Ibandronate

(ih-ban-druh-nate)

Trade/other name(s): Boniva, ibandronate sodium

Why would this drug be used?

Ibandronate is a type of drug known as a bisphosphonate. It is used to prevent or treat bone thinning (osteoporosis) in women who are past menopause.

It is also being studied to see if it can help treat cancer that has spread to the bones, usually along with other treatments such as chemotherapy. Researchers are looking to see if it lowers the risk of bone pain, fractures, and other bone problems.

How does this drug work?

Bone cells called osteoclasts normally break down the hard mineral part of bone to allow for bone rebuilding. In women past menopause, the rate of breakdown is often faster than the rate at which the bone is built back up, which leads to thinning of the bones (osteoporosis). In people with cancer in the bones, osteoclasts contribute to the formation and growth of tumors in the bones by eating away at the normal bone structure. Cancer in the bones can lead to pain, fractures, and other problems.

Ibandronate slows the rate at which osteoclasts break down the mineral structure of bone. In women past menopause, this allows new bone to be formed more quickly than it is broken down, which leads to stronger bones. In people with cancer in the bones, this may help slow the growth of tumors in the bone and may lead to fewer problems such as pain and bone fractures.

Before taking this medicine

Tell your doctor…

• If you are allergic to any medicines, dyes, additives, or foods.
• If you have swallowing problems, heartburn, or ulcers. When taken as a tablet, this drug can irritate the esophagus, which could make these worse. You may need to get ibandronate as an intravenous (IV) injection instead of a pill.
• If you cannot sit or stand up for at least 60 minutes. This medicine requires that you do that after each dose if you take it in pill form.
• If you have ever had low calcium or vitamin D levels in your blood. This drug may make calcium levels low enough to be dangerous.
• If you have ever had kidney problems. This drug is usually not recommended in people with serious kidney problems.
• If you have any problems with your mouth or teeth, or if you are planning any dental procedures. This drug has been linked to serious damage of the jawbone in some people, especially if they have had recent dental work (see "Precautions" below).
• If you have any other medical conditions such as liver disease (including hepatitis), heart disease, congestive heart failure, lung disease, diabetes, gout, or infections. You may need to be watched more closely while being treated.
• If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause problems if either the male or female is taking it at the time of conception or during pregnancy. Check with your doctor about what kinds of birth control can be used with this medicine. This drug should not be used during pregnancy.
• If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Talk with your doctor about the possible risks of breast-feeding while taking this drug.
• If you think you might want to have children in the future. It is not known whether or not this drug can affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
• About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Products containing calcium and similar minerals (aluminum, magnesium, or iron), such as multivitamins, supplements, and antacids, can affect how ibandronate is absorbed in the digestive tract. Ibandronate tablets should be taken at least one hour before taking any of these products.

Use of this drug with chemotherapy and/or steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone) may raise the risk of damage to the bones in the jaw.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

Food containing certain minerals can affect how ibandronate is absorbed from the digestive tract. Ibandronate tablets should be taken at least one hour before eating.

Check with your doctor, nurse, or pharmacist about whether other foods or alcohol may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Ibandronate is still being studied for use in people with cancer in the bones. The best dose and best way to give the drug in this situation is still being studied.

When used to prevent or treat osteoporosis, ibandronate is either taken by mouth as a tablet or given as an injection into a vein (intravenous, or IV).

Tablets may be taken in a smaller dose (2.5 mg) once a day or in a larger dose (150 mg) once a month. The tablet should be taken by itself first thing in the morning, at least one hour before the first food or drink of the day. Take it with a full glass of plain (not mineral) water. The tablet must be swallowed whole, not chewed, crushed, broken, or melted. To lower the risk of esophagus irritation, do not lie down for at least one hour after taking this drug. Take other morning medicines, vitamins, or supplements at least an hour after this drug.

Your doctor may recommend that you take calcium and vitamin D supplements while getting this drug.

Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets.

Ibandronate can also be given as an IV injection once every 3 months. The injection itself takes 15 to 30 seconds. If you are getting ibandronate as an injection, your doctor may delay or even stop this drug if your kidney function tests are abnormal.

Precautions

When taken as a tablet, this drug can irritate the esophagus (swallowing tube) or stomach. This could cause trouble swallowing, heartburn, pain behind the breast bone, and/or ulcers. It reduces your risk to take this drug with enough water and avoid lying down for an hour afterward. Tell your doctor or nurse right away if you notice any problems.

In rare cases, this drug can damage the bones in the jaw, a condition called osteonecrosis of the jaw (ONJ). Most cases have been in people who had recent dental procedures such as having a tooth pulled. Your doctor may recommend that you get a thorough dental exam before starting treatment with this drug. Talk with the dentist about the best ways to prevent problems while taking the drug. Be sure to check with your doctor before having any dental procedures done. Tell your doctor if you notice loose teeth, swollen gums, or pain or numbness in your jaw.

In rare cases, getting this drug could lead to low blood calcium levels (hypocalcemia). Possible symptoms of low calcium levels could include muscle spasms or cramps, muscle or joint pains, changes in sensations on the face, hands or feet, confusion, or seizures. Tell your doctor right away if you notice any of these symptoms.

Your doctor will do blood tests to track blood chemistry levels and check on your kidney function. Based on the test results, your doctor may need to change your treatment plan. Your doctor may also recommend that you get plenty of fluids while getting this drug to reduce the chance of kidney damage. Tell your doctor or nurse right away if you notice blood in the urine, lowered urine output, increased thirst, nausea, or vomiting.

Rarely, people who have been taking this drug for years have had an unusual type of fracture (break) in the bone of the upper thigh. Tell your doctor if you have any aching or pain in the thigh or groin.

In rare cases, this drug may cause allergic reactions when the drug is given. Mild reactions may consist of hives or fever and chills. More serious reactions are rare, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), fever, chills, hives, nausea, itching, headache, coughing, shortness of breath, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after you get the drug.

Avoid pregnancy while taking this drug and for some time afterward. The drug can stay in your body for years after you stop taking it. It is not known if the drug may harm the fetus. Talk with your doctor about this.

Possible side effects

You will probably not have most of the following side effects, but if you have any, talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

• None

Less common

• Diarrhea
• Pain in the arms or legs
• Back pain
• Muscle aches
• Upset stomach
• Pain or trouble swallowing*
• Heartburn*
• Stomach ulcers*
• Flu-like symptoms (fever, chills, headache, bone and muscle aches)
• Headache
• Runny nose
• Cough
• Shortness of breath
• Nausea/vomiting
• Loss of appetite
• Constipation
• Feeling dizzy or faint
• Feeling tired
• Pain or redness at injection site

Rare

• Low blood calcium levels (could lead to muscle pain, cramps, or spasms; abnormal sensations on the face, hands, or feet; or seizures)*
• Damage to jaw bone*
• Allergic reactions*
• Eye irritation or redness
• Severe bone, joint, or muscle pain that required the drug be stopped
• Damage to the esophagus, such as ulcers, strictures, or holes
• Irregular heartbeat (atrial fibrillation)
• Unusual fracture (break) in the thigh bone (femur)

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2003.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.