Pronunciation:

eye-BAN-droe-nate

Brand Names:

• Boniva
• Bondronat

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

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

This medicine is to be given only by or under the direct supervision of a doctor.

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 injection 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 injection 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, tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (eg, dental surgery)—May increase risk for severe jaw problems.

• Diabetes or
• Heart disease or
• Hypertension (high blood pressure)—Use with caution. May increase risk for more kidney problems.

• Hypocalcemia (low calcium in the blood), uncorrected or
• Hypovitaminosis D (low blood vitamin D) or
• Kidney disease, severe—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine is usually given once every 3 months. If you missed a dose, call your doctor to make another appointment as soon as possible.

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). It is recommended that you receive calcium and vitamin D supplements while receiving this medicine.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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

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. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

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 receiving ibandronate injection. If you are having dental procedures while using ibandronate injection, you may have an increased chance of getting 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.

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.

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 or nurse immediately if any of the following side effects occur:

More common

Back pain

blurred vision

difficulty with moving

dizziness

headache

muscle pain or stiffness

nervousness

pain in the joints

pounding in the ears

slow or fast heartbeat

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

difficulty with breathing

ear congestion

fever

frequent urge to urinate

general feeling of discomfort or illness

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

muscle cramping

nasal congestion

nausea

pain in the arms or legs

pain, swelling, or redness in the joints

shivering

shortness of breath

sneezing

sore throat

sweating

swollen joints

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Abdominal or stomach cramps

agitation

blurred vision or other change in vision

bone, joint, or muscle pain (severe)

coma

confusion

convulsions

decreased urine output

decreased vision

depression

difficulty with swallowing

eye pain

eye redness

eye tenderness

heavy jaw feeling

hives

hostility

increased tearing

irregular heartbeats

irritability

itching

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

lethargy

loosening of a tooth

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

muscle twitching

nausea

numbness and tingling around the mouth, fingertips, or feet

pain, swelling, or numbness in the mouth or jaw

rapid weight gain

rash

seizures

sensitivity of the eye to light

severe eye pain

stupor

tearing

tremor

unusual pain in the thighs, groin, or hips

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

Abdominal or stomach pain

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

constipation

diarrhea

heartburn

indigestion

red streaks on the skin

stomach discomfort or upset

stuffy nose

swelling, tenderness, or pain at the injection site

tenderness in the stomach area

weakness

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.