GANCICLOVIR SODIUM
Ganciclovir sodium is an antiviral medication used to manage cytomegalovirus (CMV) infections in specific high-risk populations. It treats CMV retinitis in adults with weakened immune systems, such as those living with AIDS. Additionally, it helps patients who have received organ transplants by preventing CMV disease from developing.
How GANCICLOVIR SODIUM Works
This drug works by inhibiting CMV DNA polymerase, which is an enzyme the virus needs to replicate its DNA. As a deoxynucleoside analogue, it provides targeted antiviral activity that stops the virus from spreading within the patient's body.
Details
- Status
- Prescription
- First Approved
- 2003-07-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
GANCICLOVIR SODIUM Approval History
What GANCICLOVIR SODIUM Treats
2 indicationsGANCICLOVIR SODIUM is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Cytomegalovirus Disease
GANCICLOVIR SODIUM Boxed 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 [see Warnings and Precautions (5.1) ] . Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see 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 [see Warnings and Precautions (5.1) ] . Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP 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 for Injection, USP has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ] . Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection, USP has the potential to cause cancers in humans [see Warnings and Precautions (5.5) ] . WARNING: 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 ( 5.1 ). Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP 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 for Injection, USP has the potential to cause birth defects in humans ( 5.4 ). Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection, USP has the potential to cause cancer in humans ( 5.5 ).
GANCICLOVIR SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03586284 STACCATO results posted | 18-24396 | Ph 2, Ph 3 | terminated | Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GANCICLOVIR SODIUM FDA Label Details
Indications & Usage
GANCICLOVIR SODIUM is indicated for the treatment of Cytomegalovirus Retinitis; Cytomegalovirus Disease.
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 [see Warnings and Precautions (5.1) ] . Impairment of Fert...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.