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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

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

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 - May 2025
cabozantinibCabometyxPharmaceutical company: Exelixis, Inc.NEW INDICATION & DOSAGEPreviously 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.durvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEMuscle-invasive bladder cancerAdults 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.eculizumabSolirisPharmaceutical company: Alexion PharmaceuticalsNEW INDICATION & DOSAGEGeneralized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positiveChildren 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.emtricitabine-rilpivirine-tenofovir alafenamideOdefseyPharmaceutical company: Gilead SciencesNEW INDICATION & DOSAGEHIV-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 componentsChildren 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.epinephrineNeffyPharmaceutical company: ARS PharmaNEW AVAILABLE FORMNasal spray: 1 mg/0.1 mL per single-dose sprayNEW INDICATION & DOSAGEType I allergic reactions, including anaphylaxisAdults 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.furosemideFuroscixPharmaceutical company: scPharmaceuticalsNEW INDICATION & DOSAGEEdema in patients with chronic kidney disease, including the nephrotic syndromeAdults: 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.glucagonBaqsimiPharmaceutical company: Amphastar PharmaceuticalsNEW INDICATION & DOSAGESevere hypoglycemia in patients with diabetesChildren 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.pembrolizumabKeytrudaPharmaceutical company: MerckNEW INDICATION & DOSAGEFirst-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 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 in patients without disease recurrence. Give before trastuzumab and chemotherapy, when given the same day.Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.tenecteplaseTNKasePharmaceutical company: GenentechNEW INDICATION & DOSAGEAcute ischemic strokeAdults 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 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.tesamorelin acetateEgrifta WRPharmaceutical company: TheratechnologiesNEW AVAILABLE FORMInjection (Egrifta WR):11.6-mg vialsNEW INDICATION & DOSAGEReduction of excess abdominal fat in patients infected with HIV-1 with lipodystrophyAdults: Inject 1.28 mg (0.16 mL) subcut once daily in abdomen.Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
New Drug Indications - April 2025
apomorphine hydrochlorideOnapgoPharmaceutical company: Supernus PharmaceuticalsNEW AVAILABLE FORMSolution for infusion: 98 mg/20 mL (4.9 mg/mL) in single-dose cartridgesNEW INDICATION & DOSAGEMotor fluctuations in patients with advanced Parkinson diseaseAdults: Initially, 1 mg/hr subcut infusion for up to 16 hours per day. Titrate, as needed, no more than once per day in 0.5 mg/hr to 1 mg/hr increments. Maximum, 6 mg/hr while awake during the day, up to 16 hours. May give bolus dose when starting the infusion in the morning, when restarting the infusion after a 1-hour or longer break, or to supplement continuous infusion to manage acute, uncontrolled "off" symptoms. Titrate bolus dose to clinical response and tolerance in increments of 0.5 mg or 1 mg. Maximum bolus, 2 mg. Give no more than 3 bolus doses per day with at least 3 hours between doses. Consider increasing the continuous infusion rate if 3 bolus doses/day are routinely required. Total maximum daily dosage, including bolus doses, is 98 mg.Adjust-a-dose: In patients with mild to moderate kidney impairment, don't exceed 1 mg for initial bolus dose.Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.brentuximab vedotinAdcetrisPharmaceutical company: Pfizer, Inc.NEW INDICATION & DOSAGERelapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy in patients who are not eligible for autologous hematopoietic stem cell transplantation or chimeric antigen receptor T-cell therapy, in combination with lenalidomide and rituximabAdults: 1.2-mg/kg IV infusion every 3 weeks or until disease progression or unacceptable toxicity occurs. Maximum dose, 120 mg. Give with granulocyte colony-stimulating factor beginning cycle 1.Adjust-a-dose: In patients with normal total bilirubin and AST greater than the upper limit of normal (ULN), or total bilirubin more than 1 to 1.5 x ULN and any AST, reduce dosage to 0.9 mg/kg every 3 weeks. Maximum dose, 90 mg. Avoid use in patients with total bilirubin more than 1.5 x ULN.Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.ranibizumabSusvimoPharmaceutical company: GenentechNEW INDICATION & DOSAGEDiabetic macular edema in patients who have previously responded to at least two intravitreal injections of a VEGF inhibitor (Susvimo)Adults: 2 mg (0.02 mL of 100 mg/mL solution) continuous delivery by ocular implant with refills every 24 weeks.Adjust-a-dose: May give a supplemental intravitreal injection to affected eye, with ocular implant in place, if needed.Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.semaglutideOzempicPharmaceutical company: Novo NordiskNEW INDICATION & DOSAGEReduce risk of sustained estimated GFR decline, kidney failure, and cardiovascular death in patients with type 2 diabetes and chronic kidney disease (Ozempic only)Adults: Initially, 0.25 mg subcut once weekly for 4 weeks; then increase to 0.5 mg once weekly. After 4 weeks, increase to maintenance dose of 1 mg once weekly.Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
