Actonel with Calcium and Raloxifene Hydrochloride

• Generic Name: calcium carbonate / risedronate
• Dosage Forms: tablets
• Other Brand Names: Actonel with Calcium, Actonel and Calcium

Actonel with Calcium (risedronate and calcium) is packaged as two separate medicines: 4 Actonel tablets and 24 calcium tablets. Risedronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractise.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Actonel is used to treat or prevent postmenopausal and steroid-induced osteoporosis. Actonel is also used to treat Paget's disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Actonel with Calcium may also be used for purposes not listed in this medication guide.

• Generic Name: raloxifene
• Dosage Forms: n.a.
• Other Brand Names: Evista

Prevention of osteoporosis in postmenopausal women. Risk factors for postmenopausal osteoporosis and related fractures include early menopause, advanced age, low bone mineral density (BMD), low body mass index (BMI), previous fracture or family history of fracture/osteoporosis, excessive alcohol intake, smoking, inadequate physical activity, low calcium and vitamin D intake, certain drugs (e.g., glucocorticoids), and medical conditions or diseases (e.g., rheumatoid arthritis, diabetes mellitus, Cushing syndrome, hyperparathyroidism).

Treatment of osteoporosis in postmenopausal women.

In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients.

Use of a drug with proven antifracture efficacy is recommended; experts generally recommend raloxifene as a second- or third-line agent after other therapies (e.g., bisphosphonates) have been attempted.

Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors.

Use supplemental calcium and/or vitamin D concomitantly if daily dietary intake is considered inadequate.

Has been used for prevention and treatment of glucocorticoid-induced osteoporosis.

American College of Rheumatology (ACR) recommends optimizing calcium and vitamin D intake and lifestyle modifications (e.g., diet, smoking cessation, weight-bearing or resistance-training exercise) in all patients receiving long-term glucocorticoid therapy; in addition, pharmacologic therapy with an oral bisphosphonate is recommended in patients at moderate-to-high risk of fracture. Oral bisphosphonates are preferred because of their demonstrated antifracture benefits, safety, and cost; experts state raloxifene may be used in postmenopausal women if no other therapy is available.

Reduction in the incidence of invasive breast cancer in postmenopausal women with osteoporosis.

Reduction in the incidence of invasive breast cancer in postmenopausal women at high risk for developing the disease. Long-term follow-up (approximately 7 years) demonstrated reduced efficacy compared with tamoxifen in reducing the risk of invasive breast cancer (STAR trial). Effect on breast cancer incidence in women with BRCA1 or BRCA2 genetic mutations not established.

Not studied in women with a history of exposure to thoracic radiation, which is considered a possible risk factor for breast cancer.

Not indicated for the treatment of breast cancer or to reduce the risk of recurrence of breast cancer. Not indicated for reduction in the risk of noninvasive breast cancer.