dine is excreted in human milk (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Nursing Mothers). Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving RETROVIR (see Pediatric Use and INDICATIONS AND USAGE: Maternal-Fetal HIV Transmission).
Pediatric Use:
RETROVIR has been studied in HIV-infected pediatric patients over 3 months of age who had HIV-related symptoms or who were asymptomatic with abnormal laboratory values indicating significant HIV-related immunosuppression. RETROVIR has also been studied in neonates perinatally exposed to HIV (see ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, INDICATIONS AND USAGE: Description of Clinical Studies, and CLINICAL PHARMACOLOGY: Pharmacokinetics).
Geriatric Use:
Clinical studies of RETROVIR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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 patients with more advanced infection at the time of initiation of therapy.
Table 5 summarizes events reported at a statistically significantly greater incidence for patients receiving RETROVIR orally in a monotherapy study:
Table 5. Percentage (%) of Patients 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%
aReported in ≥5% of study population.
bNot statistically significant versus placebo.
In addition to the adverse events listed in Table 5, other adverse events observed in clinical studies were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, hyperbilirubinemia, insomnia, musculoskeletal pain, myalgia, and neuropathy.
Selected laboratory abnormalities observed during a clinical study of monotherapy with oral RETROVIR are shown in Table 6.
Table 6. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Patients 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/mm3) 1.8% 1.6%
Thrombocytopenia (platelets<50,000/mm3) 0% 0.5%
A |
