ently monitor cyclosporine whole blood concentrations during treatment and after discontinuation of PREVYMIS and adjust the dose of cyclosporine accordingly.sirolimus↑ sirolimusWhen PREVYMIS is co-administered with sirolimus, frequently monitor sirolimus whole blood concentrations during treatment and after discontinuation of PREVYMIS and adjust the dose of sirolimus accordingly.When PREVYMIS is co-administered with cyclosporine and sirolimus, refer to the sirolimus prescribing information for specific sirolimus dosing recommendations. tacrolimus↑ tacrolimusFrequently monitor tacrolimus whole blood concentrations during treatment and after discontinuation of PREVYMIS and adjust the dose of tacrolimus accordingly.Proton pump inhibitorsomeprazole↓omeprazoleClinical monitoring and dose adjustment may be needed.pantoprazole↓ pantoprazoleClinical monitoring and dose adjustment may be needed.CYP3A SubstratesExamples: alfentanil, fentanyl, midazolam, and quinidine↑ CYP3A substrateWhen PREVYMIS is co-administered with a CYP3A substrate, refer to the prescribing information for dosing of the CYP3A substrate with a moderate CYP3A inhibitor.When PREVYMIS is co-administered with cyclosporine, the combined effect on CYP3A substrates may be similar to a strong CYP3A inhibitor. Refer to the prescribing information for dosing of the CYP3A substrate with a strong CYP3A inhibitor.CYP3A substrates pimozide and ergot alkaloids are contraindicated [see Contraindications (4)].
7.4 Drugs Without Clinically Significant Interactions With Prevymis
No clinically significant interactions were observed in clinical drug-drug interaction studies of letermovir and acyclovir, digoxin, mycophenolate mofetil, posaconazole, ethinyl estradiol, and levonorgestrel.
8.4 Pediatric Use
Safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
8.5 Geriatric Use
Of the 373 subjects treated with PREVYMIS in Trial P001, 56 (15%) subjects were 65 years of age or older. Safety and efficacy were similar across older and younger subjects. No dosage adjustment of PREVYMIS is required based on age [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
For patients with CLcr greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment [see Clinical Pharmacology (12.3)]. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.In patients with CLcr less than 50 mL/min receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, could occur. Closely monitor serum creatinine levels in these patients.
8.7 Hepatic Impairment
No dosage adjustment of PREVYMIS is required for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment [see Clinical Pharmacology (12.3)].
10 Overdosage
There is no specific antidote for overdose with PREVYMIS. In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment be instituted.It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.
11 Description
PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase |
