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New Drug Indications - May 2024

fluticasone propionate

Xhance
Pharmaceutical company: Optinose, Inc.

NEW INDICATION & DOSAGE
Chronic rhinosinusitis with or without polyps
Adults: 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

maralixibat

Livmarli
Pharmaceutical company: Mirum Pharmaceuticals

NEW INDICATION & DOSAGE
Cholestatic 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

alirocumab

Praluent
Pharmaceutical company: Regeneron Pharmaceuticals

NEW INDICATION & DOSAGE
Adjunct to diet and other LDL-C-lowering therapies in patients with heterozygous familial hypercholesterolemia to reduce LDL-C
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

nivolumab

Opdivo
Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE
With 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

rilpivirine

Edurant
Pharmaceutical company: Janssen Therapeutics

NEW FORMULATION
Tablets for oral suspension: 2.5 mg (Edurant Ped)

NEW INDICATION & DOSAGE
HIV-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 antiretrovirals
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

remdesivir

Veklury
Pharmaceutical company: Gilead Sciences, Inc.

NEW INDICATION & DOSAGE
Coronavirus disease 2019 (COVID-19) requiring hospitalization
Children 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 death
Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

semaglutide

Wegovy
Pharmaceutical company: Novo Nordisk

NEW INDICATION & DOSAGE
To 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

zanubrutinib

Brukinsa
Pharmaceutical company: BeiGene

NEW INDICATION & DOSAGE
With 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

New Drug Indications - February 2022
abataceptOrenciaPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEProphylaxis of acute graft-versus-host disease, in combination with a calcineurin inhibitor and methotrexate, in patients undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donorAdults and children age 6 and older: 10 mg/kg dose (maximum dose 1,000 mg) IV infusion over 60 minutes on the day before transplantation, followed by a dose on days 5, 14, and 28 after transplant.Children ages 2 to less than 6: 15 mg/kg dose IV infusion over 60 minutes on the day before transplantation, followed by 12 mg/kg on days 5, 14, and 28 after transplant.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerbudesonideTarpeyoPharmaceutical company: Calliditas TherapeuticsNEW AVAILABLE FORMDelayed-release capsules: 4 mgINDICATION & DOSAGEProteinuria in patients with primary immunoglobulin A nephropathy at risk for rapid disease progressionAdults: 16 mg PO daily in the morning at least 1 hour before a meal.Adjust-a-dose: Reduce dose to 8 mg daily for 2 weeks before discontinuing the drug.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwercarfilzomibKyprolisPharmaceutical company: Amgen, Inc.NEW INDICATION & DOSAGERelapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj and dexamethasone after one to three prior lines of therapyAdults: For twice-weekly 20/56 mg/m2 regimen, give as a 30-minute IV infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle in combination with subcut daratumumab and hyaluronidase-fihj, and dexamethasone until disease progression or unacceptable toxicity occurs. Initially, give 20 mg/m2 on cycle 1, days 1 and 2. If tolerated, escalate to 56 mg/m2 on cycle 1, day 8 and thereafter. Give dexamethasone 30 minutes to 4 hours before carfilzomib and 1 to 3 hours before IV daratumumab and hyaluronidase-fihj.For once-weekly 20/70 mg/m2 regimen, give as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day cycle in combination with subcut daratumumab and hyaluronidase-fihj, and dexamethasone until disease progression or unacceptable toxicity occurs. Initially, give 20 mg/m2 on cycle 1, day 1. If tolerated, escalate to 70 mg/m2 on cycle 1, day 8 and thereafter. Give dexamethasone 30 minutes to 4 hours before carfilzomib and 1 to 3 hours before IV daratumumab and hyaluronidase-fihj.Adjust-a-dose: Refer to the manufacturer's instructions for daratumumab and hyaluronidase-fihj for dosage information.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwerclindamycin phosphateXaciatoPharmaceutical company: Daré BiosciencesNEW FORMULATIONGel: 2%INDICATION & DOSAGEBacterial vaginosisAdults and children age 12 and older: 1 applicatorful vaginally as a single dose.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwerelbasvir–grazoprevirZepatierPharmaceutical company: Merck Sharp & Dohme CorpNEW INDICATION & DOSAGEChronic hepatitis C virus (HCV) genotypes 1 or 4 infection, with or without ribavirinChildren age 12 and older or weighing at least 30 kg: 1 tablet PO once daily. See manufacturer's instructions for recommended dosing regimens and durations for treatment of HCV genotype 1 or 4 in patients with or without cirrhosis.Adjust-a-dose: If ALT level is greater than 10 times the upper limit of normal, consider discontinuing the drug. If ALT level is elevated and accompanied by signs or symptoms of liver inflammation, increased conjugated bilirubin or alkaline phophatase level, or increased INR, discontinue the drug. If creatinine clearance is 50 mL/minute or less and ribavirin is used, refer to ribavirin prescribing information for ribavirin dose adjustment.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEAdjuvant treatment of melanoma with lymph node involvement after complete resectionChildren age 12 and older: 2 mg/kg IV over 30 minutes every 3 weeks up to maximum dose of 200 mg. Continue until disease recurrence or unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerrituximabRituxanPharmaceutical company: GenentechNEW INDICATION & DOSAGEPreviously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia in combination with chemotherapyChildren age 6 months and older: 375 mg/m2 IV infusion in combination with systemic Lymphome Malin B chemotherapy. Give the drug on day 2 and day 1 (48 hours apart) of each of the induction courses, and on day 1 of each of the two consolidation courses. Give prednisone component of regimen before rituximab. Refer to the manufacturer's instructions for additional dosing information.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwertofacitinibXeljanz and Xeljanz XRPharmaceutical company: PfizerNEW INDICATION & DOSAGEAnkylosing spondylitis after inadequate response or intolerance to one or more tumor necrosis factor blockersAdults: 5 mg (immediate-release) PO twice daily. Or, 11 mg (extended-release) PO once daily.Adjust-a-dose: Reduce dosage to 5 mg (immediate-release) PO daily in patients with moderate to severe renal impairment or moderate hepatic impairment in those receiving concurrent potent CYP3A4 inhibitors, and in those receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - January 2022
