BONIVA (Ibandronate)

BONIVA

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Important Safety Information

BONIVA (ibandronate) is a prescription infusion medication used to treat osteoporosis in postmenopausal women. It does so by slowly increasing bone density and slowing down bone loss.

Talk with your doctor about your medical history — patients with low levels of calcium in the blood, stomach ulcers, vitamin D deficiency, severe kidney disease, or problems with the mouth, teeth, and/or gums should not take BONIVA. Also mention all medications you’re currently taking, regardless of whether they’re prescription, over-the-counter, herbal supplements, or vitamins.

BONIVA may increase the risk of thigh bone fractures. Your medical provider may recommend modifying your diet — if necessary — to include foods high in calcium and vitamin D. You may also need to reduce alcohol intake.

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

In rare cases, BONIVA may cause bone loss along the jaw. Symptoms include red or swollen gums, loose teeth, and jaw pain or numbness. This is more likely to occur if you have a blood clotting disorder, anemia, pre-existing dental problems, or are a cancer patient who has received chemotherapy or radiation. If any of these scenarios apply to you, talk with your doctor to discuss your options.

It is unknown whether BONIVA could affect an unborn child or whether the medication could be passed to a baby through breast milk. Let your healthcare provider know if you are pregnant, planning on becoming pregnant, or are breastfeeding or planning on doing so.

Side Effects of BONIVA

As with any prescription medication, BONIVA carries a risk of side effects. The most common ones include:

  • Flu-like symptoms
  • Eye redness
  • Headache
  • Joint pain
  • Back pain
  • Muscle pain
  • Heartburn
  • Indigestion
  • Diarrhea
  • Frequent urination

In rare cases, side effects may be a sign of life-threatening complications, including severe allergic reactions. Seek medical attention immediately if you experience any of the following:

  • Coughing up blood
  • Chest pain
  • Difficulty swallowing
  • Burning sensation under the ribs or back
  • Hip pain
  • Jaw pain, numbness, or swelling
  • Muscle spasms
  • Numbness or tingling in fingers, toes, and/or around your mouth
  • Worsening heartburn
  • Skin rash

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

BONIVA is used to treat and prevent osteoporosis in postmenopausal women. It is administered intravenously approximately every three months. Doing so may help reduce bone loss for up to five years. Whether to continue with infusion therapy after five years depends on the patient’s medical history and specific needs.

Please refer to the full prescribing information.