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New Drug Indications - July 2024


upadacitinib

Rinvoq LQ
Pharmaceutical company: AbbVie

NEW FORMULATION
Oral solution: 1 mg/mL

NEW INDICATION & DOSAGE
Active psoriatic arthritis in patients who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


diazepam

Libervant
Pharmaceutical company: Aquestive Therapeutics

NEW FORMULATION
Buccal film: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg

NEW INDICATION & DOSAGE
Acute 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


apremilast

Otezla
Pharmaceutical company: Amgen

NEW INDICATION & DOSAGE
Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


methoxy polyethylene glycol-epoetin beta

Mircera
Pharmaceutical company: CSL Vifor (International) Inc.

NEW INDICATION & DOSAGE
Anemia 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 ESA
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive


New Drug Indications - January 2023
brentuximab vedotinAdcetrisPharmaceutical company: Seagen, Inc.NEW INDICATION & DOSAGEPreviously untreated high-risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamideChildren age 2 and older: 1.8 mg/kg IV over 30 minutes every 3 weeks until a maximum of 5 doses, disease progression, or unacceptable toxicity. Maximum dose is 180 mg. Give granulocyte colony stimulating factor beginning with cycle 1.Adjust-a-dose: Refer to prescribing information for chemotherapy agents for additional information.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwercemiplimab-rwlcLibtayoPharmaceutical company: RegeneronNEW INDICATION & DOSAGELocally advanced or metastatic non–small-cell lung cancer with no EGFR, ALK or ROS1 aberrations as first-line treatment in combination with platinum‐based chemotherapyAdults: 350-mg IV infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to prescribing information for chemotherapy agents for additional information.Released: January 2023Nursing Drug Handbook© 2023 Wolters KluwercobimetinibCotellicPharmaceutical company: Genentech, Inc.NEW INDICATION & DOSAGEMonotherapy for histiocytic neoplasmAdults: 60 mg PO once daily for the first 21 days of a 28-day cycle until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. If concurrent short-term (14 days or less) use of a moderate CYP3A inhibitor is unavoidable in patients taking cobimetinib 60 mg, decrease cobimetinib dosage to 20 mg daily. Resume pervious dosage after inhibitor is discontinued. Use an alternative to the CYP3A inhibitor in patients taking less than 60 mg.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwer dulaglutideTrulicityPharmaceutical company: LillyNEW INDICATION & DOSAGEAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetesChildren age 10 and older: 0.75 mg subcut one weekly. If after at least 4 weeks additional glycemic control is needed, may increase dosage to the maximum of 1.5 mg weekly.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - December 2022
amifampridineFirdapsePharmaceutical company: Catalyst PharmaceuticalsNEW INDICATION & DOSAGELambert-Eaton myasthenic syndromeChildren age 6 and older weighing 45 kg or more (Firdapse): 15 to 30 mg/day PO in three to four divided doses. May increase by 5 mg daily every 3 or 4 days. Maximum single dose is 20 mg; maximum daily dose is 80 mg.Children age 6 and older weighing less than 45 kg (Firdapse): 5 to 15 mg/day PO in three to four divided doses. May increase by 2.5 mg daily every 3 or 4 days. Maximum single dose is 10 mg; maximum daily dose is 40 mg.Released: December 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi RegeneronNEW INDICATION & DOSAGEPrurigo nodularisAdults: Initially, 600 mg subcut given as two 300-mg injections in different sites followed by 300 mg subcut every other week.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer durvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEUnresectable hepatocellular carcinoma in combination with tremelimumab-actlAdults weighing 30 kg or more: Tremelimumab-actl 300 mg IV over 60 minutes as a single dose day 1 of cycle followed by a 1-hour observation period; then give durvalumab 1,500 mg IV the same day followed by 1,500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Adults weighing less than 30 kg: Tremelimumab-actl 4 mg/kg over 60 minutes as a single dose day 1 of cycle 1 followed by a 1-hour observation period; then give durvalumab 20 mg/kg IV the same day followed by 20 mg/kg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer selpercatinibRetevmoPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGELocally advanced or metastatic solid tumors with RET gene fusion in patients with progression on or following prior systemic treatment, or who have no alternative treatment optionsAdults weighing 50 kg or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity.Adults weighing less than 50 kg: 120 mg PO b.i.d. until disease progression or unacceptable toxicity.