Indicated for:

Postmenopausal Osteoporosis:

• The treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis related fractures.

Osteoporosis in Men:

• The treatment to increase bone mass in men with osteoporosis.

Glucocorticoid-Induced Osteoporosis:

• The treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Paget’s Disease:

• For the treatment of Paget’s disease of bone in men and women.

Optimal duration of use has not been determined. For patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use.

Actonel is contraindicated in patients with the following conditions:

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia 
• Inability to stand or sit upright for at least 30 minutes 
• Hypocalcemia

Patients being treated with Atelvia should not receive Actonel.

Actonel, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when ACTONEL is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).

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. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (for example, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (for example, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill–fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

In postmarketing experience, there have been reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates.

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area.

Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Bisphosphonates are known to interfere with the use of bone-imaging agents.

There are no adequate and well-controlled studies of ACTONEL in pregnant women.There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. Animal studies: decreased body weight, incomplete ossification of sternebrae or skull, and cleft palate.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Actonel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Management of cancers that have metastasized to the bone. GoToSource

• Prevention of bone mineral density loss in non-metastatic prostate cancer patients. GoToSource

• Otosclerosis-related sensorineural hearing loss. GoToSource

• Calcific uraemic arteriolopathy. GoToSource

• Low bone mineral density in patients with crohn’s disease. GoToSource

• Hepatic osteodystrophy in chronic viral liver disease. GoToSource

• Prevention of hip fracture in patients with neurological diseases including alzheimer’s disease, stroke and parkinson’s disease. GoToSource

• Osteogenesis imperfecta in children. GoToSource

• Increase bone density in women with anorexia nervosa and osteopenia. GoToSource

Osteonecrosis of the jaw, hypocalcemia, secondary hyperparathyroidism and psychosis. GoToSource

Muscle weakness and pain. GoToSource

Barrett’s esophagus. GoToSource

Scleritis (inflammation of the white of the eye). GoToSource 

Femoral fractures. GoToSource

Bilateral pedicle fracture. GoToSource

Acute arthritis. GoToSource

Severe GI events including perforation and bleeding. GoToSource

Esophageal cancer. GoToSource

Lawsuits filed for osteonecrosis of the jaw, femur fractures and esophageal cancer.