Cytovene Side Effects

Generic name: ganciclovir

Note: This document contains side effect information about ganciclovir. Some of the dosage forms listed on this page may not apply to the brand name Cytovene.

Some side effects of Cytovene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ganciclovir: intravenous powder for injection, oral capsule

Serious side effects affecting the blood have been reported with the use of ganciclovir (the active ingredient contained in Cytovene) Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.

Stop taking ganciclovir and seek emergency medical attention if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• paleness and fatigue that may be signs of anemia (a low level of red blood cells);

• unusual bleeding or bruising;

• fever or signs of infection; or

• numbness or tingling in a part of your body.

Other, less serious side effects may be more likely to occur. Continue to take ganciclovir and talk to your doctor if you experience

• nausea, vomiting, diarrhea, or decreased appetite;

• increased sweating;

• itching; or

• decreased sperm production or infertility.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to ganciclovir: intravenous powder for injection, oral capsule

General

In phase 3 clinical trials, ganciclovir (the active ingredient contained in Cytovene) was discontinued due to adverse effects in 9% of patients receiving maintenance treatment for CMV retinitis. Ganciclovir was discontinued 19.5% of AIDS patients receiving CMV prophylaxis due to adverse events, new or worsening intercurrent disease, or laboratory abnormalities (compared to 16% receiving placebo).

Hematologic

Bone marrow suppression is dose-related and usually occurs before a total dose of 200 mg/kg is reached. Sargramostim (GM-CSF) or filgrastim (G-CSF) have been used for the management of neutropenia due to ganciclovir (the active ingredient contained in Cytovene)

Hematologic side effects have included neutropenia, anemia, and thrombocytopenia and are the major toxicity of ganciclovir. Leukopenia, pancytopenia, hemolytic anemia, hemolytic uremic syndrome, pure red blood cell aplasia, eosinophilia, and neutrophil dysplasia (with evidence of bone marrow hypoplasia) have also been reported. Coagulation disorder has been reported in pediatric patients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (41% to 48%), anorexia (14% to 19%), vomiting (13% to 14%), nausea, flatulence, abdominal pain, aphthous stomatitis, constipation, dyspepsia, eructation, intestinal ulceration, gastrointestinal perforation, pancreatitis, dysphasia, and cholelithiasis.

Renal

Renal side effects have included increased serum creatinine, kidney failure, abnormal kidney function, and renal tubular disorder. Abnormal kidney function has also been reported in pediatric patients.

Genitourinary

Genitourinary side effects have included urinary frequency, infertility, and testicular hypotrophy.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction, anaphylactic reaction, exfoliative dermatitis, and Stevens-Johnson syndrome.

Ocular

Ocular side effects have included retinal detachment (8% to 11%) in patients with CMV retinitis, both before and after initiation of treatment. Abnormal vision, dry eyes, vitreous disorder, cataracts, and oculomotor nerve paralysis have also been reported.

Cardiovascular

Cases of ventricular tachycardia associated with ganciclovir (the active ingredient contained in Cytovene) infusions in patients with AIDS have been reported, although it is known that HIV infection is associated with myocarditis, decreased left ventricular function, and in some cases, nonsustained ventricular tachycardia.

Cardiovascular side effects have included hypertension, phlebitis, edema, vasodilatation, cardiac arrest, cardiac conduction abnormality, vasculitis, stroke, torsades de pointes, and ventricular tachycardia. Hypertension has been reported in pediatric patients.

Dermatologic

Dermatologic side effects have included pruritus (5% to 10%), alopecia, and dry skin. Interstitial granulomatous drug reaction has been reported in at least one patient.

Hepatic

Rare cases of hepatitis associated with ganciclovir (the active ingredient contained in Cytovene) have been reported, but in most cases, other potentially hepatotoxic drugs were coadministered.

Hepatic side effects have included increased SGOT and SGPT, cholestasis, hepatic failure, and hepatitis.

Nervous system

Nervous system side effects have included neuropathy (8% to 21%), abnormal dreams, anxiety, confusion, depression, dizziness, dry mouth, insomnia, seizures, somnolence, abnormal thinking, tremor, agitation, delirium, dysesthesia, encephalopathy, extrapyramidal reaction, facial palsy, hallucinations, intracranial hypertension, irritability, loss of memory, and myelopathy.

Seizures, psychosis, nightmares, anxiety, ataxia, and somnolence have been reported, but are rare and difficult to attribute to ganciclovir therapy since the patients are otherwise very ill and receiving other medications.

Endocrine

Endocrine side effects have included sweating (11% to 14%).

Local

Local side effects have included catheter infection (4% to 9%), catheter sepsis (1% to 8%), and injection site inflammation.

Metabolic

Metabolic side effects have included weight loss, acidosis, elevated triglyceride levels, hypercalcemia, hyponatremia, and inappropriate serum ADH. Hypokalemia has been reported in pediatric patients.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, leg cramps, myalgia, myasthenia, arthritis, and rhabdomyolysis.

Respiratory

Respiratory side effects have included increased cough, dyspnea, bronchospasm, and pulmonary fibrosis. Pneumonia has been reported in pediatric patients.

Other

Other side effects have included fever (35% to 48%), infection (8% to 13%), chills (7% to 10%), sepsis (3% to 15%), abdominal enlargement, asthenia, chest pain, edema, headache, malaise, multiple organ failure, pain, taste perversion, tinnitus, loss of sense of smell, and peripheral ischemia.

Immunologic

Immunologic side effects have included immune system disorder in pediatric patients.

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