Indicated for:

Treatment of Osteoporosis in Postmenopausal Women:

• The treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures.

Prevention of Osteoporosis in Postmenopausal Women:

• The prevention of osteoporosis in postmenopausal women.

Osteoporosis in Men:

• Treatment to increase bone mass in men with osteoporosis.

Glucocorticoid-Induced Osteoporosis:

• Treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months.

Paget’s Disease of Bone:

• Treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.

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

Reclast injection must be administered as an intravenous infusion over no less than 15 minutes.

Pre-existing hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast.

In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast.

Hypocalcemia following Reclast administration is a significant risk in Paget’s disease.

While not observed in clinical trials with Reclast, there have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates.

Reclast is contraindicated in patients with:

• hypocalcemia
• creatinine clearance less than 35 mL/min
• evidence of acute renal impairment due to an increased risk of renal failure.
• Patients receiving Zometa should not receive Reclast

Osteonecrosis of the Jaw (ONJ) has been reported. All patients should have a routine oral exam by the prescriber prior to treatment.

Atypical femur fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture.

Pre-existing hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast. Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended for these patients.

Cases of iritis/uveitis/episcleritis/conjunctivitis have been reported in patients treated with bisphosphonates, including zoledronic acid.

Elderly patients and those receiving diuretic therapy are at increased risk of acute renal failure. These patients should have their fluid status assessed and be appropriately hydrated prior to administration of Reclast. Reclast should be used with caution with other nephrotoxic drugs.

Caution is advised when bisphosphonates, including zoledronic acid, are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods.

Caution should be exercised when Reclast is used in combination with loop diuretics due to an increased risk of hypocalcemia.

Caution is indicated when Reclast is used with other potentially nephrotoxic drugs such as nonsteroidal anti-inflammatory drugs.

Reclast should not be used during pregnancy Reclast may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Because many drugs are excreted in human milk, and because Reclast binds to bone long-term, Reclast should not be administered to a nursing woman.

GoToSource

• Use in patients under the age of 18. GoToSource

• Erdheim-chester disease. GoToSource

• Advanced solid cancer and bone metastases. GoToSource

• SAPHO (synovitis, acne, pustulosis, hyperostosis and osteitis) syndrome. GoToSource

• Early rheumatoid arthritis. GoToSource

• Multiple myeloma. GoToSource

• Male patients with castration-sensitive metastatic prostate cancer. GoToSource

• Advanced unresectable gastric cancer with multiple bone metastases. GoToSource

• Prevention of bone fractures in patients with high grade and/or locally advanced, non-metastatic prostate adenocarcinoma. GoToSource

• Lung cancer with bone metastases. GoToSource 

• Melorheostosis pain. GoToSource

Atrial fibrillation. GoToSource

Esophageal cancer. GoToSource

Acute kidney failure and death. GoToSource

Osteonecrosis of the jaw and osteomyelitis. GoToSource

Atypical or low trauma fractures of the femoral shaft. GoToSource

Orbital inflammation and uveitis (inflammation of middle layer of eye). GoToSource

Oral mucosal ulceration (mouth ulcers). GoToSource

Dermatomyositis (muscle disease). GoToSource

Acute-phase response including fever, pain and joint swelling, abdominal pain, vomiting, diarrhea, fatigue, nasopharyngitis and edema. GoToSource

Hypocalcaemia (low calcium levels) and secondary hyperparathyroidism (excessive parathyroid hormone in response to low blood calcium levels). GoToSource 

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin disorder). GoToSource

Lawsuits filed for osteonecrosis of the jaw, osteomyelitis, kidney failure and hip and femur fractures.