Medically reviewed by Drugs.com. Last updated on Mar 15, 2020.
Applies to the following strengths: 240 mg; 480 mg; 240 mg/12 mL; 480 mg/24 mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for CMV Prophylaxis
480 mg orally or IV once a day
Duration of therapy: Through Day 100 posttransplantation
-This drug should be started between Day 0 and Day 28 posttransplantation (before or after engraftment).
Use: For the prophylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
Renal Dose Adjustments
CrCl greater than 10 mL/min: No adjustment recommended.
CrCl up to 10 mL/min: Insufficient data to make dosing recommendations
-Patients with CrCl less than 50 mL/min using the IV formulation: Accumulation of the IV vehicle (hydroxypropyl betadex) may occur; serum creatinine levels should be monitored closely in such patients.
Liver Dose Adjustments
Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.
Coadministration with cyclosporine: Dose should be reduced to 240 mg orally or IV once a day.
-If cyclosporine is begun after starting this drug, the next dose of this drug should be reduced to 240 mg once a day.
-If cyclosporine is stopped after starting this drug, the next dose of this drug should be increased to 480 mg once a day.
-If dosing of cyclosporine is interrupted due to high cyclosporine levels, no dose adjustment of this drug is necessary.
-Coadministration with pimozide, ergot alkaloids
-With cyclosporine: Coadministration with pitavastatin, simvastatin
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Insufficient data to make dosing recommendations
-IV: 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.
-IV: Administer by IV infusion via a peripheral catheter or central venous line; infuse at a constant rate over 1 hour. Do not administer as IV bolus injection.
-IV: Do not coadminister through the same IV line (or cannula) with other drug products and diluent combinations (except those listed as compatible below).
-IV: Only use the IV formulation (which contains hydroxypropyl betadex) in patients unable to take oral therapy; switch patients to oral formulation as soon as they can take oral products.
-Oral: Administer with or without food.
-Oral: Swallow tablets whole.
-May use the oral and IV formulations interchangeably (no dose adjustment needed) at physician's discretion
-Consult the manufacturer product information regarding missed doses.
-Injection (prior to dilution): Store vials at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Store in original carton to protect from light.
-Injection (after dilution): The diluted solution is stable for up to 24 hours at room temperature or up to 48 hours under refrigeration at 2C to 8C (36F to 46F); this time includes storage in the IV bag through the duration of infusion.
-Tablets: Store in original package until use. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
-Injection: Must be diluted before IV use
-Injection: Do not use with IV bags and infusion set materials containing the plasticizer diethylhexyl phthalate (DEHP); only use with IV bags and infusion set materials that are DEHP-free (phthalate-free materials are also DEHP-free).
-Injection: The manufacturer product information should be consulted.
-COMPATIBLE DILUENTS: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP
-COMPATIBLE DRUG PRODUCTS:
---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
---In 5% Dextrose Injection, USP: Amphotericin B lipid complex, 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
-COMPATIBLE IV BAGS AND INFUSION SET MATERIALS:
---IV bag materials: Polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyolefin (polypropylene and polyethylene)
---Infusion set 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
-PHYSICALLY INCOMPATIBLE DRUG PRODUCTS: Amphotericin B liposomal, amiodarone hydrochloride (HCl), aztreonam, cefepime HCl, ciprofloxacin, cyclosporine, diltiazem HCl, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil HCl, ondansetron, palonosetron
-INCOMPATIBLE IV BAGS AND INFUSION SET MATERIALS: Polyurethane-containing IV administration set tubing, DEHP plasticizers
-Do not mix with other products.
-Injection: A clear colorless solution; may contain a few product-related small translucent or white particles
-Infections/Infestations: For CMV reactivation (upon completion of prophylaxis)
-Renal: Serum creatinine levels in patients with CrCl less than 50 mL/min using the IV formulation
-Read the US FDA-approved patient labeling (Patient Information).
-Avoid missing doses and complete the entire course of therapy.
-Store tablets in original package until use.
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