ACTONEL

What it is

Actonel is risedronate sodium, supplied as film-coated tablets containing 35 mg risedronate sodium equivalent to 32.5 mg risedronic acid. Risedronate is a third generation bisphosphonate. It 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

The recommended dose is 35 mg once a week, taken on the same day each week. Actonel must only be taken with plain water and must be taken 30 minutes before the first food or drink other than water. The patient should avoid lying down for 30 minutes after taking the tablet to facilitate delivery to the stomach.

Key safety warnings

Risedronate, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa and has been associated with oesophagitis, gastritis, oesophageal ulcerations and gastro-duodenal ulcerations. Patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new or worsened heartburn. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, has been reported in patients with cancer receiving bisphosphonates and also in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment in patients with concomitant risk factors such as cancer, chemotherapy, radiotherapy, corticosteroids or poor oral hygiene, and these patients should avoid invasive dental procedures if possible while on treatment. 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 patients experienced prodromal pain in the affected area weeks to months before a complete fracture occurred. Patients should be advised to report any thigh, hip or groin pain during bisphosphonate treatment.

Contraindications

Actonel is contraindicated in patients with known hypersensitivity to the drug or any of the ingredients, hypocalcaemia, inability to stand or sit upright for at least 30 minutes, pregnancy and lactation, and severe renal impairment with creatinine clearance less than 30 mL/min.

PBS listing

Information regarding PBS listing, strength, item count, restriction type and ex-manufacturer price is not provided in the supplied source documents.

Regulatory history

Actonel 5 mg and 30 mg tablets were first listed on the ARTG on 14 August 2000. Actonel Once-a-Month 150 mg tablets were first listed on 4 March 2009. Actonel EC Once-a-Week 35 mg enteric-coated tablets were first listed on 10 March 2011. In November 2022, the PBAC deferred consideration of an expansion to patients aged below 70 years for osteoporosis treatment, and in March 2023, the PBAC did not recommend this expansion.