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New Drug Indications - May 2025

cabozantinib

Cabometyx
Pharmaceutical company: Exelixis, Inc.


NEW INDICATION & DOSAGE
Previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic or extra-pancreatic neuroendocrine tumors (Cabometyx only)
Adults and children ages 12 and older weighing 40 kg or more: 60 mg PO daily until disease progression or unacceptable toxicity.
Children ages 12 and older weighing less than 40 kg: 40 mg PO daily until disease progression or unacceptable toxicity.

Released: May 2025

Nursing Drug Handbook

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durvalumab

Imfinzi
Pharmaceutical company: AstraZeneca


NEW INDICATION & DOSAGE
Muscle-invasive bladder cancer
Adults weighing 30 kg or more: 1,500 mg IV every 3 weeks in combination with gemcitabine and cisplatin for 4 cycles prior to surgery, followed by 1,500 mg IV every 4 weeks as a single agent for up to 8 cycles after surgery.
Adults weighing less than 30 kg: 20 mg/kg IV every 3 weeks in combination with gemcitabine and cisplatin for 4 cycles prior to surgery, followed by 20 mg/kg IV every 4 weeks as a single agent for up to 8 cycles after surgery.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

eculizumab

Soliris
Pharmaceutical company: Alexion Pharmaceuticals


NEW INDICATION & DOSAGE
Generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive
Children ages 6 and older weighing 40 kg or more: 900 mg IV once every 7 days for 4 weeks, then 1,200 mg IV 7 days later (week 5), followed by 1,200 mg IV every 2 weeks thereafter.
Children ages 6 and older weighing 30 to less than 40 kg: 600 mg IV once every 7 days for 2 weeks, then 900 mg IV 7 days later (week 3), followed by 900 mg IV every 2 weeks thereafter.
Children ages 6 and older weighing 20 to less than 30 kg: 600 mg IV once every 7 days for 2 weeks, then 600 mg IV 7 days later (week 3), followed by 600 mg IV every 2 weeks thereafter.
Children ages 6 and older weighing 10 to less than 20 kg: 600 mg IV once every 7 days on week 1, then 300 mg IV 7 days later (week 2), followed by 300 mg IV every 2 weeks thereafter.
Children ages 6 and older weighing 5 to less than 10 kg: 300 mg IV once every 7 days on week 1, then 300 mg IV 7 days later (week 2), followed by 300 mg IV every 3 weeks thereafter.

Adjust-a-dose: Give a supplemental dose within 60 minutes after each plasmapheresis or plasma exchange session. If the most recent dose was 300 mg, give 300-mg supplemental dose. If the most recent dose was 600 mg or more, give 600-mg supplemental dose. For patients receiving fresh frozen plasma, if the most recent dose was 300 mg or more, give 300-mg supplemental dose 1 hour before each unit of fresh frozen plasma. In a patient receiving concomitant IV immunoglobulin treatment, refer to the manufacturer's instructions for supplemental eculizumab dose requirements and timing.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

emtricitabine-rilpivirine-tenofovir alafenamide

Odefsey
Pharmaceutical company: Gilead Sciences


NEW INDICATION & DOSAGE
HIV-1 infection as initial therapy in patients with no antiretroviral treatment history and HIV-1 RNA of 100,000 copies/mL or less; or to replace a stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components
Children ages 6 and older weighing at least 25 kg: 1 tablet PO daily with a meal.

Adjust-a-dose: For patients on hemodialysis, give 1 tablet daily; give after hemodialysis on dialysis days. This drug isn't recommended for patients with creatinine clearance of less than 30 mL/minute or in patients with chronic kidney disease who aren't receiving long-term dialysis.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

epinephrine

Neffy
Pharmaceutical company: ARS Pharma

NEW AVAILABLE FORM
Nasal spray: 1 mg/0.1 mL per single-dose spray

NEW INDICATION & DOSAGE
Type I allergic reactions, including anaphylaxis
Adults and children ages 4 and older weighing 15 to less than 30 kg: One spray (1 mg) into one nostril. If there is no clinical response or worsening symptoms, repeat the dose after 5 minutes in the same nostril.

 

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

furosemide

Furoscix
Pharmaceutical company: scPharmaceuticals


NEW INDICATION & DOSAGE
Edema in patients with chronic kidney disease, including the nephrotic syndrome
Adults: Subcutaneous on-body infusor with prefilled cartridge preprogrammed to deliver 30 mg over first hour, followed by 12.5 mg per hour for subsequent 4 hours. Total dose, 80 mg over 5 hours.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

glucagon

Baqsimi
Pharmaceutical company: Amphastar Pharmaceuticals


NEW INDICATION & DOSAGE
Severe hypoglycemia in patients with diabetes
Children ages 1 and older: 3 mg (one actuation of intranasal device) into one nostril. If there is no response after 15 minutes, the dose may be repeated.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

pembrolizumab

Keytruda
Pharmaceutical company: Merck


NEW INDICATION & DOSAGE
First-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy
Adults: 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 in patients without disease recurrence. Give before trastuzumab and chemotherapy, when given the same day.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

tenecteplase

TNKase
Pharmaceutical company: Genentech


NEW INDICATION & DOSAGE
Acute ischemic stroke
Adults weighing 90 kg or more: 25 mg (5 mL) by IV bolus over 5 seconds.
Adults weighing 80 to less than 90 kg: 22.5 mg (4.5 mL) by IV bolus over 5 seconds.
Adults weighing 70 to less than 80 kg: 20 mg (4 mL) by IV bolus over 5 seconds.
Adults weighing 60 to less than 70 kg: 17.5 mg (3.5 mL) by IV bolus over 5 seconds.
Adults weighing less than 60 kg: 15 mg (3 mL) by IV bolus over 5 seconds.

Adjust-a-dose: Begin treatment as soon as possible and within 3 hours of the onset of stroke symptoms.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

tesamorelin acetate

Egrifta WR
Pharmaceutical company: Theratechnologies

NEW AVAILABLE FORM
Injection (Egrifta WR):11.6-mg vials

NEW INDICATION & DOSAGE
Reduction of excess abdominal fat in patients infected with HIV-1 with lipodystrophy
Adults: Inject 1.28 mg (0.16 mL) subcut once daily in abdomen.

Released: May 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.

New Drug Indications Archive

New Drug Indications - August 2021
fesoterodine fumarateToviazPharmaceutical company: PfizerNEW INDICATION & DOSAGENeurogenic detrusor overactivityChildren age 6 and older weighing more than 35 kg: 4 mg PO once daily for 1 week, then increase to 8 mg once daily.Children age 6 and older weighing more than 25 kg and up to 35 kg: 4 mg PO once daily. May increase to 8 mg once daily if needed.Adjust-a-dose: In children weighing more than 25 kg and up to 35 kg, recommended dose is 4 mg daily; this drug is not recommended if eGFR is 29 mL/min/1.73 m2. In children weighing 35 kg or more and eGFR is 29 mL/min/1.73 m2, recommended dose is 4 mg daily; this drug is not recommended if eGFR is less than 15 mL/min/1.73 m2. If coadministering strong CYP3A4 inhibitor in children weighing more than 35 kg, maximum dose is 4 mg daily; coadministration is not recommended in children weighing more than 25 kg and up to 35 kg.CONTRAINDICATIONS AND CAUTIONSAlert: Contraindicated in patients hypersensitive to tolterodine tartrate.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerglecaprevir–pibrentasvirMavyretPharmaceutical company: AbbVie, Inc.NEW AVAILABLE FORMOral pellets: 50 mg glecaprevir and 20 mg pibrentasvirNEW INDICATION & DOSAGEChronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection in treatment-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh class A)Children age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 8 weeks.HCV genotype 1 infection with or without compensated cirrhosis (Child-Pugh class A) in patients previously treated with an HCV NS5A inhibitor but without an NS3/4A protease inhibitor (PI)Children age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 16 weeks.HCV genotype 1 infection with or without compensated cirrhosis (Child-Pugh class A) in patients previously treated with an NS3/4A PI without an NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 12 weeks.HCV genotype 1, 2, 4, 5, or 6 infection without cirrhosis in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 8 weeks.HCV genotype 1, 2, 4, 5, or 6 infection with compensated cirrhosis (Child-Pugh class A) in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir, but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 12 weeks.HCV genotype 3 infection without cirrhosis or with compensated cirrhosis (Child-Pugh class A) in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir, but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 16 weeks.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerozanimodZeposiaPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGEModerate to severe active ulcerative colitisAdults: Initially, 0.23 mg PO once daily on days 1 to 4, then 0.46 mg PO once daily on days 5 to 7, then maintenance dose of 0.92 mg PO once daily.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerposaconazoleNoxafilPharmaceutical company: Merck Sharp & Dohme Corp.NEW AVAILABLE FORMPowder for delayed-release oral suspension: 300 mgNEW INDICATION & DOSAGEPrevention of invasive Aspergillus and Candida infections in patients with a high-risk of immunocompromise until recovered from neutropenia or immunosuppressionIV infusionChildren ages 2 to less than 18: 6 mg/kg up to a maximum of 300-mg IV infusion b.i.d. on first day, then 6 mg/kg to a maximum of 300 mg once daily.Delayed-release oral suspensionChildren age 2 to less than 18 weighing 36 to 40 kg: 240 mg (8 mL) PO b.i.d on first day, then 240 mg once daily.Children age 2 to less than 18 weighing 26 to less than 36 kg: 210 mg (7 mL) PO b.i.d. on first day, then 210 mg once daily.Children age 2 to less than 18 weighing 21 to less than 26 kg: 180 (6 mL) mg PO b.i.d. on first day, then 180 mg once daily.Children age 2 to less than 18 weighing 17 to less than 21 kg: 150 mg (5 mL) PO b.i.d. on first day, then 150 mg once daily.Children age 2 to less than 18 weighing 12 to less than 17 kg: 120 mg (4 mL) PO b.i.d. on first day, then 120 mg once daily.Children age 2 to less than 18 weighing 10 to less than 12 kg: 90 mg (3 mL) PO b.i.d. on first day, then 90 mg once daily.Alert: Powder for delayed-release oral suspension is contraindicated in patients with known or suspected hereditary fructose intolerance.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerravulizumab-cwvzUltomirisPharmaceutical company: Alexion PharmaceuticalsNEW AVAILABLE FORMInjection: 300 mg/3 ml (100 mg/mL) and 1,100 mg/11 mL (100 mg/mL) single-dose vialsNEW INDICATION & DOSAGETreatment of paroxysmal nocturnal hemoglobinuriaChildren age 1 month and older 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.Children age 1 month and older 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.Children age 1 month and older 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.Children age 1 month and older weighing 30 to less than 40 kg: 1,200-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 2,700-mg IV infusion once every 8 weeks.Children age 1 month and older weighing 20 to less than 30 kg: 900-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 2,100-mg IV infusion once every 8 weeks.Children age 1 month and older weighing 10 to less than 20 kg: 600-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 600-mg IV infusion once every 4 weeks.Children age 1 month and older weighing 5 to less than 10 kg: 600-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 300-mg IV infusion once every 4 weeks.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerrimegepantNurtec ODTPharmaceutical company: Biohaven PharmaceuticalsNEW INDICATION & DOSAGEPrevention of episodic migraineAdults: 75 mg PO every other day.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwersecukinumabCosentyxPharmaceutical company: Novartis PharmaceuticalsNEW INDICATION & DOSAGEModerate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapyChildren age 6 and older weighing 50 kg or more: 150 mg subcut at weeks 0, 1, 2, 3, and 4; then 150 mg every 4 weeks thereafter.Children age 6 and older weighing less than 50 kg: 75 mg subcut at weeks 0, 1, 2, 3, and 4; then 75 mg every 4 weeks thereafter.