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New Drug Indications - December 2023


bosutinib

Bosulif

Pharmaceutical company: Pfizer

NEW FORMULATION
Capsules: 50 mg, 100 mg

NEW INDICATION & DOSAGE

Chronic-phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) in patients with resistance or intolerance to prior therapy

Children age 1 and older: 100 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs.
If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.

Newly diagnosed chronic-phase Ph+ CML

Children age 1 and older: 300 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs.
If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


elexacaftor–tezacaftor–ivacaftor and ivacaftor

Trikafta

Pharmaceutical company: Vertex Pharmaceuticals

NEW FORMULATION
Oral granules: 80 mg elexacaftor, 40 mg tezacaftor, 60 mg ivacaftor (fixed-dose combination) copackaged with 59.5 mg ivacaftor; 100 mg elexacaftor, 50 mg tezacaftor, 75 mg ivacaftor (fixed-dose combination), copackaged with 75 mg ivacaftor

NEW INDICATION & DOSAGE

Cystic fibrosis in patients who have at least one F508del mutation in the CFTR gene or a CFTR gene mutation responsive to elexacaftor–tezacaftor–ivacaftor and ivacaftor based on in vitro data

Children ages 2 to younger than 6 years weighing 14 kg or more: One packet of oral granules (each containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor) PO in the morning, followed by one 75-mg ivacaftor packet of oral granules about 12 hours later.
Children ages 2 to younger than 6 years weighing 14 kg or less: One packet of oral granules (each containing 80 mg elexacaftor, 40 mg tezacaftor, and 60 mg ivacaftor) PO in the morning, followed by one 59.5-mg ivacaftor packet of oral granules about 12 hours later.

Adjust-a-dose: For patients with Child-Pugh class B liver impairment and those receiving moderate and strong CYP3A inhibitors, refer to the manufacturer's instructions for dosage adjustments.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


empagliflozin

Jardiance

Pharmaceutical company: Boehringer Ingelheim Pharmaceuticals

NEW INDICATION & DOSAGE

To reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), kidney failure, CV death, and hospitalization in patients with chronic kidney disease at risk of progression

Adults: 10 mg PO daily in the morning.

Adjust-a-dose: Discontinue the drug if eGFR is less than 30 mL/minute/1.73 m2 in patients with diabetes mellitus or an eGFR of less than 20 mL/minute/1.73 m2 in those with heart failure.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


entrectinib

Rozlytrek

Pharmaceutical company: Genentech

NEW FORMULATION
Oral pellets: 50 mg/packet

NEW INDICATION & DOSAGE

Solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, that are metastatic or when surgical resection is likely to result in severe morbidity, and that have progressed after treatment or have no satisfactory alternative

Children older than 6 months with BSA of at least 1.51 m2: 600 mg PO once daily until disease progression or unacceptable toxicity occurs.
Children older than 6 months with BSA of 1.11 to 1.50 m2: 400 mg PO once daily until disease progression or unacceptable toxicity occurs.
Children older than 6 months with BSA of 0.81 to 1.10 m2: 300 mg PO once daily until disease progression or unacceptable toxicity occurs.
Children older than 6 months with BSA of 0.51 to 0.80 m2: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.
Children older than 6 months with BSA of 0.50 m2 or less: 300 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.
Children older than 1 month to 6 months: 250 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: For patients age 2 and older, refer to the manufacturer's instructions for dosage when used with moderate or strong CYP3A4 inhibitors. After discontinuation of the CYP3A inhibitor for three to five elimination half-lives, resume entrectinib dose given before initiating the CYP3A inhibitor.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

 


nivolumab

Opdivo

Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE

Adjuvant treatment of patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma

Adults and children age 12 and older weighing 40 kg or more: 240-mg IV infusion every 2 weeks or 480 mg every 4 weeks.

Children age 12 and older weighing less than 40 kg: 3 mg/kg-IV infusion every 2 weeks or 6 mg/kg every 4 weeks.

Adjust-a-dose: Continue until disease recurrence or unacceptable toxicity for up to 1 year.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


patiromer

Veltassa

Pharmaceutical company: Vifor Pharma

NEW FORMULATION
Oral powder: 1-g packet

NEW INDICATION & DOSAGE

Nonemergency treatment of hyperkalemia

Children ages 12 to 17: Initially, 4 g PO once daily. Monitor serum potassium level and adjust dose by 4 g daily, as needed, at intervals of 1 week or longer to reach desired potassium concentration. Maximum dosage is 25.2 g once daily.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


pembrolizumab

Keytruda

Pharmaceutical company: Merck & Co.

NEW INDICATION & DOSAGE

Resectable (tumors of at least 4 cm or node positive) non–small-cell lung cancer in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery

Adults: 200-mg IV infusion every 3 weeks or 400 mg every 6 weeks. Continue adjuvant treatment until disease recurrence, unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


pilocarpine ophthalmic

Qlosi

Pharmaceutical company: Orasis Pharmaceuticals, Inc.

NEW FORMULATION
Ophthalmic solution: 0.4%

NEW INDICATION & DOSAGE

Presbyopia (Qlosi)

Adults: Instill one drop of 0.4% solution in each eye daily. May repeat after 2 to 3 hours for an effect up to 8 hours.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


temozolomide

Temodar

Pharmaceutical company: Merck Sharp & Dohme

NEW INDICATION & DOSAGE

Adjuvant treatment of patients with newly diagnosed anaplastic astrocytoma

Adults: Initiate the drug four weeks after the end of radiotherapy. Cycle 1, give 150 mg/m2 PO daily on days 1 to 5 of a 28-day cycle. Then, cycles 2 to 12, give 200 mg/m2 daily on days 1 to 5 of each 28-day cycle. If the dose wasn't increased at the start of cycle 2 due to toxicity, don't increase during cycles 3 to 6.

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

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


vosoritide

Voxzogo

Pharmaceutical company: BioMarin Pharmaceutical, Inc.

NEW INDICATION & DOSAGE

Increase of linear growth in patients with achondroplasia with open epiphyses

Children weighing 3 kg or more: 0.096 mg to 0.8 mg subcut once daily, based on actual body weight. Refer to the prescribing information for dosing table.

Adjust-a-dose: Adjust the dose every 3 to 6 months, according to actual body weight. Permanently discontinue the drug upon confirmation of closed epiphyses.

Released: December 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer