphocytes, decreased leukocytes, neutropenia, thrombocytopenia.
Hepatic: increased liver function studies.
Metabolic: hyperglycemia, hypocalcemia, hypophosphatemia, hyperkalemia.
Musculoskeletal: pain.
Other: COVID-19.
Reactions in bold italics are life-threatening.
Released: December 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer