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Drug overview for GANCICLOVIR SODIUM (ganciclovir sodium):
Generic name: GANCICLOVIR SODIUM (gan-SYE-klo-veer)
Drug class: Antiviral - CMV Infection
Therapeutic class: Anti-Infective Agents
Ganciclovir, a synthetic nucleoside analog of guanine, is an antiviral agent active against herpesviruses.
No enhanced Uses information available for this drug.
Generic name: GANCICLOVIR SODIUM (gan-SYE-klo-veer)
Drug class: Antiviral - CMV Infection
Therapeutic class: Anti-Infective Agents
Ganciclovir, a synthetic nucleoside analog of guanine, is an antiviral agent active against herpesviruses.
No enhanced Uses information available for this drug.
DRUG IMAGES
GANCICLOVIR 500 MG VIAL
The following indications for GANCICLOVIR SODIUM (ganciclovir sodium) have been approved by the FDA:
Indications:
CMV retinitis in AIDS patient
CMV retinitis in immunocompromised patient
Prevention of CMV disease after organ transplant
Professional Synonyms:
Cytomegalovirus prophylaxis in organ transplantation
Cytomegalovirus retinitis in AIDS
Prevention of CMV infection after organ transplantation
Indications:
CMV retinitis in AIDS patient
CMV retinitis in immunocompromised patient
Prevention of CMV disease after organ transplant
Professional Synonyms:
Cytomegalovirus prophylaxis in organ transplantation
Cytomegalovirus retinitis in AIDS
Prevention of CMV infection after organ transplantation
The following dosing information is available for GANCICLOVIR SODIUM (ganciclovir sodium):
Ganciclovir is commercially available as the base and as ganciclovir sodium; dosage is expressed in terms of ganciclovir.
In patients with impaired renal function, doses and/or frequency of administration of ganciclovir must be modified in response to the degree of impairment.
Dosage should be based on the patient's measured or estimated creatinine clearance. The patient's creatinine clearance (Ccr) can be estimated by using the following formulas:
When IV ganciclovir is used for the management of CMV retinitis in adults with renal impairment, the manufacturers recommend the following dosage for initial treatment (induction therapy) and maintenance therapy (secondary prophylaxis) based on creatinine clearance. (See Table 1.)
Table 1. Dosage of IV Ganciclovir for Management of CMV Retinitis in Adults with Renal Impairment
Creatinine Clearance Initial Treatment Maintenance Dosage (mL/minute) (Induction) Dosage 50-69 2.5 mg/kg every 12 hours 2.5 mg/kg every 24 hours 25-49 2.5
mg/kg every 24 hours 1.25 mg/kg every 24 hours 10-24 1.25 mg/kg every 24 0.625
mg/kg every 24 hours hours Less than 10 1.25 mg/kg 3 times 0.625 mg/kg 3 times weekly weekly
In adults undergoing hemodialysis, dosage of IV ganciclovir for initial treatment (induction therapy) of CMV retinitis should not exceed 1.25 mg/kg 3 times weekly and dosage for maintenance therapy should not exceed 0.625 mg/kg 3 times weekly. Because hemodialysis may reduce ganciclovir plasma concentrations by approximately 50% (see Pharmacokinetics: Elimination), dosing of the drug should be timed so that doses administered on the days of dialysis are given shortly after completion of dialysis.
In patients with impaired renal function, doses and/or frequency of administration of ganciclovir must be modified in response to the degree of impairment.
Dosage should be based on the patient's measured or estimated creatinine clearance. The patient's creatinine clearance (Ccr) can be estimated by using the following formulas:
When IV ganciclovir is used for the management of CMV retinitis in adults with renal impairment, the manufacturers recommend the following dosage for initial treatment (induction therapy) and maintenance therapy (secondary prophylaxis) based on creatinine clearance. (See Table 1.)
