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New Drug Indications - November 2024


certolizumab pegol

Cimzia
Pharmaceutical company: UCB, Inc.

NEW INDICATION & DOSAGE
Active polyarticular juvenile idiopathic arthritis
Adults and children ages 2 and older weighing 40 kg or more: 400 mg subcut at weeks 0, 2, and 4; then maintenance dose of 200 mg every 2 weeks.
Adults and children ages 2 and older weighing 20 to less than 40 kg: 200 mg subcut at weeks 0, 2, and 4; then maintenance dose of 100 mg every 2 weeks.
Adults and children ages 2 and older weighing 10 to less than 20 kg: 100 mg subcut at weeks 0, 2, and 4; then maintenance dose of 50 mg every 2 weeks.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


letermovir

Prevymis
Pharmaceutical company: Merck & Co.

NEW AVAILABLE FORM
Oral pellets: 20 mg; 120 mg packet

NEW INDICATION & DOSAGE
Prophylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
Children age 12 and older weighing at least 30 kg: 480 mg PO or IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 15 to less than 30 kg: 240 mg PO or 120-mg IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 7.5 to less than 15 kg: 120-mg oral pellets or 60-mg IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 6 to less than 7.5 kg: 80-mg oral pellets or 40-mg IV infusion once daily through 100 days post-HSCT.

Adjust-a-dose: May begin therapy between day 0 and day 28 post-HSCT. In patients at risk for late CMV infection and disease, may continue through 200 days post-HSCT. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily in children age 12 and older weighing at least 30 kg; 120 mg in children younger than age 12 weighing 15 to less than 30 kg; 60 mg in children younger than age 12 weighing 7.5 to less than 15 kg; or 40 mg in children younger than age 12 weighing 6 to less than 7.5 kg. If initiating cyclosporine after start of letermovir, decrease the next dose of letermovir. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.

Prophylaxis of CMV disease in patients who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)
Adults and children ages 12 and older weighing at least 40 kg: 480 mg PO or IV infusion once daily through 200 days posttransplant.

Adjust-a-dose: May begin therapy between day 0 and day 7 posttransplant. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir to 480 mg once daily. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


pembrolizumab

Keytruda
Pharmaceutical company: Merck & Co.

NEW INDICATION & DOSAGE
First-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma, in combination with pemetrexed and platinum chemotherapy
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 before chemotherapy when given the same day.
 

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


ribociclib

Kisqali
Pharmaceutical company: Novartis

INDICATION & DOSAGE
Adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, stage II and III early breast cancer in patients at high risk for recurrence, in combination with an aromatase inhibitor
Adults: 400 mg PO once daily for 21 consecutive days followed by 7 days off therapy. Continue for 3 years, or until disease recurrence or unacceptable toxicity occurs. Refer to the aromatase inhibitor prescribing information for dosage and administration specifics.

Adjust-a-dose: For patients with early breast cancer and Child-Pugh class B or C liver impairment, no dose adjustment is necessary. If use with a strong CYP3A inhibitor can't be avoided, reduce ribociclib dose to 200 mg once daily; allow 5 half-lives of the inhibitor after discontinuation of the inhibitor before returning to the initial ribociclib dose.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer