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FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
Date:6/5/2008

lly devastating and life-threatening consequences of osteoporosis."

Reclast is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget's disease of bone, the second most common metabolic bone disorder(5).

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year(1). Zoledronic acid is also available in a different dosage under the brand name Zometa(R) (zoledronic acid) Injection 4 mg administered every three to four weeks in certain oncologic indications(6).

Patients should not take Reclast if they're on Zometa as it contains the same ingredient; if they have low blood calcium, kidney problems, or are allergic to Reclast or Zometa; or they're pregnant, plan to become pregnant or nursing.

It's important for patients to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects are flu-like symptoms, fever, muscle or joint pain and headache. Patients should tell their doctor if they have dental problems because rarely, problems with the jaw have been reported with Reclast. Patients should tell their doctor if they have low blood calcium or cannot take calcium and vitamin D, had surgery involving the neck or intestines. In patients with Paget's disease of bone, it is especially important for them to take 1500 mg of calcium and 800 IU of vitamin D daily, particularly during the first 2 weeks after getting Reclast. Patients should discuss all medicines they're taking, including prescription and non-prescription, vitamins and herbal supplements. Patients should contact their doctor if they develop severe bone, joint or muscle pain, numbness, tingling or muscle spasms.

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

Disclaimer

The foregoing release contains forward-look
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SOURCE Novartis
Copyright©2008 PR Newswire.
All rights reserved

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9. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
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