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer upadacitinibRinvoqPharmaceutical company: AbbVieNEW INDICATION & DOSAGEActive nonradiographic axial spondyloarthritis in patients with inadequate response or intolerance to TNF blocker therapyAdults: 15 mg PO daily.Adjust-a-dose: If serious infection develops, interrupt the drug until the infection is controlled. Interrupt therapy if ANC is less than 1,000 cells/mm3, or absolute lymphocyte count (ALC) is less than 500 cells/mm3, or hemoglobin level is less than 8 g/dL. May restart the drug once ANC, ALC, or hemoglobin level returns to above these values. If hepatic transaminase levels rise and drug-induced liver injury is suspected, interrupt therapy.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - November 2022
durvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEMetastatic or locally advanced biliary tract cancer in combination with gemcitabine and cisplatinAdults weighing 30 kg or more: 1,500-mg IV infusion every 3 weeks (21 days) for up to eight cycles in combination with chemotherapy, followed by 1,500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Adults weighing less than 30 kg: 20-mg/kg IV infusion every 3 weeks (21 days) for up to eight cycles in combination with chemotherapy, followed by 20 mg/kg every 2 weeks as a single agent until disease progression or unacceptable toxicity occurs.Released: November 2022Nursing Drug Handbook© 2022 Wolters Kluwerlumacaftor and ivacaftorOrkambiPharmaceutical company: Vertex PharmaceuticalsNEW AVAILABLE FORMOral granules (single-dose packets):lumacaftor 150 mg and ivacaftor 188 mg; lumacaftor 100 mg and ivacaftor 125 mg; lumacaftor 75 mg and ivacaftor 94 mgINDICATION & DOSAGETreatment of cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator geneChildren ages 1 to 2 and weighing 14 kg or greater: 1 granule packet (lumacaftor 150 mg and ivacaftor 188 mg) every 12 hours with fat-containing food.Children ages 1 to 2 and weighing 9 to less than 14 kg: 1 granule packet (lumacaftor 100 mg and ivacaftor 125 mg) every 12 hours with fat-containing food.Children ages 1 to 2 and weighing 7 to less than 9 kg: 1 granule packet (lumacaftor 75 mg and ivacaftor 94 mg) every 12 hours with fat-containing food.Released: November 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - October 2022
baloxavir marboxilXofluzaPharmaceutical company: GenentechNEW INDICATION & DOSAGETreatment of acute, uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, who are otherwise healthyChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Postexposure influenza prophylaxisChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Children age 5 and older weighing less than 20 kg: 2 mg/kg PO as a single dose.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  belimumabBenlystaPharmaceutical company: GlaxoSmithKlineNEW INDICATION & DOSAGEActive lupus nephritis in patients who are receiving standard therapyChildren age 5 and older: 10 mg/kg IV infusion every 2 weeks for first three doses, then every 4 weeks thereafter.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ibrutinibImbruvicaPharmaceutical company: Pharmacyclics and Janssen BiotechNEW INDICATION & DOSAGEChronic graft-versus-host disease (GVHD) after failure of one or more lines of systemic therapyChildren age 12 and older: 420 mg PO once daily until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Children age 1 to less than 12 years: 240 mg/m2 PO once daily (maximum dose 420 mg) until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  relugolix–estradiol–norethindrone acetateMyfembreePharmaceutical company: Myovant Sciences NEW INDICATION & DOSAGEManagement of moderate to severe pain associated with endometriosisAdults: 1 tablet PO daily for up to 24 months.Adjust-a-dose: If use with oral P-glycoprotein inhibitors can’t be avoided, give relugolix–estradiol–norethindrone acetate first, and separate dosing by at least 6 hours.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ustekinumabStelaraPharmaceutical company: Janssen BiotechNEW INDICATION & DOSAGEAcute psoriatic arthritisChildren ages 6 to 17 weighing more than 100 kg with coexistent moderate-to-severe plaque psoriasis: Initially, 90 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 90 mg subcut every 12 weeks.Children ages 6 to 17 weighing 60 kg or more: Initially, 45 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 45 mg subcut every 12 weeks.Children ages 6 to 17 weighing less than 60 kg: Initially, 0.75 mg/kg subcut; repeat dose in 4 weeks, followed by maintenance dose of 0.75 mg/kg subcut every 12 weeks.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - September 2022
