Ganciclovir (ophthalmic)
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From MedlinePlus, U.S. National Library of Medicine
Handling and access
NIOSH hazardous drug
Table 1NIOSH lists ganciclovir as a hazardous drug. AHFS class: 8:18.32 nucleosides and nucleotides; 52:04.20 antivirals.
- The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, Nucleoside Analog Antiviral
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Contraindications
None. None.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Ganciclovir is a nucleoside analogue and antiviral agent used in therapy of cytomegalovirus infections. Valganciclovir is the valyl ester prodrug of ganciclovir which can be given orally. When given intravenously, ganciclovir can cause mild, transient and asymptomatic elevations in serum aminotransferase levels, but neither ganciclovir nor valganciclovir have been associated with clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data on use of ZIRGAN or ganciclovir during pregnancy to inform any drug-associated risk. Intravenous administration of ganciclovir to pregnant mice or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant doses ( see Data ). The background risk in the U.S. general population of major birth defects is 2 to 4% and the risk of miscarriage is 15 to 20% of clinically recognized pregnancies.
Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice [up to 108 mg/kg/day, approximately 1400 times the maximum recommended human ocular dose (RHOD) of 0.375 mg] and rabbits [up to 60 mg/kg/day, approximately 2400 times the maximum RHOD], and also to female mice [up to 90 mg/kg, approximately 1174 times the maximum RHOD] prior to mating, during gestation, and during lactation. Fetal resorptions were present in at least 85% of rabbits and mice. Additional effects observed in rabbits included fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity.
Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. A maternal no observed adverse effect level (NOAEL) was observed at 36 mg/kg/day (approximately 470 times higher than the maximum RHOD, based on body surface area) in mice and at 6 mg/kg/day (approximately 240 times higher than the maximum RHOD, based on body surface area) in rabbits.
In pre/postnatal development studies in mice, there were maternal/fetal toxicity and embryolethality which included fetal effects of hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach. A maternal no observed adverse effect level (NOAEL) was observed at 20 mg/kg/day (approximately 261 times higher than the maximum RHOD, based on body surface area).
Breastfeeding (LactMed)
Several factors might affect the decision to use ganciclovir in a nursing mother. No information is available on the clinical use of ganciclovir during breastfeeding. Cytomegalovirus (CMV) can be transmitted to infants though breastmilk, with preterm and immunocompromised infants at greatest risk. No information is available on any changes in the risk of transmission if the mother is being treated with ganciclovir. Although the manufacturer recommends avoiding breastfeeding during ganciclovir use because of the risk of infant drug toxicity, neonates with CMV infections are often treated directly with ganciclovir. It is unlikely that topical ophthalmic ganciclovir administration results in sufficient systemic absorption to produce detectable quantities in breastmilk.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.