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adverse reactions
ADVERSE REACTIONS The adverse events reported during intravenous administration of RETROVIR IV Infusion are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term intravenous administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse events. Local reaction, pain, and slight irritation during intravenous administration occur infrequently. Adults: The frequency and severity of adverse events associated with the use of RETROVIR are greater in subjects with more advanced infection at the time of initiation of therapy. Table 5 summarizes events reported at a statistically significantly greater incidence for subjects receiving RETROVIR orally in a monotherapy trial. Table 5. Percentage (%) of Subjects with Adverse Events a in Asymptomatic HIV Infection (ACTG 019) Adverse Event RETROVIR 500 mg/day (n = 453) Placebo (n = 428) Body as a whole Asthenia 8.6% b 5.8% Headache 62.5% 52.6% Malaise 53.2% 44.9% Gastrointestinal Anorexia 20.1% 10.5% Constipation 6.4% b 3.5% Nausea 51.4% 29.9% Vomiting 17.2% 9.8% a Reported in ≥5% of trial population. b Not statistically significant versus placebo. In addition to the adverse events listed in Table 5, other adverse events observed in clinical trials were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, hyperbilirubinemia, insomnia, musculoskeletal pain, myalgia, and neuropathy. Selected laboratory abnormalities observed during a clinical trial of monotherapy with oral RETROVIR are shown in Table 6. Table 6. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Subjects with Asymptomatic HIV Infection (ACTG 019) Adverse Event RETROVIR 500 mg/day (n = 453) Placebo (n = 428) Anemia (Hgb<8 g/dL) 1.1% 0.2% Granulocytopenia (<750 cells/mm 3 ) 1.8% 1.6% Thrombocytopenia (platelets<50,000/mm 3 ) 0% 0.5% ALT (>5 x ULN) 3.1% 2.6% AST (>5 x ULN) 0.9% 1.6% Alkaline phosphatase (>5 x ULN) 0% 0% ULN = Upper limit of normal. Pediatrics: Trial ACTG300: Selected clinical adverse events and physical findings with a ≥5% frequency during therapy with EPIVIR ® (lamivudine) 4 mg/kg twice daily plus RETROVIR 160 mg/m 2 orally 3 times daily compared with didanosine in therapy-naive (≤56 days of antiretroviral therapy) pediatric subjects are listed in Table 7. Table 7. Selected Clinical Adverse Events and Physical Findings (≥5% Frequency) in Pediatric Subjects in Trial ACTG300 Adverse Event EPIVIR plus RETROVIR (n = 236) Didanosine (n = 235) Body as a Whole Fever 25% 32% Digestive Hepatomegaly 11% 11% Nausea & vomiting 8% 7% Diarrhea 8% 6% Stomatitis 6% 12% Splenomegaly 5% 8% Respiratory Cough 15% 18% Abnormal breath sounds/wheezing 7% 9% Ear, Nose, and Throat Signs or symptoms of ears a 7% 6% Nasal discharge or congestion 8% 11% Other Skin rashes 12% 14% Lymphadenopathy 9% 11% a Includes pain, discharge, erythema, or swelling of an ear. Selected laboratory abnormalities experienced by therapy-naive (≤56 days of antiretroviral therapy) pediatric subjects are listed in Table 8. Table 8. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Subjects in Trial ACTG300 Test (Abnormal Level) EPIVIR plus RETROVIR Didanosine Neutropenia (ANC<400 cells/mm 3 ) 8% 3% Anemia (Hgb<7.0 g/dL) 4% 2% Thrombocytopenia (platelets<50,000/mm 3 ) 1% 3% ALT (>10 x ULN) 1% 3% AST (>10 x ULN) 2% 4% Lipase (>2.5 x ULN) 3% 3% Total amylase (>2.5 x ULN) 3% 3% ULN = Upper limit of normal. ANC = Absolute neutrophil count. Additional adverse events reported in open-label trials in pediatric subjects receiving RETROVIR 180 mg/m 2 every 6 hours were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, macrocytosis, nervousness/irritability, and weight loss. The clinical adverse events reported among adult recipients of RETROVIR may also occur in pediatric patients. Use for the Prevention of Maternal-Fetal Transmission of HIV: In a randomized, double-blind, placebo-controlled trial in HIV-infected women and their neonates conducted to determine the utility of RETROVIR for the prevention of maternal-fetal HIV transmission, RETROVIR Syrup at 2 mg/kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. The most commonly reported adverse experiences were anemia (hemoglobin <9.0 g/dL) and neutropenia (<1,000 cells/mm 3 ). Anemia occurred in 22% of the neonates who received RETROVIR and in 12% of the neonates who received placebo. The mean difference in hemoglobin values was less than 1.0 g/dL for neonates receiving RETROVIR compared to neonates receiving placebo. No neonates with anemia required transfusion and all hemoglobin values spontaneously returned to normal within 6 weeks after completion of therapy with RETROVIR. Neutropenia was reported with similar frequency in the group that received RETROVIR (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to RETROVIR are unknown. Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during use of RETROVIR in clinical practice. 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 their seriousness, frequency of reporting, potential causal connection to RETROVIR, or a combination of these factors. Body as a Whole: Back pain, chest pain, flu-like syndrome, generalized pain. Cardiovascular: Cardiomyopathy, syncope. Endocrine: Gynecomastia. Eye: Macular edema. Gastrointestinal: Constipation, dysphagia, flatulence, oral mucosal pigmentation, mouth ulcer. General: Sensitization reactions including anaphylaxis and angioedema, vasculitis. Hemic and Lymphatic: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia. Hepatobiliary Tract and Pancreas: Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis. Musculoskeletal: Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV disease), rhabdomyolysis, tremor. Nervous: Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo. Respiratory: Cough, dyspnea, rhinitis, sinusitis. Skin: Changes in skin and nail pigmentation, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria. Special Senses: Amblyopia, hearing loss, photophobia, taste perversion. Urogenital: Urinary frequency, urinary hesitancy.