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New Drug Indications - September 2022


crizotinib

Xalkori

Pharmaceutical company: Pfizer

NEW INDICATION & DOSAGE

Unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumor

Adults: 250 mg PO b.i.d.

Adjust-a-dose: For creatinine clearance less than 30 mL/minute (not requiring dialysis), give 250 mg once daily. For preexisting moderate hepatic impairment, give 200 mg b.i.d. For preexisting severe hepatic impairment, give 250 mg once daily. For unavoidable concomitant use with strong CYP3A inhibitors, decrease crizotinib to 250 mg once daily. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Children age 1 and older: 280 mg/m2 PO b.i.d.

Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments, dosage adjustments for renal or hepatic impairment, and for concomitant use of strong CYP3A inhibitors.

Released: September 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 

phentermine and topiramate

Qsymia

Pharmaceutical company: Vivus LLC

NEW INDICATION & DOSAGE

Chronic weight management, as an adjunct to diet and increased physical activity in children with BMI in the 95th percentile or more standardized for age and sex

Children age 12 and older: Initially, 3.75 mg phentermine/23 mg topiramate PO every morning for 14 days; then increase to 7.5 mg phentermine/46 mg topiramate every morning. Evaluate weight loss after 12 weeks of therapy. If the child hasn't lost at least 3% of baseline BMI, escalate dose to 11.25 mg phentermine/69 mg topiramate every morning for 14 days, followed by 15 mg phentermine/92 mg topiramate every morning. Evaluate BMI 12 weeks after dose escalation. If the patient hasn't lost at least 5% of baseline BMI, discontinue the drug by decreasing the dose to every other day for at least 1 week before stopping therapy altogether.

Adjust-a-dose: If the child's weight loss exceeds 0.9 kg/week, consider dose reduction. For patients with moderate renal impairment (creatinine clearance of 30 to less than 50 mL/minute), severe renal impairment (creatinine clearance less than 30 mL/minute), or moderate hepatic impairment (Child-Pugh class B), don't exceed 7.5 mg phentermine/46 mg topiramate once daily.

Released: September 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 

stiripentol

Diacomit

Pharmaceutical company: Biocodex

NEW INDICATION & DOSAGE

Seizures associated with Dravet syndrome in patients taking clobazam

Children age 1 and older weighing 10 kg or more: 25 mg/kg PO b.i.d. or 16.67 mg/kg PO t.i.d.

Children age 1 and older weighing 7 to less than 10 kg: 25 mg/kg PO b.i.d.

Children age 6 months to younger than age 1 weighing 7 kg or more: 25 mg/kg PO b.i.d.

Adjust-a-dose: If exact dosage can't be achieved with the available strengths, round to the nearest dosage, which is usually within 50 to 150 mg of the recommended 50 mg/kg/day. Maximum dose, 3,000 mg/day. If somnolence occurs, consider reducing clobazam dosage by 25%. If somnolence persists, consider decreasing clobazam dosage by an additional 25%. Consider adjusting the dosage of other concomitant anticonvulsants with sedating properties.

Released: September 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer