Medical Editor: John P. Cunha, DO, FACOEP
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:
- diarrhea,
- upset stomach,
- nausea,
- vomiting,
- decreased appetite,
- dizziness,
- drowsiness,
- unsteadiness,
- shaking (tremors),
- injection site reactions (pain, redness, or irritation),
- increased sweating,
- itching,
- decreased sperm production, or
- infertility.
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.
SLIDESHOW
A Timeline of the HIV/AIDS Pandemic See Slideshow3 pharmacies near 23917 have coupons for cytovene (Brand Names:Cytovene for 10ML of 500MG/10ML)
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.
QUESTION
What is HIV? See AnswerSIDE 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 Reaction | Maintenance Treatment Studies | |
| CYTOVENE-IV (n=179) | Ganciclovir Capsules (n=326) | |
| Pyrexia | 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% |
| Decreased appetite | 14% | 15% |
| Vomiting | 13% | 13% |
| Infection | 13% | 9% |
| Hyperhidrosis | 12% | 11% |
| Chills | 10% | 7% |
| Neuropathy peripheral | 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 CYTOVENE-IV 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* | |
| CYTOVENE-IV† 5 mg/kg/day (N=175) | Ganciclovir Capsules‡ 3000 mg/day (N=320) % | |
| Neutropenia with Absolute Neutrophil Count (ANC) per μL: | ||
| <500 | 25% | 18% |
| 500 - <749 | 14% | 17% |
| 750 - <1000 | 26% | 19% |
| Anemia with Hemoglobin (g/dL): | ||
| <6.5 g/dL | 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 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 Neutrophil | CYTOVENE-IV | |||
| Heart Allograft* | Nonce Marrow Allograft† | |||
| CYTOVENE-IV (n=76) | Placebo (n=73) | CYTOVENE-IV (n=57) | Control (n=55) | |
| Count (ANC) per μL | ||||
| <500 | 4% | 3% | 12% | 6% |
| 500-1000 | 3% | 8% | 29% | 17% |
| Total ANC ≤1000/μL | 7% | 11% | 41% | 23% |
| Thrombocytopenia | ||||
| Platelet count per μL <25,000 | 3% | 1% | 32% | 28% |
| 25,000-50,000 | 5% | 3% | 25% | 37% |
| Total Platelet Count ≤50,000/μL | 8% | 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 1496 | Bone Marrow Allograft ICM 1570 | Bone 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/dL | 18% | 4% | 20% | 0% | 0% | 0% |
| ≥1.5 - <2.5 | 58% | 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.
Health Solutions From Our Sponsors