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FDA-Approved Medication Guide

Read the Medication Guide that comes with BONIVA (ibandronate sodium) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions about BONIVA.

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

BONIVA (ibandronate sodium) can cause serious side effects including:

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

1. Esophagus problems.

Some people who take BONIVA (ibandronate sodium) may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.

• It is important that you take BONIVA (ibandronate sodium) exactly as prescribed to help lower your chance of getting esophagus problems (see the section “How should I take BONIVA?”).
• Stop taking BONIVA (ibandronate sodium) and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

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

BONIVA (ibandronate sodium) 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 take 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 take BONIVA. Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain.

Some people who take BONIVA (ibandronate sodium) develop severe bone, joint, or muscle pain.

4. Severe jaw bone problems (osteonecrosis).

Severe jaw bone problems may happen when you take 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. 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 (ibandronate sodium) is a prescription medicine used to treat or prevent osteoporosis in women after menopause. BONIVA (ibandronate sodium) helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

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

It is not known if BONIVA (ibandronate sodium) is safe and effective in children.

Who should not take BONIVA?

Do not take BONIVA (ibandronate sodium) if you:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 60 minutes
• Have low levels of calcium in your blood
• Are allergic to BONIVA (ibandronate sodium) or any of its ingredients. A list of ingredients is at the end of this leaflet

What should I tell my doctor before taking BONIVA?

Before you start BONIVA, be sure to talk to your doctor if you:

• Have problems with swallowing
• Have stomach or digestive problems
• Have low blood calcium
• Plan to have dental surgery or teeth removed
• Have kidney problems
• 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 (ibandronate sodium) can harm your unborn baby.
• Are breast-feeding or plan to breast-feed. It is not known if BONIVA (ibandronate sodium) 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. Certain medicines may affect how BONIVA (ibandronate sodium) works.

Especially tell your doctor if you take:

• antacids
• aspirin
• Nonsteroidal Anti-Inflammatory (NSAID) medicines

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take BONIVA?

• Take BONIVA (ibandronate sodium) exactly as your doctor tells you.
• BONIVA (ibandronate sodium) works only if taken on an empty stomach.
• Take 1 BONIVA (ibandronate sodium) tablet, after you get up for the day and before taking your first food, drink, or other medicine.
• Take BONIVA (ibandronate sodium) while you are sitting or standing.
• Do not chew or suck on a tablet of BONIVA.
• Swallow BONIVA (ibandronate sodium) tablet with a full glass (6-8 oz) of plain water only.
• Do not take BONIVA (ibandronate sodium) with mineral water, coffee, tea, soda, or juice.

After swallowing BONIVA (ibandronate sodium) tablet, wait at least 60 minutes:

• Before you lie down. You may sit, stand or walk, and do normal activities like reading.
• Before you take your first food or drink except for plain water.
• Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 60 minutes after you take BONIVA (ibandronate sodium) and do not eat your first food of the day for at least 60 minutes after you take BONIVA.

If you miss a dose of BONIVA, do not take it later in the day. Call your doctor for instructions.

If you take too much BONIVA, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of BONIVA?

BONIVA (ibandronate sodium) may cause serious side effects.

• See “What is the most important information I should know about BONIVA?”

The most common side effects of BONIVA (ibandronate sodium) are:

• Back pain
• Heartburn
• Stomach area (abdominal) pain
• Pain in your arms and legs
• Diarrhea
• Headache
• Muscle pain
• Flu-like symptoms

You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue or throat.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BONIVA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store BONIVA?

• Store BONIVA (ibandronate sodium) at room temperature, 59°F to 86°F (15°C to 30°C).
• Keep BONIVA (ibandronate sodium) in a tightly closed container.

Keep BONIVA (ibandronate sodium) and all medicines out of the reach of children.

General information about the safe and effective use of BONIVA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BONIVA (ibandronate sodium) for a condition for which it was not prescribed. Do not give BONIVA (ibandronate sodium) to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about BONIVA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BONIVA (ibandronate sodium) that is written for health professionals.

For more information, go to www.myboniva.com or call 1-888-692-6648.

What are the ingredients in BONIVA?

Active ingredient: ibandronate sodium

Inactive ingredients: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. Tablet film coating contains: hypromellose, titanium dioxide, talc, polyethylene glycol 6000 and purified water.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.