ibandronate

Generic Name: ibandronate (eye BAN dro nate)Brand names: Boniva, Bondronat

What is ibandronate?

Ibandronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Ibandronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Ibandronate is used to treat or prevent osteoporosis in women after menopause.

Ibandronate may also be used for other purposes not listed in this medication guide.

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

Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.

Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet.

For at least the first 60 minutes after taking an ibandronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to ibandronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problems.

Ibandronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before using ibandronate?

You should not use this medication if you are allergic to ibandronate, or if you have low blood levels of calcium (hypocalcemia).

Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

Some people using medicines similar to ibandronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. It is not known whether ibandronate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ibandronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use ibandronate?

Use ibandronate exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Ibandronate tablets are taken either once each day or once each month. Ibandronate intravenous solution is given as an injection into one of your veins once every three (3) months. Your doctor, nurse, or other healthcare professional will give you the ibandronate injection. Ibandronate tablets can be taken at home.

Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine. If you take an ibandronate tablet only once a month, take it on the same day each month and always first thing in the morning.

Take each ibandronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet. Do not crush, chew, or suck the ibandronate tablet. Swallow the pill whole.

After taking an ibandronate tablet, carefully follow these instructions:

• Do not lie down or recline for at least 60 minutes after taking ibandronate.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes after taking ibandronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Ibandronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store ibandronate tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take ibandronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take ibandronate tablets once a month: If you forget to take ibandronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular monthly schedule on your chosen dose day. If your next scheduled dose is less than 7 days away, wait until then to take the medicine and skip the missed dose. Do not take two (2) tablets in one week.

If you receive ibandronate injections once a month: Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, pain in the abdomen, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking ibandronate?

Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes before or after taking an ibandronate tablet. Do not lie down for at least 1 hour (60 minutes) after you take an ibandronate tablet.

Ibandronate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ibandronate and call your doctor at once if you have any of these serious side effects:

• chest pain;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• new or worsening heartburn;

• severe joint, bone, or muscle pain; or

• jaw pain, numbness, or swelling.

Less serious side effects may include:

• back pain, headache;

• redness or swelling of your eyes;

• diarrhea;

• flu symptoms;

• redness or swelling where the medicine was injected;

• nausea or upset stomach; or

• pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ibandronate Dosing Information

Usual Adult Dose for Osteoporosis:

2.5 mg orally once daily150 mg orally once monthly on the same day each month3 mg by bolus intravenous injection over 15 to 30 seconds every three months.Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.

Usual Adult Dose for Prevention of Osteoporosis:

2.5 mg orally once daily150 mg orally once monthly on the same day each month3 mg by bolus intravenous injection over 15 to 30 seconds every three months.Oral ibandronate should be administered with 6 to 8 ounces of plain water at least 60 minutes before the first food, beverage or medication of the day. Beverages other than water, food, and certain medications reduce the absorption of ibandronate. Plain water is the only drink that should be taken with ibandronate. Some mineral waters may have a higher concentration of calcium and therefore should not be used.Patients should remain upright (standing or sitting) for at least 60 minutes following administration of oral ibandronate.

What other drugs will affect ibandronate?

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

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

This list is not complete and there may be other drugs that can interact with ibandronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ibandronate.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 12/11/2009 10:40:05 AM.