Usual Adult Dose for CMV Prophylaxis

480 mg orally or IV once a day
Duration of therapy: Through Day 100 posttransplantation

Comments:

• This drug should be started between Day 0 and Day 28 posttransplantation (before or after engraftment).

Renal Dose Adjustments

CrCl greater than 10 mL/min: No adjustment recommended.
CrCl up to 10 mL/min: Insufficient data to make dosing recommendations

Comments:

• 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.

Dose Adjustments

Coadministration with cyclosporine: Dose should be reduced to 240 mg orally or IV once a day.

Comments:

• 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.

Precautions

CONTRAINDICATIONS:

• Coadministration with pimozide, ergot alkaloids
• With cyclosporine: Coadministration with pitavastatin, simvastatin

Dialysis

Insufficient data to make dosing recommendations

Other Comments

Administration advice:

• 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.