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New Drug Indications - November 2024

certolizumab pegol

Cimzia
Pharmaceutical company: UCB, Inc.

NEW INDICATION & DOSAGE
Active polyarticular juvenile idiopathic arthritis
Adults 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

letermovir

Prevymis
Pharmaceutical company: Merck & Co.

NEW AVAILABLE FORM
Oral pellets: 20 mg; 120 mg packet

NEW INDICATION & DOSAGE
Prophylaxis 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

pembrolizumab

Keytruda
Pharmaceutical company: Merck & Co.

NEW INDICATION & DOSAGE
First-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma, in combination with pemetrexed and platinum 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 progression. Give before chemotherapy when given the same day.
 

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

ribociclib

Kisqali
Pharmaceutical company: Novartis

INDICATION & DOSAGE
Adjuvant 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 inhibitor
Adults: 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

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
New Drug Indications - June 2024
alectinib hydrochlorideAlecensaPharmaceutical company: GenentechNEW INDICATION & DOSAGEAdjuvant treatment in patients with resected anaplastic lymphoma kinase-positive non-small-cell lung cancer tumors (at least 4 cm or node-positive)Adults: 600 mg PO b.i.d. for 2 years or until disease recurrence or unacceptable toxicity occurs.Adjust-a-dose: For patients with Child-Pugh class C liver impairment, give 450 mg PO b.i.d. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwerdolutegravir/lamivudineDovatoPharmaceutical company: ViiV HealthcareNEW INDICATION & DOSAGEHIV-1 infection in patients with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual componentsChildren age 12 and older weighing 25 kg or more: 1 tablet PO once daily. HIV-1 infection as replacement for a current stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) with no history of treatment failure and no known substitutions associated with resistance to the individual componentsChildren age 12 and older weighing 25 kg or more: 1 tablet PO once daily.Released: June 2024Nursing Drug Handbook© 2024 Wolters KluwerhydroxyureaXromiPharmaceutical company: Rare Disease Therapeutics, Inc.NEW FORMULATIONOral solution: 100 mg/mLNEW INDICATION & DOSAGETo reduce frequency of painful crises and need for blood transfusions in patients with sickle cell anemia with recurrent moderate-to-severe painful crisesChildren ages 6 months to younger than 2 years (Xromi): 15 mg/kg PO once daily. Monitor blood counts every 2 weeks. If blood counts are in acceptable range, may increase dosage by 5 mg/kg daily every 8 to 12 weeks until maximum tolerated dosage or 35 mg/kg daily. If blood counts are considered toxic, withhold drug until blood counts recover. Resume therapy after reducing dosage by 2.5 mg/kg to 5 mg/kg daily. See the manufacturer's instructions for blood count parameters.Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwerravulizumab–cwvcUltomirisPharmaceutical company: Alexion PharmaceuticalsNEW INDICATION & DOSAGENeuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody positiveAdults weighing 100 kg or more: 3,000-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,600-mg IV infusion once every 8 weeks.Adults weighing 60 to less than 100 kg: 2,700-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,300-mg IV infusion once every 8 weeks.Adults weighing 40 to less than 60 kg: 2,400-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,000-mg IV infusion once every 8 weeks.Released: June 2024Nursing Drug Handbook© 2024 Wolters KluweriloperidoneFanaptPharmaceutical company: Vanda PharmaceuticalsNEW INDICATION & DOSAGEAcute treatment of manic or mixed episodes associated with bipolar I disorderAdults: Initially, 1 mg PO b.i.d. Increase dosage daily, as tolerated, according to the following schedule: 3 mg b.i.d. on day 2; 6 mg b.i.d. on day 3; 9 mg b.i.d. on day 4; 12 mg b.i.d. on day 5. Recommended daily dose, 12 mg b.i.d.Adjust-a-dose:  For patients who are poor metabolizers of CYP2D6 and those taking CYP2D6 or CYP3A4 inhibitors, reduce dosage by 50%. Patients with Child-Pugh class B liver impairment may need dosage reduction if clinically indicated. Avoid use in patients with Child-Pugh class C liver impairment.Released: June 2024Nursing Drug Handbook© 2024 Wolters KluwerrisperidoneRisvanPharmaceutical company: Laboratorios Farmaceuticos RoviNEW FORMULATIONInjection (IM extended-release suspension): 75 mg; 100 mg single-dose kitNEW INDICATION & DOSAGESchizophreniaAdults: 75 mg or 100 mg IM once monthly after establishing tolerability with oral risperidone. For patients stable on 3 mg of PO risperidone daily, give 75 mg IM; or for patients stable on 4 mg of PO risperidone daily, give 100 mg IM starting one day after the last PO risperidone dose.Adjust-a-dose:  Recommended dosage is 75 mg once monthly after titration to at least 3 mg PO risperidone in patients with kidney or liver impairment. Two to four weeks before starting a strong CYP2D6 inhibitor, decrease risperidone dosage to 75 mg once monthly, if applicable. If given with a strong CYP3A4 inducer, increase risperidone dosage from 75 mg to 100 mg once daily; additional oral risperidone may be considered in patients on 100-mg dose. Reevaluate dosage after discontinuing CYP3A4 inducer.Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwertenofovir alafenamideVemlidyPharmaceutical company: Gilead SciencesNEW INDICATION & DOSAGEChronic hepatitis B virus infectionChildren age 6 and older weighing at least 25 kg: 25 mg PO daily.Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - May 2024
