Drug Detail:Prevymis (Letermovir (oral/injection) [ le-term-oh-vir ])
Generic Name: LETERMOVIR 240mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous antivirals
Important Dosing and Administration Information
PREVYMIS Tablets
- Administer with or without food.
- Swallow tablets whole.
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 at a constant rate over 1 hour.
- Do not administer as an intravenous bolus injection.
Recommended Dosage for Adult Patients
The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.
Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine [see Dosage and Administration (2.4)].
PREVYMIS injection, which contains hydroxypropyl betadex, should be used only in patients unable to take oral therapy. Patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. PREVYMIS tablet and injection may be used interchangeably at the discretion of the physician, and no dosage adjustment is necessary when switching formulations.
HSCT
Initiate PREVYMIS between Day 0 and Day 28 post-transplant (before or after engraftment) and continue through Day 100 post-transplant.
Kidney Transplant
Initiate PREVYMIS between Day 0 and Day 7 post-transplant and continue through Day 200 post-transplant.
Patient Monitoring
Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation is recommended.
Dosage Adjustment When Co-administered with Cyclosporine
If oral or intravenous PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily [see Drug Interactions (7.1, 7.2, 7.3) and Clinical Pharmacology (12.3)].
- 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 interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
Use in Patients with Renal Impairment
- For patients with creatinine clearance (CLcr) greater than 10 mL/min, no dosage adjustment of PREVYMIS is required based on renal impairment [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
- There are insufficient data in patients with CLcr 10 mL/min or less or in patients on dialysis to make PREVYMIS dosing recommendations.
- In patients with CLcr less than 50 mL/min receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, may occur. Closely monitor serum creatinine levels in these patients.
Use in Patients with 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 Use in Specific Populations (8.7)].
Preparation and Administration of Intravenous Solution
PREVYMIS injection is supplied in 30 mL single-dose vials containing either 240 mg/12 mL per vial (20 mg/mL) or 480 mg/24 mL per vial (20 mg/mL). The preparation and administration instructions are the same for either dose.
PREVYMIS vials are for single use only. Discard any unused portion.
Preparation and Administration Instructions
- PREVYMIS must be diluted prior to intravenous (IV) use.
- Inspect vial contents for discoloration and particulate matter prior to dilution. PREVYMIS injection is a clear colorless solution and may contain a few product-related small translucent or white particles.
- Do not use the vial if the solution is cloudy, discolored, or contains matter other than a few small translucent or white particles.
- Do not use PREVYMIS injection with IV bags and infusion set materials containing the plasticizer diethylhexyl phthalate (DEHP). Use only with IV bags and infusion set materials that are DEHP-free. Materials that are phthalate-free are also DEHP-free.
- Do not shake PREVYMIS vial.
- Add one single-dose vial of PREVYMIS injection into a 250 mL pre-filled IV bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and mix bag gently. Do not shake. Only 0.9% Sodium Chloride and 5% Dextrose are chemically and physically compatible with PREVYMIS injection.
- Use compatible IV bags and infusion set materials. PREVYMIS injection is compatible with the following IV bags and infusion set materials. PREVYMIS injection is not recommended with any IV bags or infusion set materials not listed below (note that PREVYMIS injection is not recommended for use with polyurethane-containing IV administration set tubing).
IV Bags Materials:
Polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and polyolefin (polypropylene and polyethylene)
Infusion Sets Materials:
PVC, polyethylene (PE), polybutadiene (PBD), silicone rubber (SR), styrene–butadiene copolymer (SBC), styrene-butadiene-styrene copolymer (SBS), polystyrene (PS)
Plasticizers:Tris (2-ethylhexyl) trimellitate (TOTM), benzyl butyl phthalate (BBP)
Catheters:
Radiopaque polyurethane - Once diluted, the solution of PREVYMIS is clear, and ranges from colorless to yellow. Variations of color within this range do not affect the quality of the product.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
- Discard if the diluted solution is cloudy, discolored, or contains matter other than a few small translucent or white particles.
- The diluted solution is stable for up to 24 hours at room temperature or up to 48 hours under refrigeration at 2°C to 8°C (36°F to 46°F) (this time includes storage of the diluted solution in the intravenous bag through the duration of infusion).
- The diluted solution must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter.
- Do not administer through a filter other than a sterile 0.2 micron or 0.22 micron PES in-line filter.
- Administer the entire contents of the intravenous bag by intravenous infusion via a peripheral catheter or central venous line at a constant rate over 1 hour [see Dosage and Administration (2.1)].
Compatible Drug Products Used for Intravenous Administration
Compatible Drug Products
The physical compatibility of PREVYMIS injection with selected injectable drug products was evaluated in two commonly available diluents. PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other drug products and diluent combinations except those listed below. Refer to the respective prescribing information of the co-administered drug(s) to confirm compatibility of simultaneous co-administration.
List of Compatible Drug Products when PREVYMIS and Drug Products are Prepared in 0.9% Sodium Chloride Injection, USP:
- Ampicillin sodium, ampicillin sodium/sulbactam sodium, anti-thymocyte globulin, caspofungin, daptomycin, fentanyl citrate, fluconazole, furosemide, human insulin, magnesium sulfate, methotrexate, micafungin.
List of Compatible Drug Products when PREVYMIS and Drug Products are Prepared in 5% Dextrose Injection, USP:
- Amphotericin B (lipid complex)1, anidulafungin, cefazolin sodium, ceftaroline, ceftriaxone sodium, doripenem, famotidine, folic acid, ganciclovir sodium, hydrocortisone sodium succinate, morphine sulfate, norepinephrine bitartrate, pantoprazole sodium, potassium chloride, potassium phosphate, tacrolimus, telavancin, tigecycline.
- 1
- Amphotericin B (lipid complex) is compatible with PREVYMIS. However, Amphotericin B (liposomal) is incompatible [see Dosage and Administration (2.9)].
Incompatible Drug Products and Other Materials Used for Intravenous Administration
Incompatible Drug Products
PREVYMIS injection is physically incompatible with amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
