Ganciclovir

Pronunciation: gan-SYE-kloe-vir.

Generic name
ganciclovir
Drug class
Antiviral (Nucleoside Analogue DNA Polymerase Inhibitor)
Form
Powder for solution for infusion (500 mg/vial)
Route
Intravenous infusion
Legal status
Prescription-only; hospital/specialist-administered

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Cymevene (4), Ganciclovir Agila (4) · Full directory

What ganciclovir is and how it works

Ganciclovir is a prescription-only intravenous antiviral medicine used to treat and prevent cytomegalovirus (CMV) disease -- a viral infection that can cause serious eye, lung, and other organ disease in people with weakened immune systems, such as those with AIDS, organ or bone marrow transplant recipients, or people on chemotherapy. (1)

Ganciclovir is given by slow intravenous infusion in a hospital or closely supervised setting, never as a rapid injection or into a muscle. It carries a boxed warning -- the FDA's strongest safety warning -- covering serious blood-cell effects, and, based on animal studies, effects on fertility, the potential for birth defects, and the potential to cause cancer. Your care team will monitor your blood counts closely and discuss contraception requirements with you before and during treatment.

Mechanism of action: how ganciclovir works

Ganciclovir is a synthetic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpesviruses, including cytomegalovirus (CMV), in vitro and in vivo. It is phosphorylated intracellularly to ganciclovir triphosphate, which inhibits viral DNA polymerase and is incorporated into viral DNA, terminating or slowing further DNA elongation. (1) (3)

What ganciclovir is used for

Treatment of CMV retinitis

Used to treat cytomegalovirus (CMV) retinitis (a sight-threatening eye infection) in immunocompromised adults, including people with AIDS. (1) (5)

Prevention of CMV disease in transplant recipients

Used to prevent CMV disease in adult transplant recipients (including bone marrow, solid organ, liver, and heart transplant recipients) who are at risk of developing it. (1) (3) (5)

Treatment of CMV pneumonitis in bone marrow transplant patients

Used to treat confirmed CMV pneumonitis (lung infection) specifically in bone marrow transplant patients, per New Zealand product information. (5)

Before taking ganciclovir

Do not take / not appropriate for

  • Do not receive ganciclovir if you have had an allergic reaction to ganciclovir, valganciclovir, or aciclovir/valaciclovir -- cross-hypersensitivity between these medicines is possible due to their similar chemical structure. (all confirmed markets) (1) (3)
  • Ganciclovir is not indicated for congenital or neonatal CMV disease, or for CMV infection in people who are not immunocompromised. (New Zealand, Canada) (5) (3)
  • Do not breastfeed while receiving ganciclovir. (United Kingdom) (2)

Tell your clinician about

  • Whether you or your partner may become pregnant -- effective contraception is required for women during treatment and for at least 30 days afterward, and barrier contraception for men during treatment and for at least 90 days afterward.
  • Any plans for a family -- ganciclovir may temporarily or permanently reduce sperm production and fertility, based on animal studies.
  • Any kidney problems, since your dose depends on kidney function.
  • Any low blood counts or bleeding problems.
  • All other medicines you take, especially imipenem-cilastatin, didanosine, zidovudine, probenecid, ciclosporin, amphotericin B, or other medicines that affect the kidneys or bone marrow.
  • Whether you are already, or may be, pregnant -- pregnancy testing is recommended before starting treatment for women who could become pregnant.
(1) (2) (3)

How to take ganciclovir

  • Given only by slow intravenous infusion over 1 hour, by a healthcare professional, into a vein with adequate blood flow.
  • Must NEVER be given as a rapid or bolus IV injection, or by intramuscular or subcutaneous injection -- this can cause severe tissue irritation and increased toxicity due to the solution's high pH.
  • You will have regular blood tests (complete blood count, including platelets) before and throughout treatment.
  • Your dose is individualised based on your kidney function, weight, and clinical response -- do not attempt to adjust it yourself.
(1) (5)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Because ganciclovir is given by a healthcare professional on a scheduled infusion program, a missed dose is managed directly by your care team rather than something to self-manage at home.

