Ibandronate (By mouth)

Introduction

Ibandronate (eye-BAN-droe-nate)

Treats or prevents weak bones (osteoporosis) in women after menopause.

Brand Name(s)

Boniva

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney problems, stomach ulcers, heartburn, trouble swallowing, or any other kind of stomach or bowel problems. Tell your doctor if you have anemia, blood clotting problems, cancer, infection of any kind, or dental problems. Tell your doctor if you have trouble absorbing minerals in your stomach (malabsorption syndrome).
• This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
• You may need to have a dental exam before you start using this medicine.
• It is important that you tell your doctor or dentist that you are taking this medicine. If you are having dental procedures done, you may have an increased chance of getting a severe problem of your jaw.
• Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
• Your doctor may recommend weight-bearing exercise or diet changes to further decrease your risk of osteoporosis.
• This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burping or belching that causes burning in your throat.
• Changes in how much or how often you urinate, or painful urination.
• Chest pain, heartburn, or burning in your throat.
• Difficult or painful swallowing.
• Eye pain or redness.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Heavy jaw feeling.
• Loosening of a tooth.
• Pain, swelling, or numbness in the mouth or jaw.
• Severe bone, joint, or muscle pain.
• Severe headache and dizziness.
• Tooth problems.
• Trouble breathing.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, or stomach pain or upset.
• Mild back pain, neck pain, or joint pain.
• Mild headache and dizziness.
• Pain in your hands, arms, legs, or feet.
• Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is sometimes used daily, or as one tablet taken one time per month. If you are on a monthly dosing schedule, take the medicine on the same date each month.
• If any of this medicine stays in your esophagus, it may cause serious damage. The esophagus is the tube that carries food from your mouth to your stomach when you swallow. To lower the risk of this problem, take the tablets exactly as directed below.
• It is best to take this medicine on an empty stomach.
• Take this medicine first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything. Swallow the tablet whole with a large glass (6 to 8 ounces) of plain water only (not mineral water, coffee, tea, soda, juice, or any other liquid). Do not chew or suck on the tablet. Take this medicine while you are sitting or standing. Do not take the medicine while you are still in bed, and do not take it at bedtime.
• Wait at least 60 minutes after you swallow the tablet before you eat or drink anything or take any other medicines. This will help your body absorb the medicine.
• Do not lie down or bend over for at least 60 minutes after taking the medicine, and do not lie down until after you have eaten some food.
• Carefully follow your doctor's instructions about any special diet. It is especially important that you get enough calcium and vitamin D in your diet.
• Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss your monthly dose and your next month's scheduled dose is more than 7 days away, wait until the next morning to take it. Then return to your regularly scheduled day of the month for taking your next dose.
• If you miss your monthly dose and your next month's scheduled dose is 1 to 7 days away, wait until then to take your medicine and skip the missed dose.
• If you miss your daily dose or you forget to take your medicine, wait until the next morning to take it.
• Follow all of the usual instructions about taking the medicine on an empty stomach and not lying down for at least 60 minutes. Do not use extra medicine to make up for a missed dose.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer treatment.
• It is best not to take this medicine with food or milk, or together with an antacid or products containing calcium, aluminum, magnesium, or iron. Wait at least 60 minutes after you take ibandronate before taking calcium or mineral supplements, or antacids that contain aluminum, magnesium, or calcium (such as Maalox®, Mylanta®, or Tums®).
• Make sure your doctor knows if you are also using pain or arthritis medicine (NSAIDs) such as aspirin, ibuprofen, naproxen, diclofenac, Advil®, or Voltaren®.
• This medicine may interact with the dye used for bone scans.
• Do not drink alcohol or smoke tobacco. Both alcohol and smoking can make your bone problems worse.