BONIVA
[bon-EE-va] (ibandronate sodium) Tablets.

Read this patient information carefully before you start taking BONIVA. Read this patient information each time you get a refill for BONIVA. There may be new information. This information is not everything you need to know about BONIVA. It does not take the place of talking with your health care provider about your condition or your treatment. Talk about BONIVA with your health care provider before you start taking it, and at your regular check-ups.

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

BONIVA may cause serious problems in the stomach and the esophagus (the tube that connects your mouth and stomach) such as trouble swallowing, heartburn, and ulcers (see “What are the possible side effects of BONIVA?”).

You must take BONIVA exactly as prescribed for BONIVA to work for you and to lower the chance of serious side effects (see “How should I take BONIVA?”).

What is BONIVA?

BONIVA is a prescription medicine used to treat or prevent osteoporosis in women after menopause (see the end of this leaflet for “What is osteoporosis?”).

BONIVA may reverse bone loss by stopping more loss of bone and increasing bone mass 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 or prevent osteoporosis, you have to take it as prescribed. BONIVA will not work if you stop taking it.

Who should not take BONIVA?

Do not take BONIVA if you:

• have low blood calcium (hypocalcemia)
• cannot sit or stand up for at least 1 hour (60 minutes)
• have kidneys that work very poorly
• are allergic to ibandronate sodium or any of the other ingredients of BONIVA (see the end of this leaflet for a list of all the ingredients in BONIVA)

Tell your health care provider before using BONIVA:

• if you are pregnant or planning to become pregnant. It is not known if BONIVA can harm your unborn baby.
• if you are breast-feeding. It is not known if BONIVA passes into your milk and if it can harm your baby.
• have swallowing problems or other problems with your esophagus (the tube that connects your mouth and stomach)
• if you have kidney problems
• if you are planning a dental procedure such as tooth extraction

Tell your health care provider (including your dentist) about all the medicines you take including prescription and non-prescription medicines, vitamins and supplements. Some medicines, especially certain vitamins, supplements, and antacids can stop BONIVA from getting to your bones. This can happen if you take other medicines too close to the time that you take BONIVA (see “How should I take BONIVA?”).

How should I take BONIVA?

• Take BONIVA exactly as instructed by your health care provider.
• Take BONIVA first thing in the morning at least 1 hour (60 minutes) before you eat, drink anything other than plain water, or take any other oral medicine.
• Take BONIVA with 6 to 8 ounces (about 1 full cup) of plain water. Do not take it with any other drink besides plain water. Do not take it with other drinks, such as mineral water, sparkling water, coffee, tea, dairy drinks (such as milk), or juice.
• Swallow BONIVA whole. Do not chew or suck the tablet or keep it in your mouth to melt or dissolve.
• After taking BONIVA you must wait at least 1 hour (60 minutes) before:
  • Lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk.
  • Eating or drinking anything except for plain water.
  • Taking other oral medicines including vitamins, calcium, or antacids. Take your vitamins, calcium, and antacids at a different time of the day from the time when you take BONIVA.
• If you take too much BONIVA, drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit. Do not lie down.
• Keep taking BONIVA for as long as your health care provider tells you. BONIVA will not work if you stop taking it.
• Your health care provider may tell you to exercise and take calcium and vitamin supplements to help your osteoporosis.
• Your health care provider may do a test to measure the thickness (density) of your bones or do other tests to check your progress.

What is my BONIVA schedule?

Schedule for taking BONIVA 150 mg once monthly:

• Take one BONIVA 150-mg tablet once a month.
• Choose one date of the month (your BONIVA day) that you will remember and that best fits your schedule to take your BONIVA 150-mg tablet.
• Take one BONIVA 150-mg tablet in the morning of your chosen day (see “How should I take BONIVA?”).

What to do if I miss a monthly dose:

• If your next scheduled BONIVA day is more than 7 days away, take one BONIVA 150-mg tablet in the morning following the day that you remember (see “How should I take BONIVA?”). Then return to taking one BONIVA 150-mg tablet every month in the morning of your chosen day, according to your original schedule.
• Do not take two 150-mg tablets within the same week. If your next scheduled BONIVA day is only 1 to 7 days away, wait until your next scheduled BONIVA day to take your tablet. Then return to taking one BONIVA 150-mg tablet every month in the morning of your chosen day, according to your original schedule.
• If you are not sure what to do if you miss a dose, contact your health care provider who will be able to advise you.

Schedule for taking BONIVA 2.5 mg once daily:

• Take one BONIVA 2.5-mg tablet once a day first thing in the morning at least 1 hour (60 minutes) before you eat, drink anything other than plain water, or take any other oral medicine (see “How should I take BONIVA?”).

What to do if I miss a daily dose:

• If you forget to take your BONIVA 2.5-mg tablet in the morning, do not take it later in the day. Just return to your normal schedule and take 1 tablet the next morning. Do not take two tablets on the same day.
• If you are not sure what to do if you miss a dose, contact your health care provider who will be able to advise you.

What should I avoid while taking BONIVA?

• Do not take other medicines, or eat or drink anything but plain water before you take BONIVA and for at least 1 hour (60 minutes) after you take it.
• Do not lie down for at least 1 hour (60 minutes) after you take BONIVA.

What are the possible side effects of BONIVA?

Stop taking BONIVA and call your health care provider right away if you have:

• pain or trouble with swallowing
• chest pain
• very bad heartburn or heartburn that does not get better

BONIVA MAY CAUSE:

• pain or trouble swallowing (dysphagia)
• heartburn (esophagitis)
• ulcers in your stomach or esophagus (the tube that connects your mouth and stomach)

Common side effects with BONIVA are:

• diarrhea
• pain in extremities (arms or legs)
• dyspepsia (upset stomach)

Less common side effects with BONIVA are short-lasting, mild flu-like symptoms (usually improve after the first dose). These are not all the possible side effects of BONIVA. For more information ask your health care provider or pharmacist.

Rarely, patients have reported severe bone, joint, and/or muscle pain starting within one day to several months after beginning to take, by mouth, bisphosphonate drugs to treat osteoporosis (thin bones). This group of drugs includes BONIVA. Most patients experienced relief after stopping the drug. Contact your health care provider if you 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 you experience jaw problems, please contact your health care provider and dentist.

What is osteoporosis?

Osteoporosis is a disease that causes bones to become thinner. Thin bones can break easily. Most people think of their bones as being solid like a rock. Actually, bone is living tissue, just like other parts of the body, such as your heart, brain, or skin. Bone just happens to be a harder type of tissue. Bone is always changing. Your body keeps your bones strong and healthy by replacing old bone with new bone.

Osteoporosis causes the body to remove more bone than it replaces. This means that bones get weaker. Weak bones are more likely to break. Osteoporosis is a bone disease that is quite common in women after menopause. At first, osteoporosis has no symptoms, but people with osteoporosis may develop loss of height and are more likely to break (fracture) their bones, especially the back (spine), wrist, and hip bones.

Osteoporosis can be prevented, and with proper therapy it can be treated.

Who is at risk for osteoporosis?

Talk to your health care provider about your chances for getting osteoporosis.

Many things put people at risk for osteoporosis. The following people have a higher chance of getting osteoporosis:

Women who:

• are going through or who are past menopause (“the change”)
• are white (Caucasian) or Asian

People who:

• are thin
• have a family member with osteoporosis
• do not get enough calcium or vitamin D
• do not exercise
• smoke
• drink alcohol often
• take bone thinning medicines (like prednisone) for a long time

General information about BONIVA

Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do not use BONIVA for a condition for which it was not prescribed. Do not give BONIVA to other people, even if they have the same symptoms you have. It may harm them.

Store BONIVA at 77°F (25°C) or at room temperature between 59°F and 86°F (15°C and 30°C).

Keep BONIVA and all medicines out of the reach of children.

This summarizes the most important information about BONIVA. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about BONIVA that is written for health professionals.

For more information about BONIVA, call 1-888-MY-BONIVA or visit www.myboniva.com.

What are the ingredients of BONIVA?

BONIVA (active ingredient): ibandronate sodium

BONIVA (inactive ingredients): lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. The tablet film coating contains hypromellose, titanium dioxide, talc, polyethylene glycol 6000 and purified water.

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