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New Drug Indications - August 2024


blinatumomab

Blincyto
Pharmaceutical company: Amgen, Inc.

NEW INDICATION & DOSAGE
CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy
Adults and children weighing 45 kg or more: A single consolidation cycle of 28 mcg/day continuous IV infusion for 28 days followed by a 14-day treatment-free interval (total, 42 days).
Adults and children weighing less than 45 kg: A single consolidation cycle of 15 mcg/m2/day continuous IV infusion for 28 days followed by a 14-day treatment-free interval (total, 42 days). Maximum dose, 28 mcg/day.

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


dapagliflozin

Farxiga
Pharmaceutical company: AstraZeneca

NEW INDICATION & DOSAGE
Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes
Children age 10 and older with eGFR of 45 mL/minute/1.73 m2 or greater: Initially, 5 mg PO once daily. For patients who require additional glycemic control, may increase to 10 mg daily.

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


durvalumab

Imfinzi
Pharmaceutical company: AstraZeneca

NEW INDICATION & DOSAGE
Primary advanced or recurrent endometrial cancer that is mismatch repair deficient in combination with carboplatin and paclitaxel
Adults weighing 30 kg or more: 1,120 mg IV every 3 weeks (21 days) in combination with carboplatin and paclitaxel for six cycles; followed by 1,500 mg IV every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.
Adults weighing less than 30 kg: 15 mg/kg IV every 3 weeks (21 days) in combination with carboplatin and paclitaxel for six cycles; followed by 20 mg/kg IV every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


pembrolizumab

Keytruda
Pharmaceutical company: Merck

NEW INDICATION & DOSAGE
Primary advanced or recurrent endometrial carcinoma in combination with carboplatin and paclitaxel, followed by pembrolizumab as a single agent
Adults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks, prior to carboplatin and paclitaxel when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or, for pembrolizumab, up to 24 months

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


risankizumab-rzaa

Skyrizi
Pharmaceutical company: AbbVie

NEW INDICATION & DOSAGE
Moderately to severely active ulcerative colitis
Adults: 1,200-mg IV infusion over at least 2 hours at weeks 0, 4, and 8. Then, 180 mg or 360 mg subcut at week 12 and every 8 weeks thereafter. Use the lowest effective dosage.

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


sarilumab

Kevzara
Pharmaceutical company: Sanofi and Regeneron Pharmaceuticals, Inc.

NEW INDICATION & DOSAGE
Active polyarticular juvenile idiopathic arthritis
Adults and children weighing at least 63 kg: 200 mg subcut once every 2 weeks as a single agent or in combination with other conventional disease-modifying antirheumatic drugs.

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

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


selpercatinib

Retevmo
Pharmaceutical company: Eli Lilly and Company

NEW FORMULATION
Tablets: 40 mg, 80 mg, 120 mg, 160 mg

NEW INDICATION & DOSAGE
Advanced or metastatic RET-mutant medullary thyroid cancer
Children ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.

Advanced or metastatic RET fusion-positive thyroid cancer
Children ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.

Locally advanced or metastatic solid tumors with RET gene fusion in patients with progression on or following prior systemic therapy, or who have no alternative treatment options
Adults and children age 12 and older weighing 50 kg or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Adults and children age 12 and older weighing less than 50 kg: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.
Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.

Released: August 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer