Treatment of Osteoporosis

Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by 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 [see Clinical Studies].

Paget's Disease of Bone

Reclast is indicated for 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 [see Clinical Studies].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Patients must be appropriately hydrated prior to administration of Reclast [see WARNINGS and PRECAUTIONS].

Administration of acetaminophen or ibuprofen following Reclast administration may reduce the incidence of acute-phase reaction symptoms.

The following recommended doses of Reclast are for patients with creatinine clearance > 35 mL/min [see WARNINGS and PRECAUTIONS].

Treatment of Osteoporosis

The recommended regimen is a single 5 mg infusion once a year given intravenously over no less than 15 minutes.

For osteoporosis treatment, and to reduce the risk of hypocalcemia, patients must be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient. Postmenopausal women require an average of 1200 mg calcium and 800-1000 IU vitamin D daily.

Treatment of Paget's Disease of Bone

The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.

To reduce the risk of hypocalcemia, all patients with Paget's disease should receive 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 IU vitamin D daily, particularly in the 2 weeks following Reclast administration. All patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia [see WARNINGS and PRECAUTIONS].

Re-treatment of Paget's Disease

After a single treatment with Reclast in Paget's disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Reclast may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.

Method of Administration

The Reclast infusion time must not be less than 15 minutes given over a constant infusion rate.

Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.

If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C–8°C (36°F - 46°F) [see HOW SUPPLIED/Storage and Handling].

Dosage Forms And Strengths

5 mg in a 100 mL ready to infuse solution.

Storage and Handling

Each bottle contains 5 mg/100 mL. NDC 0078-0435-61

Handling

After opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F).

If refrigerated, allow the refrigerated solution to reach room temperature before administration.

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Manufactured by: Novartis Pharma Stein, AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA revision date: 6/3/2008

Bookmark this page: