ALENAMI

What it is

ALENAMI contains phentermine as an ion-exchange resin complex, available in 15 mg, 30 mg and 40 mg modified release capsules. Phentermine is a sympathomimetic amine with significant anorectic activity. The ion-exchange resin releases phentermine at a controlled rate over a 10 to 14 hour period through continuous ionic exchange in the gastrointestinal tract.

Approved indications

— Management of obesity as a short-term adjunct in obese patients with a body mass index of 30 kg/m² or greater, as part of a medically monitored comprehensive regimen including exercise, diet and behaviour modification. — Management of obesity in overweight patients with a body mass index of 25 to 29.9 kg/m² who have conditions that increase the risk of morbidity from multiple disorders.

Dosing overview

ALENAMI is taken as one capsule daily at breakfast, swallowed whole. The recommended starting dose is 30 mg daily. Larger framed individuals may require 40 mg daily. The recommended maintenance dose, either continuous or intermittent, is 15 to 40 mg daily depending on responsiveness. Patients require medical review after a defined course of treatment, which should not exceed three months.

Key safety warnings

Serious regurgitant cardiac valvular disease has been reported in persons who took a combination of fenfluramine or dexfenfluramine with phentermine, but there have been no reported cases of valvular heart disease occurring with the use of phentermine alone. Cases of severe, sometimes fatal primary pulmonary hypertension have been reported in patients who have received anorectic agents. While very rare cases of primary pulmonary hypertension in patients who have taken phentermine alone have been reported, the possibility of an association cannot be ruled out. The initial symptom of primary pulmonary hypertension is usually dyspnoea, with other early symptoms including angina pectoris, syncope, lower extremity oedema or unexplained onset or aggravation of diminished exercise tolerance. Under these circumstances, treatment should be immediately discontinued and the patient referred to a specialist unit for investigation. Cardiovascular and cerebrovascular events have rarely been reported, mainly in association with rapid weight loss, and weight loss should be gradual and controlled in obese patients undergoing treatment with ALENAMI. Evening dosing should be avoided, as this agent may induce insomnia.

Contraindications

ALENAMI is contraindicated in pulmonary artery hypertension; existing heart valve abnormalities or heart murmurs; moderate to severe arterial hypertension; cerebrovascular disease; severe cardiac disease including arrhythmias and advanced arteriosclerosis; known hypersensitivity to sympathomimetic drugs; hyperthyroidism; agitated states or history of psychiatric illnesses including anorexia nervosa and depression; glaucoma; history of drug or alcohol abuse or dependence; and concomitant treatment with Monoamine Oxidase Inhibitors or within 14 days following their administration.

PBS listing

No information regarding PBS listing is contained in the provided source documents.

Regulatory history

ALENAMI phentermine 15 mg, 30 mg and 40 mg sustained release capsules were first listed on the ARTG on 25 February 2021.