Table 1. Dosage of IV Ganciclovir for Management of CMV Retinitis in Adults with Renal Impairment
Creatinine Clearance Initial Treatment Maintenance Dosage (mL/minute) (Induction) Dosage 50-69 2.5 mg/kg every 12 hours 2.5 mg/kg every 24 hours 25-49 2.5
mg/kg every 24 hours 1.25 mg/kg every 24 hours 10-24 1.25 mg/kg every 24 0.625
mg/kg every 24 hours hours Less than 10 1.25 mg/kg 3 times 0.625 mg/kg 3 times weekly weekly
In adults undergoing hemodialysis, dosage of IV ganciclovir for initial treatment (induction therapy) of CMV retinitis should not exceed 1.25 mg/kg 3 times weekly and dosage for maintenance therapy should not exceed 0.625 mg/kg 3 times weekly. Because hemodialysis may reduce ganciclovir plasma concentrations by approximately 50% (see Pharmacokinetics: Elimination), dosing of the drug should be timed so that doses administered on the days of dialysis are given shortly after completion of dialysis.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GANCICLOVIR 500 MG VIAL | Maintenance | Adults infuse 5 mg/kg over 1 hour(s) by intravenous route every 12 hours |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GANCICLOVIR 500 MG VIAL | Maintenance | Adults infuse 5 mg/kg over 1 hour(s) by intravenous route every 12 hours |
The following drug interaction information is available for GANCICLOVIR SODIUM (ganciclovir sodium):
There are 0 contraindications.
There are 6 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Zidovudine/Ganciclovir, Valganciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The magnitude of the toxic effects of both drugs are increased. CLINICAL EFFECTS: Increased side effects, including hematologic and gastrointestinal toxicity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid this combination. Coadministration should be considered only if the potential benefits are judged to outweigh the risks. Dose reduction or interruption may be needed. Monitor with frequent complete blood counts with differential and platelet counts. DISCUSSION: Patients receiving zidovudine and ganciclovir concurrently developed hematologic toxicity, including neutropenia and anemia, and gastrointestinal toxicity. Both ganciclovir and zidovudine have box warnings regarding hematologic toxicity. Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported. In a study in 12 patients, an oral dose of ganciclovir (1000 mg every 8 hours) administered concurrently with zidovudine (100 mg every 4 hours) decreased the mean steady state area-under-the-curve (AUC) of ganciclovir 17% and increased the zidovudine AUC 19%. |
LAMIVUDINE-ZIDOVUDINE, RETROVIR, ZIDOVUDINE |
| Imipenem-Cilastatin/Ganciclovir,Valganciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown, but may involve additive or synergistic effects on the seizure threshold. CLINICAL EFFECTS: Concurrent use of imipenem-cilastatin with ganciclovir may result in generalized seizures.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of imipenem-cilastatin states that imipenem-cilastatin and ganciclovir should not be coadministered unless the potential benefits outweigh the risks of seizures.(1) DISCUSSION: Generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin.(1) |
IMIPENEM-CILASTATIN SODIUM, PRIMAXIN, RECARBRIO |
| Deferiprone/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis may increase the frequency or risk for severe toxicity.(1) CLINICAL EFFECTS: Concurrent use of deferiprone and myelosuppressive agents may result in severe neutropenia or agranulocytosis, which may be fatal. PREDISPOSING FACTORS: Agranulocytosis may be less common in patients receiving deferiprone for thalassemia, and more common in patients treated for other systemic iron overload conditions (e.g. myelodysplastic syndromes, sickle cell disease).(2,3) Inadequate monitoring appears to increase the risk for severe outcomes. Manufacturer post market surveillance found that in all fatal cases of agranulocytosis reported between 1999 and 2005, data on weekly white blood count (WBC) monitoring was missing. In three fatal cases, deferiprone was continued for two to seven days after the detection of neutropenia or agranulocytosis.(2) PATIENT MANAGEMENT: If possible, discontinue one of the drugs associated with risk for neutropenia or agranulocytosis. If alternative therapy is not available, documentation and adherence to the deferiprone monitoring protocol is essential. Baseline absolute neutrophil count (ANC) must be at least 1,500/uL prior to starting deferiprone. Monitor ANC weekly during therapy. If infection develops, interrupt deferiprone therapy and monitor ANC more frequently. If ANC is less than 1,500/uL but greater than 500/uL, discontinue deferiprone and any other drugs possibly associated with neutropenia. Initiate ANC and platelet counts daily until recovery (i.e. ANC at least 1,500/uL). If ANC is less than 500/uL, discontinue deferiprone, evaluate patient and hospitalize if appropriate. Do not resume deferiprone unless potential benefits outweigh potential risks.(1) DISCUSSION: Drugs linked to this monograph have an FDA Boxed Warning for risk of neutropenia, agranulocytosis, or pancytopenia, or have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(1-25) In pooled clinical studies submitted to the FDA, 6.1% of deferiprone patients met criteria for neutropenia and 1.7% of patients developed agranulocytosis.(1) The time to onset of agranulocytosis was highly variable with a range of 65 days to 9.2 years (median, 161 days).(3) |
