The FDA approves Contrave(NB) for weight loss

In September 2014, the United States Food and Drug Administration(U.S. FDA) approved a new weight loss drug, Contrave, a novel combination product for the treatment of obesity composed of bupropion and naltrexone)hereafter called NB) developed by Orexigen.

Indications for Contrave: The treatment of obesity and weight management, including weightloss and maintenance of weight loss, used along with lifestyle modification.

Contrave is recommended for patients with an initial body mass index ≥30 kg/m2 or ≥27 kg/m2 with one or more risk factors (e.g. diabetes, dyslipidemia, sleep apnea, or hypertension).

Dosing of Contrave: The recommended daily dose of Contrave is two 8 mg naltrexone/90 mgbupropion (8/90) tablets taken twice daily for a total daily dose of 32 mg naltrexone/360 mg bupropion (32/360).

Assess Effectiveness of Contrave in 4 months: Most patients who respond to Contrave will havedone so by 4 months of treatment. If a patient has not exhibited clinically meaningful weight loss (e.g., at least 5%) after 4 months of treatment, the physician should consider discontinuation of Contrave and initiation of other weight management strategies should be considered.

Dose Escalation of Contrave: Upon initiation, Contrave dosing should be escalated starting with one tablet taken daily for the first week, followed by the addition of another tablet each day during each subsequent week, until the total daily maintenance dose of two tablets twice a day (32/360) is reached at the start of Week 4.

Patients may experience elevated blood pressure or pulse during Contrave treatment; the risk may be greater during the initial 3 months of therapy. If clinically relevant and sustained (e.g., at least two consecutive measurements) increases in blood pressure or pulse occur, Contrave should be discontinued. As patients with hypertension or a history of hypertension may be at increased risk of blood pressure elevations, care should be exercised when initiating treatment with Contrave in such patients.

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