New Drug Indications - March 2025
acalabrutinibCalquencePharmaceutical company: AstraZenecaNEW INDICATION & DOSAGETreatment of previously untreated mantle cell lymphoma in combination with bendamustine and rituximab in patients who are ineligible for autologous hematopoietic stem cell transplantationAdults: 100 mg PO every 12 hours until disease progression or unacceptable toxicity occurs. Give bendamustine 90 mg/m2 IV on days 1 and 2, and rituximab 375 mg/m2 IV on day 1 of cycle 1 and continue for a total of six 28-day cycles. Patients achieving a partial or complete response after the first six cycles may continue maintenance rituximab on day 1 of every other cycle for a maximum of 12 additional doses, starting on cycle 8 up to cycle 30. Refer to bendamustine and rituximab prescribing information for additional information.Treatment of previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma in combination with obinutuzumabAdults: 100 mg PO every 12 hours until disease progression or unacceptable toxicity occurs. Start obinutuzumab on day 1 of cycle 2 for a total of six 28-day cycles. Refer to the obinutuzumab prescribing information for dosing and additional information.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.canagliflozinInvokanaPharmaceutical company: Janssen PharmaceuticalsNEW INDICATION & DOSAGEAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetesChildren ages 10 and older: 100 mg PO once daily before the first meal of the day. May increase to 300 mg/day in patients with an estimated GFR of 60 mL/minute/1.73 m2 or greater.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.canagliflozin and metFORMIN hydrochlorideInvokamet, Invokamet XRPharmaceutical company: Johnson & JohnsonNEW INDICATION & DOSAGEAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes when treatment with both canagliflozin and metformin is appropriateChildren ages 10 and older currently not treated with either canagliflozin or metformin: One tablet of immediate-release canagliflozin 50 mg and metformin 500 mg PO b.i.d. with meals. Or two tablets of extended-release canagliflozin 50 mg and metformin 500 mg PO daily with morning meal.Children ages 10 and older already on metformin: Immediate-release, 50 mg canagliflozin plus previously prescribed or nearest appropriate dose of metformin in divided doses PO b.i.d. with meals. Or extended-release, 100 mg canagliflozin plus previously prescribed or nearest appropriate dose of metformin once daily with morning meal. Patients taking an evening dose of metformin extended-release should skip their last dose before starting this drug the following morning.Children ages 10 and older already on canagliflozin: Immediate-release, 500 mg metformin plus previously prescribed dose of canagliflozin in divided doses PO b.i.d. with meals. Or extended-release, 1,000 mg metformin plus previously prescribed dose of canagliflozin PO once daily with morning meal.Children ages 10 and older already on canagliflozin and metformin: Switch to the same total daily doses of each component divided PO b.i.d. with meals for immediate-release, or PO once daily with morning meal for extended-release. Patients taking an evening dose of metformin extended-release should skip their last dose before starting this drug the following morning.Adjust-a-dose: In patients who have an estimated GFR of 60 mL/minute/1.73 m2 or greater and require additional glycemic control: If tolerating immediate-release canagliflozin 50 mg b.i.d., increase the canagliflozin dose to 150 mg b.i.d., with gradual metformin dose escalation based on tolerability; if tolerating extended-release canagliflozin 100 mg once daily, increase the canagliflozin dose to 300 mg once daily, with gradual metformin dose escalation based on tolerability.Adjust-a-dose: Increase the dose gradually, if needed, to reduce metformin's GI adverse effects. Don't exceed the maximum daily dose of 2,000 mg of metformin and 300 mg of canagliflozin. Limit the total daily dose of the canagliflozin component to 100 mg in patients with abnormal kidney function with estimated GFR of 45 to less than 60 mL/minute/1.73 m2. If estimated GFR is 30 to 45 mL/minute/1.73m2, assess the benefit and risk of continuing the combination product, and limit the dose of canagliflozin component to 100 mg daily. Use is contraindicated in patients with an estimated GFR less than 30 mL/minute/1.73 m2 and in those with kidney failure with replacement therapy or who are on hemodialysis. If concomitant use of uridine 5'-diphospho-glucuronosyltransferase enzyme inducer is required, increase the total daily dose of canagliflozin to 200 mg in patients currently tolerating 100 mg daily; may increase to 300 mg daily in patients currently tolerating 200 mg daily with an estimated GFR of more than 60 mL/minute/1.73m2.