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First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
Date:9/17/2007

ve ingredient found in Zometa. Patients already being treated with Zometa should not be treated with Reclast. Reclast should not be used during pregnancy because of potential harm to the fetus. Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance <35 mL/min) and infusion time should not be less than 15 minutes.

The most common side effects associated with Reclast are fever; pain in the muscles, bones or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within 3 to 4 days of onset but resolution could take up to 7 to 14 days. Patients have reported severe bone, joint and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (ONJ) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. Hypocalcemia may occur with Reclast therapy.

All patients with Paget's disease should receive 1500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration. It is recommended that patients with postmenopausal osteoporosis take calcium and vitamin D supplements, if dietary intake is not sufficient.

For more information about Reclast, visit http://www.reclast.com or call 866- RECLAST (866-732-5278).

Disclaimer

The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "can", "will", "probably", "may", "generally follows", "expected", or similar expressions, or by express or implied discussions regarding potential future regulatory approvals of Reclast/Aclasta, or for additional indications or labeling for Reclast/Aclasta, or potential future sales of Reclast
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SOURCE Novartis Pharmaceuticals Corporation
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