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New Drug Indications - May 2024


fluticasone propionate

Xhance
Pharmaceutical company: Optinose, Inc.

NEW INDICATION & DOSAGE
Chronic rhinosinusitis with or without polyps
Adults: 1 spray (93 mcg/spray) in each nostril b.i.d. May increase to maximum dose of 2 sprays in each nostril b.i.d.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


maralixibat

Livmarli
Pharmaceutical company: Mirum Pharmaceuticals

NEW INDICATION & DOSAGE
Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)
Adults and children age 5 and older: Initially, 285 mcg/kg PO once daily in the morning. Increase as tolerated to 285 mcg/kg b.i.d., then to 428 mcg/kg b.i.d., and then to recommended dosage of 570 mcg/kg PO b.i.d. 30 minutes before a meal. The maximum dose is 38 mg daily.

Adjust-a-dose: Decrease dosage or interrupt therapy for new liver function test (LFT) abnormalities or GI adverse reactions. When LFT values return to baseline or stabilize at new baseline values, consider restarting at last tolerated dose, and increase as tolerated. If LFT abnormalities or GI reactions recur, or signs and symptoms consistent with clinical hepatitis, portal hypertension, or liver decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy. This drug isn't recommended in a subgroup of PFIC type 2 patients with nonfunctional or complete absence of bile salt export pump protein.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


alirocumab

Praluent
Pharmaceutical company: Regeneron Pharmaceuticals

NEW INDICATION & DOSAGE
Adjunct to diet and other LDL-C-lowering therapies in patients with heterozygous familial hypercholesterolemia to reduce LDL-C
Children age 8 and older weighing 50 kg or more: 300 mg subcut every 4 weeks. If LDL-C reduction is inadequate, adjust dosage to 150 mg every 2 weeks.
Children age 8 and older weighing less than 50 kg: 150 mg subcut every 4 weeks. If LDL-C reduction is inadequate, adjust dosage to 75 mg subcut every 2 weeks.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


nivolumab

Opdivo
Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE
With cisplatin and gemcitabine, for unresectable or metastatic urothelial carcinoma (first-line treatment)
Adults: 360-mg IV infusion with cisplatin and gemcitabine on the same day every 3 weeks for up to 6 cycles; then 240-mg IV infusion every 2 weeks or 480-mg IV infusion every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs, or up to 2 years from the first dose.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


rilpivirine

Edurant
Pharmaceutical company: Janssen Therapeutics

NEW FORMULATION
Tablets for oral suspension: 2.5 mg (Edurant Ped)

NEW INDICATION & DOSAGE
HIV-1 infection in patients who are antiretroviral-naive with HIV-1 RNA 100,000 copies/mL or less at start of therapy, in combination with other antiretrovirals
Children age 2 and older weighing 25 kg or more: 25 mg PO once daily.
Children age 2 and older weighing 20 kg to less than 25 kg: 15 mg (6 tablets for oral suspension) PO once daily.
Children age 2 and older weighing 14 kg to less than 20 kg: 12.5 mg (5 tablets for oral suspension) PO once daily.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


remdesivir

Veklury
Pharmaceutical company: Gilead Sciences, Inc.

NEW INDICATION & DOSAGE
Coronavirus disease 2019 (COVID-19) requiring hospitalization
Children age 28 days and older weighing 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis with 2.5 mg/kg-IV infusion on day 1, followed by maintenance dose of 1.25 mg/kg-IV infusion once daily starting on day 2 for 5 days in patients not requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). If no clinical improvement, may extend therapy 5 additional days. Give the drug for 10 days to patients requiring invasive mechanical ventilation or ECMO.
Children younger than 28 days weighing at least 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis with 2.5 mg/kg-IV infusion on day 1, followed by maintenance dose of 1.25 mg/kg-IV infusion once daily starting on day 2 for 5 days in patients not requiring invasive mechanical ventilation or ECMO. If no clinical improvement, may extend therapy 5 additional days. Give the drug for 10 days to patients requiring invasive mechanical ventilation or ECMO.

Adjust-a-dose:  Consider discontinuing the drug if ALT level increases to greater than 10 times the upper limit of normal (ULN). Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.

Nonhospitalized patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including hospitalization or death
Children age 28 days and older weighing 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 2.5 mg/kg-IV infusion on day 1, followed by 1.25 mg/kg-IV infusion once daily on days 2 and 3.
Children younger than 28 days weighing at least 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 2.5 mg/kg-IV infusion on day 1, followed by 1.25 mg/kg-IV infusion once daily on days 2 and 3.

Adjust-a-dose:  Consider discontinuing the drug if ALT level increases to greater than 10 times the ULN. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


semaglutide

Wegovy
Pharmaceutical company: Novo Nordisk

NEW INDICATION & DOSAGE
To reduce the risk of major CV events (CV death, nonfatal MI, or nonfatal stroke) in patients with established CV disease and either obesity or overweight (Wegovy only)
Adults: Initially, 0.25 mg subcut once weekly for 4 weeks, then increase to 0.5 mg for 4 weeks, then 1 mg for 4 weeks, then 1.7 mg for 4 weeks, then to a 2.4-mg weekly maintenance dose.

Adjust-a-dose:  If any dose is not initially tolerated, delay dose escalation for 4 weeks. If a 2.4-mg dose is not tolerated, decrease to maintenance dose of 1.7 mg. If the 1.7 mg dose is not tolerated, discontinue the drug.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


zanubrutinib

Brukinsa
Pharmaceutical company: BeiGene

NEW INDICATION & DOSAGE
With obinutuzumab, for relapsed or refractory follicular lymphoma (after two or more lines of systemic therapy)
Adults: 160 mg PO b.i.d. or 320 mg PO once daily until disease progression or unacceptable toxicity occurs.

Released: May 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive


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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