Boniva® (ibandronate sodium) Tablets
Full Prescribing Information (221K/PDF)
Important Patient Information (67K/PDF)
May 26, 2005 Boniva 2.5 mg Customer Letter (46K/PDF)

06-30-2009 Boniva® (ibandronate sodium) 2.5mg Tablets Product On Back Order (652K/PDF)

02-27-2009 Boniva® (ibandronate sodium) 2.5mg Tablets Short-Dated Supply Situation (393K/PDF)

Boniva is a prescription medication used for osteoporosis treatment in women after menopause. Boniva helps reverse bone loss 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 osteoporosis, patients have to take it as prescribed. Boniva will not work if patients stop taking it.

Important Safety Information for Boniva Tablets

• People should not take Boniva if they have certain problems with their esophagus (the tube that connects the mouth and stomach), low blood calcium, cannot sit or stand for at least 60 minutes, have severe kidney disease, or are allergic to Boniva.
• Patients should stop taking Boniva and tell their doctor right away if they experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems.
• Patients must follow the dosing instructions for once-monthly Boniva carefully to lower the chance of these events occurring. Side effects may include diarrhea, pain in the arms or legs, or upset stomach.
• Patients should tell their doctor and dentist about all the medicines they take.
• Patients should tell their doctor and dentist if they develop jaw problems (especially following a dental procedure) or severe bone, joint, and/or muscle pain. Their doctor may also recommend a calcium and vitamin D supplement.

For additional important safety information, including the full prescribing information, please visit www.boniva.com.

 

Boniva® (ibandronate sodium) Injection
Full Prescribing Information (245K/PDF)
Important Patient Information (84K/PDF)

06-13-2008 Packaging Change: Boniva® (ibandronate sodium) Single-Use Pre-Filled Syringe (3mg/ml) (210K/PDF)

03-01-2006 New Product Announcement Boniva® (ibandronate sodium) Injection (345K/PDF)

Boniva Injection is indicated for the treatment of osteoporosis in postmenopausal women.

Important Safety Information for Boniva Injection Boniva Injection must be administered intravenously only by a health care professional. Patients with severe kidney problems should not receive Boniva Injection. Low blood calcium levels must be corrected before starting Boniva Injection therapy. Patients must also must take calcium and vitamin D supplements while receiving Boniva Injection therapy.

Patients must not begin treatment with Boniva Injection if they:

• have low blood calcium (hypocalcemia) or low blood vitamin D (hypovitaminosis D)
• have kidneys that work very poorly
• are allergic to ibandronate sodium or any of the other ingredients of Boniva Injection

Patients must tell their health care provider (including their dentist) about all the medicines they take, including prescription and non-prescription medicines, vitamins and supplements.

Common side effects with Boniva Injection are:

• bone, muscle, or joint pains
• influenza-like illness
• headache

Patients may experience flu-like symptoms consisting of fever, chills, joint, bone and/or muscle pain, and fatigue. These symptoms usually occur only after the first injection and generally will not happen again as treatment continues. Without treatment, the symptoms generally disappear within 24 to 48 hours.

Patients may experience irritation at the site of injection, such as redness or swelling, but this does not happen often. Rarely, patients have reported severe bone, joint, and/or muscle pain starting within one day to several months after beginning to take bisphosphonate drugs to treat osteoporosis (thin bones). This group of drugs includes Boniva. Most patients experienced relief after stopping the drug. Patients should contact their health care provider if they develop these symptoms after starting Boniva.

Rarely, patients taking bisphosphonates have reported serious jaw problems associated with delayed healing and infection, often following dental procedures such as tooth extraction. If patients experience jaw problems, they should contact their health care provider and dentist.

View full prescribing information for additional safety information.