GANCICLOVIR 2 mg/mL Injection, Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- Ganciclovir is an antiviral that stops certain viruses from copying themselves. The injection form is used mainly to treat or prevent CMV (cytomegalovirus) infections — a serious v...
- Why has my doctor prescribed ganciclovir — what exactly does it do?
- The most important ones to watch for with the injection form are signs of low blood counts — things like unusual bruising, bleeding gums, persistent fever, or feeling unusually wea...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1574 | No ASP payment limit on file for J1574 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ganciclovir 2 mg/mLthis 51754-2500-03 | EXELA | 1 pouch | — | — | Discontinued | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9486530 ↗ | Drug product | — | Sep 2, 2034 |
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51754-2500-01 | 250 mL in 1 BAG (51754-2500-1) | 2017-02-28 | Discontinued by firm |
| 51754-2500-03 You're viewing this | 10 BAG in 1 POUCH (51754-2500-3) / 250 mL in 1 BAG | 2017-02-28 | Discontinued by firm |
Pack size FAQ
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, and CARCINOGENICITY 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, 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 cancer in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, and CARCINOGENICITY 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, GANCICLOVIR INJECTION may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. ( 5.2 ) Fetal Toxicity: Based on animal data, GANCICLOVIR INJECTION has the potential to cause birth defects in humans. ( 5.3 ) Mutagenesis and Carcinogenesis: Based on animal data, GANCICLOVIR INJECTION has the potential to cause cancer in humans.
( 5.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE GANCICLOVIR INJECTION is a nucleoside analogue CMV DNA polymerase inhibitor indicated for the: Treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) Prevention of CMV disease in adult transplant recipients at risk for CMV disease. ( 1.2 )
1.1Treatment of CMV Retinitis GANCICLOVIR INJECTION is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14 )] .
1.2Prevention of CMV Disease in Transplant Recipients GANCICLOVIR INJECTION is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies ( 14 ) ] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosage in Adult Patients with Normal Renal Function ( 2.3 , 2.4 ) Treatment of CMV retinitis ( 2.3 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients ( 2.4 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days.
Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation. Adult patients with renal impairment: Adjust dosage based on creatinine clearance. ( 2.5 )
2.1Important Dosing and Administration Information Do not administer GANCICLOVIR INJECTION by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels. The recommended dosage and infusion rate for GANCICLOVIR INJECTION should not be exceeded. Administration of GANCICLOVIR INJECTION should be accompanied by adequate hydration.
GANCICLOVIR INJECTION should only be infused into veins with adequate blood flow to permit rapid dilution and distribution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2.2Testing Before and During Treatment Females of reproductive potential should undergo pregnancy testing before initiation of GANCICLOVIR INJECTION [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 , 8.3 )]. Complete blood counts with differential and platelet counts should be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenias, or in whom absolute neutrophil counts are less than 1000 cells/μL at the beginning of treatment [see Warnings and Precautions ( 5.1 )] .
All patients should be monitored for renal function before and during treatment with GANCICLOVIR INJECTION and dosage should be adjusted as needed [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 )]. Patients with CMV retinitis should have frequent ophthalmological examinations during treatment with GANCICLOVIR INJECTION to monitor disease status and for other retinal abnormalities [see Adverse Reactions ( 6.1 )].
2.3Recommended Dosage for Treatment of CMV Retinitis in Adult Patients with Normal Renal Function Induction Dosage: The recommended initial dosage of GANCICLOVIR INJECTION for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance Dosage: Following induction treatment, the recommended maintenance dosage of GANCICLOVIR INJECTION is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week.
2.4Recommended Dosage for Prevention of CMV Disease in Adult Transplant Recipients with Normal Renal Function Induction Dosage : The recommended initial dosage of GANCICLOVIR INJECTION for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance Dosage : Following induction, the recommended maintenance dosage of GANCICLOVIR INJECTIONS is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation.
2.5Recommended Dosage in Adult Patients with Renal Impairment For patients with renal impairment, refer to Table 1 for recommended doses of GANCICLOVIR INJECTION for induction and maintenance dosage for treatment of CMV retinitis and prevention of CMV disease in transplant patients. Monitor serum creatinine or creatinine c…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 500 mg of ganciclovir in 250 mL (2 mg per mL) sterile, unpreserved, colorless solution in a single-dose bag for intravenous use. Injection: 500 mg ganciclovir in 250 mL (2 mg per mL) solution in a single-dose bag for intravenous use. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS GANCICLOVIR INJECTION is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. Hypersensitivity to ganciclovir, valganciclovir or acyclovir. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hematologic toxicity: Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported with use of ganciclovir. Avoid the use of GANCICLOVIR INJECTION if absolute neutrophil count is less than 500 cells/µL, hemoglobin is less than 8 g/dL, or platelet count is less than 25,000 cells/µL. Use with caution in patients with pre-existing cytopenias or in patients receiving myelosuppressive drugs or irradiation.
Monitor with frequent complete blood and platelet counts. ( 5.1 ) Impairment of renal function: Increased serum creatinine levels have been observed with the use of ganciclovir, particularly in elderly patients and transplant patients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with GANCICLOVIR INJECTION, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairment.
( 5.2 ) Impairment of fertility: Based on animal studies, GANCICLOVIR INJECTION may cause temporary or permanent female and male infertility. ( 5.3 ) Fetal toxicity: Based on findings in animal studies, GANCICLOVIR INJECTION may cause fetal toxicity. Females of reproductive potential should use effective contraception during treatment and for at least 30 days following treatment with GANCICLOVIR INJECTION.
Males should practice barrier contraception during treatment and for at least 90 days following treatment with GANCICLOVIR INJECTION. ( 5.4 ) Mutagenicity and carcinogenicity: Based on animal studies, GANCICLOVIR INJECTION is potentially mutagenic and carcinogenic. ( 5.5 )
5.1Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been observed in patients treated with ganciclovir. The frequency and severity of these events vary widely in different patient populations [see Adverse Reactions ( 6.1 )]. GANCICLOVIR INJECTION is not recommended if the absolute neutrophil count is less than 500 cells/μL, hemoglobin is less than 8 g/dL, or the platelet count is less than 25,000 cells/μL.
GANCICLOVIR INJECTION should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Neutropenia usually occurs during the first or second week of treatment but may occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug.
Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir for treatment of CMV retinitis. Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving GANCICLOVIR INJECTION, complete blood counts with differential and platelet counts should be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment [see Dosage and Administration ( 2.2 )] .
5.2Impairment of Renal Function Increased serum creatinine levels have been reported in elderly patients and in transplant patients receiving concomitant nephrotoxic medications (i.e., cyclosporine and amphotericin B). Monitoring renal function during therapy with GANCICLOVIR INJECTION is essential, especially for elderly patients and those patients receiving concomitant agents that may cause nephrotoxicity [see Dosage and Administration ( 2.5 ), Use in Specific Populations ( 8.5 )] .
5.3Impairment of Fertility Based on animal data, GANCICLOVIR INJECTION at the recommended human dose (RHD) may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females. Advise patients that fertility may be impaired with use of GANCICLOVIR INJECTION [see Use in Specific Population ( 8.1 ), Nonclinical Toxicology ( 13.1 )] .
5.4 Fetal Toxicity GANCICLOVIR INJECTION may cause fetal toxicity whe…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions ( 5.1 )] Impairment of Renal Function [see Warnings and Precautions ( 5.2 )] Impairment of Fertility [see Warnings and Precautions ( 5.3 )] Fetal Toxicity [see Warnings and Precautions ( 5.4 )] Mutagenesis and Carcinogenesis [see Warnings and Precautions ( 5.5 )] Most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were fever, diarrhea, leukopenia, anemia, catheter-related events (including catheter infection and catheter sepsis), and elevated creatinine levels.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients with CMV Retinitis Three controlled, randomized, phase 3 trials comparing intravenous ganciclovir and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, 9% of subjects were prematurely discontinued because of adverse reactions.
Selected adverse reactions and laboratory abnormalities reported during the conduct of these controlled trials are summarized in Table 2 and Table 3, respectively [see Clinical Studies ( 14 )] . Table 2. Pooled Selected Adverse Events Reported in ≥ 5% of Subjects Comparing Intravenous Ganciclovir to Ganciclovir Capsules for Maintenance Treatment of CMV Retinitis Adverse Event Maintenance Treatment Studies Intravenous Ganciclovir (n=179) Ganciclovir Capsules (n=326) Fever 48% 38% Diarrhea 44% 41% Leukopenia 41% 29% Anemia 25% 19% Total catheter events: 22% 6% Catheter infection 9% 4% Catheter sepsis 8% 1% Other catheter related events 5% 1% Sepsis 15% 4% Anorexia 14% 15% Vomiting 13% 13% Infection 13% 9% Sweating 12% 11% Chills 10% 7% Neuropathy 9% 8% Thrombocytopenia 6% 6% Pruritus 5% 6% Retinal Detachment Retinal detachment has been observed in subjects with CMV retinitis both before and after initiation of therapy with ganciclovir.