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwersofosbuvir–velpatasvirEpclusaPharmaceutical company: Gilead SciencesNEW AVAILABLE FORMOral pellets: 150 mg sofosbuvir and 37.5 mg velpatasvir; 200 mg sofosbuvir and 50 mg velpatasvir packetsNEW INDICATION & DOSAGEChronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh class A) or with decompensated cirrhosis (Child-Pugh class B or C) in combination with ribavirinChildren age 3 and older weighing at least 30 kg: 400 mg sofosbuvir and 100 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Children age 3 and older weighing 17 to less than 30 kg: 200 mg sofosbuvir and 50 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Children age 3 and older weighing less than 17 kg: 150 mg sofosbuvir and 37.5 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluweravapritinibAyvakitPharmaceutical company: Blueprint MedicinesNEW INDICATION & DOSAGEAdvanced systemic mastocytosisAdults: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Reduce starting dose to 50 mg PO once daily when giving with moderate CYP3A inhibitor. Recommended dose has not been established for patients with severe renal impairment, end-stage renal disease, or severe hepatic impairment. This drug is not recommended for patients with platelet counts less than 50 x 109/L. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Permanently discontinue drug if patient cannot tolerate 25 mg once daily.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerdabigatranPradaxaPharmaceutical company: Boehringer IngelheimNEW INDICATION & DOSAGETreatment of venous thromboembolism (VTE) in children previously treated with parenteral anticoagulant for at least 5 daysChildren age 8 to less than 18 (capsules): Weight-based dose PO b.i.d. according to the manufacturer's instructions.Children age 3 months to less than 12 years (pellets): Weight-based dose PO b.i.d. according to the manufacturer's instructions.Adjust-a-dose: Avoid use in children with eGFR less than 50 mL/min/1.73 m2.To reduce the risk of recurrence of VTE in previously treated childrenChildren age 8 to less than 18 (capsules): Weight-based dose PO b.i.d. after previous treatment according to the manufacturer's instructions.Children age 3 months to less than 12 years (pellets): Weight-based dose PO b.i.d. after previous treatment according to the manufacturer's instructions.Adjust-a-dose: Avoid use in children with eGFR less than 50 mL/min/1.73 m2.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerelexacaftor–tezacaftor–ivacaftor and ivacaftorTrikaftaPharmaceutical company: Vertex PharmaceuticalsNEW AVAILABLE FORMTablets: 50 mg elexacaftor, 25 mg tezacaftor, and 37.5 mg ivacaftor (fixed-dose combination), copackaged with 75 mg ivacaftorNEW INDICATION & DOSAGECystic fibrosis in patients who have at least one F508del mutation in the CFTR geneChildren age 6 to less than 12 years weighing 30 kg or more: Two tablets (each containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor) PO in the morning, followed by one 150-mg ivacaftor tablet in the evening about 12 hours later.Children age 6 to less than 12 years weighing less than 30 kg: Two tablets (each containing 50 mg elexacaftor, 25 mg tezacaftor, and 37.5 mg ivacaftor) PO in the morning, followed by one 75-mg ivacaftor tablet in the evening about 12 hours later.Adjust-a-dose: For patients with moderate hepatic impairment (Child-Pugh class B), two tablets (each containing elexacaftor, tezacaftor, and ivacaftor) PO in the morning on day 1, alternating with one tablet in the morning on day 2. No evening dose of ivacaftor should be taken. For patients currently receiving moderate and strong CYP3A inhibitors, refer to the manufacturer's instructions for dosage adjustments.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - July 2021
dapagliflozinFarxigaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGETo reduce the risk of sustained eGFR decline, end-stage renal disease (ESRD), CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk for progressionAdults: 10 mg PO once daily.Adjust-a-dose: This drug is not recommended for initiation when eGFR is less than 25 mL/min/1.73 m2; however, patient may continue 10 mg PO once daily to reduce the risk of eGFR decline, ESRD, CV death, and hospitalization for heart failure.CONTRAINDICATIONS & CAUTIONSThis drug is not recommended for treatment of chronic kidney disease in patients with polycystic kidney disease or those with current or recent immunosuppressive therapy for kidney disease.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwerdiclofenac potassiumZipsorPharmaceutical company: Assertio Therapeutics, Inc.NEW INDICATION & DOSAGEMild to moderate acute pain (Zipsor)Adults and children age 12 and older: 25 mg PO q.i.d.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapyAdults: 240-mg IV infusion every 2 weeks, or 480-mg IV infusion every 4 weeks, until disease progression or unacceptable toxicity occurs, or up to 1 year of treatment.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEFirst-line treatment in patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks prior to trastuzumab and chemotherapy when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Monotherapy treatment in patients with locally recurrent advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerspinosadNatrobaPharmaceutical company: ParaPRONEW INDICATION & DOSAGEScabies infestationAdults and children age 4 and older: Apply to skin to completely cover body from the neck to soles of feet. Patients with balding scalp should also apply to scalp, hairline, temples, and forehead. Allow skin to dry for 10 minutes before getting dressed. Leave on skin for 6 hours before showering or bathing.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwer
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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