crizotinibXalkoriPharmaceutical company: PfizerNEW INDICATION & DOSAGEUnresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumorAdults: 250 mg PO b.i.d.Adjust-a-dose: For creatinine clearance less than 30 mL/minute (not requiring dialysis), give 250 mg once daily. For preexisting moderate hepatic impairment, give 200 mg b.i.d. For preexisting severe hepatic impairment, give 250 mg once daily. For unavoidable concomitant use with strong CYP3A inhibitors, decrease crizotinib to 250 mg once daily. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Children age 1 and older: 280 mg/m2 PO b.i.d.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments, dosage adjustments for renal or hepatic impairment, and for concomitant use of strong CYP3A inhibitors.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer phentermine and topiramateQsymiaPharmaceutical company: Vivus LLCNEW INDICATION & DOSAGEChronic weight management, as an adjunct to diet and increased physical activity in children with BMI in the 95th percentile or more standardized for age and sexChildren age 12 and older: Initially, 3.75 mg phentermine/23 mg topiramate PO every morning for 14 days; then increase to 7.5 mg phentermine/46 mg topiramate every morning. Evaluate weight loss after 12 weeks of therapy. If the child hasn't lost at least 3% of baseline BMI, escalate dose to 11.25 mg phentermine/69 mg topiramate every morning for 14 days, followed by 15 mg phentermine/92 mg topiramate every morning. Evaluate BMI 12 weeks after dose escalation. If the patient hasn't lost at least 5% of baseline BMI, discontinue the drug by decreasing the dose to every other day for at least 1 week before stopping therapy altogether.Adjust-a-dose: If the child's weight loss exceeds 0.9 kg/week, consider dose reduction. For patients with moderate renal impairment (creatinine clearance of 30 to less than 50 mL/minute), severe renal impairment (creatinine clearance less than 30 mL/minute), or moderate hepatic impairment (Child-Pugh class B), don't exceed 7.5 mg phentermine/46 mg topiramate once daily.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer stiripentolDiacomitPharmaceutical company: BiocodexNEW INDICATION & DOSAGESeizures associated with Dravet syndrome in patients taking clobazamChildren age 1 and older weighing 10 kg or more: 25 mg/kg PO b.i.d. or 16.67 mg/kg PO t.i.d.Children age 1 and older weighing 7 to less than 10 kg: 25 mg/kg PO b.i.d.Children age 6 months to younger than age 1 weighing 7 kg or more: 25 mg/kg PO b.i.d.Adjust-a-dose: If exact dosage can't be achieved with the available strengths, round to the nearest dosage, which is usually within 50 to 150 mg of the recommended 50 mg/kg/day. Maximum dose, 3,000 mg/day. If somnolence occurs, consider reducing clobazam dosage by 25%. If somnolence persists, consider decreasing clobazam dosage by an additional 25%. Consider adjusting the dosage of other concomitant anticonvulsants with sedating properties.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - August 2022
brexanoloneZulressoPharmaceutical company: Sage TherapeuticsNEW INDICATION & DOSAGEPostpartum depressionWomen age 15 and older: Give as continuous IV infusion over a total of 60 hours, titrating dose as follows: 0 to 4 hours, 30 mcg/kg/hour; 4 to 24 hours, increase infusion rate to 60 mcg/kg/hour; 24 to 52 hours, increase infusion rate to 90 mcg/kg/hour or consider a dose of 60 mcg/kg/hour if higher infusion rate isn't tolerated; 52 to 56 hours, decrease infusion rate to 60 mcg/kg/hour; 56 to 60 hours, decrease infusion rate to 30 mcg/kg/hour.Adjust-a-dose: For excessive sedation, stop infusion until symptoms resolve and resume at the same or lower infusion rate.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer brolucizumab-dbllBeovuPharmaceutical company: NovartisNEW INDICATION & DOSAGEDiabetic macular edemaAdults: 6-mg intravitreal injection every 6 weeks (every 39 to 45 days) for five doses, then every 8 to 12 weeks thereafter.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer dabrafenib mesylateTafinlarPharmaceutical company: NovartisNEW INDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation as detected by an FDA-approved test in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with trametinibAdults and children ages 6 to 17 weighing 51 kg or more: 150 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.Children ages 6 to 17 weighing 38 to 50 kg: 100 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.Children ages 6 to 17 weighing 26 to 37 kg: 75 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the trametinib prescribing information for recommended trametinib dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer dupilumabDupixentPharmaceutical company: RegeneronNEW INDICATION & DOSAGEModerate-to-severe atopic dermatitis not adequately controlled with topical therapy or when those therapies aren't advisableChildren ages 6 months to 5 years weighing 15 to less than 30 kg: 300 mg subcut every 4 weeks.Children ages 6 months to 5 years weighing 5 to less than 15 kg: 200 mg subcut every 4 weeks.