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Consumer Information Sheet
Ibandronate Sodium (marketed as Boniva)

Boniva®
Brand Name: Boniva®
Active Ingredient:   ibandronate sodium
Strength(s): 2.5mg, 150mg
Dosage Form(s):   Tablet
Company Name:    Roche Laboratories, Inc.
Availability:         Prescription only, for professional use only
*Date Approved by FDA:   May 16, 2003
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Boniva used for?

Boniva is used to treat or prevent osteoporosis in women after menopause. Boniva may increase bone mass by slowing loss of bone in most women who take it, even though they won’t be able to see or feel a difference. Boniva may help lower the chances of breaking bones (fractures). For Boniva to treat or prevent osteoporosis, you have to take it as prescribed. Boniva will not work if you stop taking it.

Who should not take Boniva?

You should not take Boniva if you: 

  • have low blood calcium (hypocalcemia). 
  • cannot sit or stand up for at least 1 hour (60 minutes) after taking Boniva. 
  • have kidneys that work very poorly. 
  • are allergic to ibandronate sodium or any of the other ingredients of Boniva.

Special Warning(s) with Boniva:

Boniva may cause serious problems in the stomach and the esophagus (the tube that connects your mouth and stomach) such as trouble swallowing, heartburn, and ulcers.

What should I tell my health care provider?

Tell your health care provider if you: 

  • are pregnant or planning to become pregnant. 
  • are breast-feeding. 
  • have swallowing problems or other problems with your esophagus (the tube that connects your mouth and stomach). 
  •  have kidney problems. 

Tell your health care provider about all the medicines you take including prescription and non-prescription medicines, vitamins and supplements. Some medicines, especially certain vitamins, supplements, and antacids can stop Boniva from getting to your bones. This can happen if you take other medicines too close to the time that you take Boniva.

What are some possible side effects of Boniva? (This list is NOT a complete list of side effects reported with Boniva. Your health care provider can discuss with you a more complete list of side effects.)

Stop taking Boniva and call your health care provider right away if you have: 

  • pain or trouble with swallowing
  • chest pain
  • very bad heartburn or heartburn that does not get better 

Boniva may cause: 

  • pain or trouble swallowing (dysphagia) 
  • heartburn (esophagitis) 
  • ulcers in your stomach or esophagus (the tube that connects your mouth and stomach) 

Common side effects with Boniva are: 

  • diarrhea 
  • pain in extremities (arms or legs) 
  • upset stomach (dyspepsia)

For more detailed information about Boniva, ask your health care provider or pharmacist.

Link to Boniva's Approved Labeling and Patient Information 

 

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Date created:  June 24, 2003, updated:  July 25, 2005

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