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.fondaparinux sodiumArixtraPharmaceutical company: MylanNEW INDICATION & DOSAGEVenous thromboembolismChildren ages 1 and older weighing at least 10 kg to 20 kg: 0.1 mg/kg subcut daily. Round patient-specific dose to nearest 0.1 mg.Children ages 1 and older weighing more than 20 kg to 40 kg: 2.5 mg/0.5 mL prefilled syringe.Children ages 1 and older weighing more than 40 kg to 60 kg: 5 mg/0.4 mL prefilled syringe.Children ages 1 and older weighing more than 60 kg: 7.5 mg/0.6 mL prefilled syringe.Adjust-a-dose: If full prefilled syringe dosing in children weighing more than 20 kg doesn't achieve therapeutic levels, a patient-specific dose may be prepared to achieve the peak anti-Xa level target of 0.5 mg/L to 1 mg/L. If the anti-Xa level is less than 0.3 mg/L, increase the dose by 0.03 mg/kg; if the level is 0.3 mL to 0.49 g/L, increase the dose by 0.01 mg/kg. If the anti-Xa level is 1.01 mg/L to 1.2 mg/L, decrease the dose by 0.01 mg/kg; if the level is greater than 1.2 mg/L, decrease the dose by 0.03 mg/kg. Round the patient-specific dose to the nearest 0.1 mg. Maximum daily dose is 7.5 mg.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.tapinarofVtamaPharmaceutical company: Dermavant Sciences, Inc.NEW INDICATION & DOSAGEAtopic dermatitisAdults and children ages 2 and older: Apply a thin layer to affected areas once daily.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.tirzepatideZepboundPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEModerate to severe obstructive sleep apnea in patients with obesity (Zepbound only)Adults: Initially, 2.5 mg subcut weekly for 4 weeks, then increase to 5 mg. May increase in 2.5-mg increments after at least 4 weeks at current dose. Recommended maintenance dose is 10 mg or 15 mg once weekly based on response and tolerability.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
New Drug Indications - February 2025
New Drug Indications - January 2025
New Drug Indications - December 2024
dalteparin sodiumFragminPharmaceutical company: PfizerNEW INDICATION & DOSAGESymptomatic venous thromboembolism in childrenChildren from birth (gestational age at least 35 weeks) to younger than 2 years: 150 international units/kg subcut b.i.d. for three doses; then assess anti-Xa level.Adjust-a-dose: Adjust dosage in increments of 25 international units/kg to achieve target anti-Xa level between 0.5 and 1 international unit/mL. If the platelet count is 50,000 to 100,000/mm3, reduce dosage by 50% until platelet count exceeds 100,000/mm3. If the platelet count is less than 50,000/mm3, stop the drug until the platelet count exceeds 50,000/mm3.Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi and Regeneron PharmaceuticalsNEW INDICATION & DOSAGEAdd-on maintenance treatment for inadequately controlled COPD and an eosinophilic phenotypeAdults: 300 mg subcut every other week.Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGENeoadjuvant treatment of resectable non–small-cell lung cancer (tumors at least 4 cm or node-positive) without known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, in combination with platinum-doublet chemotherapy; followed by single-agent nivolumab as adjuvant treatmentAdults: 360-mg IV infusion with platinum-doublet chemotherapy on the same day every 3 weeks for up to 4 cycles or until disease progression or unacceptable toxicity occurs; then as a single-agent, 480 mg every 4 weeks after surgery for up to 13 cycles or until disease recurrence or unacceptable toxicity occurs.  Released: December 2024Nursing Drug Handbook© 2024 Wolters KluweronabotulinumtoxinABotox CosmeticPharmaceutical company: Allergan Aesthetics/AbbVieINDICATION & DOSAGETemporary improvement in the appearance of moderate to severe platysma bands associated with platysma muscle activityAdults: 2 units (0.05 mL) IM into each of four sites in the upper segment of the platysma muscles below the jawline on each side; and 1 unit (0.025 mL) into five sites on each vertical neck band per side (1 to 2 bands per side). Depending on platysma band severity, total dose may be 26 units (1 band per side), 31 units (1 band one side, 2 bands other side), or 36 units (2 bands each side). Administer no more frequently than every 3 months.Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerosimertinibTagrissoPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGELocally advanced, unresectable (stage III) non–small-cell lung cancer in patients whose disease hasn't progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutationsAdults: 80 mg PO once daily until disease progression or unacceptable toxicity occurs.Released: December 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - November 2024
certolizumab pegolCimziaPharmaceutical company: UCB, Inc.NEW INDICATION & DOSAGEActive polyarticular juvenile idiopathic arthritisAdults and children ages 2 and older weighing 40 kg or more: 400 mg subcut at weeks 0, 2, and 4; then maintenance dose of 200 mg every 2 weeks.Adults and children ages 2 and older weighing 20 to less than 40 kg: 200 mg subcut at weeks 0, 2, and 4; then maintenance dose of 100 mg every 2 weeks.Adults and children ages 2 and older weighing 10 to less than 20 kg: 100 mg subcut at weeks 0, 2, and 4; then maintenance dose of 50 mg every 2 weeks.Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerletermovirPrevymisPharmaceutical company: Merck & Co.NEW AVAILABLE FORMOral pellets: 20 mg; 120 mg packetNEW INDICATION & DOSAGEProphylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)Children age 12 and older weighing at least 30 kg: 480 mg PO or IV infusion once daily through 100 days post-HSCT.Children ages 6 months to younger than 12 years weighing 15 to less than 30 kg: 240 mg PO or 120-mg IV infusion once daily through 100 days post-HSCT.Children ages 6 months to younger than 12 years weighing 7.5 to less than 15 kg: 120-mg oral pellets or 60-mg IV infusion once daily through 100 days post-HSCT.Children ages 6 months to younger than 12 years weighing 6 to less than 7.5 kg: 80-mg oral pellets or 40-mg IV infusion once daily through 100 days post-HSCT.Adjust-a-dose: May begin therapy between day 0 and day 28 post-HSCT. In patients at risk for late CMV infection and disease, may continue through 200 days post-HSCT. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily in children age 12 and older weighing at least 30 kg; 120 mg in children younger than age 12 weighing 15 to less than 30 kg; 60 mg in children younger than age 12 weighing 7.5 to less than 15 kg; or 40 mg in children younger than age 12 weighing 6 to less than 7.5 kg. If initiating cyclosporine after start of letermovir, decrease the next dose of letermovir. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.Prophylaxis of CMV disease in patients who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)Adults and children ages 12 and older weighing at least 40 kg: 480 mg PO or IV infusion once daily through 200 days posttransplant.Adjust-a-dose: May begin therapy between day 0 and day 7 posttransplant. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir to 480 mg once daily. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEFirst-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma, in combination with pemetrexed and platinum 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 in patients without disease progression. Give before chemotherapy when given the same day.  Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerribociclibKisqaliPharmaceutical company: NovartisINDICATION & DOSAGEAdjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, stage II and III early breast cancer in patients at high risk for recurrence, in combination with an aromatase inhibitorAdults: 400 mg PO once daily for 21 consecutive days followed by 7 days off therapy. Continue for 3 years, or until disease recurrence or unacceptable toxicity occurs. Refer to the aromatase inhibitor prescribing information for dosage and administration specifics.Adjust-a-dose: For patients with early breast cancer and Child-Pugh class B or C liver impairment, no dose adjustment is necessary. If use with a strong CYP3A inhibitor can't be avoided, reduce ribociclib dose to 200 mg once daily; allow 5 half-lives of the inhibitor after discontinuation of the inhibitor before returning to the initial ribociclib dose.Released: November 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - October 2024
paliperidone palmitateErzofriPharmaceutical company: Luye PharmaNEW FORMULATIONInjection: 351 mg/2.25 mLINDICATION & DOSAGESchizophrenia and schizoaffective disorderAdults: Initially, paliperidone (Erzofri) 351 mg IM administered in the deltoid muscle on treatment day 1, followed by monthly maintenance dose of 117 mg administered in the deltoid or gluteal muscles. Adjust monthly doses based on tolerability and efficacy using available strengths. Maximum monthly dose is 234 mg. See the manufacturer's instructions for missed dosage schedules.Adjust-a-dose: For creatinine clearance 50 to less than 80 mL/minute, give paliperidone (Erzofri) 234 mg IM on treatment day 1, followed by monthly injections of 78 mg IM. Maximum monthly dose is 156 mg. This drug isn't recommended in patients with creatinine clearance less than 50 mL/minute.Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwermaralixibatLivmarliPharmaceutical company: Mirum PharmaceuticalsNEW FORMULATIONOral solution: 19 mg/mLNEW INDICATION & DOSAGECholestatic pruritus in patients with Alagille syndromeAdults and children ages 3 months and older: Initially, 190 mcg/kg PO once daily, 30 minutes before a morning meal, using a 9.5-mg/mL solution. After 1 week, increase dosage to 380 mcg/kg once daily, as tolerated. Maximum dose, 28.5 mg (3 mL) daily in patients weighing 70 kg or more.Cholestatic pruritus in patients with progressive familial intrahepatic cholestasisAdults and children ages 12 months and older:Initially, 285 mcg/kg PO once daily in the morning using a 19-mg/mL solution. Increase dosage to 285 mcg/kg b.i.d., 428 mcg/kg b.i.d., and then to 570 mcg/kg b.i.d., as tolerated. Maximum daily dose, 38 mg (2 mL) in patients weighing 60 kg or more.Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerepinephrineNeffyPharmaceutical company: ARS PharmaNEW FORMULATIONNasal spray: 2 mg/0.1 mL per single-dose sprayNEW INDICATION & DOSAGEType I allergic reactions, including anaphylaxisAdults and children weighing 30 kg or more: One spray (2 mg) into one nostril. If there is no clinical response or worsening symptoms, repeat the dose after 5 minutes in the same nostril.Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerdurvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEResectable non–small-cell lung cancer with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase arrangements, in combination with platinum-containing chemotherapy before surgery, and then continued as a single agent after surgeryAdults weighing 30 kg or more: Before surgery, 1,500 mg IV every 3 weeks with chemotherapy for up to 4 cycles; after surgery, 1,500 mg as a single agent every 4 weeks for up to 12 cycles or until the disease progresses or unacceptable toxicity occurs.Adults weighing less than 30 kg:Before surgery, 20 mg/kg IV every 3 weeks with chemotherapy for up to 4 cycles; after surgery, 20 mg/kg IV as a single agent every 4 weeks for up to 12 cycles or until the disease progresses or unacceptable toxicity occurs.Released: October 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - September 2024
roflumilastZoryveoPharmaceutical company: Arcutis BiotherapeuticsNEW FORMULATIONCream: 0.15%INDICATION & DOSAGEMild to moderate atopic dermatitisAdults and children ages 6 and older: Apply once daily to affected areas.Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerpitolisantWakixPharmaceutical company: Harmony BiosciencesNEW INDICATION & DOSAGEExcessive daytime sleepiness in patients with narcolepsyChildren ages 6 and older: Titrate dosage as follows: Week 1: Initiate with 4.45 mg PO once daily. Week 2: Increase dose to 8.9 mg PO once daily. Week 3: Increase dose to 17.8 mg PO once daily, maximum dose for children weighing less than 40 kg, based on tolerability. Week 4: For children weighing 40 kg or more, may increase to maximum recommended dose, 35.6 mg PO once daily, based on tolerability.Adjust-a-dose: See the manufacturer's instructions for dosage adjustments in children with Child-Pugh class B liver impairment; estimated GFR less than 60 mL/minute/1.73 m2; concomitant use of strong CYP2D6 inhibitors or strong CYP3A4 inducers; or in children who are known CYP2D6 poor metabolizers.Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwerimmune globulin intravenousYimmugoPharmaceutical company: Grifols' BiotestNEW INDICATION & DOSAGEPrimary humoral immunodeficiencyAdults and children ages 2 and older: 300 to 800 mg/kg IV every 3 to 4 weeks. For the first infusion, initially infuse at 0.5 mg/kg/minute and increase every 30 minutes, if tolerated, to 3 mg/kg/minute. From second infusion onward, initially infuse at 0.5 mg/kg/minute for 30 minutes; then gradually increase up to 13 mg/kg/minute, as tolerated.Released: September 2024Nursing Drug Handbook© 2024 Wolters KluweradagrasibKrazatiPharmaceutical company: Mirati TherapeuticsNEW INDICATION & DOSAGEKRAS G12C-mutated locally advanced or metastatic colorectal cancer in combination with cetuximab in patients who have received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapyAdults: 600 mg P.O. b.i.d. until disease progresses or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments. The first dosage reduction for adverse reactions is 400 mg P.O. b.i.d.; the second dosage reduction is 600 mg P.O. daily. Permanently discontinue the drug if the patient can't tolerate 600 mg/day. Refer to the cetuximab prescribing information for cetuximab dosage information.Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwer
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