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New Drug Indications - July 2023


avapritinib

Ayvakit

Pharmaceutical company: Blueprint Medicines

NEW INDICATION & DOSAGE

Indolent systemic mastocytosis (ISM)

Adults: 25 mg PO once daily.

Adjust-a-dose: For Child-Pugh class C liver impairment, give 25 mg every other day. Avoid use with strong or moderate CYP3A inhibitors. This drug isn't recommended for ISM with platelet count less than 50 X 109/L.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


brexpiprazole

Rexulti

Pharmaceutical company: Otsuka

NEW INDICATION & DOSAGE

Agitation associated with dementia due to Alzheimer disease

Adults: Initially, 0.5 mg PO once daily on days 1 to 7. Increase to 1 mg PO once daily on days 8 to 14. Then, increase to target dose of 2 mg PO once daily on day 15. May increase to maximum daily dose of 3 mg after at least 2 weeks based on patient's response and tolerability.

Adjust-a-dose: If Child-Pugh score is 7 or more or creatinine clearance is less than 60 mL/minute, maximum daily dose is 2 mg.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


buprenorphine

Brixadi

Pharmaceutical company: Braeburn, Inc.

NEW FORMULATIONS
Injection (extended-release weekly): 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL, 32 mg/0.64 mL prefilled syringes
Injection (extended-release monthly): 64 mg/0.18 mL, 96 mg/0.27 mL, 128 mg/0.36 mL prefilled syringes

INDICATION & DOSAGE

Moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine-containing product, or who are already being treated with buprenorphine

Adults: Individualized dose based on tolerability or efficacy. After a test dose of 4 mg transmucosally to establish tolerance without withdrawal, begin weekly dosing subcut every 7 days. Or, in patients currently treated with other buprenorphine-containing products, switch to either weekly subcut dosing every 7 days or monthly dosing subcut every 28 days.

Adjust-a-dose: May give weekly dose up to 2 days before or after the weekly time point. May give monthly dose up to 1 week before or after the monthly time point.

Alert: Weekly and monthly formulations aren't interchangeable. Weekly formulation can't be combined to yield a monthly dose.

Boxed Warning: Serious harm or death could result from IV administration of Brixadi. This drug is only available through a REMS program to prevent risk of IV self-administration.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


escitalopram

Lexapro

Pharmaceutical company: AbbVie

INDICATION & DOSAGE

Generalized anxiety disorder

Children age 7 and older: 10 mg PO once daily. May increase to 20 mg once daily after at least 2 weeks.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 


fluticasone furoate–vilanterol trifenatate

Breo Ellipta

Pharmaceutical company: GlaxoSmithKline

NEW FORMULATIONS
Powder for inhalation: Inhaler containing two double-foil blister strips of powder formulation: One strip contains fluticasone furoate 50 mcg/blister; the other contains vilanterol 25 mcg/blister

INDICATION & DOSAGE

Asthma

Adolescents ages 12 to 17: 1 inhalation of 100 mcg fluticasone furoate–25 mcg vilanterol trifenatate once daily.
Children ages 5 to 11: 1 inhalation of 50 mcg fluticasone furoate–25 mcg vilanterol trifenatate once daily.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


ibuprofen

Caldolor

Pharmaceutical company: Cumberland Pharmaceuticals

INDICATION & DOSAGE

Mild to moderate pain; moderate to severe pain as an adjunct to opioid analgesics; fever reduction in children

Children age 3 months to less than 6 months: 10 mg/kg IV up to a maximum single dose of 100 mg. Infusion time must be at least 10 minutes.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


ivacaftor

Kalydeco

Pharmaceutical company: Vertex Pharmaceuticals

NEW AVAILABLE FORM
Oral granules (unit-dose packets):: 5.8 mg, 13.4 mg

INDICATION & DOSAGE

Cystic fibrosis (CF) in patients who have one mutation in the CF transmembrane conductance regulator gene that's responsive to ivacaftor potentiation based on clinical data, in vitro assay data, or both

Children age 2 months to younger than 4 months weighing 3 kg or more: 13.4 mg granules PO every 12 hours.
Children age 1 month to younger than 2 months weighing 3 kg or more: 5.8 mg granules PO every 12 hours.
 

Adjust-a-dose: Use in children younger than age 6 months with any level of liver impairment isn't recommended. Use in children age 1 to younger than 6 months born earlier than a gestational age of 37 weeks hasn't been evaluated. Refer to the manufacturer's instructions for liver insufficiency, drug-interaction, and toxicity-related dose adjustments.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


polatuzumab vedotin-piiq

Polivy

Pharmaceutical company: Genentech

INDICATION & DOSAGE

Previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma in patients who have an International Prognostic Index score of 2 or greater, in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP)

Adults: 1.8 mg/kg IV infusion every 21 days for six cycles. Give with R-CHP in any order after administration of prednisone on day 1 of each cycle. Prednisone is given on days 1 to 5 of each cycle. Give prophylactic granulocyte colony-stimulating factor.

Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


upadacitinib

Rinvoq

Pharmaceutical company: AbbVie


INDICATION & DOSAGE

Moderately to severely active Crohn disease in patients who have had an inadequate response or intolerance to one or more TNF blockers

Adults: Induction dosage, 45 mg PO once daily for 12 weeks; then maintenance dosage, 15 mg daily. May increase maintenance dose to 30 mg for patients with refractory, severe, or extensive disease. Discontinue the drug if response with 30-mg dose is inadequate. Use the lowest effective dose needed to maintain response.

Adjust-a-dose:  If the patient has eGFR of 15 to less than 30 mL/minute/1.73 m2 or Child-Pugh class A or B liver impairment or is taking strong CYP3A4 inhibitors, give induction dose of 30 mg for 12 weeks and maintenance dose of 15 mg once daily.
This drug isn't recommended for use in combination with other JAK inhibitors, biological therapies for Crohn disease, or with potent immunosuppressants.

Released: July 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer