ATOVAQUOPRO

What it is

AtovaquoPro is a fixed combination product containing atovaquone and proguanil hydrochloride. It is available in two strengths: 250 mg atovaquone with 100 mg proguanil hydrochloride, and 62.5 mg atovaquone with 25 mg proguanil hydrochloride. Both formulations are presented as pink, round, biconvex, film-coated tablets.

Approved indications

— Prophylaxis of Plasmodium falciparum malaria in adults and children ≥ 11 kg. — Treatment of Plasmodium falciparum malaria in adults and children aged 3 years or older.

Dosing overview

The daily dose should be taken with food or a milky drink at the same time each day. For prophylaxis, treatment should start 1 to 2 days before entering a malaria-endemic area and be continued daily until seven days after leaving the area. In the event of vomiting within 1 hour of dosing, a repeat dose should be taken.

Key safety warnings

Cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme have been reported. If signs and symptoms suggestive of SCARs appear, treatment must be discontinued immediately and alternative treatment should be given. AtovaquoPro has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria including hyperparasitaemia, pulmonary oedema or renal failure. Parasite relapse occurred commonly when P. vivax malaria was treated with atovaquone and proguanil alone. Travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either of these parasites, will require additional treatment with a drug such as primaquine that is active against hypnozoites. Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting. In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered. If AtovaquoPro is used to treat malaria in these patients, parasitaemia should be closely monitored.

Contraindications

AtovaquoPro is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or to any component of the formulation. AtovaquoPro is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min).

Regulatory history

AtovaquoPro was first registered on the ARTG on 16 August 2022, with eight registered entries covering both the 250/100 mg and 62.5/25 mg strengths in blister pack and bottle presentations.