Cytovene

Last updated on RxList: 2/10/2021
Cytovene Side Effects Center

What Is Cytovene?

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.

What Are Side Effects of Cytovene?

Common side effects of Cytovene include:

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

  • mental/mood changes (such as confusion, hallucinations),
  • changes in the amount of urine, or
  • seizures
  • allergic reaction (difficulty breathing, closing of the throat, swelling of the lips/tongue/face, or hives),
  • paleness and fatigue (may be signs of anemia),
  • unusual bleeding or bruising,
  • fever or signs of infection, or
  • numbness or tingling in a part of your body.

Dosage for Cytovene

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.

What Drugs, Substances, or Supplements Interact with Cytovene?

Cytovene may interact with zidovudine, didanosine, probenecid, or imipenem-cilastatin. Tell your doctor all medications you use.

Cytovene During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Cytovene Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • pain or burning when you urinate;
  • a seizure; or
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Side effects may be more likely in older adults.

Common side effects may include:

  • nausea, diarrhea, stomach pain, loss of appetite;
  • fever, weakness, low blood cell counts;
  • headache;
  • cough, trouble breathing; or
  • increased sweating.

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.

Read the entire detailed patient monograph for Cytovene (Ganciclovir)

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SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Impairment of Fertility [see WARNINGS AND PRECAUTIONS]
  • Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Mutagenesis and Carcinogenesis [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience In Adult Patients

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 rates observed in practice. The most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, and blood creatinine increased.

Selected adverse reactions that occurred during clinical trials of CYTOVENE-IV are summarized below, according to the participating study patient population.

Adverse Reactions In Patients With CMV Retinitis

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 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].

Table 2: Pooled Selected Adverse Reactions Reported in ≥ 5% of Subjects Comparing CYTOVENE-IV to Ganciclovir Capsules for Maintenance Treatment of CMV Retinitis

Adverse ReactionMaintenance Treatment Studies
CYTOVENE-IV
(n=179)
Ganciclovir Capsules
(n=326)
Pyrexia48%38%
Diarrhea44%41%
Leukopenia41%29%
Anemia25%19%
Total catheter events22%6%
Catheter infection9%4%
Catheter sepsis8%1%
Other catheter related events5%1%
Sepsis15%4%
Decreased appetite14%15%
Vomiting13%13%
Infection13%9%
Hyperhidrosis12%11%
Chills10%7%
Neuropathy peripheral9%8%
Thrombocytopenia6%6%
Pruritus5%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 CYTOVENE-IV and in 8% of patients treated with ganciclovir capsules.

Table 3: Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis

Laboratory AbnormalitiesCMV Retinitis Treatment*
CYTOVENE-IV† 5 mg/kg/day
(N=175)
Ganciclovir Capsules‡ 3000 mg/day
(N=320)
%
Neutropenia with Absolute Neutrophil Count (ANC) per μL:
<50025%18%
500 - <74914%17%
750 - <100026%19%
Anemia with Hemoglobin (g/dL):
<6.5 g/dL5%2%
6.5 - <8.016%10%
8.0 - <9.526%25%
Serum Creatinine (mg/dL):
≥2.52%1%
≥1.5 - <2.514%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 CYTOVENE-IV for the prevention of CMV disease in transplant recipients. Selected laboratory abnormalities are summarized in Table 4 and Table 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].

Table 4: Laboratory Abnormalities in Controlled Trials - Transplant Recipients who Received CYTOVENE-IV, Placebo or Control

NeutropeniaAbsolute NeutrophilCYTOVENE-IV
Heart Allograft*Nonce Marrow Allograft†
CYTOVENE-IV
(n=76)
Placebo
(n=73)
CYTOVENE-IV
(n=57)
Control
(n=55)
Count (ANC) per μL
<5004%3%12%6%
500-10003%8%29%17%
Total ANC ≤1000/μL7%11%41%23%
Thrombocytopenia
Platelet count per μL <25,0003%1%32%28%
25,000-50,0005%3%25%37%
Total Platelet Count ≤50,000/μL8%4%57%65%
*Study ICM 1496. Mean duration of treatment = 28 days
†Study ICM 1570 and ICM 1689. Mean duration of treatment = 45 days