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer ipilimumabYervoyPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEUnresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with nivolumabAdults: 1 mg/kg IV infusion every 6 weeks with nivolumab, 3 mg/kg IV infusion every 2 weeks, or 360-mg IV infusion every 3 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer ivosidenibTibsovoPharmaceutical company: Servier PharmaceuticalsNEW INDICATION & DOSAGENewly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test in patients age 75 and older, or who have comorbidities that preclude use of intensive induction chemotherapy, in combination with azacitidineAdults age 75 and older: 500 mg PO daily with azacitidine 75 mg/m2 subcut or IV once daily on days 1 to 7 (or days 1 to 5 and 8 to 9) of each 28-day cycle until disease progression or unacceptable toxicity occurs. Treat for a minimum of 6 months to allow time for clinical response. Refer to the azacitidine manufacturer's instructions for additional dosing information.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEUnresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 240-mg IV infusion every 2 weeks or 480-mg IV infusion every 4 weeks in combination with chemotherapy. Continue nivolumab until disease progression or unacceptable toxicity occurs, or up to 2 years.Unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumabAdults: 3 mg/kg IV infusion every 2 weeks or 360-mg IV infusion every 3 weeks with ipilimumab 1 mg/kg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer risankizumab-rzaaSkyriziPharmaceutical company: AbbVieNEW FORMInjection (IV): 600 mg/10 mL single-dose vialINDICATION & DOSAGEModerate to severe Crohn diseaseAdults: 600-mg IV infusion over at least 1 hour at weeks 0, 4, and 8, then 360 mg subcut at week 12 and every 8 weeks thereafter.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer tisagenlecleucelKymriahPharmaceutical company: NovartisINDICATION & DOSAGERelapsed or refractory follicular lymphoma after two or more lines of systemic therapyAdults: 0.6 to 6.0 x 108 CAR-positive viable T cells IV infusion 2 to 6 days after completion of lymphodepleting chemotherapy.Adjust-a-dose: May omit lymphodepleting chemotherapy if patient's WBC count is less than 1 x 109/L within 1 week before tisagenlecleucel infusion.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer trametinibMekinistPharmaceutical company: NovartisINDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation as detected by an FDA-approved test in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with dabrafenibAdults and children ages 6 to 17 weighing 51 kg or more: 2 mg PO once daily until disease progression or unacceptable toxicity occurs.Children ages 6 to 17 weighing 38 to 50 kg: 1.5 mg PO once daily until disease progression or unacceptable toxicity occurs.Children ages 6 to 17 weighing 26 to 37 kg: 1 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - July 2022
azacitidineVidazaPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGENewly diagnosed juvenile myelomonocytic leukemia (JMML)Children age 1 and older weighing 10 kg or more: 75 mg/m2 IV infusion daily for 7 days in a 28-day cycle. Treat for minimum of 3 cycles and maximum of 6 cycles.Children age 1 month to less than 1 year or weighing less than 10 kg: 2.5 mg/kg IV infusion daily for 7 days in a 28-day cycle. Treat for minimum of 3 cycles and maximum of 6 cycles.Adjust-a-dose: Treatment delays up to 14 days can be considered for nonhematologic toxicities. Hematologic toxicity will be difficult to differentiate from natural course of JMML; dose reduction for hematologic toxicity isn't recommended during the first 3 cycles. Discontinue therapy if neutrophil count is less than 0.5 x 109/L at the end of cycle 3 or on day 1 of cycles 5 or 6. Refer to the manufacturer's instructions for toxicity-related dose adjustments.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Regeneron PharmaceuticalsNEW INDICATION & DOSAGEEosinophilic esophagitisAdults and children age 12 and older weighing at least 40 kg: 300 mg subcut once a week.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluweredaravoneRadicava ORSPharmaceutical company: Mitsubishi Tanabe Pharma AmericaNEW FORMOral suspension: 105 mg/5 mL.NEW INDICATION & DOSAGEAmyotrophic lateral sclerosisAdults: For initial treatment cycle, 105 mg PO or via nasogastric tube in the morning after overnight fasting for 14 days followed by a 14-day drug-free period. For all subsequent cycles, 105 mg PO or via nasogastric tube daily for 10 out of 14 days, followed by a 14-day drug-free period.Adjust-a-dose: Patient may be switched from 60 mg IV daily to 105 mg PO solution daily.Released: July 2022Nursing Drug Handbook© 2022 Wolters Kluwerravulizumab-cwvzUltomirisPharmaceutical company: Alexion PharmaceuticalsINDICATION & DOSAGEGeneralized myasthenia gravis in patients who are anti-acetylcholine receptor 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.Adjust-a-dose (all-indications):Supplemental dosing is required for patients weighing 40 kg or more receiving concomitant plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg). Additional dose is given within 4 hours following PE, PP, or IVIg and is based on weight, current dose, and concomitant treatment. Refer to the manufacturer's instructions for ravulizumab-cwvz dosing.