ALENDROBELL

What it is

ALENDROBELL is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. ALENDROBELL 10 mg contains alendronic acid 10 mg (as sodium alendronate anhydrous). In animal studies, alendronate localises preferentially to sites of bone resorption, specifically under osteoclasts, and inhibits osteoclastic bone resorption with no direct effect on bone formation. Since bone formation and bone resorption are coupled, bone formation is also reduced, but less so than resorption, leading to progressive gains in bone mass.

Approved indications —

Osteoporosis in adults, including glucocorticoid-induced osteoporosis — Prevention of osteoporosis in postmenopausal women with low bone mass not receiving oestrogen — Prevention of glucocorticoid-induced osteoporosis in patients on long-term corticosteroid therapy

Dosing overview

The recommended dosage for treatment of osteoporosis is one 10 mg tablet once daily. For treatment and prevention of glucocorticoid-induced osteoporosis in postmenopausal women not receiving oestrogen, the recommended dosage is one 10 mg tablet once a day.

Key safety warnings

Severe oesophageal ulceration has been reported in patients taking alendronate. Alendronate, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa. Oesophageal adverse experiences, such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture or perforation, have been reported. In some cases these have been severe and required hospitalisation. The risk of severe oesophageal adverse experiences appears to be greater in patients who lie down after taking ALENDROBELL and/or who fail to swallow it with the recommended amount of water, and/or who continue to take ALENDROBELL after developing symptoms suggestive of oesophageal irritation. Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported rarely with oral bisphosphonates including alendronate. As of November 2006, the Australian Adverse Drug Reactions Advisory Committee had received 25 reports of osteonecrosis of the jaw in patients receiving alendronate. A small number of long-term (usually longer than three years) alendronate-treated patients developed stress fractures of the proximal femoral shaft. Some patients experienced prodromal pain in the affected area, often associated with imaging features of stress fracture, weeks to months before a complete fracture occurred. The number of reported cases is very low, with some 40 reported cases world-wide. Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating.

Contraindications

ALENDROBELL is contraindicated in patients with abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia, inability to stand or sit upright for at least 30 minutes, hypersensitivity to any component of the product, and hypocalcaemia.

Regulatory history

ALENDROBELL 10 mg was first listed on the ARTG on 25 July 2007.