Pronunciation:

i-BAN-droh-nate

Brand Names:

• Boniva

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Ibandronate is used to treat or 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—

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ibandronate in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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
• Cancer treatment or
• Dental or oral disease or
• Infection—May put you at risk for a serious jaw problem.

• Asian or Caucasian race or
• Family history of osteoporosis or
• Other bone problems or
• Previous broken bone or
• Smoking or
• Thin body frame—These conditions may make it more difficult for this medicine to prevent osteoporosis.

• Digestion problems—Taking ibandronate may be harmful to the esophagus, intestine, or stomach.

• Esophagus problems or
• Intestine problems or
• Stomach problems—Ibandronate may make these conditions worse.

• Hypocalcemia (low calcium levels in the blood)—Must be treated first, before beginning treatment with ibandronate.

• Inability to stand or sit upright for at least 60 minutes—You should not take this medicine because it could cause serious problems to your esophagus and stomach.

• Kidney problems—The effects of ibandronate may be increased.

Proper Use of This Medicine:

Make certain your health care professional 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 in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages, such as mineral water, coffee, tea, 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.

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. However, do not take any food, beverages, or calcium or vitamin supplements within 60 minutes or longer of taking ibandronate. To do so may keep this medicine from working properly.

Swallow the tablet whole. Do not crush, break, chew, or suck it.

For the injection: You will receive this medicine from a healthcare professional every 3 months. You should not receive this injection more often than every 3 months.

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 treatment of postmenopausal osteoporosis (thinning of bone)
    • 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 medication. You should take ibandronate with six to eight ounces of plain water.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of postmenopausal osteoporosis (thinning of bone)
    • Adults—2.5 mg once a day in the morning or 150 mg once a month on the same date each month (if directed by your doctor), taken at least 60 minutes before the first food, beverage, or medication. You should take ibandronate with six to eight ounces of plain 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.

Call your doctor or pharmacist for instructions.

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.

Tell your doctor right away if you develop symptoms of your esophagus being irritated such as new or worsening difficulty swallowing, pain on swallowing, pain behind your breast bone, or heartburn. Using aspirin or nonsteroidal anti-inflammatory drugs (e.g. Aleve®, Motrin®) may also increase your risk for stomach problems.

It is important that you tell all of your health care providers that you are taking ibandronate. If you are having a dental procedure while taking ibandronate, you may have an increased chance of having a severe problem with 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.

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 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 chest

wheezing

Less common

Bloody or cloudy urine

body aches or pain

congestion

difficult, burning, or painful urination

difficulty swallowing

dizziness

dryness of throat

fast heartbeat

frequent urge to urinate

hives

hoarseness

itching

large amount of cholesterol in the blood

numbness

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

runny nose

skin rash

tender, swollen glands in neck

tingling

trouble in swallowing

unusual tiredness or weakness

voice changes

Incidence unknown

Blurred vision or other change in vision

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

eye redness

eye tenderness

heavy jaw feeling

loosening of a tooth

pain, swelling, or numbness in the mouth or jaw

sensitivity to light

severe eye pain

tearing

Symptoms of overdose

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

Abdominal cramps

acid or sour stomach

belching

bone pain

burning feeling in chest or stomach

chest pain

confusion

convulsions

difficulty in breathing

difficulty in swallowing

heartburn

indigestion

irregular heartbeats

loss of appetite

mood or mental changes

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

numbness and tingling around the mouth, fingertips, or feet; pain or burning in throat

shortness of breath

sores, ulcers

stomach discomfort, upset, or pain

tenderness in stomach area

tremor

ulcer

unusual tiredness or weakness

vomiting

white spots on 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 extremity (arms and legs)

Less common

Abdominal or stomach pain

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

cough

difficulty having a bowel movement [stool]

difficulty in moving

discouragement

feeling of constant movement of self or surroundings

feeling sad or empty

general feeling of discomfort or illness

irritability

joint pain

lack of appetite

lack or loss of strength

lightheadedness

loss of interest or pleasure

muscle aches and pain

muscle pain or stiffness

nausea

pain, swelling, or redness in joints

sensation of spinning

shivering

stuffy nose

sweating

tooth disorder

trouble concentrating

trouble sleeping

Rare

Sleeplessness

unable to sleep

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