New Drug Indications - October 2021


dalbavancin

Dalvance

Pharmaceutical company: Allergan

NEW INDICATION & DOSAGE

Acute 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 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

empagliflozin

Jardiance

Pharmaceutical company: Boehringer Ingelheim and Eli Lilly

NEW INDICATION & DOSAGE

To reduce the risk of CV death or hospitalization for heart failure in patients with heart failure and reduced ejection fraction

Adults: 10 mg PO daily in the morning.

CONTRAINDICATIONS & CAUTIONS

  • Not 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 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

immune globulin IV (human)

Octagam

Pharmaceutical company: Octapharma

NEW INDICATION & DOSAGE

Dermatomyositis (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 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

ivosidenib

Tibsovo

Pharmaceutical company: Servier Pharmaceuticals

NEW INDICATION & DOSAGE

Locally advanced or metastatic cholangiocarcinoma with IDH1 mutation as detected by an FDA-approved test in patients who have been previously treated

Adults: 500 mg PO daily until disease progression or unacceptable toxicity occurs.

Released: October 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

lenvatinib

Lenvima

Pharmaceutical company: Eisai, Inc.

NEW INDICATION & DOSAGE

Advanced 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 pembrolizumab

Adults: 20 mg PO once daily until disease progression or unacceptable toxicity occurs. Give with pembrolizumab according to the manufacturer's prescribing information.

Released: October 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

mepolizumab

Nucala

Pharmaceutical company: GlaxoSmithKline

NEW INDICATION & DOSAGE

Maintenance treatment of chronic rhinosinusitis with nasal polyps in patients with inadequate response to nasal corticosteroids

Adults: 100 mg subcut once every 4 weeks into upper arm, thigh, or abdomen.

Released: October 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

nivolumab

Opdivo

Pharmaceutical company: Bristol Myers Squibb

NEW INDICATION & DOSAGE

Adjuvant treatment of urothelial carcinoma in patients who are at high risk for recurrence after undergoing radical resection

Adults: 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 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

pembrolizumab

Keytruda

Pharmaceutical company: Merck Sharp & Dohme

NEW INDICATION & DOSAGE

Advanced 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 lenvatinib

Adults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in patients without disease progression. Give 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 surgery

Adults: 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 chemotherapy

Adults: 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 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

rivaroxaban

Xarelto

Pharmaceutical company: Janssen

NEW INDICATION & DOSAGE

To 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 established

Adults: 2.5 mg PO b.i.d., in combination with aspirin (75 to 100 mg) once daily.

Released: October 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

New Drug Indications Archive


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
New Drug Indications - May 2021
adalimumabHumiraPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerately to severely active ulcerative colitisChildren age 5 and older weighing 40 kg or more: Initially, 160 mg subcut on day 1, given in 1 day or split over 2 consecutive days; then 80 mg on days 8 and 15, followed by a maintenance dose of 80 mg every other week or 40 mg every week starting at week 4 (day 29).Children age 5 and older weighing from 20 to less than 40 kg: Initially, 80 mg subcut on day 1, followed by 40 mg on days 8 and 15, followed by a maintenance dose of 40 mg every other week or 20 mg every week starting at week 4 (day 29).Released: May 2021© 2021 Wolters KluweraxicabtageneYescartaPharmaceutical company: Kite Pharma NEW INDICATION & DOSAGERelapsed or refractory follicular lymphoma after two or more lines of systemic therapyAdults: Target dose is 2 × 106 CAR-positive viable T cells/kg of body weight (or a maximum of 2 × 108 CAR-positive viable T cells for patients weighing 100 kg or more).Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: May 2021© 2021 Wolters KluwermirabegronMyrbetriq; Myrbetriq GranulesPharmaceutical company: Astellas Pharma, Inc. NEW INDICATION & DOSAGENeurogenic detrusor overactivityChildren age 3 and older weighing 35 kg or more (extended-release tablets): 25 mg PO once daily. After 4 to 8 weeks, may increase to maximum dose of 50 mg once daily.Children age 3 and older weighing 35 kg or more (extended-release granules): Initially, 6 mL (48 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 10 mL (80 mg) once daily.Children age 3 and older weighing 22 to less than 35 kg (extended-release granules): Initially, 4 mL (32 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 8 mL (64 mg) once daily.Children age 3 and older weighing 11 to less than 22 kg (extended-release granules): Initially, 3 mL (24 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 6 mL (48 mg) once daily.Released: May 2021© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & Dohme Corp. NEW INDICATION & DOSAGELocally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapyAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months. Give pembrolizumab before chemotherapy when given on the same day.Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 as determined by an FDA-approved testAdults: 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.Released: May 2021© 2021 Wolters KluwertocilizumabActemraPharmaceutical company: Genentech NEW INDICATION & DOSAGESlowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung diseaseAdults: 162 mg subcut once every week.Released: May 2021© 2021 Wolters Kluwer