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3. Severe kidney problems.

Severe kidney problems, including kidney failure, may happen when you receive BONIVA. Your doctor should do blood tests to check your kidneys before you receive each dose of BONIVA.

4. Severe jaw bone problems (osteonecrosis).

Severe jaw bone problems may happen when you receive BONIVA. Your doctor may examine your mouth before you start BONIVA. Your doctor may tell you to see your dentist before you start BONIVA. It is important for you to practice good mouth care during treatment with BONIVA.

5. Bone, joint, or muscle pain. Some people who receive BONIVA develop severe bone, joint, or muscle pain.

6. Unusual thigh bone fractures.

Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

What is BONIVA?

BONIVA is a prescription medicine used to treat osteoporosis in women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long BONIVA works for the treatment of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.

It is not known if BONIVA is safe and effective in children.

Who should not receive BONIVA? Do not receive BONIVA if you:

  • Have low levels of calcium in your blood

  • Are allergic to ibandronate sodium or any of the ingredients in BONIVA. See the end of

this leaflet for a complete list of ingredients in BONIVA. What should I tell my healthcare provider before receiving BONIVA? Before you receive BONIVA, tell your doctor if you:

  • Have low blood calcium

  • Plan to have dental surgery or teeth removed

  • Have kidney problems or other problems that may affect your kidneys

  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)

  • Are pregnant or plan to become pregnant. It is not known if BONIVA can harm your unborn baby.

  • Are breast-feeding or plan to breast-feed. It is not known if BONIVA passes into your milk and may harm your baby.

Tell your doctor and dentist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Reference ID: 3295864

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