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New Drug Indications - August 2023


bezlotoxumab

Zinplava

Pharmaceutical company: Merck Sharp & Dohme

NEW INDICATION & DOSAGE

To reduce recurrence of Clostridioides difficile infection (CDI) in patients receiving antibacterial treatment for CDI and who are at high risk for CDI recurrence

Children age 1 and older: 10 mg/kg by IV infusion over 60 minutes as a one-time dose during antibacterial treatment for CDI.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


colchicine

Lodoco

Pharmaceutical company: Agepha Pharma

NEW FORM

Tablets: 0.5 mg

NEW INDICATION & DOSAGE

To reduce the risk of MI, stroke, coronary revascularization, and CV death in patients with established atherosclerotic disease or multiple risk factors for CV disease (Lodoco only)

Adults: 0.5 mg PO once daily.

Adjust-a-dose: Use is contraindicated in patients with creatinine clearance less than 15 mL/minute, Child-Pugh class C liver impairment, preexisting blood dyscrasias, or concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


ferric carboxymaltose

Injectafer

Pharmaceutical company: Daiichi-Sankyo

NEW INDICATION & DOSAGE

Iron deficiency in patients with New York Heart Association class II/III heart failure to improve exercise capacity

Adults weighing at least 70 kg:  If hemoglobin (Hb) is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 1,000 mg if Hb is less than 10 g/dL or 500 mg if Hb is 10 to 14 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.

Adults weighing less than 70 kg:  If Hb is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 500 mg if Hb is less than 10 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.

Adjust-a-dose: Give addition maintenance dose of 500 mg IV at weeks 12, 24, and 36 if ferritin level is less than 100 ng/mL or ferritin is 100 to 300 ng/mL with transferrin saturation of less than 20%. May repeat treatment if iron deficiency recurs.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


letermovir

Prevymis

Pharmaceutical company: Merck Sharp & Dohme

NEW INDICATION & DOSAGE

Prophylaxis of CMV disease in kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)

Adults: 480 mg administered once daily PO or IV infusion over 1 hour beginning day 0 to 7 posttransplant through 200 days posttransplant.

Adjust-a-dose:  If the drug is administered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after the start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after the start of letermovir, increase the next dose of letermovir 480 mg once daily. If cyclosporine dosing is interrupted due to high cyclosporine level, no letermovir dosage adjustment is needed.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 


linaclotide

Linzess

Pharmaceutical company: AbbVie

NEW INDICATION & DOSAGE

Functional constipation

Children ages 6 to 17: 72 mcg PO once daily.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


odevixibat

Bylvay

Pharmaceutical company: Albireo Pharma

NEW INDICATION & DOSAGE

Cholestatic pruritus in patients with Alagille syndrome

Adults and children age 12 months and older: 120 mcg/kg PO once daily in the morning with a meal.

Adjust-a-dose:  May decrease to 40 mcg/kg/day if intolerance occurs without other cause. Once tolerability stabilizes, increase to 120 mcg/kg/day. Interrupt therapy if new-onset liver function test abnormalities or signs and symptoms of hepatitis occur. Once liver function test values return to baseline or stabilize at new baseline, restart drug at 40 mcg/kg/day and increase dose as tolerated. Consider permanently stopping the drug if liver function test abnormalities recur. Discontinue the drug if hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy) occurs. Interrupt therapy if persistent diarrhea occurs. Restart drug at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated. Stop the drug if diarrhea persists and no alternative etiology is identified.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


olaparib

Lynparza

Pharmaceutical company: AstraZeneca

NEW INDICATION & DOSAGE

Deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone

Adults: 300 mg PO b.i.d., until disease progression or unacceptable toxicity occurs. Give in combination with a GnRH analogue or after bilateral orchiectomy. Recommended abiraterone dosage, 1,000 mg PO once daily in combination with prednisone or prednisolone 5 mg PO b.i.d. Refer to the abiraterone prescribing information for additional information.

Released: August 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer