2 The technology
Marketing authorisation
2.1 Adjunct to a reduced-calorie diet and increased physical activity, Naltrexone–bupropion (Mysimba) is indicated for the management of weight in adult patients (aged 18 and over) with an initial BMI of
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30 kg/m2 or more (obese) or
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from 27 kg/m2 to 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (such as type 2 diabetes, dyslipidaemia, or controlled hypertension).
Treatment should be stopped after 16 weeks if the patient has not lost at least 5% of their initial body weight.
Recommended dose and schedule
2.2 Administered orally in a prolonged-release tablet. Dose is escalated over a 4‑week period to a total dose of 32 mg naltrexone and 360 mg bupropion: week 1, 1 tablet in the morning; week 2, 1 tablet morning and evening; week 3, 2 tablets in the morning and 1 in the evening; from week 4, 2 tablets morning and evening.