RISEDRONATE-WGR

What it is

RISEDRONATE-WGR is risedronate sodium hemipentahydrate presented as film-coated tablets. Each tablet contains 35, 75 or 150 mg risedronate sodium as the active ingredient. Risedronate is a third generation bisphosphonate. Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption.

Approved indications

— Treatment of osteoporosis. — Treatment of glucocorticoid-induced osteoporosis. — Preservation of bone mineral density in patients on long-term corticosteroid therapy.

Dosing overview

RISEDRONATE-WGR tablets are intended for oral administration and must only be taken with plain water. Risedronate must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, risedronate should be taken while the patient is in an upright position and patients should avoid lying down for 30 minutes. For osteoporosis, the recommended dose is either 5 mg daily; 35 mg once-a-week, taken on the same day each week; 75 mg taken for two consecutive days on the same dates each month; or 150 mg taken once-a-month.

Key safety warnings

Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Caution should be used in patients who have a history of oesophageal disorders which delay oesophageal transit or emptying such as stricture or achalasia, in patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet, and if risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems including known Barrett's oesophagus. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection including osteomyelitis, has been reported in patients with cancer receiving primarily intravenously-administered bisphosphonates, and has also been reported in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors such as cancer, chemotherapy, radiotherapy, corticosteroids or poor oral hygiene, and while on treatment these patients should avoid invasive dental procedures if possible. A small number of patients on long-term bisphosphonate therapy, usually longer than three years, have developed stress fractures of the proximal femoral shaft, some of which occurred in the absence of apparent trauma, and some of these patients experienced prodromal pain in the affected area weeks to months before a complete fracture occurred. During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.

Contraindications

— Known hypersensitivity to the drug or any of the ingredients in the tablets. — Hypocalcaemia. — Inability to stand or sit upright for at least 30 minutes.

PBS listing

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

Regulatory history

RISEDRONATE-WGR 35 mg tablets were first listed on the ARTG on 11 November 2010. The 150 mg and 75 mg tablet strengths were first listed on the ARTG on 8 March 2012.