Ibandronate (Intravenous)

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

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

It is important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

This medicine may cause a serious 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 notice 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 inform all of your health care providers that you are receiving ibandronate injection. If you are undergoing dental procedures while using ibandronate injection, you may have a higher chance of experiencing a severe problem with your jaw.

Make sure to tell your doctor about any new medical issues, especially related to your teeth or jaws. Inform your doctor if you experience severe bone, joint, or muscle pain while using this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This risk may be greater if you use it for a long time. Contact 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.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may bring. Here are things to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to understand how ibandronate injection affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any age-related problems that would limit the use of ibandronate injection in older adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be taken together even if there is a chance of interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. The following interactions have been noted for their significance but are not a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, which might be unavoidable. If used together, your doctor may adjust the dose or frequency of use, or provide special instructions regarding food, alcohol, or tobacco.

• Dairy Food
• food

Other Medical Problems

Other medical conditions may impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Diabetes or
• Heart disease or
• Hypertension (high blood pressure)—Use with caution. May increase the 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.

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.

In the U.S.

• Boniva

In Canada

• Bondronat

Available Dosage Forms:

• Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

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.