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Cytovene

Last reviewed on RxList: 12/21/2016
Cytovene Side Effects Center

Last reviewed on RxList 12/21/2016

Cytovene (ganciclovir) is an antiviral drug used to treat and prevent infections caused by cytomegalovirus. This infection usually occurs in patients who have suppressed immune systems such as patients with AIDS and organ transplant patients. Cytovene is available in generic form. Common side effects of Cytovene include:

Tell your doctor immediately if you have unlikely but serious side effects of Cytovene including:

The recommended initial dosage of Cytovene 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. The recommended maintenance dosage is 5 mg/kg given as intravenous infusion over 1 hour once daily, 7 days per week, or 6 mg/kg once daily, 5 days per week. Cytovene may interact with zidovudine, didanosine, probenecid, or imipenem-cilastatin. Tell your doctor all medications you use. During pregnancy, Cytovene should be used only when prescribed. It may harm a fetus. Men should use effective barrier protection (such as latex or polyurethane condoms) during sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age should use at least 2 forms of birth control (such as birth control pills and condoms); consult your doctor. It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. If you have HIV, do not breastfeed because breast milk can transmit HIV.

Our Cytovene (ganciclovir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cytovene Consumer Information

Serious side effects affecting the blood have been reported with the use of ganciclovir. 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cytovene (Ganciclovir)

Cytovene Professional Information

SIDE EFFECTS

Adverse events that occurred during clinical trials of CYTOVENE-IV solution are summarized below, according to the participating study subject population.

Subjects With AIDS

Three controlled, randomized, phase 3 trials comparing CYTOVENE-IV and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, CYTOVENE-IV or ganciclovir capsules were prematurely discontinued in 9% of subjects because of adverse events. Laboratory data and adverse events reported during the conduct of these controlled trials are summarized below.

Laboratory Data

Table 4 Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis

Treatment CMV Retinitis Treatment*
Ganciclovir Capsules
3000 mg/day
CYTOVENE-IV
5 mg/kg/day
Subjects, number 320 175
Neutropenia:
  <500 ANC/μL 18% 25%
  500 – <749 17% 14%
  750 – <1000 19% 26%
Anemia Hemoglobin:
  <6.5 g/dL 2% 5%
  6.5 – <8.0 10% 16%
  8.0 – <9.5 25% 26%
Maximum Serum Creatinine:
  ≥2.5 mg/dL 1% 2%
  ≥1.5 – <2.5 12% 14%
*Pooled data from Treatment Studies, ICM 1653, Study ICM 1774 and Study AVI 034
Mean time on therapy = 91 days, including allowed reinduction treatment periods
Mean time on therapy = 103 days, including allowed reinduction treatment periods (See Clinical Trials.)

Adverse Events

The following table shows selected adverse events reported in 5% or more of the subjects in three controlled clinical trials during treatment with either CYTOVENE-IV solution (5 mg/kg/day) or ganciclovir capsules (3000 mg/day), and in one controlled clinical trial with CYTOVENE capsules (3000 mg/day).

Table 5 Selected Adverse Events Reported in ≥ 5% of Subjects in Three Randomized Phase 3 Studies Comparing Ganciclovir Capsules to CYTOVENE-IV Solution for Maintenance Treatment of CMV Retinitis

Body System Adverse Event Maintenance Treatment Studies
Capsules
(n=326)
IV
(n=179)
Body as a Whole Fever 38% 48%
Infection 9% 13%
Chills 7% 10%
Sepsis 4% 15%
Digestive System Diarrhea 41% 44%
Anorexia 15% 14%
Vomiting 13% 13%
Hemic and Lymphatic System Leukopenia 29% 41%
Anemia 19% 25%
Thrombocytopenia 6% 6%
Nervous System Other Neuropathy 8% 9%
Sweating 11% 12%
Pruritus 6% 5%
Catheter Related* Total Catheter Events 6% 22%
Catheter Infection 4% 9%
Catheter Sepsis 1% 8%
*Some of these events also appear under other body systems.

The following events were frequently observed in clinical trials but occurred with equal or greater frequency in placebo-treated subjects: abdominal pain, nausea, flatulence, pneumonia, paresthesia, rash.

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 CYTOVENE-IV solution and in 8% of patients treated with ganciclovir capsules. Patients with CMV retinitis should have frequent ophthalmologic evaluations to monitor the status of their retinitis and to detect any other retinal pathology.

Transplant Recipients

There have been three controlled clinical trials of CYTOVENE-IV solution for the prevention of CMV disease in transplant recipients. Laboratory data and adverse events reported during these trials are summarized below.

