Boniva Intravenous

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.

Headache, flu-like symptoms (such as fever, chills, tiredness, joint/muscle ache), or injection site reactions (such as redness, swelling) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, vision changes, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ibandronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate, pamidronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood calcium levels (hypocalcemia), severe kidney disease.

Some people using ibandronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having surgery (especially dental procedures), tell your doctor and dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking ibandronate before your surgery. Ask for specific instructions about stopping or starting this medication.

Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with ibandronate.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain laboratory tests (bone-imaging agents), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements and make lifestyle changes. Consult your doctor for specific advice.

Laboratory and/or medical tests (such as bone density tests, X-rays, height, blood mineral levels, kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, reschedule with your health care professional as soon as possible. Continue every 3 months from the date you actually receive the missed dose. If you have any questions, ask your doctor or pharmacist.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.