Overdose

Because ganciclovir is administered by a healthcare professional, any concern about an incorrect dose is identified and managed by the treating team. Overdose has been associated with increased toxicity, particularly to the bone marrow and kidneys; seek immediate medical attention if an overdose is suspected. (3)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Low white blood cell count (neutropenia).

What to notice: Low white blood cell count (neutropenia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Anaemia and low platelet count (thrombocytopenia).

What to notice: Anaemia and low platelet count (thrombocytopenia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Fever, diarrhoea, and catheter-related events (including catheter infection).

What to notice: Fever, diarrhoea, and catheter-related events (including catheter infection).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Decreased appetite, headache, cough, dermatitis (skin inflammation).

What to notice: Decreased appetite, headache, cough, dermatitis (skin inflammation).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Elevated creatinine (a sign of change in kidney function).

What to notice: Elevated creatinine (a sign of change in kidney function).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of low blood counts — boxed_warning

Symptoms: Unusual tiredness, pale skin, fever, sore throat, unusual bruising or bleeding.

Action: Your care team monitors your complete blood count and platelet count closely, and will not start or will pause treatment if your counts fall below specific thresholds (neutrophil count under 500 cells/microlitre, platelets under 25,000 cells/microlitre, or haemoglobin under 8 g/dL). Report any new symptoms promptly. (1) (2)

Effects on fertility — boxed_warning

Symptoms: Not applicable -- this is a treatment-related risk identified in animal studies, not a symptom to watch for.

Action: Ganciclovir may temporarily or permanently reduce sperm production in men and suppress fertility in women, based on animal data. Discuss family planning with your care team before starting treatment. (1) (2)

Risk to an unborn baby (teratogenicity) — boxed_warning

Symptoms: Not applicable -- this is a treatment-related risk identified in animal studies.

Action: Ganciclovir has the potential to cause birth defects in humans, based on animal data. Women who could become pregnant should use effective contraception during treatment and for at least 30 days afterward, and should be tested for pregnancy before starting if applicable. Men should use barrier contraception during treatment and for at least 90 days afterward. (1) (2)

Cancer risk (carcinogenicity) — boxed_warning

Symptoms: Not applicable -- this is a treatment-related risk identified in animal studies.

Action: Ganciclovir has the potential to cause cancer in humans, based on animal data. This is weighed by your care team against the seriousness of the CMV disease being treated or prevented -- ganciclovir is only used in immunocompromised patients where the potential benefit outweighs these risks. (1) (3)

Signs of kidney problems — high caution

Symptoms: Reduced urination, swelling, or unusual tiredness.

Action: Your care team monitors kidney function during treatment and adjusts your dose based on creatinine clearance, particularly if you are elderly or take other medicines that can affect the kidneys. (1) (3)

Seizures (with imipenem-cilastatin) — high caution

Symptoms: Convulsions or seizure activity.

Action: Generalised seizures have been reported when ganciclovir is used together with imipenem-cilastatin -- tell your care team about all your other medicines. (1)

Eye problems (retinal detachment) in people being treated for CMV retinitis — moderate caution

Symptoms: New vision changes, flashes of light, or a curtain-like shadow in vision.

Action: Report any new visual symptoms to your care team promptly. (2)

Interactions

  • Didanosine: ganciclovir can substantially increase didanosine levels (38-67% AUC increase) -- monitor closely for didanosine toxicity. (1) (2)
  • Zidovudine: combined use has the potential to cause neutropenia and anaemia -- monitor white blood cell counts with differential and haemoglobin levels frequently. (1)
  • Probenecid: may reduce ganciclovir clearance and increase levels -- monitor for evidence of ganciclovir toxicity. (1)
  • Imipenem-cilastatin: generalised seizures have been reported with concomitant use. (1)
  • Ciclosporin or amphotericin B: monitor renal function closely. (1)
  • Other medicines that can affect bone marrow (such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations) or other nucleoside analogues should be combined with ganciclovir only if the potential benefit outweighs the risk. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Ganciclovir has the potential to cause birth defects in humans, based on animal studies. Women of reproductive potential should have a pregnancy test before starting treatment, use effective contraception during treatment, and continue contraception for at least 30 days after the last dose. (1) (2) (3) (4) (5) (6)

Breastfeeding

Breastfeeding is not recommended during treatment with ganciclovir (UK label); discuss with your care team. (1) (2) (3) (4) (5) (6)

Children

Safety and efficacy in children have not been established. Use in children warrants extreme caution due to the probability of long-term carcinogenicity and reproductive toxicity, and is not recommended unless the potential benefits outweigh these considerable risks, based on careful individual evaluation. (1) (2) (3) (4) (5) (6)

Elderly

No specific studies of ganciclovir in elderly patients have been conducted. Because older adults may have reduced kidney function, ganciclovir should be given with care and with special attention to renal status in this age group. (1) (2) (3) (4) (5) (6)

Renal_impairment

Dose and dosing interval are reduced according to creatinine clearance using a specific dosing table; patients on haemodialysis are recommended IV ganciclovir dosed around dialysis sessions. (1) (2) (3) (4) (5) (6)

Source_ids

US-FDA-GANCICLOVIR-INJECTION-2017,UK-EMC-GANCICLOVIR-500MG-2026,CA-HEALTHCANADA-GANCICLOVIR-INJECTION-2023 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Complete blood count (including platelets) and haemoglobin
  • Kidney function (creatinine clearance)
  • Pregnancy test for women of reproductive potential
  • Review of other medicines for interactions

During treatment

  • Frequent complete blood counts with differential and platelet counts.
  • Kidney function monitoring, particularly in elderly patients or those on other nephrotoxic medicines.
  • Monitoring for signs of infection, unusual bleeding, or bruising.
  • Ongoing contraception use throughout treatment and for the required period afterward.
  • Monitoring for new visual symptoms in patients being treated for CMV retinitis.
(1) (2)

Storage

Stored, reconstituted, and prepared by pharmacy/hospital staff according to the product's specific storage and handling requirements (including precautions for handling a cytotoxic/potentially carcinogenic agent); not self-stored by patients at home.

Professional information

Clinician-facing context only, sourced from the current US, UK, Canadian, and New Zealand labels; verify against the current full label before prescribing.

United States / United Kingdom / New Zealand

Indication: CMV retinitis treatment; CMV disease prevention in transplant recipients

Dose summary: Induction 5 mg/kg IV every 12 hours for 7-21 days depending on indication; maintenance 5 mg/kg once daily 7 days/week or 6 mg/kg once daily 5 days/week.

Renal context: Dose and interval reduced per creatinine clearance dosing table; haemodialysis patients dosed around dialysis sessions (~50% ganciclovir plasma reduction per 4-hour session). (1) (5) (3)

Mechanism of action

Hepatic guidance

No specific regulator-reviewed hepatic-impairment dose adjustment was identified in the sources reviewed for this dossier.

Overdose note

Overdose is associated with increased toxicity, particularly haematological and renal; hydration and haemodialysis may help reduce plasma concentrations in cases of significant overdose in patients with renal impairment. (1) (3)

Frequently asked questions

Does ganciclovir carry a boxed warning?

Yes. The current US FDA label carries a boxed warning -- the FDA's strongest warning -- covering four areas: hematologic toxicity (granulocytopenia, anemia, thrombocytopenia, pancytopenia), impairment of fertility (based on animal data), fetal toxicity/teratogenicity (based on animal data), and mutagenesis/carcinogenesis (based on animal data). Health Canada's product monograph carries an equivalent 'Serious Warnings and Precautions' box with the same substance. (1) (3)

Why do I need contraception during and after ganciclovir treatment?

Based on animal studies, ganciclovir has the potential to cause birth defects and can affect fertility. Women who could become pregnant should use effective contraception during treatment and for at least 30 days after the last dose. Men should use barrier contraception during treatment and for at least 90 days after the last dose. (1) (2)

Why can't ganciclovir be given as a quick injection?

Ganciclovir must be given by slow intravenous infusion over 1 hour into a vein with good blood flow. A rapid or bolus injection can cause excessive plasma levels and increase toxicity, and it must never be given into a muscle or under the skin because the solution's high pH (around 11) can cause severe tissue irritation. (1) (5)

Is ganciclovir available in the European Union?

Yes. There is no single centralised EU marketing authorisation, but ganciclovir (Cymevene) is authorised nationally across EU member states, with an EMA Article 30 referral used to harmonise the product information across those national authorisations. (6)

What is the mechanism of action of ganciclovir?

Ganciclovir is a synthetic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpesviruses, including cytomegalovirus (CMV), in vitro and in vivo. It is phosphorylated intracellularly to ganciclovir triphosphate, which inhibits viral DNA polymerase and is incorporated into viral DNA, terminating or slowing further DNA elongation. (1) (3)

What is the generic name of Ganciclovir?

The generic name is ganciclovir. (1) (2)

What class of drug is ganciclovir?

Ganciclovir is classed as: Antiviral (Nucleoside Analogue DNA Polymerase Inhibitor). (1) (2)

References

  1. GANCICLOVIR INJECTION, for intravenous use -- full prescribing information (label revised 02/2017, accessdata document 209347lbl.pdf)U.S. Food and Drug Administration, accessdata.fda.gov full prescribing information · United States · accessed 2026-07-30 · source 1
  2. Ganciclovir 500 mg Powder for solution for infusion vial -- Summary of Product Characteristics (SmPC, dated 30/07/2025)UK Medicines and Healthcare products Regulatory Agency / electronic medicines compendium (emc), Summary of Product Characteristics · United Kingdom · accessed 2026-07-30 · source 2
  3. GANCICLOVIR FOR INJECTION (500 mg/vial), Product Monograph, dated 12 April 2023Health Canada -- Formative Pharma Inc., product monograph · Canada · accessed 2026-07-30 · source 3
  4. Ganciclovir injection -- ARTG registrations (Cymevene 500mg ARTG 10047, Ganciclovir Agila 500mg ARTG 233583)Australian Therapeutic Goods Administration (TGA), Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-30 · source 4
  5. Cymevene 500 mg powder for intravenous infusion -- New Zealand Data Sheet (DS 181120)New Zealand Medicines and Medical Devices Safety Authority (Medsafe) · New Zealand · accessed 2026-07-30 · source 5
  6. Cymevene IV (INN: ganciclovir) -- Article 30 referral, harmonisation of product information across EU member states (11 April 2016)European Medicines Agency (EMA) -- Committee for Medicinal Products for Human Use (CHMP) · European Union · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient ganciclovir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • ZIRGAN1.5 mg/g · bausch & lomb incorporated

United Kingdom

  • Ganciclovir 500 mg powder for solution for infusion (generic); Cymevene (Neon Healthcare Ltd) (2)UK licensed IV · 500 mg/vial · multiple UK-licensed manufacturers

Canada

  • CYTOVENE

Australia

  • Cymevene (4)TGA ARTG registered · 500 mg · ARTG 10047
  • Ganciclovir Agila (4)TGA ARTG registered · 500 mg · ARTG 233583 (MedTAS Pty Ltd)

New Zealand

  • Cymevene (5)Medsafe authorised · 500 mg/vial · Medsafe-registered supplier
View brands in additional countries.

European Union

Cymevene (6)

This page provides general reference information about ganciclovir and is not a substitute for advice from the clinical team managing your treatment. All dosing, monitoring, and contraception decisions should be made with your treating specialist, in the hospital or clinical setting appropriate to your treatment.

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