Laboratory Data

The following table shows the frequency of granulocytopenia (neutropenia) and thrombocytopenia observed:

Table 6 Controlled Trials – Transplant Recipients

  CYTOVENE-IV
Heart Allograft* Bone Marrow Allograft
CYTOVENE-IV
(n=76)
Placebo
(n=73)
CYTOVENE-IV
(n=57)
Control
(n=55)
Neutropenia        
Minimum ANC
  <500/μL
4% 3% 12% 6%
Minimum ANC
  500-1000/μL
3% 8% 29% 17%
TOTAL ANC
  ≤1000/μL
7% 11% 41% 23%
Thrombocytopenia        
Platelet count
  <25,000/μL
3% 1% 32% 28%
Platelet count
  25,000-50,000/μL
5% 3% 25% 37%
TOTAL Platelet
  ≤50,000/μL
8% 4% 57% 65%
*Study ICM 14 96. Mean duration of treatment = 28 days
Study ICM 1570 and ICM 1689. Mean duration of treatment = 4 5 days (See Clinical Trials.)

The following table shows the frequency of elevated serum creatinine values in these controlled clinical trials:

Table 7 Controlled Trials - Trans plant Recipients

  CYTOVENE-IV
Heart Allograft
ICM 1496
Bone Marrow Allograft
ICM 1570
Bone Marrow Allograft
ICM 1689
Maximum Serum
Creatinine Levels
CYTOVENE-IV
(n=76)
Placebo
(n=73)
CYTOVENE-IV
(n=20)
Control
(n=20)
CYTOVENE-IV
(n=37)
Placebo
(n=35)
Serum Creatinine≥2.5 mg/dL 18% 4% 20% 0% 0% 0%
Serum Creatinine≥1.5 - <2.5 mg/dL 58% 69% 50% 35% 43% 44%

In these three trials, patients receiving CYTOVENE-IV solution had elevated serum creatinine levels when compared to those receiving placebo. Most patients in these studies also received cyclosporine. The mechanism of impairment of renal function is not known. However, careful monitoring of renal function during therapy with CYTOVENE-IV solution is essential, especially for those patients receiving concomitant agents that may cause nephrotoxicity.

General

Other adverse events that were thought to be "probably" or "possibly" related to CYTOVENE-IV solution or ganciclovir capsules in controlled clinical studies in either subjects with AIDS or transplant recipients are listed below. These events all occurred in at least 3 subjects.

Body as a Whole: abdomen enlarged, asthenia, chest pain, edema, headache, injection site inflammation, malaise, pain

Digestive System: abnormal liver function test, aphthous stomatitis, constipation, dyspepsia, eructation

Hemic and Lymphatic System: pancytopenia

Respiratory System: cough increased, dyspnea

Nervous System: abnormal dreams, anxiety, confusion, depression, dizziness, dry mouth, insomnia, seizures, somnolence, thinking abnormal, tremor

Skin and Appendages: alopecia, dry skin

Special Senses: abnormal vision, taste perversion, tinnitus, vitreous disorder

Metabolic and Nutritional Disorders: creatinine increased, SGOT increased, SGPT increased, weight loss

Cardiovascular System: hypertension, phlebitis, vasodilatation

Urogenital System: creatinine clearance decreased, kidney failure, kidney function abnormal, urinary frequency

Musculoskeletal System: arthralgia, leg cramps, myalgia, myasthenia

The following adverse events reported in patients receiving ganciclovir may be potentially fatal: gastrointestinal perforation, multiple organ failure, pancreatitis and sepsis.

Adverse Events Reported During Postmarketing Experience With CYTOVENE-IV And Ganciclovir Capsules

The following events have been identified during postapproval use of the drug. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either the seriousness, frequency of reporting, the apparent causal connection or a combination of these factors:

acidosis, allergic reaction, anaphylactic reaction, arthritis, bronchospasm, cardiac arrest, cardiac conduction abnormality, cataracts, cholelithiasis, cholestasis, congenital anomaly, dry eyes, dysesthesia, dysphasia, elevated triglyceride levels, encephalopathy, exfoliative dermatitis, extrapyramidal reaction, facial palsy, hallucinations, hemolytic anemia, hemolytic uremic syndrome, hepatic failure, hepatitis, hypercalcemia, hyponatremia, inappropriate serum ADH, infertility, intestinal ulceration, intracranial hypertension, irritability, loss of memory, loss of sense of smell, myelopathy, oculomotor nerve paralysis, peripheral ischemia, pulmonary fibrosis, renal tubular disorder, rhabdomyolysis, Stevens- Johnson syndrome, stroke, testicular hypotrophy, Torsades de Pointes, vasculitis, ventricular tachycardia

Read the entire FDA prescribing information for Cytovene (Ganciclovir)

Related Resources for Cytovene

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© Cytovene Patient Information is supplied by Cerner Multum, Inc. and Cytovene Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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