ibandronate (oral/injection)

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

Do not take an ibandronate tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes after taking the tablet.

What is ibandronate?

Ibandronate is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

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

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

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

• severe kidney disease; or
• low blood levels of calcium (hypocalcemia).

To make sure ibandronate is safe for you, tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin using ibandronate);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use ibandronate, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

How should I use ibandronate?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ibandronate tablets are taken once per month. Ibandronate injection is given into a vein through an IV once every 3 months.

Ibandronate tablets can be taken at home, but a healthcare provider must give the ibandronate injection.

Take the ibandronate tablet first thing in the morning, at least 60 minutes before you eat or drink anything or take any other medicine. Take the medicine on the same day each month and always first thing in the morning.

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while using ibandronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using ibandronate.

Ibandronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Your doctor will determine how long to treat you with this medicine. Ibandronate is often given for only 3 to 5 years.

What happens if I miss a dose?

Ibandronate tablets: If you forget to take a tablet first thing in the morning on your scheduled day, do not take it later in the day. Wait until the next morning to take 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 and skip the missed dose. Do not take two (2) doses in one week.

What happens if I overdose?

Since ibandronate injections are given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while taking ibandronate?

Avoid taking any other medicines for at least 60 minutes after taking ibandronate. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb ibandronate.

What are the possible side effects of ibandronate?

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels --muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

• heartburn, stomach pain, diarrhea;
• back pain, bone pain, muscle or joint pain;
• pain in your arms or legs;
• headache; or
• fever, chills, tiredness, flu-like symptoms.

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.

What other drugs will affect ibandronate?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) --ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with ibandronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.

Where can I get more information?

Your pharmacist can provide more information about ibandronate.