Treatment for PCP-Positive Patients Enrolled in the Pentamidine Comparative Study
Primary Treatment Salvage Treatment
Outcome of Therapy
MEPRON
(n = 56)
Pentamidine
(n = 53) P Value
MEPRON
(n = 14)
Pentamidine
(n = 11) P Value
Therapy success 32 (57%) 21 (40%) 0.09 13 (93%) 7 (64%) 0.14
Therapy failure
-Lack of response 16 (29%) 9 (17%) 0.18 0 0 —
-Adverse experience 2 (3.6%) 19 (36%) <0.01 0 3 (27%) 0.07
-Uneva luable 6 (11%) 4 (8%) 0.75 1 (7%) 1 (9%) 1.00
Required alternate PCP therapy during study 19 (34%) 29 (55%) 0.04 0 4 (36%) 0.03
CONTRAINDICATIONS
MEPRON Suspension is contraindicated for patients who develop or have a history of potentially life-threatening allergic reactions to any of the components of the formulation.
WARNINGS
Clinical experience with MEPRON for the treatment of PCP has been limited to patients with mild-to-moderate PCP [(A-a)DO2≤45 mm Hg]. Treatment of more severe episodes of PCP has not been systematically studied with this agent. Also, the efficacy of MEPRON in patients who are failing therapy with TMP-SMX has not been systematically studied.
PRECAUTIONS
General
Absorption of orally administered MEPRON is limited but can be significantly increased when the drug is taken with food. Plasma atovaquone concentrations have been shown to correlate with the likelihood of successful treatment and survival. Therefore, parenteral therapy with other agents should be considered for patients who have difficulty taking MEPRON with food (see CLINICAL PHARMACOLOGY). Gastrointestinal disorders may limit absorption of orally administered drugs. Patients with these disorders also may not achieve plasma concentrations of atovaquone associated with response to therapy in controlled trials.
Based upon the spectrum of in vitro antimicrobial activity, atovaquone is not effective therapy for concurrent pulmonary conditions such as bacterial, viral, or fungal pneumonia or mycobacterial diseases. Clinical deterioration in patients may be due to infections with other pathogens, as well as progressive PCP. All patients with acute PCP should be carefully eva luated for other possible causes of pulmonary disease and treated with additional agents as appropriate.
Rare cases of hepatitis, elevated liver function tests and one case of fatal liver failure have been reported in patients treated with atovaquone. A causal relationship between atovaquone use and these events could not be established because of numerous confounding medical conditions and concomitant drug therapies. (See ADVERSE REACTIONS.)
If it is necessary to treat patients with severe hepatic impairment, caution is advised and administration should be closely monitored.
Information for Patients
The importance of taking the prescribed dose of MEPRON should be stressed. Patients should be instructed to take their daily doses of MEPRON with meals, as the presence of food will significantly improve the abs |
