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Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Date:8/19/2007

xecutive director of the National Osteoporosis Foundation (NOF). "NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."

Reclast/Aclasta is approved in more than 60 countries, including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of Reclast to prevent fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis.

The active ingredient in Reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa(R) (zoledronic acid 4 mg) Injection for use in certain oncology indications.

Reclast is contraindicated in patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Reclast contains the same active 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
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SOURCE Novartis Pharmaceuticals Corporation

Copyright©2007 PR Newswire.

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