bictegravir–emtricitabine–tenofovir alafenamideBiktarvyPharmaceutical company: Gilead SciencesNEW AVAILABLE FORMTablets: 30 mg bictegravir; 120 mg emtricitabine; 15 mg tenofovir alafenamideNEW INDICATION & DOSAGEHIV-1 infection in children weighing 14 to less than 25 kg who have no antiretroviral treatment history, or to replace current antiretroviral regimen in children who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to individual componentsChildren weighing 14 to less than 25 kg: 1 tablet of 30 mg bictegravir; 120 mg emtricitabine; 15 mg tenofovir alafenamide PO daily.Released: January 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi and Regeneron PharmaceuticalsNEW INDICATION & DOSAGEAdd-on maintenance treatment of moderate to severe eosinophilic or oral corticosteroid-dependent asthmaChildren ages 6 to 11 weighing 30 kg or more: 200 mg subcut every other week.Children ages 6 to 11 weighing 15 to less than 30 mg: 100 mg subcut every other week or 300 mg every 4 weeks.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwerferric carboxymaltoseInjectaferPharmaceutical company: Daiichi SankyoNEW INDICATION & DOSAGEIron deficiency anemia in patients intolerant to or who have had unsatisfactory response to oral ironChildren age 1 and older weighing 50 kg or more: 750 mg IV on day 1; repeat dose after at least 7 days. May repeat course of therapy if anemia recurs. Maximum cumulative dose is 1,500 mg per course.Children age 1 and older weighing less than 50 kg: 15 mg/kg IV on day 1; repeat dose after at least 7 days. May repeat course of therapy if anemia recurs.Released: January 2022Nursing Drug Handbook© 2022 Wolters KluwerlacosamideVimpatPharmaceutical company: UCB, Inc.NEW INDICATION & DOSAGEMonotherapy for partial-onset seizuresChildren age 1 month and older weighing 6 to less than 11 kg: Initially, 1 mg/kg PO or IV b.i.d. Then increase by 1 mg/kg b.i.d. at weekly intervals to recommended dose of 3 to 6 mg/kg b.i.d.Children age 1 month and older weighing less than 6 kg: Initially, 0.66 mg/kg IV t.i.d. Then increase by 0.66 mg/kg IV t.i.d. at weekly intervals to recommended IV dose of 2.5 to 5 mg/kg t.i.d. Or initially, 1 mg/kg PO b.i.d. Then increase by 1 mg/kg b.i.d. at weekly intervals to recommended PO dose of 3.75 to 7.5 mg/kg b.i.d.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwerpilocarpine hydrochloride (ophthalmic)VuityPharmaceutical company: AllerganNEW AVAILABLE FORMOphthalmic solution: 1.25%INDICATION & DOSAGEPresbyopia (Vuity)Adults: Instill 1 drop of 1.25% solution in each eye once daily.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - December 2021
abemaciclibVerzenioPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEAdjuvant treatment for hormone receptor-positive, HER2-negative, node-positive, early breast cancer, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), in patients at high risk of recurrence and with a Ki-67 score of 20% or more as determined by an FDA-approved testAdults: 150 mg PO b.i.d. until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity occurs.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluweratezolizumabTecentriqPharmaceutical company: GenentechNEW INDICATION & DOSAGEAdjuvant treatment after resection and platinum-based chemotherapy for patients with stage II to IIIA non–small-cell lung cancer whose tumors express PD-L1, as determined by an FDA-approved testAdults: 840-mg IV infusion every 2 weeks; or 1,200 mg every 3 weeks; or 1,680 mg every 4 weeks until disease recurrence or unacceptable toxicity occurs, or up to 1 year.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwercetuximabErbituxPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEMetastatic colorectal cancer with BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy, in combination with encorafenibAdults: Initially, 400 mg/m2 IV infusion over 120 minutes, then 250 mg/m2 IV infusion over 60 minutes weekly with encorafenib 300 mg PO daily until disease progression or unacceptable toxicity occurs. Refer to encorafenib prescribing information.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwerdexamethasone ophthalmic insertDextenzaPharmaceutical company: Ocular TherapeutixNEW FORMULATIONOphthalmic insert:0.4 mgINDICATION & DOSAGEOcular itching associated with allergic conjunctivitisAdults: Place a single 0.4-mg insert into lower lacrimal canaliculus.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerevolocumabRepathaPharmaceutical company: AmgenINDICATION & DOSAGEAdjunct to diet and other LDL-lowering therapies to reduce LDL cholesterol in children with heterozygous familial hypercholesterolemiaChildren age 10 and older: 140 mg subcut every 2 weeks or 420 mg subcut once monthly. When switching dosage regimens, give first dose of new regimen on next scheduled date of prior regimen.Adjunct to other LDL-lowering therapies for homozygous familial hypercholesterolemia in those who require additional lowering of LDL cholesterolAdults and children age 10 and older: 420 mg subcut once monthly. May increase dose to 420 mg every 2 weeks if clinically meaningful response isn't achieved in 12 weeks. Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks given after apheresis session is complete.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeINDICATION & DOSAGEPersistent, recurrent, or metastatic cervical cancer in patients whose tumors express PD-L1, as determined by an FDA-approved test, in combination with chemotherapy, with or without bevacizumabAdults: 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 with or without bevacizumab when given the same day.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - November 2021
brivaracetamBriviactPharmaceutical company: UCB, Inc.NEW INDICATION & DOSAGEAdjunctive therapy or monotherapy for partial-onset seizures in patients with epilepsyChildren age 1 month and older weighing 20 to less than 50 kg: 0.5 to 1 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.5 mg/kg b.i.d.; maximum dose, 2 mg/kg b.i.d.Children age 1 month and older weighing 11 to less than 20 kg: 0.5 to 1.25 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.5 mg/kg b.i.d.; maximum dose, 2.5 mg/kg b.i.d.Children age 1 month and older weighing less than 11 kg: 0.75 mg/kg to 1.5 mg/kg PO b.i.d. Adjust dosage based on clinical response and tolerability. Minimum dose, 0.75 mg/kg b.i.d.; maximum dose, 3 mg/kg b.i.d.