Note: Table displays data from separate studies involving Actonel 5 mg daily vs placebo.
Note: Table displays data from separate studies involving Actonel 5 mg daily vs placebo.
*p=0.03 vs control. Combined retrospective analysis of 383 postmenopausal women with low lumbar spine BMD (T-score <-2.5) and no prevalent fractures, from 3 studies up to 3 years in duration. All patients received 1000 mg/d calcium and, if baseline levels were low, some received up to 500 IU/d vitamin D. Vertebral fractures were confirmed radiographically; some were associated with symptoms.
†p=0.001 vs control. A 1-year analysis of a 3-year multinational study in 1226 postmenopausal women with at least 2 prevalent vertebral fractures at baseline. All patients received 1000 mg/d calcium and, if baseline levels were low, up to 500 IU/d vitamin D. Vertebral fractures were confirmed radiographically; some were associated with symptoms.
Actonel is indicated for the treatment of postmenopausal osteoporosis.
Actonel 5 mg and 35 mg are indicated for the prevention of postmenopausal osteoporosis.
Actonel 150 mg may be considered for use for prevention of postmenopausal osteoporosis.
Selected Safety Information for Actonel
Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least
30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).
Bisphosphonates, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur. There have also been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates.
Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actonel. Patients who develop ONJ while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan (including the consideration of discontinuation of bisphosphonate therapy) of each patient based on individual benefit/risk assessment.
Most common adverse reactions reported in >10% of patients treated with Actonel and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.
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References:
1. Heaney RP, Zizic TM, Fogelman I, et al. Risedronate reduces the risk of first vertebral fracture in osteoporotic women. Osteoporos Int. 2002;13(6):501-505.
2. Reginster J-Y, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int. 2000;11(1):83-91.
3. Actonel package insert. Cincinnati, OH: Procter & Gamble Pharmaceuticals; August 2009.
