WELLVONE

What it is

WELLVONE is an atovaquone formulation registered on the Australian Register of Therapeutic Goods. Atovaquone is available in a fixed combination product with proguanil hydrochloride, containing atovaquone 250 mg and proguanil hydrochloride 100 mg per tablet, or atovaquone 62.5 mg and proguanil hydrochloride 25 mg in junior tablet formulation.

Approved indications

MALARONE (the product containing atovaquone and proguanil hydrochloride) is indicated for: — Prophylaxis of *Plasmodium falciparum* malaria in adults and children weighing 11 kg or more. — 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. For prophylaxis in adults, the dose is one MALARONE TABLET (250/100) daily. In children, dosing is based on body weight: 1 junior tablet (62.5/25) for 11–20 kg, 2 junior tablets for 21–30 kg, 3 junior tablets for 31–40 kg, and 1 adult tablet (250/100) for children over 40 kg. For treatment in adults, four tablets are taken as a single dose for three consecutive days. In children, dosing is based on body weight: 1 adult tablet (250/100) for 11–20 kg, 2 tablets for 21–30 kg, 3 tablets for 31–40 kg, and 4 tablets for children over 40 kg.

Key safety warnings

Cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and erythema multiforme have been reported in patients treated with the product. As SCARs can be life-threatening or fatal, if signs and symptoms suggestive of SCARs appear, treatment must be discontinued immediately and alternative treatment given. The product 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 the product 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. Persons taking the product for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing.

Contraindications

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

PBS listing

WELLVONE oral suspension 750 mg per 5 mL in 210 mL bottles is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$670.15.

Regulatory history

WELLVONE atovaquone 250 mg tablets were first registered on the Australian Register of Therapeutic Goods on 9 May 1995. An oral liquid suspension formulation (750 mg per 5 mL) was registered on 7 December 1998.