Boniva contains ibandronate sodium in the form of propylene glycol solvate, a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. It is available as 150 mg film-coated tablets intended for once-monthly oral administration. The tablets include inactive ingredients such as microcrystalline cellulose and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label on the same day of each month.Take the dose right after waking up. Do not eat or drink anything before taking it. Do not take it with any other drink except water. Do not chew or crush the tablet. After taking it, do not eat breakfast, drink, or take any other drugs or vitamins for at least 30 minutes. Sit or stand up for at least 60 minutes after you take it. Do not lie down. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose and the next scheduled dose is more than 7 days away, take the missed dose on the morning after you remember. Do not take two doses on the same day.

If you miss a dose and the next scheduled dose is only 1 to 7 days away, skip it. Take the next dose on the morning of the next scheduled dose. Do not take two doses on the same day.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Pain or trouble swallowing
• Severe bone, joint, or muscle pain
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Headache
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Cancer
• Dental disease
• Difficulty swallowing
• Kidney disease
• Low levels of calcium or other minerals in the blood
• Low red blood cell level
• Receiving steroids, such as dexamethasone or prednisone
• Stomach or intestine problems
• An unusual or allergic reaction to ibandronate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Aluminum hydroxide
• Antacids
• Aspirin
• Calcium supplements
• Medications for inflammation, such as ibuprofen, naproxen, other NSAIDs
• Iron supplements
• Magnesium supplements
• Vitamins with minerals

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

Some people who take this medication have severe bone, joint, or muscle pain. This medication may also increase your risk for jaw problems or a broken thigh bone. Tell your care team right away if you have severe pain in your jaw, bones, joints, or muscles. Tell your care team if you have any pain that does not go away or that gets worse.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

You should make sure you get enough calcium and vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

You may need bloodwork while taking this medication.