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