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  cabozantinibCabometyxPharmaceutical company: Exelixis, Inc.NEW INDICATION & DOSAGELocally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy in those who are radioactive iodine-refractory or ineligible (Cabometyx only)Adults and children age 12 and older with BSA of 1.2 m2 or more: 60 mg PO daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Reduce starting dose to 40 mg PO once daily for patients with moderate hepatic impairment (Child-Pugh class B). Refer to the manufacturer's instructions for toxicity-related dosage adjustments and for use with strong CYP3A4 inducers or inhibitors.Children age 12 and older with BSA less than 1.2 m2: 40 mg PO daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Reduce starting dose to 20 mg PO once daily for patients with moderate hepatic impairment (Child-Pugh class B). Refer to the manufacturer's instructions for toxicity-related dosage adjustments and for use with strong CYP3A4 inducers or inhibitors.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  paliperidone palmitateInvega HafyeraPharmaceutical company: JanssenNEW AVAILABLE FORMInjection: 1,092 mg/3.5 mL; 1,560 mg/5 mL single-dose, prefilled syringesNEW INDICATION & DOSAGESchizophreniaAdults: Use 6-month IM paliperidone (Invega Hafyera) only after monthly IM paliperidone (Invega Sustenna) has been established as adequate treatment for at least 4 months and at the same dosage for at least 2 months, or after IM paliperidone (Invega Trinza) has been established as adequate treatment for at least a one 3-month cycle. Initiate when the next once-a-month injection is scheduled, or up to 1 week before or after. Initiate when the next every-3-month injection is scheduled, or up to 2 weeks before or after. Dosage is based on dosage of previous product. If last dose of once-a-month product was 156 mg, give 1,092 mg of 6-month product; if last dose of once-a-month product was 234 mg, give 1,560 mg of 6-month product. If last dose of 3-month product was 546 mg, give 1,092 mg of 6-month product; if last dose of 3-month product was 819 mg, give 1,560 mg of 6-month product. Because of long-acting nature of Invega Hafyera, patient's response to adjusted dose may not be apparent for several months. See the manufacturer's instructions for missed dosage schedules.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  ruxolitinibJakafiPharmaceutical company: IncyteNEW INDICATION & DOSAGEChronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapyAdults and children age 12 and older: 10 mg PO b.i.d.Adjust-a-dose: Recommended starting dose is 5 mg b.i.d. in patients with moderate to severe renal impairment (creatinine clearance of 15 to 59 mL/min) or when given concomitantly with fluconazole 200 mg or less. Starting dose for patients with end-stage-renal disease on dialysis is 10 mg after dialysis session. After 6 months of treatment in patients who have discontinued corticosteroids, taper the drug by one dose level every 8 weeks (10 mg b.i.d. to 5 mg b.i.d. to 5 mg once daily). Consider retreatment if acute GVHD recurs during or after taper. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  zanubrutinibBrukinsaPharmaceutical company: BeiGeneNEW INDICATION & DOSAGEWaldenström macroglobulinemiaAdults: 160 mg PO b.i.d. or 320 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: For patients with severe hepatic impairment (Child-Pugh class C), reduce dose to 80 mg PO b.i.d. If given with strong CYP3A inhibitor, reduce dose to 80 mg PO once daily. If given with moderate CYP3A inhibitor, reduce dose to 80 mg PO b.i.d. After stopping CYP3A inhibitor, resume previous zanubrutinib dose. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Relapsed or refractory marginal zone lymphoma in patients who have received at least one anti-CD20-based regimenAdults: 160 mg PO b.i.d. or 320 mg PO once daily, until disease progression or unacceptable toxicity occurs.Adjust-a-dose: For patients with severe hepatic impairment (Child-Pugh class C), reduce dose to 80 mg PO b.i.d. If given with strong CYP3A inhibitor, reduce dose to 80 mg PO once daily. If given with moderate CYP3A inhibitor, reduce dose to 80 mg PO b.i.d. After stopping CYP3A inhibitor, resume previous zanubrutinib dose. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - October 2021
dalbavancinDalvancePharmaceutical company: AllerganNEW INDICATION & DOSAGEAcute bacterial skin and skin-structure infections caused by susceptible strains of gram-positive microorganisms (Staphylococcus aureus [including MRSA], Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group [S. anginosus,S. intermedius, S. constellatus], Enterococcus faecalis (vancomycin-susceptible strains)Children age 6 to less than 18: 18 mg/kg IV infusion as a single dose, up to a maximum of 1,500 mg.Children from birth to less than age 6: 22.5 mg/kg IV infusion as a single dose, up to a maximum of 1,500 mg.Adjust-a-dose: Dose adjustment for children with creatinine clearance less than 30 mL/minute has not been established.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwerempagliflozinJardiancePharmaceutical company: Boehringer Ingelheim and Eli LillyNEW INDICATION & DOSAGETo reduce the risk of CV death or hospitalization for heart failure in patients with heart failure and reduced ejection fractionAdults: 10 mg PO daily in the morning.CONTRAINDICATIONS & CAUTIONSNot recommended for glycemic control in patients with eGFR less than 30 mL/min/1.73 m2.Dosing recommendations have not been determined for patients with type 2 diabetes and established CV disease with eGFR less than 30 mL/min/1.73 m2, or who have heart failure with reduced ejection fraction with eGFR less than 20 mL/min/1.73 m2.Released: October 2021Nursing Drug Handbook© 2021 Wolters Kluwerimmune globulin IV (human)OctagamPharmaceutical company: OctapharmaNEW INDICATION & DOSAGEDermatomyositis (Octagam 10%)Adults: 2 g/kg divided in equal doses given over 2 to 5 consecutive days every 4 weeks. Initial infusion rate is 0.01 mL/kg/min (1 mg/kg/min) for the first 30 minutes. If tolerated, the rate may be gradually increased to 0.02 mL/kg/min (2 mg/kg/min) and, if tolerated, may gradually increase to a maximum of 0.04 mL/kg/min (4 mg/kg/min).Alert: Patients with dermatomyositis are at increased risk for thromboembolic events; do not exceed infusion rate of 0.04 mL/kg/min.