ganciclovir

Contraindicated in:

Hypersensitivity to ganciclovir or acyclovir
Bone marrow depression or immunosuppression or thrombocytopenia (do not administer if absolute neutrophil count [ANC] <500/mm³ or platelet count <25,000/mm³)
Lactation: Lactation.

Use Cautiously in:

Renal impairment (dose ↓ required if CCr <80 mL/min)
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
Rep: Women of reproductive potential and men with female partners of reproductive potential
Geri: Dose ↓ recommended in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, edema, hypertension, hypotension.

Derm: alopecia, photosensitivity, pruritus, rash, urticaria.

Endo: hypoglycemia.

GI: ↑ liver enzymes, abdominal pain, GI BLEEDING, nausea, vomiting.

GU: ↓ fertility, gonadal suppression, hematuria, renal impairment.

Hemat: neutropenia, thrombocytopenia, anemia, eosinophilia.

Local: pain/phlebitis at IV site.

Neuro: abnormal dreams, ataxia, confusion, dizziness, drowsiness, headache, malaise, nervousness, SEIZURES, tremor.

Resp: dyspnea.

Misc: fever.

Interactions ⬆ ⬇

Drug-Drug:

Toxicity may be ↑ by probenecid.
↑ risk of seizures with imipenem/cilastatin; concurrent use not recommended.
Concurrent use of cyclosporine or amphotericin B ↑ risk of nephrotoxicity.
↑ risk of nephrotoxicity and hematological toxicity with mycophenolate mofetil.
Concurrent use with dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine, or zidovudine ↑ risk of nephrotoxicity and myelosuppression.

Availability ⬆ ⬇

(Generic available)

Lyophilized powder for injection: 500 mg/vial;
Solution for injection: 50 mg/mL;
Premixed infusion: 500 mg/250 mL;

Route/Dosage ⬆ ⬇

IV (Adults and Children >3 mo): Induction: 5 mg/kg every 12 hr for 14–21 days. Maintenance regimen: 5 mg/kg/day or 6 mg/kg for 5 days of each wk. If progression occurs, ↑ to every 12 hr regimen. Prevention: 5 mg/kg every 12 hr for 7–14 days, then 5 mg/kg/day or 6 mg/kg for 5 days of each wk.
IV (Neonates): Congenital CMV infection: 12 mg/kg/day divided every 12 hr for 6 wk.

Renal Impairment

IV (Adults and Children): Induction: CCr 50–69 mL/min: 2.5 mg/kg/dose every 12 hr; CCr 25–49 mL/min: 2.5 mg/kg/dose every 24 hr; CCr 10–24 mL/min: 1.25 mg/kg/dose every 24 hr; CCr <10 mL/min: 1.25 mg/kg 3 times/wk after hemodialysis; Maintenance: CCr 50–69 mL/min: 2.5 mg/kg/dose every 24 hr; CCr 25–49 mL/min: 1.25 mg/kg/dose every 24 hr; CCr 10–24 mL/min: 0.625 mg/kg/dose every 24 hr; CCr <10 mL/min: 0.625 mg/kg 3 times/wk after hemodialysis.

Action ⬆ ⬇

CMV converts ganciclovir to its active form (ganciclovir phosphate) inside the host cell, where it inhibits viral DNA polymerase.

Therapeutic Effects:

Antiviral effect directed preferentially against CMV-infected cells.

Classifications ⬆ ⬇

Therapeutic Classification: antivirals

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed; enters CSF.

Protein Binding: 1–2%.

Metabolism/Excretion: 90% excreted unchanged by the kidneys.

Half-life: Adults: 2.9 hr; Children 9 mo–12 yr: 2.4 ±0.7 hr; Neonates: 2.4 hr (↑ in renal impairment).

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(antiviral levels)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	12–24 hr

Patient/Family Teaching ⬆ ⬇

Inform patient that ganciclovir is not a cure for CMV retinitis. Progression of retinitis may continue in immunocompromised patients during and after therapy. Advise patients to have regular ophthalmic exams at least every 6 wk. Duration of therapy for CMV prevention is based on the duration and degree of immunosuppression.
Advise patient to notify health care professional if fever; chills; sore throat; other signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Rep: May cause fetal harm. Advise female patients of reproductive potential to use a nonhormonal method of contraception during and for at least 30 days after last dose and to avoid breastfeeding during therapy. Advise male patients to use condoms during and for at least 90 days after therapy. Inform patients that ganciclovir may cause temporary or permanent female and male infertility.
Emphasize the importance of frequent follow-up exams to monitor blood counts.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code^*

0004- Genentech, Inc.
0004-6940- Cytovene IV
0004-6940-04- 5 VIAL in 1 CARTON (0004-6940-04) > 10 mL in 1 VIAL

14335- Hainan Poly Pharm. Co., Ltd.
14335-030- Ganciclovir 14335-030-01- 10 VIAL in 1 CARTON (14335-030-01) > 10 mL in 1 VIAL

14335- Hainan Poly Pharm. Co., Ltd.
14335-030- Ganciclovir 14335-030-25- 25 VIAL in 1 CARTON (14335-030-25) > 10 mL in 1 VIAL

24208- Bausch and Lomb Incorporated
24208-535- ZIRGAN 24208-535-15- 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) > 1.5 g in 1 TUBE, WITH APPLICATOR

24208- Bausch and Lomb Incorporated
24208-535- ZIRGAN 24208-535-35- 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) > 5 g in 1 TUBE, WITH APPLICATOR

25021- Sagent Pharmaceuticals
25021-185- ganciclovir 25021-185-10- 25 VIAL in 1 CARTON (25021-185-10) > 10 mL in 1 VIAL

25021- Sagent Pharmaceuticals
25021-185- ganciclovir 25021-185-11- 1 VIAL in 1 CARTON (25021-185-11) > 10 mL in 1 VIAL

42023- Par Pharmaceutical, Inc.
42023-173- Ganciclovir 42023-173-25- 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) > 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

51754- EXELA PHARMA SCIENCES, LLC
51754-2500- GANCICLOVIR 51754-2500-1- 250 mL in 1 BAG (51754-2500-1)

51754- EXELA PHARMA SCIENCES, LLC
51754-2500- GANCICLOVIR 51754-2500-3- 10 BAG in 1 POUCH (51754-2500-3) > 250 mL in 1 BAG

51817- Pharmascience Inc.
51817-171- Ganciclovir 51817-171-01- 25 VIAL in 1 CARTON (51817-171-01) > 10 mL in 1 VIAL

61269- H2-Pharma, LLC
61269-450- Cytovene IV
61269-450-20- 5 VIAL in 1 CARTON (61269-450-20) > 10 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
63323-315- Ganciclovir 63323-315-10- 25 VIAL in 1 TRAY (63323-315-10) > 10 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
63323-315- Ganciclovir 63323-315-94- 25 VIAL in 1 TRAY (63323-315-94) > 10 mL in 1 VIAL

70436- Slate Run Pharmaceuticals
70436-089- Ganciclovir 70436-089-55- 25 VIAL in 1 CARTON (70436-089-55) > 10 mL in 1 VIAL

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Indications ⬇

Contraind./Precautions ⬆ ⬇