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adverse reactions
ADVERSE REACTIONS Adverse events that occurred during clinical trials of ganciclovir capsules are summarized below, according to the participating study subject population. Subjects With AIDS Three controlled, randomized, phase 3 trials comparing ganciclovir-IV and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, ganciclovir-IV or ganciclovir capsules were prematurely discontinued in 9% of subjects because of adverse events. In a placebo-controlled, randomized, phase 3 trial of ganciclovir capsules for prevention of CMV disease in AIDS, treatment was prematurely discontinued because of adverse events, new or worsening intercurrent illness, or laboratory abnormalities in 19.5% of subjects treated with ganciclovir capsules and 16% of subjects receiving placebo. Laboratory data and adverse events reported during the conduct of these controlled trials are summarized below. Laboratory Data: Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis and Prevention of CMV Disease * Pooled data from Treatment Studies, ICM 1653, Study ICM 1774 and Study AVI 034. # Mean time on therapy = 91days, including allowed reinduction treatment periods ## Mean time on therapy = 103 days, including allowed reinduction treatment periods $ Data from Prevention Study, ICM 1654 || Mean time on ganciclovir = 269 days & Mean time on placebo = 240 days (See discussion of clinical trials under INDICATIONS AND USAGE .) CMV Retinitis Treatment * CMV Disease Prevention $ Treatment Ganciclovir Capsules # 3000 mg/day Ganciclovir-IV ## 5 mg/kg/day Ganciclovir Capsules || 3000 mg/day Placebo & Subjects, number 320 175 478 234 Neutropenia: < 500 ANC/µL 18% 25% 10% 6% 500 < 749 17% 14% 16% 7% 750 < 1000 19% 26% 22% 16% Anemia: Hemoglobin: < 6.5 g/dL 2% 5% 1% < 1% 6.5 < 8 10% 16% 5% 3% 8 < 9.5 25% 26% 15% 16% Maximum Serum Creatinine: ≥ 2.5 mg/dL 1% 2% 1% 2% ≥ 1.5 to < 2.5 12% 14% 19% 11% 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 ganciclovir capsules (3000 mg/day) and in one controlled clinical trial in which ganciclovir capsules (3000 mg/day) were compared to placebo for the prevention of CMV disease. Selected Adverse Events Reported in ≥ 5% of Subjects in Three Randomized Phase 3 Studies Comparing Ganciclovir Capsules to Ganciclovir-IV Solution for Maintenance Treatment of CMV Retinitis and in One Phase 3 Randomized Study Comparing Ganciclovir Capsules to Placebo for Prevention of CMV Disease *Some of these events also appear under other body systems. Maintenance Treatment Studies Prevention Study Body System Adverse Event Capsules (n = 326) IV (n = 179) Capsules (n = 478) Placebo (n = 234) Body as a Whole Fever 38% 48% 35% 33% Infection 9% 13% 8% 4% Chills 7% 10% 7% 4% Sepsis 4% 15% 3% 2% Digestive System Diarrhea 41% 44% 48% 42% Anorexia 15% 14% 19% 16% Vomiting 13% 13% 14% 11% Hemic and Lymphatic System Leukopenia 29% 41% 17% 9% Anemia 19% 25% 9% 7% Thrombocytopenia 6% 6% 3% 1% Nervous System Neuropathy 8% 9% 21% 15% Other Sweating 11% 12% 14% 12% Pruritus 6% 6% 10% 9% Catheter Related* Total Catheter Events 6% 22% – – Catheter Infection 4% 9% – – Catheter Sepsis 1% 8% – – 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 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 has been one controlled clinical trial of ganciclovir capsules 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: ## Study GAN040. Mean duration of ganciclovir treatment = 82 days (See discussion of clinical trails under INDICATIONS AND USAGE .) Ganciclovir Capsules Liver Allograft ## Ganciclovir Capsules (n = 150) Placebo (n = 154) Neutropenia Minimum ANC < 500/µL 3% 1% Minimum ANC 500 to 1000/µL 3% 2% TOTAL ANC ≤ 1000/µL 6% 3% Thrombocytopenia Platelet count < 25,000/µL 0% 3% Platelet count 25,000 to 50,000/µL 5% 3% TOTAL Platelet ≤ 50,000/µL 5% 6% The following table shows the frequency of elevated serum creatinine values in these controlled clinical trials: Controlled Trials – Transplant Recipients Ganciclovir Capsules Liver Allograft Study 040 Maximum Serum Creatinine Levels Ganciclovir Capsules (n = 150) Placebo (n = 154) Serum Creatinine ≥ 2.5 mg/dL 16% 10% Serum Creatinine ≥ 1.5 to < 2.5 mg/dL 39% 42% In 3 out of 4 trials, patients receiving either ganciclovir-IV solution or ganciclovir capsules 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 ganciclovir capsules 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 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 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