2). In a study of MEPRON Suspension in 27 HIV-infected, asymptomatic infants and children between 1 month and 13 years of age, the pharmacokinetics of atovaquone were age-dependent (see CLINICAL PHARMACOLOGY: Special Populations). No drug-related treatment-limiting adverse events were observed in the pharmacokinetic study.
Geriatric Use
Clinical studies of MEPRON 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
Because many patients who participated in clinical trials with MEPRON had complications of advanced HIV disease, it was often difficult to distinguish adverse events caused by MEPRON from those caused by underlying medical conditions. There were no life-threatening or fatal adverse experiences caused by MEPRON.
PCP Prevention Studies
In the dapsone comparative study of MEPRON Suspension, adverse experience data were collected only for treatment-limiting events. Among the entire population (n = 1,057), treatment-limiting events occurred at similar frequencies in patients treated with MEPRON Suspension or dapsone (Table 6). Among patients who were taking neither dapsone nor atovaquone at enrollment (n = 487), treatment-limiting events occurred in 43% of patients treated with dapsone and 20% of patients treated with MEPRON Suspension (P <0.001). In both populations, the type of treatment-limiting events differed between the 2 treatment arms. Hypersensitivity reactions (rash, fever, allergic reaction) and anemia were more common in patients treated with dapsone, while gastrointestinal events (nausea, diarrhea, and vomiting) were more common in patients treated with MEPRON Suspension.
Table 6. Treatment-Limiting Adverse Experiences in the Dapsone Comparative PCP Prevention Study
Treatment-Limiting
Adverse Experience Percentage of Patients with Treatment-Limiting Adverse Experience
All Patients Patients Not Taking Either Drug at Enrollment
MEPRON
1,500 mg/day
(n = 536)
Dapsone
100 mg/day
(n = 521)
MEPRON
1,500 mg/day
(n = 238)
Dapsone
100 mg/day
(n = 249)
Any event 24.4% 25.9% 20.2% 43.4%
Rash 6.3% 8.8% 7.6% 16.1%
Nausea 4.1% 0.6% 2.5% 0.8%
Diarrhea 3.2% 0.2% 2.1% 0.4%
Vomiting 2.2% 0.6% 1.3% 0.8%
Allergic reaction 1.1% 2.9% 0.8% 4.8%
Fever 0.6% 2.9% 0% 5.6%
Anemia 0% 1.5% 0% 2.0%
Table 7 summarizes the clinical adverse experiences reported by ≥20% of patients in any group in the aerosolized pentamidine comparative study of MEPRON Suspension (n = 549), regardless of attribution. The incidence of adverse experiences at the recommended dose was similar to that seen with aerosolized pentamidine. Rash was the only individual adverse experience that occurred significantly more commonly in patients treated with both dosages of MEPRON Suspension (39% to 46%) than in |
