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|Ibandronate

IBANDRONATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Boniva

† Not commercially available in Canada.

Category

• Bone resorption inhibitor

Description

Ibandronate (i-BAN-dro-nate) is used to treat or prevent osteoporosis (thinning of the bone) in women after menopause.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Tablets

• Parenteral
• Injection

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ibandronate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ibandronate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ibandronate has not been studied in pregnant women. However, studies in animals have shown that ibandronate may causes birth defects and other pregnancy problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether ibandronate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ibandronate in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.

Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of ibandronate. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypocalcemia (low calcium levels in the blood)—Must be treated first, before beginning treatment with ibandronate

• Inability to stand or sit upright for at least 60 minutes—You should not take this medicine because it could cause serious problems to your esophagus and stomach.

• Anemia or
• Blood clotting problems or
• Cancer or
• Cancer treatment or
• Dental or oral disease or
• Infection—May put you at risk for a serious jaw problem

• Asian or Caucasian race or
• Family history of osteoporosis or
• Other bone problems or
• Previous broken bone or
• Smoking or
• Thin body frame—These conditions may make it more difficult for this medicine to prevent osteoporosis.

• Digestion problems—Taking ibandronate may be harmful to the esophagus, intestine, or stomach

• Esophagus problems or
• Intestine problems or
• Stomach problems—Ibandronate may make these conditions worse.

• Kidney problems—The effects of ibandronate may be increased.

Proper Use of This Medicine

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products).

Take ibandronate with a full glass (6 to 8 ounces) of plain water on an empty stomach . It should be taken in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages, such as mineral water, coffee, tea, or juice, will decrease the amount of ibandronate absorbed by the body. Waiting longer than 60 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium or vitamin supplements will also decrease the absorption of ibandronate.

Do not lie down for 60 minutes after taking ibandronate . This will help ibandronate reach your stomach faster. It will also help prevent irritation to your esophagus.

Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). However, do not take any food, beverages, or calcium or vitamin supplements within 60 minutes or longer of taking ibandronate. To do so may keep this medicine from working properly.

For the injection : You will receive this medicine from a healthcare professional every 3 months. You should not receive this injection more often than every 3 months.

Dosing—The dose of ibandronate will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of ibandronate. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of postmenopausal osteoporosis (thinning of bone)
    • Adults—2.5 mg once a day in the morning or 150 mg once a month on the same date each month, taken at least 60 minutes before the first food, beverage, or medication. You should take ibandronate with six to eight ounces of plain water.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of postmenopausal osteoporosis (thinning of bone)
    • Adults—2.5 mg once a day in the morning or 150 mg once a month on the same date each month (if directed by your doctor), taken at least 60 minutes before the first food, beverage, or medication. You should take ibandronate with six to eight ounces of plain water.
    • Children—Use and dose must be determined by your doctor.

Missed dose—For 2.5 mg tablet once a day—If you miss a dose of this medicine, do not take it later in the day. Resume your schedule the next morning. Do not double doses.

For 150 mg tablet once a month—If you miss a dose of this medicine and your next scheduled dose is more than 7 days away, take one tablet in the morning. Resume your schedule the next month. If you miss a dose of this medicine and your next scheduled dose is only 1 to 7 days away, you must wait until your next scheduled dose. Resume your schedule the next month. Do not double doses. Do not take more than two tablets within the same week.

For injection every 3 months—If you miss a scheduled appointment to receive a dose of this medicine, it should be rescheduled as soon as possible. Then, resume the schedule of every 3 months from the date of the last injection.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.

Tell your doctor right away if you develop symptoms of your esophagus being irritated such as new or worsening difficulty swallowing, pain on swallowing, pain behind your breast bone, or heartburn.

Importance of not lying down for at least 60 minutes after taking ibandronate.

Importance of taking ibandronate at least 60 minutes before first food, beverage, or medication of the day.

Importance of taking antacids, calcium supplements, or other products containing aluminum, iron, or magnesium at least 60 minutes after ibandronate.

Use of aspirin or nonsteroidal anti-inflammatory drugs (e.g. Aleve, Motrin) may increase your risk for stomach problems.

Do not chew or suck on the tablet. Swallow whole with 6 to 8 ounces of plain water.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 03/25/2004
Revised: 02/08/2006

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