fluticasone propionateXhancePharmaceutical company: Optinose, Inc.NEW INDICATION & DOSAGEChronic rhinosinusitis with or without polypsAdults: 1 spray (93 mcg/spray) in each nostril b.i.d. May increase to maximum dose of 2 sprays in each nostril b.i.d.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwermaralixibatLivmarliPharmaceutical company: Mirum PharmaceuticalsNEW INDICATION & DOSAGECholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)Adults and children age 5 and older: Initially, 285 mcg/kg PO once daily in the morning. Increase as tolerated to 285 mcg/kg b.i.d., then to 428 mcg/kg b.i.d., and then to recommended dosage of 570 mcg/kg PO b.i.d. 30 minutes before a meal. The maximum dose is 38 mg daily.Adjust-a-dose: Decrease dosage or interrupt therapy for new liver function test (LFT) abnormalities or GI adverse reactions. When LFT values return to baseline or stabilize at new baseline values, consider restarting at last tolerated dose, and increase as tolerated. If LFT abnormalities or GI reactions recur, or signs and symptoms consistent with clinical hepatitis, portal hypertension, or liver decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy. This drug isn't recommended in a subgroup of PFIC type 2 patients with nonfunctional or complete absence of bile salt export pump protein.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluweralirocumabPraluentPharmaceutical company: Regeneron PharmaceuticalsNEW INDICATION & DOSAGEAdjunct to diet and other LDL-C-lowering therapies in patients with heterozygous familial hypercholesterolemia to reduce LDL-CChildren age 8 and older weighing 50 kg or more: 300 mg subcut every 4 weeks. If LDL-C reduction is inadequate, adjust dosage to 150 mg every 2 weeks.Children age 8 and older weighing less than 50 kg: 150 mg subcut every 4 weeks. If LDL-C reduction is inadequate, adjust dosage to 75 mg subcut every 2 weeks.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEWith cisplatin and gemcitabine, for unresectable or metastatic urothelial carcinoma (first-line treatment)Adults: 360-mg IV infusion with cisplatin and gemcitabine on the same day every 3 weeks for up to 6 cycles; then 240-mg IV infusion every 2 weeks or 480-mg IV infusion every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs, or up to 2 years from the first dose.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwerrilpivirineEdurantPharmaceutical company: Janssen TherapeuticsNEW FORMULATIONTablets for oral suspension: 2.5 mg (Edurant Ped)NEW INDICATION & DOSAGEHIV-1 infection in patients who are antiretroviral-naive with HIV-1 RNA 100,000 copies/mL or less at start of therapy, in combination with other antiretroviralsChildren age 2 and older weighing 25 kg or more: 25 mg PO once daily.Children age 2 and older weighing 20 kg to less than 25 kg: 15 mg (6 tablets for oral suspension) PO once daily.Children age 2 and older weighing 14 kg to less than 20 kg: 12.5 mg (5 tablets for oral suspension) PO once daily.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwerremdesivirVekluryPharmaceutical company: Gilead Sciences, Inc.NEW INDICATION & DOSAGECoronavirus disease 2019 (COVID-19) requiring hospitalizationChildren age 28 days and older weighing 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis with 2.5 mg/kg-IV infusion on day 1, followed by maintenance dose of 1.25 mg/kg-IV infusion once daily starting on day 2 for 5 days in patients not requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). If no clinical improvement, may extend therapy 5 additional days. Give the drug for 10 days to patients requiring invasive mechanical ventilation or ECMO.Children younger than 28 days weighing at least 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis with 2.5 mg/kg-IV infusion on day 1, followed by maintenance dose of 1.25 mg/kg-IV infusion once daily starting on day 2 for 5 days in patients not requiring invasive mechanical ventilation or ECMO. If no clinical improvement, may extend therapy 5 additional days. Give the drug for 10 days to patients requiring invasive mechanical ventilation or ECMO.Adjust-a-dose:  Consider discontinuing the drug if ALT level increases to greater than 10 times the upper limit of normal (ULN). Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.Nonhospitalized patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including hospitalization or deathChildren age 28 days and older weighing 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 2.5 mg/kg-IV infusion on day 1, followed by 1.25 mg/kg-IV infusion once daily on days 2 and 3.Children younger than 28 days weighing at least 1.5 kg to less than 3 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 2.5 mg/kg-IV infusion on day 1, followed by 1.25 mg/kg-IV infusion once daily on days 2 and 3.Adjust-a-dose:  Consider discontinuing the drug if ALT level increases to greater than 10 times the ULN. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwersemaglutideWegovyPharmaceutical company: Novo NordiskNEW INDICATION & DOSAGETo reduce the risk of major CV events (CV death, nonfatal MI, or nonfatal stroke) in patients with established CV disease and either obesity or overweight (Wegovy only)Adults: Initially, 0.25 mg subcut once weekly for 4 weeks, then increase to 0.5 mg for 4 weeks, then 1 mg for 4 weeks, then 1.7 mg for 4 weeks, then to a 2.4-mg weekly maintenance dose.Adjust-a-dose:  If any dose is not initially tolerated, delay dose escalation for 4 weeks. If a 2.4-mg dose is not tolerated, decrease to maintenance dose of 1.7 mg. If the 1.7 mg dose is not tolerated, discontinue the drug.Released: May 2024Nursing Drug Handbook© 2024 Wolters KluwerzanubrutinibBrukinsaPharmaceutical company: BeiGeneNEW INDICATION & DOSAGEWith obinutuzumab, for relapsed or refractory follicular lymphoma (after two or more lines of systemic therapy)Adults: 160 mg PO b.i.d. or 320 mg PO once daily until disease progression or unacceptable toxicity occurs.Released: May 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - April 2024
irinotecan liposome Onivyde Pharmaceutical company: Ipsen Biopharmaceuticals  NEW INDICATION & DOSAGEMetastatic pancreatic adenocarcinoma, as first-line treatment in combination with oxaliplatin, fluorouracil (5-FU), and leucovorinAdults: 50 mg/m2 IV infusion every 2 weeks. Premedicate with a corticosteroid and an antiemetic 30 minutes before infusion. Administer the drug before oxaliplatin, leucovorin, and 5-FU.Adjust-a-dose:  Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluwerceftazidime—avibactam sodiumAvycazPharmaceutical company: AbbVie  NEW INDICATION & DOSAGEComplicated intra-abdominal infections caused by susceptible microorganisms, used in combination with metronidazoleInfants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 5 to 14 days.Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 5 to 14 days.Complicated UTI, including pyelonephritis, caused by susceptible microorganismsInfants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 7 to 14 days.Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 7 to 14 days.Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible microorganismsInfants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 7 to 14 days.Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 7 to 14 days.Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluweromalizumab Xolair Pharmaceutical company: Genentech and Novartis  NEW INDICATION & DOSAGEReduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in patients with IgE-mediated food allergyAdults and children age 1 year and older: 75 to 600 mg subcut every 2 or 4 weeks. Dose and frequency vary with pretreatment IgE level (international units/mL) and patient weight. (Refer to the manufacturer's instructions.) To be used in conjunction with food allergen avoidance.Alert:  Not indicated for emergency treatment of allergic reactions.Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluwerosimertinib Tagrisso Pharmaceutical company: AstraZeneca  NEW INDICATION & DOSAGEFirst-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer (in combination with pemetrexed and platinum-based chemotherapy) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutationsAdults: 80 mg PO once daily until disease progression or unacceptable toxicity occurs due to osimertinib.  Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - March 2024
pembrolizumab Keytruda Pharmaceutical company: Merck  NEW INDICATION & DOSAGEInternational Federation of Gynecology and Obstetrics 2014 stage III to IVA cervical cancer in combination with chemoradiotherapyAdults: 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 chemoradiotherapy when given on the same day.Released: March 2024Nursing Drug Handbook© 2024 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi and Regeneron Pharmaceuticals  NEW INDICATION & DOSAGEEosinophilic esophagitisChildren age 1 and older weighing at least 40 kg: 300 mg subcut once a week.Children age 1 and older weighing 30 to less than 40 kg: 300 mg subcut every other week.Children age 1 and older weighing 15 to less than 30 kg: 200 mg subcut every other week.Released: March 2024Nursing Drug Handbook© 2024 Wolters Kluwer
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