MALARONE

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. MALARONE has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. Dosage and administration 2 DOSAGE AND ADMINISTRATION The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken. MALARONE may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets. • MALARONE should be taken with food or a milky drink. Prophylaxis ( 2.1 ) : • Start prophylaxis 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return. • Adults: One adult strength tablet per day. • Pediatric Patients: Dosage based on body weight (see Table 1 ). Treatment ( 2.2 ) : • Adults: Four adult strength tablets as a single daily dose for 3 days. • Pediatric Patients: Dosage based on body weight (see Table 2 ). Renal Impairment ( 2.3 ) : • Do not use for prophylaxis of malaria in patients with severe renal impairment. • Use with caution for treatment of malaria in patients with severe renal impairment. 2.1 Prevention of Malaria Start prophylactic treatment with MALARONE 1 or 2 days before entering a malaria‑endemic area and continue daily during the stay and for 7 days after return. Adults One MALARONE tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day. Pediatric Patients The dosage for prevention of malaria in pediatric patients is based upon body weight ( Table 1 ). Table 1. Dosage for Prevention of Malaria in Pediatric Patients Weight (kg) Atovaquone/ Proguanil HCl Total Daily Dose Dosage Regimen 11-20 62.5 mg/25 mg 1 MALARONE pediatric tablet daily 21-30 125 mg/50 mg 2 MALARONE pediatric tablets as a single daily dose 31-40 187.5 mg/75 mg 3 MALARONE pediatric tablets as a single daily dose >40 250 mg/100 mg 1 MALARONE tablet (adult strength) as a single daily dose 2.2 Treatment of Acute Malaria Adults Four MALARONE tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days. Pediatric Patients The dosage for treatment of acute malaria in pediatric patients is based upon body weight ( Table 2 ). Table 2. Dosage for Treatment of Acute Malaria in Pediatric Patients Weight (kg) Atovaquone/ Proguanil HCl Total Daily Dose Dosage Regimen 5-8 125 mg/50 mg 2 MALARONE pediatric tablets daily for 3 consecutive days 9-10 187.5 mg/75 mg 3 MALARONE pediatric tablets daily for 3 consecutive days 11-20 250 mg/100 mg 1 MALARONE tablet (adult strength) daily for 3 consecutive days 21-30 500 mg/200 mg 2 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days 31-40 750 mg/300 mg 3 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days >40 1 g/400 mg 4 MALARONE tablets (adult strength) as a single daily dose for 3 consecutive days 2.3 Renal Impairment Do not use MALARONE for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications ( 4.2 )] . Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology ( 12.3 ).] Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Atovaquone absorption may be reduced in patients with diarrhea or vomiting. If used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required. ( 5.1 ) • In mixed P. falciparum and Plasmodium vivax infection, P. vivax relapse occurred commonly when patients were treated with MALARONE alone. ( 5.2 ) • In the event of recrudescent P. falciparum infections after treatment or prophylaxis failure, patients should be treated with a different blood schizonticide. ( 5.2 ) • Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophy