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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions (5.1) ] Renal Impairment [see Warnings and Precautions (5.2) ] Impairment of Fertility [see Warnings and Precautions (5.3) ] Fetal Toxicity [see Warnings and Precautions (5.4) ] Mutagenesis and Carcinogenesis [see Warnings and Precautions (5.5) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 the 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 ganciclovir are summarized below, according to the participating study patient population. Adverse Reactions in Patients with CMV Retinitis Three controlled, randomized, phase 3 trials comparing intravenous ganciclovir and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, intravenous ganciclovir 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 (14.1) ]. Table 2. Pooled Selected Adverse Reactions Reported in ≥5% of Subjects Comparing Intravenous Ganciclovir to Ganciclovir Capsules for Maintenance Treatment of CMV Retinitis Maintenance Treatment Studies Adverse Reaction Intravenous Ganciclovir (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 intravenous ganciclovir and in 8% of patients treated with ganciclovir capsules. Table 3. Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis CMV Retinitis Treatment Pooled data from Treatment Studies ICM 1653, ICM 1774, and AVI 034 Laboratory Abnormalities Intravenous Ganciclovir Mean time on therapy = 103 days, including allowed re-introduction treatment periods 5 mg/kg/day (N=175) % Ganciclovir Capsules Mean time on therapy = 91 days, including allowed re-introduction treatment periods 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/mL: ≥2.5 2% 1% ≥1.5-<2.5 14% 12% Adverse Reactions in Transplant Recipients There have been three controlled clinical trials of intravenous ganciclovir for the prevention of CMV disease in transplant recipients. Selected laboratory abnormalities are summarized in Tables 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 (14.2) ]. Table 4. Laboratory Abnormalities in Controlled Trials - Transplant Recipients who Received Intravenous Ganciclovir, Placebo or Control Laboratory Abnormalities Heart Allograft 1. Study ICM 1496. Mean duration of treatment = 28 days Bone Marrow Allograft Study ICM 1570 and ICM 1689. Mean duration of treatment = 45 days Intravenous Ganciclovir (n=76) Placebo (n=73) Intravenous Ganciclovir (n=57) Control (n=55) Neutropenia Absolute Neutrophil 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% Table 5. Serum Creatinine Levels in Controlled Trials - Transplant Recipients who Received Intravenous Ganciclovir or Placebo Serum Creatinine Levels (mg/dL) Heart Allograft ICM 1496 Bone Marrow Allograft ICM 1570 Bone Marrow Allograft ICM 1689 Intravenous Ganciclovir (n=76) Placebo (n=73) Intravenous Ganciclovir (n=20) Control (n=20) Intravenous Ganciclovir (n=37) Placebo (n=35) ≥2.5 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 intravenous ganciclovir or ganciclovir capsules in controlled clinical studies in either subjects with AIDS or transplant recipients are listed below [see Clinical Studies (14) ]. All these events occurred in at least 3 subjects. Blood and lymphatic disorders: pancytopenia, bone marrow failure Cardiac disorders: arrhythmias 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 infections, 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, hypoaesthesia, seizures, 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: increased cough, dyspnea Skin and subcutaneous tissues disorders: dermatitis, alopecia, dry skin, urticaria, rash Vascular disorders: hypotension, hypertension, phlebitis, vasodilation 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of intravenous ganciclovir 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