New Drug Indications - May 2021


adalimumab

Humira

Pharmaceutical company: AbbVie

NEW INDICATION & DOSAGE

Moderately to severely active ulcerative colitis

Children age 5 and older weighing 40 kg or more: Initially, 160 mg subcut on day 1, given in 1 day or split over 2 consecutive days; then 80 mg on days 8 and 15, followed by a maintenance dose of 80 mg every other week or 40 mg every week starting at week 4 (day 29).

Children age 5 and older weighing from 20 to less than 40 kg: Initially, 80 mg subcut on day 1, followed by 40 mg on days 8 and 15, followed by a maintenance dose of 40 mg every other week or 20 mg every week starting at week 4 (day 29).

Released: May 2021

© 2021 Wolters Kluwer


axicabtagene

Yescarta

Pharmaceutical company: Kite Pharma

 

NEW INDICATION & DOSAGE

Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Adults: Target dose is 2 × 106 CAR-positive viable T cells/kg of body weight (or a maximum of 2 × 108 CAR-positive viable T cells for patients weighing 100 kg or more).

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

Released: May 2021

© 2021 Wolters Kluwer


mirabegron

Myrbetriq; Myrbetriq Granules

Pharmaceutical company: Astellas Pharma, Inc.

 

NEW INDICATION & DOSAGE

Neurogenic detrusor overactivity

Children age 3 and older weighing 35 kg or more (extended-release tablets): 25 mg PO once daily. After 4 to 8 weeks, may increase to maximum dose of 50 mg once daily.

Children age 3 and older weighing 35 kg or more (extended-release granules): Initially, 6 mL (48 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 10 mL (80 mg) once daily.

Children age 3 and older weighing 22 to less than 35 kg (extended-release granules): Initially, 4 mL (32 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 8 mL (64 mg) once daily.

Children age 3 and older weighing 11 to less than 22 kg (extended-release granules): Initially, 3 mL (24 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 6 mL (48 mg) once daily.

Released: May 2021

© 2021 Wolters Kluwer


pembrolizumab

Keytruda

Pharmaceutical company: Merck Sharp & Dohme Corp.

 

NEW INDICATION & DOSAGE

Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy

Adults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months. Give pembrolizumab before chemotherapy when given on the same day.

Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 as determined by an FDA-approved test

Adults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months.

Released: May 2021

© 2021 Wolters Kluwer


tocilizumab

Actemra

Pharmaceutical company: Genentech

 

NEW INDICATION & DOSAGE

Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease

Adults: 162 mg subcut once every week.

Released: May 2021

© 2021 Wolters Kluwer