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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 - 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
New Drug Indications - February 2024
isavuconazonium Cresemba Pharmaceutical company: Astellas PharmaNEW FORMULATIONCapsules: 74.5 mg  NEW INDICATION & DOSAGEInvasive aspergillosis; invasive mucormycosisChildren age 6 to younger than 18 weighing 32 kg or more: Loading doses, 372 mg NG or PO (five 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 372 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 25 to less than 32 kg: Loading doses, 298 mg NG or PO (four 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 298 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 18 to less than 25 kg: Loading doses, 223.5 mg NG or PO (three 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 223.5 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 16 to less than 18 kg: Loading doses, 149 mg NG or PO (two 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 149 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 3 to younger than 18 weighing 37 kg or more: Loading doses, 372 mg IV every 8 hours for six doses (48 hours); followed by 372 mg IV once daily, beginning 12 to 24 hours after last loading dose.Children age 3 to younger than 18 weighing less than 37 kg: Loading doses, 10 mg/kg IV every 8 hours for six doses (48 hours); followed by 10 mg/kg IV once daily, beginning 12 to 24 hours after last loading dose.Children age 1 to younger than 3 weighing less than 18 kg: Loading doses, 15 mg/kg IV every 8 hours for six doses (48 hours); followed by 15 mg/kg IV once daily, beginning 12 to 24 hours after last loading dose.Released: February 2024Nursing Drug Handbook© 2024 Wolters KluwerpirtobrutinibJaypircaPharmaceutical company: Eli Lilly and Company  NEW INDICATION & DOSAGEChronic lymphocytic leukemia or small lymphocytic lymphoma in patients who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitorAdults: 200 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. If eGFR range is 15 to 29 mL/minute and the current dose is 200 mg once daily, reduce the dose to 100 mg once daily; otherwise reduce the dose by 50 mg. If the current dose is 50 mg once daily, discontinue the drug. If concomitant use of a strong CYP3A inhibitor can't be avoided, reduce the pirtobrutinib dose by 50 mg. If the current dose is 50 mg once daily, interrupt pirtobrutinib therapy for the duration of the strong CYP3A inhibitor use. After discontinuation of the strong CYP3A inhibitor for five half-lives, the patient may resume the pirtobrutinib dose taken before initiating the inhibitor. If concomitant use with a moderate CYP3A inducer can't be avoided and the current dose of pirtobrutinib is 200 mg once daily, increase the dose to 300 mg. If the current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg.Released: February 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - January 2024
abataceptOrenciaPharmaceutical company: Bristol-Myers Squibb  NEW INDICATION & DOSAGEActive psoriatic arthritisChildren age 2 and older weighing 50 kg or more: 125 mg subcut once weekly without an IV loading dose.Children age 2 and older weighing 25 to less than 50 kg: 87.5 mg subcut once weekly without an IV loading dose.Children age 2 and older weighing 10 to less than 25 kg: 50 mg subcut once weekly without an IV loading dose.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerenzalutamideXtandiPharmaceutical company: Astellas Pharma  NEW INDICATION & DOSAGENonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasisAdults: 160 mg PO once daily until disease progression or unacceptable toxicity occurs, with or without a gonadotropin-releasing hormone analog.Adjust-a-dose: Suspend treatment after 36 weeks of therapy if prostate-specific antigen (PSA) is undetectable (less than 2 ng/mL). Restart treatment when PSA has increased to 2 ng/ML or more for patients who had prior radical prostatectomy, or 5 ng/mL or more for patients who had prior primary radiation therapy.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwerinfliximab-dyybZymfentraPharmaceutical company: Celltrion, Inc.NEW FORMULATIONSubcut injection: 120 mg/mL prefilled syringe or pen.NEW INDICATION & DOSAGEMaintenance of moderately to severely active ulcerative colitis after initial treatment with IV infliximab productAdults: Patients responding to maintenance therapy with IV infliximab product, give first subcut dose in place of the next scheduled IV infusion. Week 10 and thereafter, give 120 mg subcut once every two weeks.Maintenance of moderately to severely active Crohn disease after initial treatment with IV infliximab productAdults: Patients responding to maintenance therapy with IV infliximab product, give first subcut dose in place of the next scheduled IV infusion. Week 10 and thereafter, give 120 mg subcut once every two weeks.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerivosidenibTibsovoPharmaceutical company: Servier PharmaceuticalsNEW INDICATION & DOSAGERelapsed or refractory myelodysplastic syndromesAdults: 500 mg PO once daily. Treat for a minimum of 6 months to allow time for clinical response or until disease progression or unacceptable toxicity occurs.