Atovaquone

MEPRON oral suspension is a quinone antimicrobial drug indicated for: • Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). • Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Limitations of Use: • Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with MEPRON has not been studied. • The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.

Atovaquone is a quinone antimicrobial drug.

• Prevention of PCP: 1,500 mg (10 mL) once daily with food. • Treatment of PCP: 750 mg (5 mL) twice daily with food for 21 days. • Supplied in foil pouches and bottles: o Foil Pouch: For a 5-mL dose, take entire contents by mouth either by dispensing into a spoon or cup or directly into the mouth. For a 10-mL dose, take entire contents of 2 pouches. o Bottle: Shake bottle gently before use.

MEPRON oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions to atovaquone or any of the components of MEPRON. Known serious allergic/hypersensitivity reaction to atovaquone or any of the components of MEPRON.

• Failure to administer MEPRON oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Patients with gastrointestinal disorders may have limited absorption resulting in suboptimal atovaquone concentrations. • Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. • Severe Cutaneous Adverse Reactions (SCARs): Cases of SCARs such as Stevens-Johnson Syndrome (SJS) have been reported. SCARs can be life-threatening or fatal. If symptoms or signs of SCARs develop, discontinue MEPRON immediately and institute appropriate therapy.

The following adverse reactions are discussed in another section of the labeling: • Hepatotoxicity. • Severe Cutaneous Adverse Reactions. • PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. • PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever.

• Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations, concomitant use with MEPRON oral suspension is not recommended. • Concomitant administration of tetracycline reduces atovaquone concentrations, use caution when coadministering. Monitor patients for potential loss of efficacy of MEPRON if coadministration of tetracycline is necessary. • Concomitant administration with metoclopramide reduces atovaquone concentrations, administer concomitantly only if other antiemetics are not available. • Concomitant administration of indinavir reduces indinavir trough concentrations, use caution when coadministering. Monitor patients for potential loss of efficacy of indinavir if coadministration is necessary.

Store at 15°C to 25°C (59°F to 77°F). Do not freeze. Do not freeze.