Table 5: Serum Creatinine Levels in Controlled Trials - Transplant Recipients who Received CYTOVENE-IV or Placebo

Serum Creatinine Levels (mg/dL)Heart Allograft ICM 1496Bone Marrow Allograft ICM 1570Bone Marrow Allograft ICM 1689
CYTOVENE-IV
(n=76)
Placebo
(n=73)
CYTOVENE- IV
(n=20)
Control
(n=20)
CYTOVENE- IV
(n=37)
Placebo
(n=35)
≥2.5 mg/dL18%4%20%0%0%0%
≥1.5 - <2.558%69%50%35%43%44%

Other Adverse Reactions In Clinical Trials In Patients With CMV Retinitis And In Transplant Recipients

Adverse drug reactions with CYTOVENE-IV or ganciclovir capsules in controlled clinical studies in either subjects with AIDS or transplant recipients are listed below [see Clinical Studies]. All these events occurred in at least 3 subjects.

Blood and lymphatic disorders: pancytopenia, bone marrow failure

Cardiac disorders: arrhythmia

Ear and labyrinth disorders: tinnitus, ear pain, deafness

Eye disorders: visual impairment, vitreous disorders, eye pain, conjunctivitis, macular edema

Gastrointestinal disorders: nausea, abdominal pain, dyspepsia, flatulence, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis, gastrointestinal perforation, eructation, dry mouth

General disorders and administration site conditions: fatigue, injection site inflammation, edema, pain, malaise, asthenia, chest pain, multiple organ failure

Immune system disorders: hypersensitivity

Infections and infestations: candida infections including oral candidiasis, upper respiratory infection, influenza, urinary tract infection, cellulitis

Investigations: blood alkaline phosphatase increased, hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, creatinine clearance decreased

Metabolism and nutrition disorders: weight decreased

Musculoskeletal and connective tissue disorders: back pain, myalgia, arthralgia, muscle spasms, leg cramps, myasthenia

Nervous system disorders: headache, insomnia, dizziness, paresthesia, hypoesthesia, seizure, somnolence, dysgeusia (taste disturbance), tremor

Psychiatric disorders: depression, confusional state, anxiety, agitation, psychotic disorder, thinking abnormal, abnormal dreams

Renal and urinary disorders: kidney failure, renal function abnormal, urinary frequency, hematuria

Respiratory, thoracic and mediastinal disorders: cough, dyspnea

Skin and subcutaneous tissues disorders: dermatitis, alopecia, dry skin, urticaria, rash

Vascular disorders: hypotension, hypertension, phlebitis, vasodilation

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CYTOVENE-IV or ganciclovir capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic disorders: hemolytic anemia, agranulocytosis, granulocytopenia

Cardiac disorders: cardiac arrest, conduction disorder, torsade de pointes, ventricular tachycardia

Congenital, familial and genetic disorders: congenital anomaly

Endocrine disorders: inappropriate antidiuretic hormone secretion

Eye disorders: cataracts, dry eyes

Gastrointestinal disorders: intestinal ulcer

Hepatobiliary disorders: cholelithiasis, cholestasis, hepatic failure, hepatitis

Immune system disorders: anaphylactic reaction, allergic reaction, vasculitis

Investigations: blood triglycerides increased

Metabolism and nutrition disorders: acidosis, hypercalcemia, hyponatremia

Musculoskeletal and connective tissue disorders: arthritis, rhabdomyolysis

Nervous system disorders: dysesthesia, dysphasia, extrapyramidal disorder, facial paralysis, amnesia, anosmia, myelopathy, cerebrovascular accident, third cranial nerve paralysis, aphasia, encephalopathy, intracranial hypertension

Psychiatric disorders: irritability, hallucinations

Renal and urinary disorders: renal tubular disorder, hemolytic uremic syndrome

Reproductive system and breast disorders: infertility, testicular hypotrophy

Respiratory, thoracic and mediastinal disorders: bronchospasm, pulmonary fibrosis

Skin and subcutaneous tissues disorders: exfoliative dermatitis, Stevens-Johnson syndrome

Vascular disorders: peripheral ischemia

Read the entire FDA prescribing information for Cytovene (Ganciclovir)

© 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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