Classifications: antiviral agent; Therapeutic: antiviral
Pregnancy Category: C
250 mg, 500 mg capsules; 500 mg powder for injection
Ganciclovir is a synthetic purine nucleoside analog that is an antiviral drug active against cytomegalovirus (CMV). It inhibits
the replication of CMV DNA.
Sensitive human viruses include CMV, herpes simplex virus-1 and -2 (HSV-1, HSV-2), Epstein-Barr virus, and varicella-zoster
CMV retinitis, prophylaxis and treatment of systemic CMV infections in immunocompromised patients including HIV-positive and
Hypersensitivity to ganciclovir or acyclovir; infection; severe thrombocytopenia; pregnancy (category C), lactation.
Renal impairment, older adults, bone marrow suppression; chemotherapy; radiation therapy.
Route & Dosage
Adult/Child (>3 mo): IV 5 mg/kg q12h for 1421 d (doses may range from 2.55 mg/kg q812h for 1035 d)
Adult/Child: IV 5 mg/kg qd 7 d/wk or 6 mg/kg qd 5 d/wk PO 1000 mg t.i.d. or 500 mg 6 times/d q3h while awake
Prevention of CMV Disease in Transplant Recipients
Adult/Child: IV 5 mg/kg q12h 714 d, then 5 mg/kg q.d. or 6 mg/kg/d 5 d/wk
Clcr 5070 mL/min: use 50% of dose; 2550 mL/min: use 50% of dose and q24h interval; 1025 mL/min: use
25% of dose and q24h interval
Hemodialysis: Give dose post-dialysis
- Note: Do not administer if neutrophil count falls below 500/mm3 or platelet count falls below 25,000/mm3.
- Avoid direct contact of powder in capsules or solution with skin and mucous membranes. Wash thoroughly with soap and water
if contact occurs.
- IV administration to infants and children: Verify correct IV concentration and rate of infusion with physician.
PREPARE: Intermittent: ??Reconstitute the 500-mg vial using only 10 mL of sterile water (supplied) for injection immediately before use to yield 50
mg/mL.??Shake well to dissolve.??Withdraw the ordered amount and add to 100 mL of NS, D5W, or RL (volume less than 100 mL may be used, but the final concentration
should be <10 mg/mL).
ADMINISTER: Intermittent: Give at a constant rate over 1 h. Avoid rapid infusion or bolus injection.
INCOMPATIBILITIES Solution/additive: Amino acid solutions (TPN), bacteriostatic water for injection, foscarnet. Y-site: Amifostine, amsacrine, aztreonam, cefepime, cytarabine, doxorubicin, fludarabine, foscarnet, gemcitabine, ondansetron, piperacillin/tazobactam, sargramostim, tacrolimus, TPN, vinorelbine.
- Store reconstituted solutions refrigerated at 4° C; use within 12 h.
- Store infusion solution refrigerated up to 24 h of preparation.
Adverse Effects (≥1%)CNS: Fever,
headache, disorientation, mental status changes, ataxia, coma
, confusion, dizziness, paresthesia, nervousness, somnolence, tremor. CV:
Edema, phlebitis. GI: Nausea, diarrhea,
anorexia, elevated liver enzymes. Hematologic: Bone marrow suppression , thrombocytopenia, granulocytopenia, eosinophilia, leukopenia,
InteractionsDrug: antineoplastic agents
, amphotericin B, didanosine, trimethoprim-sulfamethoxazole (TMP-SMZ), dapsone, pentamidine, probenecid, zidovudine
may increase bone marrow
suppression and other toxic effects of ganciclovir; may increase risk of nephrotoxicity from cyclosporine;
may increase risk of seizures due to imipenem-cilastatin.
Oral product increases didanosine
38 d. Duration:
Clinical relapse can occur 14 d to 3.5 mo after stopping therapy; positive blood and urine cultures recur 1260 d after
Distributes throughout body including CSF, eye, lungs, liver, and kidneys; crosses placenta in animals; not known if distributed
into breast milk. Metabolism:
Not metabolized. Elimination:
Unchanged in urine. Half-Life:
Assessment & Drug Effects
- Lab tests: Neutrophil and platelet counts at least every other day during twice-daily dosing and weekly thereafter; more frequent
monitoring may be indicated in certain patients. Monitor serum creatinine or creatinine clearance at least q2wk. Closely monitor
renal function in the older adult.
- Inspect IV insertion site throughout infusion for signs and symptoms of phlebitis.
Patient & Family Education
- Note: Drug is not a cure for CMV retinitis; follow regular ophthalmologic examination schedule.
- Drink lots of fluids during therapy.
- Use barrier contraception throughout therapy and for at least 90 d afterwards.
- Maintain frequent hematologic monitoring.