Bondronat

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.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

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.

Oral:
150 mg orally once a month on the same day each month

IV 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 injection

Uses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

Mild to moderate renal dysfunction (CrCl 30 mL/min or more): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Data not available

AU, UK: Use should be avoided. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.