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwerivosidenibTibsovoPharmaceutical company: Servier PharmaceuticalsNEW INDICATION & DOSAGELocally advanced or metastatic cholangiocarcinoma with IDH1 mutation as detected by an FDA-approved test in patients who have been previously treatedAdults: 500 mg PO daily until disease progression or unacceptable toxicity occurs.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwerlenvatinibLenvimaPharmaceutical company: Eisai, Inc.NEW INDICATION & DOSAGEAdvanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient in patients who have disease progression after systemic therapy in any setting and who are not candidates for curative surgery or radiation, in combination with pembrolizumabAdults: 20 mg PO once daily until disease progression or unacceptable toxicity occurs. Give with pembrolizumab according to the manufacturer's prescribing information.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwermepolizumabNucalaPharmaceutical company: GlaxoSmithKlineNEW INDICATION & DOSAGEMaintenance treatment of chronic rhinosinusitis with nasal polyps in patients with inadequate response to nasal corticosteroidsAdults: 100 mg subcut once every 4 weeks into upper arm, thigh, or abdomen.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of urothelial carcinoma in patients who are at high risk for recurrence after undergoing radical resectionAdults: 240-mg IV infusion every 2 weeks, or 480-mg IV infusion every 4 weeks, until disease recurrence or unacceptable toxicity occurs, or up to 1 year of treatment.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEAdvanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient in patients who have disease progression after systemic therapy in any setting and who are not candidates for curative surgery or radiation, in combination with lenvatinibAdults: 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 with lenvatinib according to the manufacturer's prescribing information.High-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single-agent adjuvant treatment after surgeryAdults: Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200-mg IV infusion every 3 weeks, or 4 doses of 400-mg IV infusion every 6 weeks), followed by adjuvant treatment as a single agent for up to 27 weeks (9 doses of 200-mg IV infusion every 3 weeks, or 5 doses of 400-mg IV infusion every 6 weeks) or until disease progression or unacceptable toxicity occurs. Give prior to chemotherapy when given on the same day.Locally recurrent unresectable or metastatic TNBC in patients whose tumors express PD-L1 as determined by an FDA-approved test, in combination with chemotherapyAdults: 200 mg every 3 weeks or 400 mg every 6 weeks, until disease progression or unacceptable toxicity occurs or up to 24 months in patients without disease progression. Give prior to chemotherapy when given on the same day.Released: October 2021Nursing Drug Handbook© 2021 Wolters KluwerrivaroxabanXareltoPharmaceutical company: JanssenNEW INDICATION & DOSAGETo reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD, once hemostasis is establishedAdults: 2.5 mg PO b.i.d., in combination with aspirin (75 to 100 mg) once daily.Released: October 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - September 2021
deferiproneFerriproxPharmaceutical company: Chiesi USANEW AVAILABLE FORMSOral solution: 80 mg/mLTablets: 1,000 mg for t.i.d. dosing; 1,000 mg for b.i.d. dosingINDICATION & DOSAGETreatment of transfusional iron overload in patients with thalassemia syndromesAdults and children age 8 and older: Initially, 25 mg/kg tablets or oral solution PO t.i.d., or 25 mg/kg tablets PO b.i.d., for a total of 75 mg/kg/day. May titrate to maximum dosage of 99 mg/kg/day based on patient response and therapeutic goals. Round dose to nearest 500 mg (one-half 1,000-mg tablet), 250 mg (one-half 500-mg tablet) or 2.5 mL of oral solution. Children age 3 and older: Initially, 25 mg/kg oral solution PO t.i.d., for a total of 75 mg/kg/day. May titrate to maximum dosage of 99 mg/kg/day based on patient response and therapeutic goals. Round dose to nearest 2.5 mL of oral solution. Treatment of transfusional iron overload in patients with sickle cell disease or other anemiasAdults and children age 8 and older: Initially, 25 mg/kg tablets or oral solution PO t.i.d., or 25 mg/kg tablets PO b.i.d., for a total of 75 mg/kg/day. May titrate to maximum dosage of 99 mg/kg/day based on patient response and therapeutic goals. Round dose to nearest 500 mg (one-half 1,000-mg tablet), 250 mg (one-half 500-mg tablet) or 2.5 mL of oral solution. Children age 3 and older: Initially, 25 mg/kg oral solution PO t.i.d., for a total of 75 mg/kg/day. May titrate to maximum dosage of 99 mg/kg/day based on patient response and therapeutic goals. Round dose to nearest 2.5 mL of oral solution. Adjust-a-dose (for both indications): To minimize GI upset when initiating therapy, may start at 45 mg/kg/day and increase weekly by 15 mg/kg/day. If serum ferritin level falls consistently below 500 mcg/L, consider temporary therapy interruption. For ANC less than 1,500/mm3, interrupt therapy immediately and monitor until recovery; do not rechallenge unless the potential benefit outweighs the risk. For ANC less than 500/mm3, consider hospitalization and other clinically appropriate management; do not resume unless potential benefits outweigh the risks.Released: September 2021Nursing Drug Handbook© 2021 Wolters KluwerposaconazoleNoxafilPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGETreatment of invasive aspergillosisAdults and children ages 13 to 17: 300-mg delayed-release tablet PO b.i.d. on first day, then 300 mg PO once daily. Or, 300 mg IV b.i.d. on first day, then 300 mg IV once daily for 6 to 12 weeks. May switch between IV and delayed-release tablets; no loading dose is required when switching between formulations.Released: September 2021Nursing Drug Handbook© 