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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

New Drug Indications Archive

New Drug Indications - June 2021
alirocumabPraluentPharmaceutical company: RegeneronNEW INDICATION & DOSAGEAdjunct to other LDL cholesterol (LDL-C)-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-CAdults: 150 mg subcut every 2 weeks.Released: June 2021© 2021 Wolters KluwercetuximabErbituxPharmaceutical company: LillyNEW INDICATION & DOSAGESquamous cell carcinoma of the head and neck, as a single agent or in combination with platinum-based therapy and fluorouracilAdults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before platinum-based therapy with fluorouracil. Continue therapy until disease progression or unacceptable toxicity occurs.KRAS mutation-negative (wild type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer as determined by FDA-approved tests given in combination with FOLFIRI (irinotecan, 5-FU, leucovorin) chemotherapy regimen for first-line treatment or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, or given as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecanAdults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before irinotecan or FOLFIRI. Continue therapy until disease progression or unacceptable toxicity occurs.Adjust-a-dose (for all indications): Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.Released: June 2021© 2021 Wolters Kluwerdaunorubicin and cytarabine liposomeVyxeosPharmaceutical company: Jazz PharmaceuticalsNEW INDICATION & DOSAGENewly diagnosed, therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changesChildren age 1 and older: A full course of therapy consists of one or two induction cycles followed by up to two consolidation cycles. For initial induction cycle, 44 mg/m2 daunorubicin/100 mg/m2 cytarabine IV infusion on days 1, 3, and 5. For patients who fail to achieve a response from first induction cycle, give a second induction cycle of 44 mg/m2 daunorubicin/100 mg/m2 cytarabine IV infusion on days 1 and 3. May give second induction cycle 2 to 5 weeks after first induction cycle if no unacceptable toxicity occurs with previous cycle.Give first consolidation cycle 5 to 8 weeks after start of the last induction. Recommended dose for each consolidation cycle is 29 mg/m2 daunorubicin/65 mg/m2 cytarabine IV infusion on days 1 and 3. Give second consolidation cycle 5 to 8 weeks after start of first consolidation cycle if no disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: June 2021© 2021 Wolters KluwerdiazepamDiastatPharmaceutical company: Bausch HealthNEW INDICATION & DOSAGEAcute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from patient's usual seizure patternAdults and children age 12 and older: 0.2 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Children ages 6 to 11: 0.3 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Children ages 2 to 5: 0.5 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Released: June 2021© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdvanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 360-mg IV infusion every 3 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks; or 240-mg IV infusion every 2 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years in patients without disease progression.Adjust-a-dose: Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.Released: June 2021© 2021 Wolters KluwertreprostinilTyvasoPharmaceutical company: United Therapeutics Corp.NEW INDICATION & DOSAGEPulmonary arterial hypertension associated with interstitial lung disease in patients (WHO group 3) to improve exercise abilityAdults: Initially, 3 breaths (18 mcg) per treatment session q.i.d., approximately 4 hours apart. Increase dose by 3 breaths in 1- to 2-week intervals, as tolerated, to target maintenance dose of 9 breaths (54 mcg) q.i.d. If 3 breaths are not tolerated initially, decrease to 1 or 2 breaths and increase as tolerated.Released: June 2021© 2021 Wolters KluwervalsartanDiovanPharmaceutical company: NovartisNEW INDICATION & DOSAGEHypertensionChildren ages 1 to 16: Initially, 1 mg/kg PO daily (up to 40 mg total). Adjust according to patient response and tolerability, up to 4 mg/kg or 160 mg daily.Adjust-a-dose: Consider starting dose of 2 mg/kg in select cases when greater reduction of blood pressure is needed.Released: June 2021© 2021 Wolters Kluwer
New Drug Indications - May 2021
adalimumabHumiraPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerately to severely active ulcerative colitisChildren 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 KluweraxicabtageneYescartaPharmaceutical company: Kite Pharma NEW INDICATION & DOSAGERelapsed or refractory follicular lymphoma after two or more lines of systemic therapyAdults: 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 KluwermirabegronMyrbetriq; Myrbetriq GranulesPharmaceutical company: Astellas Pharma, Inc. NEW INDICATION & DOSAGENeurogenic detrusor overactivityChildren 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 KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & Dohme Corp. NEW INDICATION & DOSAGELocally 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 chemotherapyAdults: 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 testAdults: 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 KluwertocilizumabActemraPharmaceutical company: Genentech NEW INDICATION & DOSAGESlowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung diseaseAdults: 162 mg subcut once every week.Released: May 2021© 2021 Wolters Kluwer
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