Boniva Injection® (ibandronate sodium)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

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 take 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

Important Safety Information

What is the most important information I should know about BONIVA?

BONIVA Injection is given in your vein (intravenously) and only given by a healthcare provider. Do not give BONIVA Injection to yourself.

BONIVA may cause serious side effects including:

  1. Low calcium levels in your blood (hypocalcemia)
  2. Severe allergic reaction (anaphylactic reaction)
  3. Severe kidney problems
  4. Severe jaw bone problems (osteonecrosis)
  5. Bone, joint or muscle pain
  6. Unusual thigh bone fractures

1. Low calcium levels in your blood (hypocalcemia).

BONIVA may lower the calcium levels in your blood. If you have low blood calcium before you start taking BONIVA, it may get worse during treatment. Your low blood calcium must be treated before you receive BONIVA. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you receive BONIVA. Take calcium and vitamin D as your doctor tells you to.

2. Severe allergic reactions.

Some people who received BONIVA Injection had severe allergic reactions (anaphylactic reactions) that led to death. Get medical help right away if you have any of the symptoms of a serious allergic reaction such as:

  • Swelling of your face, lips, mouth or tongue
  • Trouble breathing
  • Wheezing
  • Severe itching
  • Skin rash, redness or swelling
  • Dizziness or fainting
  • Fast heartbeat or pounding in your chest
  • Sweating

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.

Who should not take BONIVA?

Do not take BONIVA if you:

  • Have low levels of calcium in your blood
  • Are allergic to ibandronate sodium or any of the ingredients in BONIVA.

What are the most common side effects of BONIVA?

  • Pain in your bones, joints or muscles
  • Back pain
  • Abdominal pain
  • Flu-like symptoms may happen within 3 days after you receive BONIVA. Symptoms include:
    • fever
    • chills
    • bone, joint, or muscle pain
    • fatigue

If you have flu-like symptoms, they should get better within 24 to 48 hours.

Some people have pain or a sore that will not heal in their mouth or jaw while they receive BONIVA. Tell your doctor or dentist if you have mouth or jaw problems.

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information for additional important safety information.