2021 Wolters KluwersecnidazoleSolosecPharmaceutical company: Lupin PharmaceuticalsNEW INDICATION & DOSAGETreatment of trichomoniasisAdults: One single dose of 2 g PO. Treat sexual partners at same dose at same time.Released: September 2021Nursing Drug Handbook© 2021 Wolters KluwersugammadexBridionPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEReversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in patients undergoing surgeryChildren age 2 and older (routine reversal of rocuronium and vecuronium-induced neuromuscular blockade): Base doses and timing of drug administration on twitch responses and extent of spontaneous recovery. Give 4 mg/kg IV bolus over 10 seconds if recovery of twitch response has reached one to two posttetanic counts and there are no twitch responses to train-of-four (TOF) stimulation. Give 2 mg/kg IV bolus over 10 seconds if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation.Alert: Immediate reversal of rocuronium-only induced neuromuscular blockade has not been studied in children.Released: September 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - August 2021
fesoterodine fumarateToviazPharmaceutical company: PfizerNEW INDICATION & DOSAGENeurogenic detrusor overactivityChildren age 6 and older weighing more than 35 kg: 4 mg PO once daily for 1 week, then increase to 8 mg once daily.Children age 6 and older weighing more than 25 kg and up to 35 kg: 4 mg PO once daily. May increase to 8 mg once daily if needed.Adjust-a-dose: In children weighing more than 25 kg and up to 35 kg, recommended dose is 4 mg daily; this drug is not recommended if eGFR is 29 mL/min/1.73 m2. In children weighing 35 kg or more and eGFR is 29 mL/min/1.73 m2, recommended dose is 4 mg daily; this drug is not recommended if eGFR is less than 15 mL/min/1.73 m2. If coadministering strong CYP3A4 inhibitor in children weighing more than 35 kg, maximum dose is 4 mg daily; coadministration is not recommended in children weighing more than 25 kg and up to 35 kg.CONTRAINDICATIONS AND CAUTIONSAlert: Contraindicated in patients hypersensitive to tolterodine tartrate.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerglecaprevir–pibrentasvirMavyretPharmaceutical company: AbbVie, Inc.NEW AVAILABLE FORMOral pellets: 50 mg glecaprevir and 20 mg pibrentasvirNEW INDICATION & DOSAGEChronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection in treatment-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh class A)Children age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 8 weeks.HCV genotype 1 infection with or without compensated cirrhosis (Child-Pugh class A) in patients previously treated with an HCV NS5A inhibitor but without an NS3/4A protease inhibitor (PI)Children age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 16 weeks.HCV genotype 1 infection with or without compensated cirrhosis (Child-Pugh class A) in patients previously treated with an NS3/4A PI without an NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 12 weeks.HCV genotype 1, 2, 4, 5, or 6 infection without cirrhosis in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 8 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 8 weeks.HCV genotype 1, 2, 4, 5, or 6 infection with compensated cirrhosis (Child-Pugh class A) in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir, but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 12 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 12 weeks.HCV genotype 3 infection without cirrhosis or with compensated cirrhosis (Child-Pugh class A) in patients who previously received regimens containing interferon, pegylated interferon, ribavirin, or sofosbuvir, but without prior treatment with an HCV NS3/4A PI or NS5A inhibitorChildren age 3 and older or weighing at least 45 kg: 300 mg glecaprevir/120 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older or weighing 30 kg to less than 45 kg: 250 mg glecaprevir/100 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing 20 kg to less than 30 kg: 200 mg glecaprevir/80 mg pibrentasvir PO once daily for 16 weeks.Children age 3 and older weighing less than 20 kg: 150 mg glecaprevir/60 mg pibrentasvir PO once daily for 16 weeks.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerozanimodZeposiaPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGEModerate to severe active ulcerative colitisAdults: Initially, 0.23 mg PO once daily on days 1 to 4, then 0.46 mg PO once daily on days 5 to 7, then maintenance dose of 0.92 mg PO once daily.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerposaconazoleNoxafilPharmaceutical company: Merck Sharp & Dohme Corp.NEW AVAILABLE FORMPowder for delayed-release oral suspension: 300 mgNEW INDICATION & DOSAGEPrevention of invasive Aspergillus and Candida infections in patients with a high-risk of immunocompromise until recovered from neutropenia or immunosuppressionIV infusionChildren ages 2 to less than 18: 6 mg/kg up to a maximum of 300-mg IV infusion b.i.d. on first day, then 6 mg/kg to a maximum of 300 mg once daily.Delayed-release oral suspensionChildren age 2 to less than 18 weighing 36 to 40 kg: 240 mg (8 mL) PO b.i.d on first day, then 240 mg once daily.Children age 2 to less than 18 weighing 26 to less than 36 kg: 210 mg (7 mL) PO b.i.d. on first day, then 210 mg once daily.Children age 2 to less than 18 weighing 21 to less than 26 kg: 180 (6 mL) mg PO b.i.d. on first day, then 180 mg once daily.Children age 2 to less than 18 weighing 17 to less than 21 kg: 150 mg (5 mL) PO b.i.d. on first day, then 150 mg once daily.Children age 2 to less than 18 weighing 12 to less than 17 kg: 120 mg (4 mL) PO b.i.d. on first day, then 120 mg once daily.Children age 2 to less than 18 weighing 10 to less than 12 kg: 90 mg (3 mL) PO b.i.d. on first day, then 90 mg once daily.Alert: Powder for delayed-release oral suspension is contraindicated in patients with known or suspected hereditary fructose intolerance.