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerremdesivirVekluryPharmaceutical company: Gilead Sciences, Inc.INDICATION & DOSAGETreatment of nonhospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19) at high risk for progression to severe COVID-19, including hospitalization or deathChildren age 28 days and older weighing 3 kg to less than 40 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 5 mg/kg IV infusion on day 1, followed by 2.5 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 upper limit of normal (ULN). Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.Treatment of COVID-19 requiring hospitalizationChildren age 28 days and older weighing 3 kg to less than 40 kg: Initiate therapy as soon as possible after diagnosis with 5 mg/kg IV infusion on day 1, followed by maintenance dose of 2.5 mg/kg IV infusion once daily 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. Therapy duration for patients requiring invasive mechanical ventilation or ECMO is 10 days.Adjust-a-dose: Consider discontinuing the drug if ALT level increases to greater than 10 × ULN. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.ADMINISTRATIONAlert: Only remdesivir lyophilized powder form is approved for use in children weighing less than 40 kg.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVieINDICATION & DOSAGEAnkylosing spondylitis in patients who have had an inadequate response or intolerance to one of more tumor necrosis factor blockersAdults: 15 mg PO once daily.Adjust-a-dose: If serious infection develops, interrupt the drug until the infection is controlled. Interrupt therapy if absolute neutrophil count (ANC) is less than 1,000 cells/mm3, or absolute lymphocyte count (ALC) is less than 500 cells/mm3, or hemoglobin (Hb) level is less than 8 g/dL. May restart the drug once ANC, ALC, or Hb level returns to above these values. If hepatic transaminase levels rise and drug-induced liver injury is suspected, interrupt therapy.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerviloxazineQelbreePharmaceutical company: Supernus PharmaceuticalsINDICATION & DOSAGEAttention deficit hyperactivity disorderAdults: Initially, 200 mg PO once daily. After 1 week, may titrate by 200-mg increments to maximum dose of 600 mg daily, depending on response and tolerability.Adjust-a-dose: For severe renal impairment (eGFR less than 30 mL/min/1.73 m2), starting dose is 100 mg once daily. May titrate weekly by 50-mg to 100-mg increments once daily to maximum dose of 200 mg once daily.Released: July 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - June 2022
alpelisibVijoicePharmaceutical company: NovartisNEW INDICATION & DOSAGESevere manifestations of PIK3CA-related overgrowth spectrum requiring systemic therapy Adults: 250 mg PO once daily until disease progression or unacceptable toxicity occurs.Children ages 6 to less than 18: Initially, 50 mg PO once daily. May increase after 24 weeks to 125 mg for response optimization. Continue until disease progression or unacceptable toxicity occurs.Children ages 2 to less than 6: 50 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluweraxicabtagene ciloleucelYescartaPharmaceutical company: Kite Pharma, Inc.NEW INDICATION & DOSAGELarge B-cell lymphoma that is refractory to or relapses within 12 months of first-line chemoimmunotherapyAdults: Target dose is 2 × 106 CAR-positive viable T cells/kg of body weight (or a maximum of 2 × 108 CAR-positive viable T cells for patients weighing 100 kg or more).Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerceftolozane and tazobactamZerbaxaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEComplicated intra-abdominal infections caused by Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, S. constellatus, or S. salivarius treated concurrently with metronidazoleBirth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 5 to 14 days.Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.Complicated UTIs, including pyelonephritis, caused by Escherichia coli, K. pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosaBirth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 7 to 14 days.Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerdexmedetomidine hydrochlorideIgalmiPharmaceutical company: Bioxcel TherapeuticsNEW FORMSublingual film: 120 mcg, 180 mcgINDICATION & DOSAGEAcute treatment of agitation associated with schizophrenia or bipolar I or II disorderAdults: 120 mcg sublingually or buccally for mild or moderate, agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart. Or 180 mcg sublingually or buccally for severe agitation; if agitation persists, may give up to two additional 90-mcg doses at least 2 hours apart.Adults age 65 or older: 120 mcg sublingually or buccally for mild, moderate, or severe agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart.Adjust-a-dose: If mild or moderate hepatic impairment, give 90 mcg for mild or moderate agitation or 120 mcg for severe agitation. If severe hepatic impairment, give 60 mcg for mild or moderate agitation, or 90 mcg for severe agitation. If agitation persists in patients with hepatic impairment, may give up to two additional 60-mcg doses at least 2 hours apart. If systolic blood pressure (SBP) is less than 90 mm Hg, diastolic blood pressure (DBP) is less than 60 mm Hg, heart rate is less than 60 beats per minute or postural decrease in SBP is more than 20 mm Hg or DBP is more than 10 mm Hg after prior dose, don't repeat dose.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerfluticasone propionateArmonAir DigihalerPharmaceutical company: Teva RespiratoryNEW FORMOral inhalation powder: 30 mcg, 55 mcg, 113 mcg, 232 mcgINDICATION & DOSAGEAs preventive maintenance of chronic asthma in patients requiring oral corticosteroids (ArmonAir Digihaler)Adults and children age 12 and older not on an inhaled corticosteroid: 55 mcg by oral inhalation b.i.d. Patients with greater asthma severity may use 113 mcg or 232 mcg by oral inhalation b.i.d. Maximum dose is 232 mcg b.i.d.Adults and children age 12 and older previously taking inhaled corticosteroids: 55 mcg, 113 mcg, or 232 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Maximum dose is 232 mcg b.i.d.Children ages 4 to 11 not on an inhaled corticosteroid: 30 mcg by oral inhalation b.i.d. After 2 weeks, may increase dose to 55 mcg b.i.d.Children ages 4 to 11 previously taking inhaled corticosteroids: 30 mcg or 55 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Doses above 55 mcg b.i.d. haven't been established in children ages 4 to 11.Adjust-a-dose: For patients who don't respond adequately to starting dose after 2 weeks of therapy, an increased dose may improve control.Released: June 2022Nursing Drug Handbook© 2022 Wolters KluwerrilpivirineEdurantPharmaceutical company: Janssen ProductsINDICATION & DOSAGEIn combination with cabotegravir for short-term treatment of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen as an oral lead-in to assess tolerability of rilpivirine before use of cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensionsAdolescents age 12 and older weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily. Use oral lead-in dose for at least 28 days.In combination with cabotegravir for short-term treatment of HIV-1 infection in patients with HIV-1 RNA less than 50 copies/mL who are on a stable oral therapy regimen but who will miss scheduled injections with cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensions by more than 7 days to up to 2 consecutive monthsAdolescents age 12 and older and weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily starting about 1 month after the last injection and continuing until the day injection dosing is restarted. Refer to the Cabenuva prescribing information for dosing instructions.Adjust-a-dose: For oral therapy with rilpivirine and cabotegravir of durations greater than 2 months, an alternative oral regimen is recommended, which may include rilpivirine.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - May 2022
nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGENeoadjuvant treatment of resectable non–small-cell lung cancer (tumors of at least 4 cm or node-positive) in combination with platinum-doublet chemotherapyAdults: 360-mg IV infusion followed by platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwersirolimusHyftorPharmaceutical company: Nobelpharma AmericaNEW FORMTopical gel:2 mg/gINDICATION & DOSAGEFacial angiofibroma associated with tuberous sclerosisAdults and children age 12 and older: Apply to facial skin b.i.d. Maximum dose, 800 mg (2.5 cm).Children ages 6 to 11: Apply to facial skin b.i.d. Maximum dose, 600 mg (2 cm).Adjust-a-dose: Reevaluate need for the drug if symptoms don’t improve within 12 weeks of treatment.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerate to severe active ulcerative colitis after inadequate response or intolerance to one or more TNF blockersAdults: 45 mg PO once daily for 8 weeks, followed by a maintenance dose of 15 mg once daily. May increase maintenance dose to 30 mg once daily for patients with refractory, severe, or extensive disease. If patient response to 30-mg dose is inadequate, discontinue the drug. Use the lowest effective dose needed to maintain response.Adjust-a-dose: If the patient has severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), mild to moderate hepatic impairment (Child-Pugh class A or B), or is taking a strong CYP3A4 inhibitor, give induction dose, 30 mg once daily for 8 weeks; then maintenance dose, 15 mg once daily.Released: May 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
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