LT (>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:
Study 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/m2 orally 3 times daily compared with didanosine in therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 7.
Table 7. Selected Clinical Adverse Events and Physical Findings (≥5% Frequency) in Pediatric Patients in Study 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 earsa 7% 6%
Nasal discharge or congestion 8% 11%
Other
Skin rashes 12% 14%
Lymphadenopathy 9% 11%
aIncludes pain, discharge, erythema, or swelling of an ear.
Selected laboratory abnormalities experienced by therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 8.
Table 8. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Patients in Study ACTG300 Test
(Abnormal Level) EPIVIR plus RETROVIR Didanosine
Neutropenia (ANC<400 cells/mm3) 8% 3%
Anemia (Hgb<7.0 g/dL) 4% 2%
Thrombocytopenia (platelets<50,000/mm3) 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 studies in pediatric patients receiving RETROVIR 180 mg/m2 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/mm3). 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%)
