Antiprotozoals.

Atovaquone

Suspension.

Each ml of suspension contains 150 mg atovaquone A unit dose of 5 ml contains 750 mg atovaquone

Wellvone Suspension is indicated for:

Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. carinii) (alveolar - arterial oxygen tension difference [(A-a) DO₂] < 45 mmHg (6 kPa) and oxygen tension in arterial blood (PaO₂) 60 mmHg (8 kPa) breathing room air) in patients who are intolerant of co-trimoxazole therapy.

The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.

Dosage in adults

Pneumocystis pneumonia:

The recommended oral dose is 750 mg twice a day (1 x 5 ml morning and evening) administered with food each day for 21 days.

Higher doses may be more effective in some patients

Renal or hepatic impairment

Wellvone has not been specifically studied in patients with significant hepatic or renal impairment. If it is necessary to treat such patients with Wellvone, caution is advised and administration should be closely monitored.

Clinical efficacy has not been studied.

There have been no studies of Wellvone in the elderly.

Diarrhoea, renal or hepatic impairment, patients with difficulty taking the drug with food, elderly. Exclude other causes of pulmonary disease. Pregnancy, lactation.

Diarrhoea at the start of treatment has been shown to be associated with significantly lower atovaquone plasma levels. These in turn correlated with a higher incidence of therapy failures and a lower survival rate. Therefore, alternative therapies should be considered for such patients and for patients who have difficulty taking Wellvone with food.

The concomitant administration of atovaquone and rifampicin or rifabutin is not recommended.

The efficacy of Wellvone has not been systematically evaluated i) in patients failing other PCP therapy, including co-trimoxazole, ii) for treatment of severe episodes of PCP [(A-a) DO₂ > 45 mmHg (6kPa)], iii) as a prophylactic agent for PCP, or iv) versus intravenous pentamidine for treatment of PCP.

No data are available in non-HIV immuno-compromised patients suffering with PCP.

No clinical experience of atovaquone treatment has been gained in elderly patients. Therefore use in the elderly should be closely monitored.

Patients with pulmonary disease should be carefully evaluated for causes of disease other than PCP and treated with additional agents as appropriate. Wellvone is not expected to be effective therapy for other fungal, bacterial, mycobacterial or viral diseases.

Metoclopramide, rifampicin, zidovudine, didanosine, plasma protein bound drugs.

Rash, nausea, diarrhoea, headache, vomiting, fever, insomnia. Elevated liver enzymes, hyponatraemia, neutropenia, anaemia.

GlaxoSmithKline(GSK)

(POM)

17 June 2009