: 6/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Prevention of Pneumocystis jiroveci Pneumonia
MEPRON® suspension is indicated for the prevention of Pneumocystis jiroveci pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1.2 Treatment of Mild-to-Moderate Pneumocystis jiroveci Pneumonia
MEPRON suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
1.3 Limitations of Use
Clinical experience with MEPRON for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO2] ≤45 mm Hg). Treatment of more severe episodes of PCP with MEPRON has not been studied. The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for the Prevention of P. jiroveci Pneumonia
The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food.
2.2 Dosage for the Treatment of Mild-to-Moderate P. jiroveci Pneumonia
The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days.
2.3 Important Administration Instructions
Administer MEPRON oral suspension with food to avoid lower plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)].
MEPRON Foil Pouch
• Open each 5-mL pouch by removing tab at perforation and tear at notch.
• For a 5-mL dose, take entire contents either by placing directly into the mouth or by dispensing into a dosing spoon (5 mL) or cup prior to administration by mouth.
• For a 10-mL dose, take the entire contents of two pouches.
MEPRON Bottle
Shake bottle gently before administering the recommended dosage.
3 DOSAGE FORMS AND STRENGTHS
MEPRON is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone in 5 mL. MEPRON is supplied in 210-mL bottles or 5-mL foil pouches.
4 CONTRAINDICATIONS
MEPRON suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of MEPRON.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Limited Oral Absorption
Absorption of orally administered MEPRON suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer MEPRON suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Consider therapy with other agents in patients who have difficulty taking MEPRON suspension with food or in patients who have gastrointestinal disorders that may limit absorption of oral medications [see Clinical Pharmacology (12.3)].
5.2 Hepatotoxicity
Cases of cholestatic hepatitis, elevated liver enzymes, and fatal liver failure have been reported in patients treated with atovaquone [see Adverse Reactions (6.2)].
If treating patients with severe hepatic impairment, closely monitor patients following administration of MEPRON.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
• Hepatotoxicity [see Warnings and Precautions (5.2)].
6.1 Clinical Tr |
