APO-ALENDRONATE

What it is

APO-ALENDRONATE is a tablet containing alendronate sodium trihydrate equivalent to 70 mg alendronic acid. The tablets are white, oval, biconvex tablets, engraved APO on one side and ALE 70 on the reverse. Alendronate is a bisphosphonate that localises preferentially to sites of bone resorption and inhibits osteoclastic bone resorption with no direct effect on bone formation.

Approved indications

— Treatment of osteoporosis.

Dosing overview

The recommended dosage is one APO-ALENDRONATE once-weekly tablet (70 mg) once weekly. APO-ALENDRONATE must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water only. APO-ALENDRONATE should only be taken upon arising for the day. The tablet should be swallowed with a full glass of water to facilitate delivery to the stomach and reduce the potential for oesophageal irritation. Patients should not lie down for at least 30 minutes and until after their first food of the day. Patients should not crush, chew or suck on the tablet because of a potential for stomatitis or oropharyngeal ulceration.

Key safety warnings

Severe oesophageal ulceration has been reported in patients taking APO-ALENDRONATE. Oesophageal adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with alendronate. Patients should be instructed that if they develop symptoms of oesophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking APO-ALENDRONATE and consult their physician. Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) with delayed healing, has been reported rarely with oral bisphosphonates including alendronate. Before commencing invasive dental procedures, patients and their dentists should be advised of the risk of osteonecrosis of the jaw so that any symptoms, including toothache, developing during treatment can be fully assessed for cause before treatment of the tooth commences. A small number of long-term (usually longer than three years) alendronate-treated patients developed stress fractures of the subtrochanteric and proximal femoral shaft and other bones, some occurring in the absence of apparent trauma or induced by mild external force. 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. Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, and in post-marketing experience, these symptoms have rarely been severe and/or incapacitating.

Contraindications

APO-ALENDRONATE 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.

PBS listing

Information regarding PBS listing is not contained in the provided source documents.

Regulatory history

APO-ALENDRONATE was first listed on the Australian Register of Therapeutic Goods on 28 August 2006.