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New Drug Indications - June 2024


alectinib hydrochloride

Alecensa
Pharmaceutical company: Genentech

NEW INDICATION & DOSAGE
Adjuvant treatment in patients with resected anaplastic lymphoma kinase-positive non-small-cell lung cancer tumors (at least 4 cm or node-positive)
Adults: 600 mg PO b.i.d. for 2 years or until disease recurrence or unacceptable toxicity occurs.

Adjust-a-dose: For patients with Child-Pugh class C liver impairment, give 450 mg PO b.i.d. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


dolutegravir/lamivudine

Dovato
Pharmaceutical company: ViiV Healthcare

NEW INDICATION & DOSAGE
HIV-1 infection in patients with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components
Children age 12 and older weighing 25 kg or more: 1 tablet PO once daily. HIV-1 infection as replacement for a current stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) with no history of treatment failure and no known substitutions associated with resistance to the individual components
Children age 12 and older weighing 25 kg or more: 1 tablet PO once daily.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


hydroxyurea

Xromi
Pharmaceutical company: Rare Disease Therapeutics, Inc.

NEW FORMULATION
Oral solution: 100 mg/mL

NEW INDICATION & DOSAGE
To reduce frequency of painful crises and need for blood transfusions in patients with sickle cell anemia with recurrent moderate-to-severe painful crises
Children ages 6 months to younger than 2 years (Xromi): 15 mg/kg PO once daily. Monitor blood counts every 2 weeks. If blood counts are in acceptable range, may increase dosage by 5 mg/kg daily every 8 to 12 weeks until maximum tolerated dosage or 35 mg/kg daily. If blood counts are considered toxic, withhold drug until blood counts recover. Resume therapy after reducing dosage by 2.5 mg/kg to 5 mg/kg daily. See the manufacturer's instructions for blood count parameters.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


ravulizumab–cwvc

Ultomiris
Pharmaceutical company: Alexion Pharmaceuticals

NEW INDICATION & DOSAGE
Neuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody positive
Adults weighing 100 kg or more: 3,000-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,600-mg IV infusion once every 8 weeks.
Adults weighing 60 to less than 100 kg: 2,700-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,300-mg IV infusion once every 8 weeks.
Adults weighing 40 to less than 60 kg: 2,400-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,000-mg IV infusion once every 8 weeks.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


iloperidone

Fanapt
Pharmaceutical company: Vanda Pharmaceuticals

NEW INDICATION & DOSAGE
Acute treatment of manic or mixed episodes associated with bipolar I disorder
Adults: Initially, 1 mg PO b.i.d. Increase dosage daily, as tolerated, according to the following schedule: 3 mg b.i.d. on day 2; 6 mg b.i.d. on day 3; 9 mg b.i.d. on day 4; 12 mg b.i.d. on day 5. Recommended daily dose, 12 mg b.i.d.

Adjust-a-dose:  For patients who are poor metabolizers of CYP2D6 and those taking CYP2D6 or CYP3A4 inhibitors, reduce dosage by 50%. Patients with Child-Pugh class B liver impairment may need dosage reduction if clinically indicated. Avoid use in patients with Child-Pugh class C liver impairment.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


risperidone

Risvan
Pharmaceutical company: Laboratorios Farmaceuticos Rovi

NEW FORMULATION
Injection (IM extended-release suspension): 75 mg; 100 mg single-dose kit

NEW INDICATION & DOSAGE
Schizophrenia
Adults: 75 mg or 100 mg IM once monthly after establishing tolerability with oral risperidone. For patients stable on 3 mg of PO risperidone daily, give 75 mg IM; or for patients stable on 4 mg of PO risperidone daily, give 100 mg IM starting one day after the last PO risperidone dose.

Adjust-a-dose:  Recommended dosage is 75 mg once monthly after titration to at least 3 mg PO risperidone in patients with kidney or liver impairment. Two to four weeks before starting a strong CYP2D6 inhibitor, decrease risperidone dosage to 75 mg once monthly, if applicable. If given with a strong CYP3A4 inducer, increase risperidone dosage from 75 mg to 100 mg once daily; additional oral risperidone may be considered in patients on 100-mg dose. Reevaluate dosage after discontinuing CYP3A4 inducer.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


tenofovir alafenamide

Vemlidy
Pharmaceutical company: Gilead Sciences

NEW INDICATION & DOSAGE
Chronic hepatitis B virus infection
Children age 6 and older weighing at least 25 kg: 25 mg PO daily.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer