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Cytovene (GANCICLOVIR)
GANCICLOVIR works by inhibiting the DNA polymerase enzyme of cytomegalovirus, preventing viral replication.
Cytovene (GANCICLOVIR) is a small molecule nucleoside analog DNA polymerase inhibitor developed by Roche Palo, targeting the cytomegalovirus. It is FDA-approved for various indications, including CMV retinitis in AIDS patients, CMV retinitis in immunocompromised patients, and prevention of CMV disease after cardiac and kidney transplantation. Cytovene is off-patent, with a single generic manufacturer. Key safety considerations include its short half-life of 3.7 hours and low bioavailability of 4%. It is used to treat viral infections caused by cytomegalovirus.
At a glance
| Generic name | GANCICLOVIR |
|---|---|
| Sponsor | Roche Palo |
| Drug class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor |
| Target | Metabotropic glutamate receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1989 |
Mechanism of action
Ganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4)].
Approved indications
- CMV Retinitis in AIDS Patients
- CMV Retinitis in Immunocompromised Patients
- Cytomegaloviral retinitis
- Herpes simplex dendritic keratitis
- Myocardial Perfusion Imaging Adjunct
- Paroxysmal supraventricular tachycardia
- Prevention of CMV Disease After Cardiac Transplantation
- Prevention of CMV Disease After Kidney Transplantation
- Prevention of CMV Disease After Kidney-Pancreas Transplantation
- Prevention of CMV Disease After Organ Transplant
- Prevention of CMV Disease in Advanced HIV Patients
Boxed warnings
- WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir Injection [see Warnings and Precautions (5.1) ]. Impairment of Fertility: Based on animal data and limited human data, Ganciclovir Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions (5.3) ]. Fetal Toxicity: Based on animal data, Ganciclovir Injection has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ]. Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir Injection has the potential to cause cancers in humans [ see Warnings and Precautions (5.5 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESISWARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning. Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir Injection . ( 5.1 ) Impairment of Fertility: Based on animal data and limited human data, Ganciclovir Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. ( 5.3 ) Fetal Toxicity: Based on animal data, Ganciclovir Injection has the potential to cause birth defects in humans. ( 5.4 ) Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir Injection has the potential to cause cancer in humans. ( 5.5 )
Common side effects
- Fever
- Infection
- Chills
- Diarrhea
- Anorexia
- Vomiting
- Leukopenia
- Anemia
- Thrombocytopenia
- Neuropathy
- Sepsis
- Retinal Detachment
Drug interactions
- rifampicin
- zidovudine
Key clinical trials
- A Multicenter, Randomized, Open-Label Study of Haplo-Cord HSCT for the Treatment of Aplastic Anemia (NA)
- CMV CTLs in Neonates With CMV Infection (PHASE2)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis (NA)
- Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (PHASE2)
- Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors (PHASE1)
- Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) (PHASE2)
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9486530 | 2034-09-02 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cytovene CI brief — competitive landscape report
- Cytovene updates RSS · CI watch RSS
- Roche Palo portfolio CI