DEFERIPRONE, DEFERIPRONE (3 TIMES A DAY), FERRIPROX, FERRIPROX (2 TIMES A DAY), FERRIPROX (3 TIMES A DAY) |
| Clozapine/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine and other myelosuppressive agents may be associated with neutropenia or agranulocytosis.(2) CLINICAL EFFECTS: Moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). The disease treated by the myelosuppressive agent may be compromised if myelosuppression requires dose reduction, delay, or discontinuation of the myelosuppressive agent. Undetected severe neutropenia or agranulocytosis may be fatal. PREDISPOSING FACTORS: Low white blood counts prior to initiation of the myelosuppressive agent may increase risk for clinically significant neutropenia. PATIENT MANAGEMENT: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(2) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(1-2) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(2) DISCUSSION: Clozapine is only available through a restricted distribution system which requires documentation of the ANC prior to dispensing.(1) Agents linked to this interaction generally have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(3-26) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
| Ganciclovir; Valganciclovir/Maribavir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Maribavir may inhibit pUL97 protein kinase which catalyzes the phosphorylation step required for activation of ganciclovir or valganciclovir.(1) CLINICAL EFFECTS: Concurrent administration of maribavir with ganciclovir or valganciclovir may antagonize the antiviral activity of ganciclovir or valganciclovir, resulting in decreased clinical efficacy and/or virological failure of ganciclovir and valganciclovir.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of maribavir states that the concurrent use of maribavir with ganciclovir or valganciclovir is not recommended.(1) DISCUSSION: Ganciclovir and valganciclovir require activation via phosphorylation to the active form by human CMV pUL97 protein kinase.(2,3) The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of pUL97 and may antagonize the antiviral activity of ganciclovir or valganciclovir.(1) In the setting of combination therapy, in vitro data suggests antagonistic activity when maribavir is coadministered with ganciclovir or valganciclovir.(4-7) |
LIVTENCITY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tenofovir/Selected Nephrotoxic Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tenofovir and other nephrotoxic agents may result in additive or synergistic effects on renal function and increase nephrotoxicity risk.(1) CLINICAL EFFECTS: Concurrent use of tenofovir and other nephrotoxic agents may result in renal toxicity and acute renal failure.(1) Reports of acute renal failure and Fanconi syndrome have been reported with tenofovir use.(2,3) However, this has been reported in 3 case reports and the renal failure may have been complicated by other pre-existing conditions.(2) PREDISPOSING FACTORS: Pre-existing renal dysfunction, long duration of use, low body weight, concomitant use of drugs that may increase tenofovir levels may increase the risk of nephrotoxicity.(1) PATIENT MANAGEMENT: The US prescribing information for tenofovir recommends avoiding concurrent or recent use of a nephrotoxic agent.(3) Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Tenofovir should be avoided with high-dose or multiple NSAIDs. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.(3) Patients receiving concurrent NSAIDs with tenofovir should be monitored for possible renal toxicity.(1,2) The dosing interval should be adjusted in patients with a baseline creatinine clearance of less than 50 ml/min.(1-3) DISCUSSION: From March 18, 2003 to December 1, 2005, Health Canada received 10 reports of nephrotoxic reactions with tenofovir. Three of these occurred following the addition of a NSAID to tenofovir therapy. In the first report, a patient maintained on tenofovir for 29 months developed acute renal failure and acute tubular necrosis requiring dialysis 5 days after beginning indomethacin (100 mg rectally twice daily). In the second report, a patient maintained on tenofovir for 7 months developed acute renal failure and acute tubular necrosis after taking 90 tablets of naproxen (375 mg) over 2 months. The patient died. In the third report, a patient maintained on tenofovir for over a year developed acute renal failure and nephrotic syndrome after 2 months of valdecoxib (20 mg daily) therapy. Symptoms subsided following discontinuation of valdecoxib.(1) |