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwer  pembrolizumabKeytrudaPharmaceutical company: MerckNEW INDICATION & DOSAGEAdvanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatinAdults 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression, unacceptable toxicity occurs, or up to 24 months. Give before chemotherapy when given the same day.First-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression, unacceptable toxicity occurs, or up to 24 months. Give before chemotherapy when given on the same day.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwersecukinumabCosentyxPharmaceutical company: NovartisNEW INDICATION & DOSAGEModerate to severe hidradenitis suppurativaAdults: 300 mg subcut at weeks 0,1,2,3, and 4; then every 4 weeks thereafter. If inadequate response, may increase to 300 mg every 2 weeks.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwertirzepatideZepboundPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEAdjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (for example, hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease) (Zepbound only)Adults: Initially, 2.5 mg subcut once weekly for 4 weeks, then increase to 5 mg. May increase in 2.5-mg increments after at least 4 weeks at the current dose. The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg once weekly based on response and tolerability.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - December 2023
bosutinibBosulifPharmaceutical company: PfizerNEW FORMULATIONCapsules: 50 mg, 100 mgNEW INDICATION & DOSAGEChronic-phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) in patients with resistance or intolerance to prior therapyChildren age 1 and older: 100 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs. If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.Newly diagnosed chronic-phase Ph+ CMLChildren age 1 and older: 300 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs. If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwerelexacaftor–tezacaftor–ivacaftor and ivacaftorTrikaftaPharmaceutical company: Vertex PharmaceuticalsNEW FORMULATIONOral granules: 80 mg elexacaftor, 40 mg tezacaftor, 60 mg ivacaftor (fixed-dose combination) copackaged with 59.5 mg ivacaftor; 100 mg elexacaftor, 50 mg tezacaftor, 75 mg ivacaftor (fixed-dose combination), copackaged with 75 mg ivacaftorNEW INDICATION & DOSAGECystic fibrosis in patients who have at least one F508del mutation in the CFTR gene or a CFTR gene mutation responsive to elexacaftor–tezacaftor–ivacaftor and ivacaftor based on in vitro dataChildren ages 2 to younger than 6 years weighing 14 kg or more: One packet of oral granules (each containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor) PO in the morning, followed by one 75-mg ivacaftor packet of oral granules about 12 hours later.Children ages 2 to younger than 6 years weighing 14 kg or less: One packet of oral granules (each containing 80 mg elexacaftor, 40 mg tezacaftor, and 60 mg ivacaftor) PO in the morning, followed by one 59.5-mg ivacaftor packet of oral granules about 12 hours later.Adjust-a-dose: For patients with Child-Pugh class B liver impairment and those receiving moderate and strong CYP3A inhibitors, refer to the manufacturer's instructions for dosage adjustments.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerempagliflozinJardiancePharmaceutical company: Boehringer Ingelheim PharmaceuticalsNEW INDICATION & DOSAGETo reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), kidney failure, CV death, and hospitalization in patients with chronic kidney disease at risk of progressionAdults: 10 mg PO daily in the morning.Adjust-a-dose: Discontinue the drug if eGFR is less than 30 mL/minute/1.73 m2 in patients with diabetes mellitus or an eGFR of less than 20 mL/minute/1.73 m2 in those with heart failure.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerentrectinibRozlytrekPharmaceutical company: GenentechNEW FORMULATIONOral pellets: 50 mg/packetNEW INDICATION & DOSAGESolid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, that are metastatic or when surgical resection is likely to result in severe morbidity, and that have progressed after treatment or have no satisfactory alternativeChildren older than 6 months with BSA of at least 1.51 m2: 600 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 1.11 to 1.50 m2: 400 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.81 to 1.10 m2: 300 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.51 to 0.80 m2: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.50 m2 or less: 300 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.Children older than 1 month to 6 months: 250 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: For patients age 2 and older, refer to the manufacturer's instructions for dosage when used with moderate or strong CYP3A4 inhibitors. After discontinuation of the CYP3A inhibitor for three to five elimination half-lives, resume entrectinib dose given before initiating the CYP3A inhibitor.