Its relationship to therapy with ganciclovir is unknown. Retinal detachment occurred in 11% of patients treated with intravenous ganciclovir and in 8% of patients treated with ganciclovir capsules. Table 3.
Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis Laboratory Abnormalities CMV Retinitis Treatment* Intravenous Ganciclovir† 5mg/kg/day (N=175) % Ganciclovir Capsules‡ 3000mg/day (N=320) % Neutropenia with Absolute Neutrophil Count (ANC) per µL: <500 25% 18% 500 - <749 14% 17% 750 - <1000 16% 19% Anemia with Hemoglobin (g/dL): <6.5 5% 2% 6.5 - <8.0 16% 10% 8.0 - <9.5 26% 25% Serum Creatinine (mg/dL): ≥2.5 2% 1% ≥1.5 - <2.5 14% 12% * Pooled data from treatment studies ICM 1653, ICM 1774, and AVI 034 † Mean time on therapy = 103 days, including allowed re-induction treatment periods ‡ Mean time on therapy = 91 days, including allowed re-induction treatment periods Adverse Reactions in Transplant Recipients There have been three controlled clinical trials of intravenous ganciclovir for the prevention of CMV disease in transplant recipients.
Selected laboratory abnormalities are summarized in Tables 4 and 5 below. Table 4 shows the frequency of neutropenia and thrombocytopenia and Table 5 shows the frequency of elevated serum creatinine values observed in these trials [see Clinical Studies ( 14 )]. Table 4.
Laboratory Abnormalities in Controlled Trials – Transplant Recipients who Received Intravenous Ganciclovir or Placebo Laboratory Abnormalities Heart Allograft* Bone Marrow Allograft† Intravenous Ganciclovir (N=76) Placebo (n=73) Intravenous Ganciclovir (n=57) Control (n=55) Ne…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 [see Clinical Pharmacology ( 12.3 )] . Table 6. Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Didanosine ↑ Didanosine Patients should be closely monitored for didanosine toxicity.
Zidovudine ↓ Ganciclovir ↑ Zidovudine Dose reduction or interruption may be needed because both zidovudine and ganciclovir have the potential to cause neutropenia and anemia. Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels. Probenecid ↑ Ganciclovir GANCICLOVIR INJECTION dose may need to be reduced.
Monitor for evidence of ganciclovir toxicity. Imipenem-cilastatin Unknown Coadministration with imipenem-cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. Cyclosporine or amphotericin B Unknown Monitor renal function when GANCICLOVIR INJECTION is co-administered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions ( 5.2 )].
Dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues Unknown Co-administration with GANCICLOVIR INJECTION should be considered only if the potential benefits are judged to outweigh the risks because of potential additive toxicity. Didanosine: Patients should be closely monitored for didanosine toxicity. ( 7 ) Zidovudine: Potential to cause neutropenia and anemia.
Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels. ( 7 ) Probenecid: Ganciclovir dose may need to be reduced. Monitor for evidence of ganciclovir toxicity.
( 7 ) Imipenem-cilastatin: Generalized seizures have been reported in patients with concomitant use of ganciclovir and imipenem-cilastatin. ( 7 ) Cyclosporine or amphotericin B: Monitor renal function. ( 5.2 , 7 ) Drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues should be considered for concomitant use with ganciclovir only if the potential benefits are judged to outweigh the risks.
( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended . ( 8.2 )
8.1Pregnancy Risk Summary Inanimal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and on at least one case report in a pregnant woman, no adequate human data are available to establish whether GANCICLOVIR INJECTION poses a risk to pregnancy outcomes.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15−20%, respectively. Clinical considerations Disease-associated maternal and/or fetal risk Most maternal CMV infections are subclinical or they may be associated with a mononucleosis-like syndrome.
However, in immunocompromised patients, CMV infections are often symptomatic and are associated with significant morbidity and mortality. The transmission of CMV to the fetus is a result of maternal viremia and transplacental infection. CMV infection can also occur perinatally from mother to infant by exposure to CMV in cervicovaginal secretions.
Approximately 10% of infected newborns are symptomatic at birth. Mortality in symptomatic infants is about 10%, and approximately 50 to 90% of survivors experience significant problems, including sensorineural hearing loss, mental retardation, and other neurologic deficits. The risk and severity of congenital CMV infection appear to be higher in infants born to mothers with primary CMV infection than in those born to mothers with reactivation of CMV infection.
Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice (108 mg/kg/day) and rabbits (60 mg/kg/day), and also to female mice (90 mg/kg) 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. 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. The systemic exposure (AUC) of ganciclovir during these studies was approximately 2-times (pregnant mice and rabbits) and 1.7-times (pre/postnatal mice) the exposure in humans at the RHD [see Nonclinical Toxicology ( 13.1 )] .
8.2Lactation Risk Summary No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production. When ganciclovir was administered to lactating rats, ganciclovir was present in milk [see Data]. Advise nursing mothers that breastfeeding is not recommended during treatment with GANCICLOVIR INJECTION because of the potential for serious adverse reactions in nursing infants.
Furthermore, the Centers for Disease Control and Prevention recommends that HIV-infected mothers not breastfeed their infants to avoid potential postnatal transmission of HIV [see Warnings and Precautions ( 5.1 , 5.3 , 5.5 ), Nonclinical Toxicology ( 13.1 )]. Data Animal Data Ganciclovir administered intravenously (at 0.13 mg/h) to lactating rats (on lactation day 15) resulted in passive transfer into milk. The milk-to-serum ratio for ganciclovir at steady state was 1.6 ± 0.33.
8.3 Females and Males of Reproductive Potential Pregnancy Testing Females of reproducti…
🆘 Overdosage ▾
10 OVERDOSAGE Adverse reactions reported with overdosage of intravenous ganciclovir included irreversible pancytopenia, acute renal failure requiring hemodialysis, neutropenia, thrombocytopenia, hepatitis, and seizures. Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations. Adequate hydration should be maintained.
The use of hematopoietic growth factors should be considered in patients with cytopenias [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ganciclovir is an antiviral drug with activity against cytomegalovirus (CMV) [see Microbiology ( 12.4 )].
12.3Pharmacokinetics Absorption: At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ±3.2 (n=16) and 26.8 ± 6.1 g·hr/mL (n=16) and C max ranged between 8.27 ± 1.02 (n=16) and 9.0 ± 1.4 g/mL (n=16). Distribution: The steady-state volume of distribution of ganciclovir after intravenous administration was 0.74 ±
0.15L/kg (n=98). Cerebrospinal fluid concentrations obtained 0.25 to 5.67 hours post-dose in 3 patients who received 2.5 mg/kg ganciclovir intravenously every 8 hours or every 12 hours ranged from 0.31 to 0.68 g/mL representing 24% to 70% of the respective plasma concentrations. Binding to plasma proteins was 1% to 2% over ganciclovir concentrations of 0.5 and 51 g/mL.
Elimination: Renal excretion of unchanged drug by glomerular filtration and active tubular secretion is the major route of elimination of ganciclovir. In patients with normal renal function, 91.3 ± 5.0% (n=4) of intravenously administered ganciclovir was recovered unchanged in the urine. Systemic clearance of intravenously administered ganciclovir was 3.52 ± 0.80 mL/min/kg (n=98) while renal clearance was 3.20 ± 0.80 mL/min/kg (n=47), accounting for 91 ± 11% of the systemic clearance (n=47).
Following intravenous administration, ganciclovir half-life was 3.5 ± 0.9 hours (n=98) with linear pharmacokinetics over the dose range of 1.6 to 5.0 mg/kg. Specific Populations Patients with Renal Impairment The pharmacokinetics of ganciclovir following intravenous administration of ganciclovir were evaluated in 10 immunocompromised patients with renal impairment who received doses ranging from 1.25 to 5.0 mg/kg (Table 7). Hemodialysis reduces plasma concentrations of ganciclovir by about 50% after intravenous administration.
Table 7. Pharmacokinetics of Ganciclovir in Patients with Renal Impairment Estimated Creatinine Clearance (mL/min) n Dose Clearance (mL/min) Mean ± SD Half-life (hours) Mean ± SD 50-79 4 3.2-5 mg/kg 128 ± 63 4.6 ± 1.4 25-49 3 3-5 mg/kg 57 ± 8 4.4 ± 0.4 <25 3 1.25-5 mg/kg 30 ± 13 10.7 ±
5.7Race (Ethnicity) and Gender The effects of race/ethnicity and gender were studied in subjects receiving a dose regimen of 1000 mg every 8 hours. Although the numbers of Blacks (16%) and Hispanics (20%) were small, there appeared to be a trend towards a lower steady-state C max and AUC 0-8 in these subpopulations as compared to Caucasians. No definitive conclusions regarding gender differences could be made because of the small number of females (12%); however, no differences between males and females were observed.