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerravulizumab-cwvzUltomirisPharmaceutical company: Alexion PharmaceuticalsNEW AVAILABLE FORMInjection: 300 mg/3 ml (100 mg/mL) and 1,100 mg/11 mL (100 mg/mL) single-dose vialsNEW INDICATION & DOSAGETreatment of paroxysmal nocturnal hemoglobinuriaChildren age 1 month and older 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.Children age 1 month and older 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.Children age 1 month and older 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.Children age 1 month and older weighing 30 to less than 40 kg: 1,200-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 2,700-mg IV infusion once every 8 weeks.Children age 1 month and older weighing 20 to less than 30 kg: 900-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 2,100-mg IV infusion once every 8 weeks.Children age 1 month and older weighing 10 to less than 20 kg: 600-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 600-mg IV infusion once every 4 weeks.Children age 1 month and older weighing 5 to less than 10 kg: 600-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 300-mg IV infusion once every 4 weeks.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerrimegepantNurtec ODTPharmaceutical company: Biohaven PharmaceuticalsNEW INDICATION & DOSAGEPrevention of episodic migraineAdults: 75 mg PO every other day.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwersecukinumabCosentyxPharmaceutical company: Novartis PharmaceuticalsNEW INDICATION & DOSAGEModerate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapyChildren age 6 and older weighing 50 kg or more: 150 mg subcut at weeks 0, 1, 2, 3, and 4; then 150 mg every 4 weeks thereafter.Children age 6 and older weighing less than 50 kg: 75 mg subcut at weeks 0, 1, 2, 3, and 4; then 75 mg every 4 weeks thereafter.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwersofosbuvir–velpatasvirEpclusaPharmaceutical company: Gilead SciencesNEW AVAILABLE FORMOral pellets: 150 mg sofosbuvir and 37.5 mg velpatasvir; 200 mg sofosbuvir and 50 mg velpatasvir packetsNEW INDICATION & DOSAGEChronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh class A) or with decompensated cirrhosis (Child-Pugh class B or C) in combination with ribavirinChildren age 3 and older weighing at least 30 kg: 400 mg sofosbuvir and 100 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Children age 3 and older weighing 17 to less than 30 kg: 200 mg sofosbuvir and 50 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Children age 3 and older weighing less than 17 kg: 150 mg sofosbuvir and 37.5 mg velpatasvir PO once daily for 12 weeks. Refer to the manufacturer's instructions for ribavirin weight-based dosing.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluweravapritinibAyvakitPharmaceutical company: Blueprint MedicinesNEW INDICATION & DOSAGEAdvanced systemic mastocytosisAdults: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Reduce starting dose to 50 mg PO once daily when giving with moderate CYP3A inhibitor. Recommended dose has not been established for patients with severe renal impairment, end-stage renal disease, or severe hepatic impairment. This drug is not recommended for patients with platelet counts less than 50 x 109/L. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Permanently discontinue drug if patient cannot tolerate 25 mg once daily.Released: August 2021Nursing Drug Handbook© 2021 Wolters KluwerdabigatranPradaxaPharmaceutical company: Boehringer IngelheimNEW INDICATION & DOSAGETreatment of venous thromboembolism (VTE) in children previously treated with parenteral anticoagulant for at least 5 daysChildren age 8 to less than 18 (capsules): Weight-based dose PO b.i.d. according to the manufacturer's instructions.Children age 3 months to less than 12 years (pellets): Weight-based dose PO b.i.d. according to the manufacturer's instructions.Adjust-a-dose: Avoid use in children with eGFR less than 50 mL/min/1.73 m2.To reduce the risk of recurrence of VTE in previously treated childrenChildren age 8 to less than 18 (capsules): Weight-based dose PO b.i.d. after previous treatment according to the manufacturer's instructions.Children age 3 months to less than 12 years (pellets): Weight-based dose PO b.i.d. after previous treatment according to the manufacturer's instructions.Adjust-a-dose: Avoid use in children with eGFR less than 50 mL/min/1.73 m2.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwerelexacaftor–tezacaftor–ivacaftor and ivacaftorTrikaftaPharmaceutical company: Vertex PharmaceuticalsNEW AVAILABLE FORMTablets: 50 mg elexacaftor, 25 mg tezacaftor, and 37.5 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 geneChildren age 6 to less than 12 years weighing 30 kg or more: Two tablets (each containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor) PO in the morning, followed by one 150-mg ivacaftor tablet in the evening about 12 hours later.Children age 6 to less than 12 years weighing less than 30 kg: Two tablets (each containing 50 mg elexacaftor, 25 mg tezacaftor, and 37.5 mg ivacaftor) PO in the morning, followed by one 75-mg ivacaftor tablet in the evening about 12 hours later.Adjust-a-dose: For patients with moderate hepatic impairment (Child-Pugh class B), two tablets (each containing elexacaftor, tezacaftor, and ivacaftor) PO in the morning on day 1, alternating with one tablet in the morning on day 2. No evening dose of ivacaftor should be taken. For patients currently receiving moderate and strong CYP3A inhibitors, refer to the manufacturer's instructions for dosage adjustments.Released: August 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - July 2021
dapagliflozinFarxigaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGETo reduce the risk of sustained eGFR decline, end-stage renal disease (ESRD), CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk for progressionAdults: 10 mg PO once daily.Adjust-a-dose: This drug is not recommended for initiation when eGFR is less than 25 mL/min/1.73 m2; however, patient may continue 10 mg PO once daily to reduce the risk of eGFR decline, ESRD, CV death, and hospitalization for heart failure.CONTRAINDICATIONS & CAUTIONSThis drug is not recommended for treatment of chronic kidney disease in patients with polycystic kidney disease or those with current or recent immunosuppressive therapy for kidney disease.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwerdiclofenac potassiumZipsorPharmaceutical company: Assertio Therapeutics, Inc.NEW INDICATION & DOSAGEMild to moderate acute pain (Zipsor)Adults and children age 12 and older: 25 mg PO q.i.d.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapyAdults: 240-mg IV infusion every 2 weeks, or 480-mg IV infusion every 4 weeks, until disease progression or unacceptable toxicity occurs, or up to 1 year of treatment.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEFirst-line treatment in patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks prior to trastuzumab and chemotherapy when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Monotherapy treatment in patients with locally recurrent advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerspinosadNatrobaPharmaceutical company: ParaPRONEW INDICATION & DOSAGEScabies infestationAdults and children age 4 and older: Apply to skin to completely cover body from the neck to soles of feet. Patients with balding scalp should also apply to scalp, hairline, temples, and forehead. Allow skin to dry for 10 minutes before getting dressed. Leave on skin for 6 hours before showering or bathing.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - June 2021
alirocumabPraluentPharmaceutical company: RegeneronNEW INDICATION & DOSAGEAdjunct to other LDL cholesterol (LDL-C)-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-CAdults: 150 mg subcut every 2 weeks.Released: June 2021© 2021 Wolters KluwercetuximabErbituxPharmaceutical company: LillyNEW INDICATION & DOSAGESquamous cell carcinoma of the head and neck, as a single agent or in combination with platinum-based therapy and fluorouracilAdults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before platinum-based therapy with fluorouracil. Continue therapy until disease progression or unacceptable toxicity occurs.KRAS mutation-negative (wild type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer as determined by FDA-approved tests given in combination with FOLFIRI (irinotecan, 5-FU, leucovorin) chemotherapy regimen for first-line treatment or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, or given as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecanAdults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before irinotecan or FOLFIRI. Continue therapy until disease progression or unacceptable toxicity occurs.Adjust-a-dose (for all indications): Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.Released: June 2021© 2021 Wolters Kluwerdaunorubicin and cytarabine liposomeVyxeosPharmaceutical company: Jazz PharmaceuticalsNEW INDICATION & DOSAGENewly diagnosed, therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changesChildren age 1 and older: A full course of therapy consists of one or two induction cycles followed by up to two consolidation cycles. For initial induction cycle, 44 mg/m2 daunorubicin/100 mg/m2 cytarabine IV infusion on days 1, 3, and 5. For patients who fail to achieve a response from first induction cycle, give a second induction cycle of 44 mg/m2 daunorubicin/100 mg/m2 cytarabine IV infusion on days 1 and 3. May give second induction cycle 2 to 5 weeks after first induction cycle if no unacceptable toxicity occurs with previous cycle.Give first consolidation cycle 5 to 8 weeks after start of the last induction. Recommended dose for each consolidation cycle is 29 mg/m2 daunorubicin/65 mg/m2 cytarabine IV infusion on days 1 and 3. Give second consolidation cycle 5 to 8 weeks after start of first consolidation cycle if no disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: June 2021© 2021 Wolters KluwerdiazepamDiastatPharmaceutical company: Bausch HealthNEW INDICATION & DOSAGEAcute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from patient's usual seizure patternAdults and children age 12 and older: 0.2 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Children ages 6 to 11: 0.3 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Children ages 2 to 5: 0.5 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.Released: June 2021© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdvanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 360-mg IV infusion every 3 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks; or 240-mg IV infusion every 2 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years in patients without disease progression.Adjust-a-dose: Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.Released: June 2021© 2021 Wolters KluwertreprostinilTyvasoPharmaceutical company: United Therapeutics Corp.NEW INDICATION & DOSAGEPulmonary arterial hypertension associated with interstitial lung disease in patients (WHO group 3) to improve exercise abilityAdults: Initially, 3 breaths (18 mcg) per treatment session q.i.d., approximately 4 hours apart. Increase dose by 3 breaths in 1- to 2-week intervals, as tolerated, to target maintenance dose of 9 breaths (54 mcg) q.i.d. If 3 breaths are not tolerated initially, decrease to 1 or 2 breaths and increase as tolerated.Released: June 2021© 2021 Wolters KluwervalsartanDiovanPharmaceutical company: NovartisNEW INDICATION & DOSAGEHypertensionChildren ages 1 to 16: Initially, 1 mg/kg PO daily (up to 40 mg total). Adjust according to patient response and tolerability, up to 4 mg/kg or 160 mg daily.Adjust-a-dose: Consider starting dose of 2 mg/kg in select cases when greater reduction of blood pressure is needed.Released: June 2021© 2021 Wolters Kluwer
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