Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibandronate injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
DRG-20073867
