Ibandronate (oral/injection)

Ibandronate is a bisphosphonate (bis FOS fo nayt) medicine that changes how bones form and break down in the body. This can slow down 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 other reasons not mentioned in this medication guide.

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 a 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.

Take the ibandronate tablet with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Do not crush, chew, or suck on an ibandronate tablet. Swallow it whole.

For at least 60 minutes (1 full hour) after taking an ibandronate tablet:

• 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.

Store at room temperature away from moisture and heat.

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

You should not use ibandronate if you have severe kidney disease or low levels of calcium in your blood.

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.

Ibandronate tablets can cause serious problems in the stomach or esophagus. Stop taking ibandronate and call your doctor right away if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in your hands and feet or around your mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

You should not use ibandronate if you are allergic to it, or if you have:

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

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. Ibandronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 1 full hour after taking ibandronate.

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 have 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.

It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ibandronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Ibandronate may cause serious side effects. Stop using ibandronate and call your doctor right away if you have:

• 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 tingling (around your mouth, or in your fingers and toes).

Common side effects of ibandronate 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.

Usual Adult Dose for Osteoporosis:

Oral:150 mg orally once a month on the same day each monthIV Injection:3 mg by IV injection over 15 to 30 seconds every three months.Comments:-The IV injection should not be administered more frequently than once every 3 months.-Obtain serum creatinine prior administration of each IV injection.-Perform a routine oral examination prior administration of IV injectionUses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

Usual Adult Dose for Prevention of Osteoporosis:

Oral:150 mg orally once a month on the same day each monthIV Injection:3 mg by IV injection over 15 to 30 seconds every three months.Comments:-The IV injection should not be administered more frequently than once every 3 months.-Obtain serum creatinine prior administration of each IV injection.-Perform a routine oral examination prior administration of IV injectionUses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

Ibandronate tablets: If you forget to take a tablet 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 go back 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.

Ibandronate injections: Call your doctor for instructions if you miss your appointment for your injection.

For oral ibandronate: Drink a full glass of milk and seek emergency medical help or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

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

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.

Avoid smoking, or try to quit. Smoking can lower your bone mineral density, increasing the risk of fractures.

Avoid drinking large amounts of alcohol. Heavy drinking can also lead to bone loss.

Tell your doctor about all the medicines you are currently taking 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.