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New Drug Indications - September 2024


roflumilast

Zoryveo
Pharmaceutical company: Arcutis Biotherapeutics

NEW FORMULATION
Cream: 0.15%

INDICATION & DOSAGE
Mild to moderate atopic dermatitis
Adults and children ages 6 and older: Apply once daily to affected areas.

Released: September 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


pitolisant

Wakix
Pharmaceutical company: Harmony Biosciences

NEW INDICATION & DOSAGE
Excessive daytime sleepiness in patients with narcolepsy
Children ages 6 and older: Titrate dosage as follows:
Week 1: Initiate with 4.45 mg PO once daily.
Week 2: Increase dose to 8.9 mg PO once daily.
Week 3: Increase dose to 17.8 mg PO once daily, maximum dose for children weighing less than 40 kg, based on tolerability.
Week 4: For children weighing 40 kg or more, may increase to maximum recommended dose, 35.6 mg PO once daily, based on tolerability.

Adjust-a-dose: See the manufacturer's instructions for dosage adjustments in children with Child-Pugh class B liver impairment; estimated GFR less than 60 mL/minute/1.73 m2; concomitant use of strong CYP2D6 inhibitors or strong CYP3A4 inducers; or in children who are known CYP2D6 poor metabolizers.

Released: September 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


immune globulin intravenous

Yimmugo
Pharmaceutical company: Grifols' Biotest

NEW INDICATION & DOSAGE
Primary humoral immunodeficiency
Adults and children ages 2 and older: 300 to 800 mg/kg IV every 3 to 4 weeks. For the first infusion, initially infuse at 0.5 mg/kg/minute and increase every 30 minutes, if tolerated, to 3 mg/kg/minute. From second infusion onward, initially infuse at 0.5 mg/kg/minute for 30 minutes; then gradually increase up to 13 mg/kg/minute, as tolerated.

Released: September 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


adagrasib

Krazati
Pharmaceutical company: Mirati Therapeutics

NEW INDICATION & DOSAGE
KRAS G12C-mutated locally advanced or metastatic colorectal cancer in combination with cetuximab in patients who have received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Adults: 600 mg P.O. b.i.d. until disease progresses or unacceptable toxicity occurs.

Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments. The first dosage reduction for adverse reactions is 400 mg P.O. b.i.d.; the second dosage reduction is 600 mg P.O. daily. Permanently discontinue the drug if the patient can't tolerate 600 mg/day. Refer to the cetuximab prescribing information for cetuximab dosage information.

Released: September 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer