Boniva

Boniva (Ibandronae Sodium)

Generic name: Boniva

Brand names: Ibandronae Sodium

What is Boniva?

Boniva is a prescription drug used to treat or prevent osteoporosis in females after end of menstrual cycle.
Boniva may reverse bone loss by stopping more loss of bone and increasing bone mass in most females who take it, even though they won’t be able to see or feel a difference. Boniva may help decrease the chances of breaking bones (fractures).

For Boniva to treat or prevent osteoporosis, you have to take it as prescribed by your medical assistant. Boniva will not work if you stop taking it.

What is the most important information you 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.

You must take Boniva exactly as prescribed for Boniva to work for you by your medical assistant and to lower the chance of serious side effects.

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.

How does Boniva work?

Up to about the age of 30, your body deposits more calcium into your bones than it takes from them. Estrogen also helps keep calcium in your bones throughout your reproductive life. But when estrogen decreases in the first few years after menopause, your bones can weaken and suffer rapid loss of calcium.

Boniva is designed to decrease activity of the cells that cause bone loss after menopause, with just one tablet a month. Boniva helps slow or stop the natural processes that dissolve bone tissue; it binds with and stays in your bones throughout the month.

In fact, Boniva is clinically proven to not only maintain bone density, but actually works with your body to help reverse bone loss. In clinical studies, 9 out of 10 females had improved bone density after 1 year on Boniva.

Who is at risk for osteoporosis?

Talk to your healthcare professional about your chances for getting osteoporosis.

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

Females 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
  

Who should not take Boniva?

You shouldn’t take Boniva if you:

• have certain problems with your esophagus, the tube that connects your mouth and stomach
• cannot sit or stand up for at least 1 minute
• have low blood calcium (hypocalcemia)
• 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)
• have kidneys that work very poorly

Tell your doctor 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 medical assistant (including your dentist) about all the drugs 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 medications too close to the time that you take Boniva.

How should you take Boniva?

• Take Boniva exactly as instructed by your healthcare professional.
• Take Boniva first thing in the morning at least 60 minutes before you eat, drink anything other than plain water, or take any other oral medication.
• Take Boniva with 6 to 8 ounces (about 1 full cup) of plain water. Do not take it with any drink other than plain water. Do not take it with other drinks, such as tea, sparkling water, mineral water, juice, coffee or dairy drinks (such as milk).
• 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 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 medications 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 at once. Do not make yourself vomit. Do not lie down.
• Keep taking Boniva for as long as your healthcare professional tells you. Boniva will not work if you stop taking it.
• Your doctor may tell you to exercise and take calcium and vitamin supplements to help your osteoporosis.
• Your doctor may do a test to measure the thickness (density) of your bones or do other tests to check your progress.

What is your Boniva schedule?

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 60 minutes before you eat, drink anything other than plain water, or take any other oral medicine.

What to do if you 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.|Never take two doses on the same day.|Do not take extra medicine to make up the missed dose on the same day.|Do not double the dose to catch up on the same day.
• If you are not sure what to do if you miss a dose, contact your doctor who will be able to advise you.

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.

What to do if you miss a monthly dose:

• If your next scheduled Boniva day is more than a week away, take one Boniva 150 mg tablet in the morning following the day that you remember. 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 doctor who will be able to advise you.

What should you 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 after you take it.
• Do not lie down for at least 1 hour after you take Boniva.

What should you do if you suspect overdose?

No specific information is available on the treatment of overdosage of Boniva. However, based on knowledge of this class of compounds, oral overdosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as gastritis, esophagitis, dyspepsia, ulcer or upset stomach. Milk or antacids should be given to bind Boniva. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.

What are the possible side effects of Boniva?

Stop taking Boniva and call your healthcare professional promptly 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 (which usually improve after the first dose). These are not all the possible side effects of Boniva. For more information ask your doctor.

Rarely:

• patients have reported allergic and skin reactions. Contact your medical assistant if you develop any symptoms of an allergic reaction including skin rash (with or without blisters), hives, wheezing, or swelling of the face, lips, tongue or throat. Get medical help at once if you have trouble breathing, swallowing or feel light-headed.
• patients have reported severe bone, joint, and/or muscle pain starting within one day to several months after beginning to take, by mouth, bisphosphonate medicines to treat osteoporosis (thin bones). This group of drugs includes Boniva. Most patients experienced relief after stopping the drug. Contact your doctor if you develop these symptoms after starting Boniva.
• 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, contact your healthcare professional and dentist.

What other medicines will affect Boniva?

Antacids, supplements, or medicines that contain iron, aluminum, calcium, magnesium or other minerals can interfere with how your body absorbs Boniva. If you use these other medicines, do not that take them for at least 60 minutes before or after taking a Boniva tablet.

Before using Boniva, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diflunisal (Dolobid), diclofenac (Voltaren), indomethacin, ketoprofen (Orudis), celecoxib (Celebrex), ketorolac (Toradol), piroxicam (Feldene), ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), and others.

This may not be a complete list of all interactions that may occur. Ask your doctor if Boniva may interact with other drugs that you take. Check with your doctor before you start, stop, or change the dose of any pill.

How should Boniva be properly stored?

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 medicine out of the reach of children.