BIKTARVY, CIMDUO, COMPLERA, DELSTRIGO, DESCOVY, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EMTRICITABINE-TENOFOVIR DISOP, GENVOYA, ODEFSEY, STRIBILD, SYMFI, SYMFI LO, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TRUVADA, VEMLIDY, VIREAD |
The following contraindication information is available for GANCICLOVIR SODIUM (ganciclovir sodium):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Anemia |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Neutropenic disorder |
| Thrombocytopenic disorder |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for GANCICLOVIR SODIUM (ganciclovir sodium):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 56 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Bacterial sepsis Drug fever Dyspnea Granulocytopenic disorder Neutropenic disorder |
Abnormal hepatic function tests Allergic dermatitis Altered mental status Infection Kidney disease with reduction in glomerular filtration rate (GFr) Mood changes Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
|
Acidosis Agranulocytosis Anaphylaxis Biliary calculus Bronchospastic pulmonary disease Candidiasis Cardiac arrest Cardiac arrhythmia Cataracts Cerebrovascular accident Chest pain Cholestasis Drug-induced psychosis Exfoliative dermatitis Extrapyramidal disease Gastrointestinal perforation Gastrointestinal ulcer Hearing loss Hematuria Hemolytic anemia Hemolytic uremic syndrome Hepatic failure Hepatitis Hypercalcemia Hypertension Hyponatremia Hypotension Macular retinal edema Multiple organ failure Muscle weakness Pancreatitis Pancytopenia Peripheral ischemia Pulmonary fibrosis Renal failure Rhabdomyolysis Seizure disorder Skin rash Stevens-johnson syndrome Torsades de pointes Vasculitis Ventricular tachycardia Visual changes |
There are 60 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anorexia Cough Diarrhea General weakness Hyperhidrosis Nausea |
Chills Peripheral neuropathy Pruritus of skin Vomiting |
| Rare/Very Rare |
|---|
|
Abdominal distension Acute cognitive impairment Alopecia Aphthous stomatitis Arthralgia Arthritis Back pain Conjunctivitis Constipation Cramps in legs Depression Dizziness Dream disorder Drowsy Dry eye Dry skin Dysesthesia Dysgeusia Dyspepsia Dysphagia Dysphasia Earache Edema Eructation Facial palsy Female infertility Flatulence Hallucinations Headache disorder Hypertriglyceridemia Hypoesthesia Injection site sequelae Insomnia Irritability Loss of sense of smell Malaise Memory impairment Myalgia Oligospermia Paresthesia Phlebitis after infusion Symptoms of anxiety Testicular atrophy Tinnitus Tremor Urticaria Vasodilation of blood vessels Weight loss Xerostomia |
The following precautions are available for GANCICLOVIR SODIUM (ganciclovir sodium):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal data indicate that ganciclovir has the potential to cause fetal toxicity, including birth defects, in humans. Data regarding use of ganciclovir in pregnant women are inadequate to establish whether the drug poses a risk to pregnancy outcomes. Ganciclovir appears to cross the placenta based on ex vivo experiments with human placenta and at least one case report in a pregnant woman.
In animal studies, ganciclovir caused maternal and fetal toxicity and embryofetal mortality in pregnant mice and rabbits and teratogenic effects in rabbits at systemic exposures that were approximately 2 times those attained in humans at the recommended human dose. IV ganciclovir administered to pregnant mice (108 mg/kg daily) and rabbits (60 mg/kg daily) and administered to female mice (90 mg/kg) prior to mating, during gestation, and during lactation resulted in fetal resorptions in at least 85% of the mice and rabbits. Fetal growth retardation, embryolethality, and teratogenic effects (cleft palate, anophthalmia/microphthalmia, hydrocephaly, brachygnathia, aplastic organs (kidney, pancreas)) were reported in the rabbits.
In pre/postnatal development studies in mice, maternal/fetal toxicity and embryolethality were observed and included hypoplasia of the testes and seminal vesicles in male offspring, as well as pathologic changes in the nonglandular region of the stomach. Although most maternal CMV infections are asymptomatic or may be associated with a self-limited mononucleosis-like syndrome, CMV infections in pregnant immunocompromised patients (e.g., HIV-infected patients with AIDS, transplant recipients) may be symptomatic and result in substantial maternal morbidity and mortality. Perinatal transmission of CMV from an infected mother to her fetus can occur resulting in congenital CMV infection and disease.
