New Drug Indications - November 2021


brivaracetam

Briviact

Pharmaceutical company: UCB, Inc.

NEW INDICATION & DOSAGE

Adjunctive therapy or monotherapy for partial-onset seizures in patients with epilepsy

Children age 1 month and older weighing 20 to less than 50 kg: 0.5 to 1 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.5 mg/kg b.i.d.; maximum dose, 2 mg/kg b.i.d.

Children age 1 month and older weighing 11 to less than 20 kg: 0.5 to 1.25 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.5 mg/kg b.i.d.; maximum dose, 2.5 mg/kg b.i.d.

Children age 1 month and older weighing less than 11 kg: 0.75 mg/kg to 1.5 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.75 mg/kg b.i.d.; maximum dose, 3 mg/kg b.i.d.

Released: November 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer
 

cabozantinib

Cabometyx

Pharmaceutical company: Exelixis, Inc.

NEW INDICATION & DOSAGE

Locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy in those who are radioactive iodine-refractory or ineligible (Cabometyx only)

Adults and children age 12 and older with BSA of 1.2 mor more: 60 mg PO daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: Reduce starting dose to 40 mg PO once daily for patients with moderate hepatic impairment (Child-Pugh class B). Refer to the manufacturer's instructions for toxicity-related dosage adjustments and for use with strong CYP3A4 inducers or inhibitors.

Children age 12 and older with BSA less than 1.2 m2: 40 mg PO daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: Reduce starting dose to 20 mg PO once daily for patients with moderate hepatic impairment (Child-Pugh class B). Refer to the manufacturer's instructions for toxicity-related dosage adjustments and for use with strong CYP3A4 inducers or inhibitors.

Released: November 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer
 

paliperidone palmitate

Invega Hafyera

Pharmaceutical company: Janssen

NEW AVAILABLE FORM

Injection: 1,092 mg/3.5 mL; 1,560 mg/5 mL single-dose, prefilled syringes

NEW INDICATION & DOSAGE

Schizophrenia

Adults: Use 6-month IM paliperidone (Invega Hafyera) only after monthly IM paliperidone (Invega Sustenna) has been established as adequate treatment for at least 4 months and at the same dosage for at least 2 months, or after IM paliperidone (Invega Trinza) has been established as adequate treatment for at least a one 3-month cycle. Initiate when the next once-a-month injection is scheduled, or up to 1 week before or after. Initiate when the next every-3-month injection is scheduled, or up to 2 weeks before or after. Dosage is based on dosage of previous product. If last dose of once-a-month product was 156 mg, give 1,092 mg of 6-month product; if last dose of once-a-month product was 234 mg, give 1,560 mg of 6-month product. If last dose of 3-month product was 546 mg, give 1,092 mg of 6-month product; if last dose of 3-month product was 819 mg, give 1,560 mg of 6-month product. Because of long-acting nature of Invega Hafyera, patient's response to adjusted dose may not be apparent for several months. See the manufacturer's instructions for missed dosage schedules.

Released: November 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer
 

ruxolitinib

Jakafi

Pharmaceutical company: Incyte

NEW INDICATION & DOSAGE

Chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy

Adults and children age 12 and older: 10 mg PO b.i.d.

Adjust-a-dose: Recommended starting dose is 5 mg b.i.d. in patients with moderate to severe renal impairment (creatinine clearance of 15 to 59 mL/min) or when given concomitantly with fluconazole 200 mg or less. Starting dose for patients with end-stage-renal disease on dialysis is 10 mg after dialysis session. After 6 months of treatment in patients who have discontinued corticosteroids, taper the drug by one dose level every 8 weeks (10 mg b.i.d. to 5 mg b.i.d. to 5 mg once daily). Consider retreatment if acute GVHD recurs during or after taper. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: November 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer
 

zanubrutinib

Brukinsa

Pharmaceutical company: BeiGene

NEW INDICATION & DOSAGE

Waldenström macroglobulinemia

Adults: 160 mg PO b.i.d. or 320 mg PO once daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: For patients with severe hepatic impairment (Child-Pugh class C), reduce dose to 80 mg PO b.i.d. If given with strong CYP3A inhibitor, reduce dose to 80 mg PO once daily. If given with moderate CYP3A inhibitor, reduce dose to 80 mg PO b.i.d. After stopping CYP3A inhibitor, resume previous zanubrutinib dose. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Relapsed or refractory marginal zone lymphoma in patients who have received at least one anti-CD20-based regimen

Adults: 160 mg PO b.i.d. or 320 mg PO once daily, until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: For patients with severe hepatic impairment (Child-Pugh class C), reduce dose to 80 mg PO b.i.d. If given with strong CYP3A inhibitor, reduce dose to 80 mg PO once daily. If given with moderate CYP3A inhibitor, reduce dose to 80 mg PO b.i.d. After stopping CYP3A inhibitor, resume previous zanubrutinib dose. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: November 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer