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New Drug Indications - March 2025

acalabrutinib

Calquence
Pharmaceutical company: AstraZeneca

NEW INDICATION & DOSAGE
Treatment of previously untreated mantle cell lymphoma in combination with bendamustine and rituximab in patients who are ineligible for autologous hematopoietic stem cell transplantation
Adults: 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 obinutuzumab
Adults: 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 2025

Nursing Drug Handbook

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

canagliflozin

Invokana
Pharmaceutical company: Janssen Pharmaceuticals

NEW INDICATION & DOSAGE
Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes
Children 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 2025

Nursing Drug Handbook

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

canagliflozin and metFORMIN hydrochloride

Invokamet, Invokamet XR
Pharmaceutical company: Johnson & Johnson

NEW INDICATION & DOSAGE
Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes when treatment with both canagliflozin and metformin is appropriate
Children 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 2025

Nursing Drug Handbook

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

fondaparinux sodium

Arixtra
Pharmaceutical company: Mylan

NEW INDICATION & DOSAGE
Venous thromboembolism
Children 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 2025

Nursing Drug Handbook

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

tapinarof

Vtama
Pharmaceutical company: Dermavant Sciences, Inc.

NEW INDICATION & DOSAGE
Atopic dermatitis
Adults and children ages 2 and older: Apply a thin layer to affected areas once daily.

