Boniva (Ibandronate Sodium)

Ibandronate Injection



(i ban' droh nate)

Boniva® Injection

Ibandronate injection is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life;'' end of menstrual periods). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

Ibandronate injection comes as a solution (liquid) to be injected into a vein by a doctor or nurse in a medical office or clinic. Ibandronate injection is usually given once every 3 months.
Your doctor will tell you to take supplements of calcium and vitamin D while you are being treated with ibandronate injection. Take these supplements exactly as directed.
You may experience a reaction after you receive your first dose of ibandronate injection. You probably will not experience this reaction after you receive later doses of ibandronate injection. Symptoms of this reaction may include flu-like symptoms, fever, headache, and bone or muscle pain. Your doctor may recommend that you take a mild pain reliever to prevent or treat these symptoms.
Ibandronate injection controls osteoporosis but does not cure it. Ibandronate injection helps to treat osteoporosis only as long as you receive regular injections. It is important that you receive your ibandronate injection once every 3 months for as long as your doctor prescribes it, but you should talk to your doctor from time to time about whether you still need to receive ibandronate injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ibandronate injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Before receiving ibandronate injection,

tell your doctor and pharmacist if you are allergic to ibandronate, any other medications, or any of the ingredients in ibandronate injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiogenesis inhibitors such as bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); cancer chemotherapy; and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you have hypocalcemia (lower than normal level of calcium in your blood). Your doctor will probably tell you not to use ibandronate injection.

tell your doctor if you are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; diabetes; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; high blood pressure; any condition that stops your blood from clotting normally; lower than normal levels of vitamin D; or heart or kidney disease.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because ibandronate may remain in your body for years after you stop using it. Call your doctor if you become pregnant during or after your treatment.

you should know that ibandronate injection may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you have dental surgery or treatment while you are receiving the medication. A dentist should examine your teeth and perform any needed treatments, including cleaning or fixing ill-fitted dentures, before you start to receive ibandronate. Be sure to brush your teeth and clean your mouth properly while you are receiving ibandronate injection. Talk to your doctor before having any dental treatments while you are receiving this medication.

you should know that ibandronate injection may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first receive ibandronate injection. Although this type of pain may begin after you have received ibandronate injection for some time, it is important for you and your doctor to realize that it may be caused by ibandronate. Call your doctor right away if you experience severe pain at any time during your treatment with ibandronate injection. Your doctor may stop giving you ibandronate injection and your pain may go away after you stop treatment with this medication.

talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive an injection of ibandronate, you should call your healthcare provider as soon as possible. The missed dose should be given as soon as it can be rescheduled. After you receive the missed dose, your next injection should be scheduled 3 months from the date of your last injection. You should not receive an ibandronate injection more often than once every 3 months.

Ibandronate injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:



stomach pain

nausea

constipation

diarrhea

heartburn

back pain

rash

pain in the arms or legs

weakness

tiredness

dizziness

headache

fever, sore throat, chills, cough, and other signs of infection

frequent or urgent need to urinate

painful urination

redness or swelling at injection spot

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before receiving any more ibandronate injection:



painful or swollen gums

loosening of the teeth

numbness or heavy feeling in the jaw

poor healing of the jaw

eye pain or swelling

vision changes

sensitivity to light

dull, aching pain in the hips, groin, or thighs
Ibandronate injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
Being treated with a bisphosphonate medication such as ibandronate injection for osteoporosis may increase the risk that you will break your thigh bone(s). You may feel pain in your hips, groin, or thighs for several weeks or months before the bone(s) break, and you may find that one or both of your thigh bones have broken even though you have not fallen or experienced other trauma. It is unusual for the thigh bone to break in healthy people, but people who have osteoporosis may break this bone even if they do not receive ibandronate injection. Talk to your doctor about the risks of receiving ibandronate injection
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to receive ibandronate injection and to check your body's response to ibandronate injection.
Before having any bone imaging study, tell your doctor and healthcare personnel that you are receiving ibandronate injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.