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwer  nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanomaAdults and children age 12 and older weighing 40 kg or more: 240-mg IV infusion every 2 weeks or 480 mg every 4 weeks.Children age 12 and older weighing less than 40 kg: 3 mg/kg-IV infusion every 2 weeks or 6 mg/kg every 4 weeks.Adjust-a-dose: Continue until disease recurrence or unacceptable toxicity for up to 1 year.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerpatiromerVeltassaPharmaceutical company: Vifor PharmaNEW FORMULATIONOral powder: 1-g packetNEW INDICATION & DOSAGENonemergency treatment of hyperkalemiaChildren ages 12 to 17: Initially, 4 g PO once daily. Monitor serum potassium level and adjust dose by 4 g daily, as needed, at intervals of 1 week or longer to reach desired potassium concentration. Maximum dosage is 25.2 g once daily.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEResectable (tumors of at least 4 cm or node positive) non–small-cell lung cancer in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgeryAdults: 200-mg IV infusion every 3 weeks or 400 mg every 6 weeks. Continue adjuvant treatment until disease recurrence, unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwerpilocarpine ophthalmicQlosiPharmaceutical company: Orasis Pharmaceuticals, Inc.NEW FORMULATIONOphthalmic solution: 0.4%NEW INDICATION & DOSAGEPresbyopia (Qlosi)Adults: Instill one drop of 0.4% solution in each eye daily. May repeat after 2 to 3 hours for an effect up to 8 hours.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwertemozolomideTemodarPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEAdjuvant treatment of patients with newly diagnosed anaplastic astrocytomaAdults: Initiate the drug four weeks after the end of radiotherapy. Cycle 1, give 150 mg/m2 PO daily on days 1 to 5 of a 28-day cycle. Then, cycles 2 to 12, give 200 mg/m2 daily on days 1 to 5 of each 28-day cycle. If the dose wasn't increased at the start of cycle 2 due to toxicity, don't increase during cycles 3 to 6.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwervosoritideVoxzogoPharmaceutical company: BioMarin Pharmaceutical, Inc.NEW INDICATION & DOSAGEIncrease of linear growth in patients with achondroplasia with open epiphysesChildren weighing 3 kg or more: 0.096 mg to 0.8 mg subcut once daily, based on actual body weight. Refer to the prescribing information for dosing table.Adjust-a-dose: Adjust the dose every 3 to 6 months, according to actual body weight. Permanently discontinue the drug upon confirmation of closed epiphyses.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - November 2023
canakinumabIlarisPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEGout flares when NSAIDs and colchicine are contraindicated, are not tolerated, or don't provide an adequate response, and when repeated courses of corticosteroids are not appropriateAdults: 150 mg subcut as a single dose. May re-treat after at least 12 weeks.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwerdabrafenib mesylateTafinlarPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with trametinibChildren ages 1 to 17 weighing 51 kg or more: 150 mg (as capsules or oral suspension) PO b.i.d.Children ages 1 to 17 weighing 38 to 50 kg: 100 mg (as capsules) PO b.i.d.Children ages 1 to 17 weighing at least 26 to 37 kg: 75 mg (as capsules) PO b.i.d.Children ages 1 to 17 weighing 8 to 50 kg: 20 to 130 mg (as oral suspension) PO b.i.d. based on body weight. See the manufacturer's instructions for recommended dosage table.  Adjust-a-dose: Refer to the trametinib prescribing information for recommended trametinib dosing information. Refer to the manufacturer's instructions for toxicity-related dose adjustments. Continue treatment until disease progression or unacceptable toxicity occurs.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwerluspatercept-aamtReblozylPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAnemia in patients with very-low-risk to intermediate-risk myelodysplastic syndromes who may require RBC transfusions and who are erythropoiesis-stimulating-agent naïveAdults: 1 mg/kg subcut once every 3 weeks. Maximum dose, 1.75 mg/kg.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwertrametinib dimethyl sulfoxideMekinistPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with dabrafenibChildren ages 1 to 17 weighing 51 kg or more: 2 mg (as tablets or oral solution) PO daily.Children ages 1 to 17 weighing 38 to 50 kg: 1.5 mg (as tablets) PO once daily.Children ages 1 to 17 weighing at least 26 to 37 kg: 1 mg (as tablets) PO once daily.Children ages 1 to 17 weighing 8 to 50 kg: 0.3 to 1.6 mg (as oral solution) PO daily based on body weight. See the manufacturer's instructions for recommended dosage table.  Adjust-a-dose: Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Refer to the manufacturer's instructions for toxicity-related dose adjustments. Continue treatment until disease progression or unacceptable toxicity occurs.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwer
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