Released: March 2025

Nursing Drug Handbook

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

tirzepatide

Zepbound
Pharmaceutical company: Eli Lilly and Company

NEW INDICATION & DOSAGE
Moderate 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 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 - 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
New Drug Indications - August 2024
blinatumomabBlincytoPharmaceutical company: Amgen, Inc.NEW INDICATION & DOSAGECD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapyAdults and children weighing 45 kg or more: A single consolidation cycle of 28 mcg/day continuous IV infusion for 28 days followed by a 14-day treatment-free interval (total, 42 days).Adults and children weighing less than 45 kg: A single consolidation cycle of 15 mcg/m2/day continuous IV infusion for 28 days followed by a 14-day treatment-free interval (total, 42 days). Maximum dose, 28 mcg/day.Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerdapagliflozinFarxigaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetesChildren age 10 and older with eGFR of 45 mL/minute/1.73 m2 or greater: Initially, 5 mg PO once daily. For patients who require additional glycemic control, may increase to 10 mg daily.Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerdurvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEPrimary advanced or recurrent endometrial cancer that is mismatch repair deficient in combination with carboplatin and paclitaxelAdults weighing 30 kg or more: 1,120 mg IV every 3 weeks (21 days) in combination with carboplatin and paclitaxel for six cycles; followed by 1,500 mg IV every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Adults weighing less than 30 kg: 15 mg/kg IV every 3 weeks (21 days) in combination with carboplatin and paclitaxel for six cycles; followed by 20 mg/kg IV every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: MerckNEW INDICATION & DOSAGEPrimary advanced or recurrent endometrial carcinoma in combination with carboplatin and paclitaxel, followed by pembrolizumab as a single agentAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks, prior to carboplatin and paclitaxel when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or, for pembrolizumab, up to 24 monthsReleased: August 2024Nursing Drug Handbook© 2024 Wolters Kluwerrisankizumab-rzaaSkyriziPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerately to severely active ulcerative colitisAdults: 1,200-mg IV infusion over at least 2 hours at weeks 0, 4, and 8. Then, 180 mg or 360 mg subcut at week 12 and every 8 weeks thereafter. Use the lowest effective dosage.Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwersarilumabKevzaraPharmaceutical company: Sanofi and Regeneron Pharmaceuticals, Inc.NEW INDICATION & DOSAGEActive polyarticular juvenile idiopathic arthritisAdults and children weighing at least 63 kg: 200 mg subcut once every 2 weeks as a single agent or in combination with other conventional disease-modifying antirheumatic drugs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerselpercatinibRetevmoPharmaceutical company: Eli Lilly and CompanyNEW FORMULATIONTablets: 40 mg, 80 mg, 120 mg, 160 mgNEW INDICATION & DOSAGEAdvanced or metastatic RET-mutant medullary thyroid cancerChildren ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.Advanced or metastatic RET fusion-positive thyroid cancerChildren ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.Locally advanced or metastatic solid tumors with RET gene fusion in patients with progression on or following prior systemic therapy, or who have no alternative treatment optionsAdults and children age 12 and older weighing 50 kg or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Adults and children age 12 and older weighing less than 50 kg: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 1.53 m2 or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 1.09 to 1.52 m2: 120 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.66 to 1.08 m2: 80 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Children ages 2 to younger than 12 with BSA of 0.33 to 0.65 m2: 40 mg PO t.i.d. until disease progression or unacceptable toxicity occurs.Released: August 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - July 2024
upadacitinibRinvoq LQPharmaceutical company: AbbVieNEW FORMULATIONOral solution: 1 mg/mLNEW INDICATION & DOSAGEActive psoriatic arthritis in patients who have had an inadequate response or intolerance to one or more tumor necrosis factor blockersChildren age 2 to younger than age 18 weighing at least 30 kg: 15-mg tablet PO once daily or 6-mg oral solution PO b.i.d.Children age 2 to younger than age 18 weighing 20 kg to less than 30 kg: 4-mg oral solution PO b.i.d.Children age 2 to younger than age 18 weighing 10 kg to less than 20 kg: 3-mg oral solution PO b.i.d.Adjust-a-dose: If serious infection develops, interrupt the drug until infection is controlled. Interrupt therapy if ANC in less than 1,000 cells/mm3, absolute lymphocyte count (ALC) is less than 500 cells/mm3, or hemoglobin level is less than 8 g/dL. Restart the drug once ANC, ALC, or hemoglobin level returns to above these values. If liver transaminase levels rise and drug-induced liver injury is suspected, interrupt therapy until diagnosis is excluded.Released: July 2024Nursing Drug Handbook© 2024 Wolters KluwerdiazepamLibervantPharmaceutical company: Aquestive TherapeuticsNEW FORMULATIONBuccal film: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mgNEW INDICATION & DOSAGEAcute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from the usual seizure pattern in children with epilepsy (Libervant)Children ages 2 to 5 weighing 26 to 30 kg: 15 mg buccal film allowed to dissolve without additional liquid, PRN.Children ages 2 to 5 weighing 21 to 25 kg: 12.5 mg buccal film allowed to dissolve without additional liquid, PRN.Children ages 2 to 5 weighing 16 to 20 kg: 10 mg buccal film allowed to dissolve without additional liquid, PRN.Children ages 2 to 5 weighing 11 to 15 kg: 7.5 mg buccal film allowed to dissolve without additional liquid, PRN.Children ages 2 to 5 weighing 6 to 10 kg: 5 mg buccal film allowed to dissolve without additional liquid, PRN.Adjust-a-dose: May give second dose PRN at least 4 hours after the first dose. Maximum dosage to treat single episode, two doses. Do not use buccal film to treat more than one episode every 5 days, or more than five episodes per month.Released: July 2024Nursing Drug Handbook© 2024 Wolters KluwerapremilastOtezlaPharmaceutical company: AmgenNEW INDICATION & DOSAGEModerate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapyChildren age 6 and older weighing 50 kg or more: Initially, 10 mg PO in a.m. on day 1; 10 mg b.i.d. (a.m. and p.m.) on day 2; 10 mg in a.m. and 20 mg in p.m. on day 3; 20 mg b.i.d. on day 4; 20 mg in a.m. and 30 mg in p.m. on day 5; then 30 mg b.i.d. on day 6 and thereafter.Children age 6 and older weighing at least 20 kg to less than 50 kg: Initially, 10 mg PO in a.m. on day 1; 10 mg b.i.d. (a.m. and p.m.) on day 2; 10 mg in a.m. and 20 mg in p.m. on day 3; then 20 mg b.i.d. on day 4 and thereafter.Adjust-a-dose: For children with creatinine clearance of less than 30 mL/minute, titrate using only the a.m. schedule (omit p.m. doses) and reduce the maintenance dose for children weighing 50 kg or more to 30 mg once daily, or for children weighing 20 kg to less than 50 kg, reduce the maintenance dose to 20 mg once daily.Released: July 2024Nursing Drug Handbook© 2024 Wolters Kluwermethoxy polyethylene glycol-epoetin betaMirceraPharmaceutical company: CSL Vifor (International) Inc.NEW INDICATION & DOSAGEAnemia caused by chronic kidney disease in children on dialysis or not on dialysis who are converting from another erythropoiesis-stimulating agent (ESA) after the hemoglobin (Hb) level was stabilized with an ESAChildren ages 3 months to 17 years: Initially, IV or subcut once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion. Refer to the manufacturer's instructions for starting dose conversion. Minimum dose, 30 mcg once every 4 weeks. In patients younger than age 6, maintain the same route of administration as previous ESA.Adjust-a-dose:  If Hb decreases by more than 1 g/dL from baseline, or less than 10 g/dL but greater than 9 g/dL, increase dose by 25% to closest dose available with a prefilled syringe. If Hb is less than 9 g/dL, increase dose by 50% to closest dose available with a prefilled syringe. If Hb increases by more than 1 g/dL from baseline or approaches or is greater than 12 g/dL, decrease dose by 25% to closest dose available with a prefilled syringe. If Hb exceeds 12 g/dL and continues to increase after dose reduction, withhold drug until Hb is less than 12 g/dL. Resume the dose at 25% below the previous dose to the closest dose available with a prefilled syringe on the next scheduled dosing day.Released: July 2024Nursing Drug Handbook© 2024 Wolters Kluwer
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