Pronunciation:

eye-BAN-droe-nate

Brand Names:

• Boniva

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Ibandronate is used to treat and prevent osteoporosis (thinning of the bone) in women after menopause.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ibandronate in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibandronate in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food
• food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Blood clotting problems or
• Cancer or
• Dental or tooth problems or
• Dental procedures (eg, dental implants, tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (eg, dental surgery)—May increase risk for severe jaw problems.

• Esophagus (the tube that runs from your throat to your stomach) problems (eg, achalasia, stricture) or
• Hypocalcemia (low calcium in the blood) or
• Inability to stand or sit upright for at least 60 minutes or
• Kidney disease, severe or
• Trouble with swallowing—Should not be used in patients with these conditions.

• Stomach or bowel problems (eg, Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Make sure your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products).

Take ibandronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken first thing in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages (eg, mineral water, coffee, tea, milk, or juice) will decrease the amount of ibandronate absorbed by the body. Waiting longer than 60 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium or vitamin supplements will also decrease the absorption of ibandronate.

Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.

Do not lie down for 60 minutes after taking ibandronate. This will help ibandronate reach your stomach faster. It will also help prevent irritation to your esophagus.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). However, do not take any food, beverages, or calcium or vitamin supplements within 60 minutes or longer after taking ibandronate. To do so may keep this medicine from working properly.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention and treatment of postmenopausal osteoporosis:
    • Adults—2.5 milligrams (mg) once a day in the morning, or 150 mg once a month on the same date each month, taken at least 60 minutes before the first food, beverage, or medicine of the day other than water.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.

For patients taking the medicine monthly: If you miss your dose and your next scheduled dose is more than 7 days away, take it the next morning after you remember. Return to your regularly scheduled day of the month for taking your next dose.

For patients taking the medicine monthly: If you miss your dose and your next scheduled dose is 1 to 7 days away, wait until then to take your medicine and skip the missed dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.

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.

This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.

It is important that you tell all of your health care providers that you are taking ibandronate. If you are having dental procedures while taking ibandronate, you may have an increased chance of getting a severe problem with your jaw. This may be more common if you use ibandronate for a long time.

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.

This medicine may increase your risk of developing fractures of the thigh bone. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

This medicine may interact with the dye used for bone scans.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

chest pain

cough producing mucus

difficult, burning, or painful urination

difficulty with breathing

fever or chills

frequent urge to urinate

lower back or side pain

nervousness

pounding in the ears

shortness of breath

slow or fast heartbeat

sneezing

sore throat

tightness in the chest

Less common

Bloody or cloudy urine

body aches or pain

congestion

difficulty with swallowing

dizziness

dryness of the throat

fast heartbeat

frequent urge to urinate

hives

hoarseness

itching

numbness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

runny nose

skin rash

tender, swollen glands in the neck

tingling

unusual tiredness or weakness

voice changes

Incidence not known

Abdominal or stomach cramps

blurred vision or other change in vision

bone, joint, or muscle pain, severe and occasionally incapacitating

confusion

convulsions

eye redness

eye tenderness

heavy jaw feeling

irregular heartbeats

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loosening of a tooth

muscle cramps in the hands, arms, feet, legs, or face

noisy breathing

numbness and tingling around the mouth, fingertips, or feet

pain, swelling, or numbness in the mouth or jaw

sensitivity to light

severe eye pain

tearing

tremor

unusual pain in the thighs, groin, or hips

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Acid or sour stomach

belching

bone pain

burning feeling in the chest or stomach

heartburn

indigestion

loss of appetite

pain or burning in the throat

sores or ulcers

stomach discomfort, upset, or pain

tenderness in the stomach area

vomiting

white spots on the lips or tongue or inside the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

ear congestion

headache

loss of voice

pain in the extremity (arms and legs)

Less common

Cough

difficulty having a bowel movement (stool)

difficulty with moving

discouragement

feeling of constant movement of self or surroundings

feeling sad or empty

general feeling of discomfort or illness

irritability

joint pain

lack or loss of strength

lightheadedness

loss of interest or pleasure

muscle aches and pain

muscle stiffness

pain, swelling, or redness in the joints

sensation of spinning

shivering

stuffy nose

sweating

tooth disorder

trouble concentrating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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