Prevymis Dosage/Direction for Use

RECOMMENDED DOSE: Recommended Dosage in Adults: The recommended dosage of PREVYMIS is 480 mg administered once daily. PREVYMIS should be started after HSCT. PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant. PREVYMIS may be started before or after engraftment. Continue PREVYMIS through 100 days post-transplant.
Dosage Adjustment in Adults: If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily [see Table 4 in Established and Other Potential Drug Interactions under INTERACTIONS].
If cyclosporine is initiated after starting PREVYMIS, the next dose of PREVYMIS should be decreased to 240 mg once daily.
If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
If cyclosporine dosing is temporarily interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
Use in Specific Populations: Pediatric Patients: Safety and efficacy of PREVYMIS have not been established in pediatric patients less than 18 years of age.
Geriatric Patients: No dose adjustment of PREVYMIS is required based on age Safety and efficacy were similar across older and younger subjects in the Phase 3 trial in HSCT recipients.
Renal Impairment: No dose adjustment of PREVYMIS is required based on renal impairment [see Hepatic Impairment as follows]. There are no data in patients with end-stage renal disease (CrCl less than 10 mL/min), including patients on dialysis.
In patients with moderate or severe renal impairment (CrCl less than 50 mL/min) receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, could occur. Serum creatinine levels should be closely monitored in these patients.
Hepatic Impairment: No dose adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child- Pugh Class B) hepatic impairment. PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.
PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment.
MODE OF ADMINISTRATION: General: PREVYMIS Tablets: Administer with or without food.
Swallow tablets whole. Do not divide, crush or chew.
PREVYMIS Injection: PREVYMIS injection must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter.
Administer by intravenous infusion via a peripheral catheter or central venous line over approximately 60 minutes.
Do not administer as an intravenous bolus injection.
PREVYMIS tablet and injection may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary.
Missed Dose: Instruct patients that if they miss a dose of PREVYMIS, they should take it as soon as they remember. If they do not remember until it is time for the next dose, instruct them to skip the missed dose and go back to the regular schedule. Instruct patients not to double their next dose or take more than the prescribed dose.