Drug Interactions Didanosine When the standard intravenous ganciclovir induction dose (5 mg/kg infused over 1 hour every 12 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, the steady-state didanosine AUC 0-12 increased 70 ± 40% (range: 3% to 121%, n=11) and C max increased 49 ± 48% (range: -28% to 125%). In a separate study, when the standard intravenous ganciclovir maintenance dose (5 mg/kg infused over 1 hour every 24 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, didanosine AUC 0-12 increased 50 ± 26% (range: 22% to 110%, n=11) and C max increased 36 ± 36% (range: -27% to 94%) over the first didanosine dosing interval.
Ganciclovir pharmacokinetics were not affected by didanosine. In both studies, there was no significant change in the renal clearance of either drug. Zidovudine At an oral dose of 1000 mg of ganciclovir every 8 hours, mean steady-state ganciclovir AUC 0-8 decreased 17 ± 25% (range: -52% to 23%) in the presence of zidovudine, 100 mg every 4 hours (n=12).
Steady-state zidovudine AUC 0-4 increased 19 ± 27% (range: -11% to 74%) in the presence of ganciclovir. No drug-drug interaction studies have been conducted with intravenous ganciclovir and zidovudine. Probenec…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING GANCICLOVIR INJECTION is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 500 mg ganciclovir in 250 mL of solution (2 mg/mL) sealed with a Twist Off port from Technoflex, and oversealed in an aluminum pouch (NDC 51754-2500-1), in cases of 10 (NDC 51754-2500-3). Follow guidelines for handling and disposal for cytotoxic drugs. 1 The premix flexible plastic container bag contains no preservative; any unused portion should be discarded [see Dosage and Administration ( 2.6 )] .
Gently shaking should redissolve any crystals that may have formed during transportation and/or storage at temperatures lower than recommended. The solution must be clear at the time of use. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION GANCICLOVIR INJECTION, 500 mg is a sterile, unpreserved solution for intravenous administration. The appearance of the solution is clear and colorless. Each mL contains 2.0 mg of ganciclovir, 8.0 mg of sodium chloride in water for injection, and may contain sodium hydroxide, and/or hydrochloric acid, as required to adjust the pH to 7.5.
Ganciclovir, an antiviral agent, is a synthetic guanine derivative, 9-[[2-hydroxy-1-(hydroxymethyl)- ethoxy]methyl]guanine. Ganciclovir is a white to off-white crystalline powder with a molecular formula of C 9 H 13 N 5 0 4 and a molecular weight of 255.23. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022.
The pK a s for ganciclovir are 2.2 and 9.4. The chemical structure of ganciclovir is: The plastic container is fabricated from a multilayer film designed for medical use. The solution is in contact with the inner polypropylene layer of the container.
No components of the plastic container material were found to migrate into the solution. Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hematologic Toxicity Inform patients of the potential for hematologic toxicity associated with the use of GANCICLOVIR INJECTION including granulocytopenia (neutropenia), anemia and thrombocytopenia. Inform patients that their blood counts will be closely monitored while on therapy [see Warnings and Precautions (5.1)] . Impairment of Renal Function Inform patients that ganciclovir has been associated with decreased renal function and that serum creatinine or creatinine clearance will be monitored carefully to allow for dosage adjustment in patients with renal impairment [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].
Impairment of Fertility Inform patients that ganciclovir has caused decreased fertility in animals and may cause temporary or permanent infertility in humans [see Warnings and Precautions (5.3), Use in Specific Populations (8.3)]. Pregnancy and Contraception Inform women of childbearing potential that ganciclovir causes birth defects in animals. Advise female patients to use effective contraception during treatment and for at least 30 days following treatment with GANCICLOVIR INJECTION.
Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with GANCICLOVIR INJECTION [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)] . Carcinogenicity Inform patients that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen [see Warnings and Precautions (5.5)] .
Drug Interactions Inform patients that GANCICLOVIR INJECTION may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions (7)]. Ophthalmological Examination in Patients with CMV Retinitis Advise patients with CMV retinitis to have frequent ophthalmological examinations while being treated with GANCICLOVIR INJECTION to monitor disease status and for other retinal abnormalities.
More frequent ophthalmological follow-up may be needed in some cases [see Dosage and Administration (2.2), Adverse Reactions (6.1)]. Lactation Advise nursing mothers that breastfeeding is not recommended during treatment with GANCICLOVIR INJECTION because of the potential for serious adverse events in nursing infants and because HIV can be passed to the baby in breast milk [see Use in Specific Populations (8.2)] .