(See Congenital Cytomegalovirus Disease under Uses: Treatment of Cytomegalovirus Infection and Disease.) Females of childbearing potential should undergo pregnancy testing before initiation of ganciclovir. Females of childbearing potential should use effective contraception during and for at least 30 days after ganciclovir therapy and male patients should use effective barrier contraceptive methods during and for at least 90 days after ganciclovir therapy.
In animal studies, ganciclovir caused maternal and fetal toxicity and embryofetal mortality in pregnant mice and rabbits and teratogenic effects in rabbits at systemic exposures that were approximately 2 times those attained in humans at the recommended human dose. IV ganciclovir administered to pregnant mice (108 mg/kg daily) and rabbits (60 mg/kg daily) and administered to female mice (90 mg/kg) prior to mating, during gestation, and during lactation resulted in fetal resorptions in at least 85% of the mice and rabbits. Fetal growth retardation, embryolethality, and teratogenic effects (cleft palate, anophthalmia/microphthalmia, hydrocephaly, brachygnathia, aplastic organs (kidney, pancreas)) were reported in the rabbits.
In pre/postnatal development studies in mice, maternal/fetal toxicity and embryolethality were observed and included hypoplasia of the testes and seminal vesicles in male offspring, as well as pathologic changes in the nonglandular region of the stomach. Although most maternal CMV infections are asymptomatic or may be associated with a self-limited mononucleosis-like syndrome, CMV infections in pregnant immunocompromised patients (e.g., HIV-infected patients with AIDS, transplant recipients) may be symptomatic and result in substantial maternal morbidity and mortality. Perinatal transmission of CMV from an infected mother to her fetus can occur resulting in congenital CMV infection and disease.
(See Congenital Cytomegalovirus Disease under Uses: Treatment of Cytomegalovirus Infection and Disease.) Females of childbearing potential should undergo pregnancy testing before initiation of ganciclovir. Females of childbearing potential should use effective contraception during and for at least 30 days after ganciclovir therapy and male patients should use effective barrier contraceptive methods during and for at least 90 days after ganciclovir therapy.
It is not known whether ganciclovir is distributed into human milk, affects the breast-fed infant, or affects milk production. The drug is distributed into milk in lactating rats; the milk-to-serum ratio at steady state is approximately 1.6 in rats.
Because of the potential for serious adverse reactions to ganciclovir in breast-fed infants, nursing women should be instructed not to breast-feed while they are receiving the drug. HIV-infected mothers should be instructed not to breast-feed their infants because of the risk of transmission of HIV.
Because of the potential for serious adverse reactions to ganciclovir in breast-fed infants, nursing women should be instructed not to breast-feed while they are receiving the drug. HIV-infected mothers should be instructed not to breast-feed their infants because of the risk of transmission of HIV.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for GANCICLOVIR SODIUM (ganciclovir sodium):
WARNING: Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems.
Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Get medical help right away if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as sore throat that doesn't go away, fever, chills, cough), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds). Ganciclovir may reduce fertility in men and women.
It may also harm an unborn baby. Talk to your doctor for more details. Ganciclovir has caused tumors in lab animals.
Although there is no information in humans, ganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.
WARNING: Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems.
Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Get medical help right away if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as sore throat that doesn't go away, fever, chills, cough), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds). Ganciclovir may reduce fertility in men and women.
It may also harm an unborn baby. Talk to your doctor for more details. Ganciclovir has caused tumors in lab animals.
Although there is no information in humans, ganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.
The following icd codes are available for GANCICLOVIR SODIUM (ganciclovir sodium)'s list of indications:
| CMV retinitis in AIDS patient | |
| B25.9 | Cytomegaloviral disease, unspecified |
| H32 | Chorioretinal disorders in diseases classified elsewhere |
| CMV retinitis in immunocompromised patient | |
| B25.9 | Cytomegaloviral disease, unspecified |
| H32 | Chorioretinal disorders in diseases classified elsewhere |
| Prevention of CMV disease after organ transplant | |
| Z94.0 | Kidney transplant status |
| Z94.1 | Heart transplant status |
| Z94.2 | Lung transplant status |
| Z94.4 | Liver transplant status |
| Z94.5 | Skin transplant status |
| Z94.6 | Bone transplant status |
| Z94.81 | Bone marrow transplant status |
| Z94.82 | Intestine transplant status |
| Z94.83 | Pancreas transplant status |
| Z94.84 | Stem cells transplant status |
Formulary Reference Tool