Denosumab (patient information)

Why is this medication prescribed?

Denosumab injection (Prolia) is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in men and in women who have undergone menopause ('change of life;' end of menstrual periods), who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medications for osteoporosis. Denosumab injection (Prolia) is also used to treat bone loss in men with prostate cancer and in women with breast cancer who are receiving certain treatments that increase their risk for fractures. Denosumab injection (Xgeva) is used to reduce fractures from certain types of cancer that began in another part of the body but has spread to the bones. Denosumab injection (Xgeva) is also used in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery or if surgery is not possible. Denosumab injection is in a class of medications called RANK ligand inhibitors. It works by decreasing bone breakdown and increasing bone strength and density (thickness).

How should this medicine be used?

Denosumab injection comes as a solution (liquid) to be injected subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area. It is usually injected by a doctor or nurse in a medical office or clinic. When denosumab injection (Prolia) is used to treat osteoporosis or to treat bone loss in men with prostate cancer and women with breast cancer, it is usually given once every 6 months. When denosumab injection (Xgeva) is used to reduce fractures from cancer that has spread to the bones, it is usually given once every 4 weeks. When denosumab injection (Xgeva) is used to treat giant cell tumor of bone, it is usually given every 7 days for the first three doses (on day 1, day 8, and day 15) and then once every 4 weeks starting 2 weeks later after the first three doses.

Your doctor will tell you to take supplements of calcium and vitamin D while you are being treated with denosumab injection. Take these supplements exactly as directed.

When denosumab injection (Prolia) is used to treat osteoporosis or bone loss, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with denosumab injection and each time you refill your prescription. 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.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving denosumab injection,

• tell your doctor and pharmacist if you are allergic to denosumab (Prolia, Xgeva), any other medications, latex, or any of the ingredients in denosumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

you should know that denosumab injection is available under the brand names Prolia and Xgeva. You should not receive more than one product containing denosumab at a time. Be sure to * tell your doctor if you are being treated with either of these medications.

• tell your doctor and pharmacist what other 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: cancer chemotherapy medications; medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Rheumatrex, Trexall), sirolimus (Rapamune), and tacrolimus (Prograf); or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred); Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had a low level of calcium in your blood. Your doctor will probably check the level of calcium in your blood before you begin treatment and will probably tell you not to receive denosumab injection if the level is too low.
• tell your doctor 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; any type of infection, especially in your mouth; problems with your mouth, teeth, gums, or dentures; dental or oral surgery (teeth removed, dental implants); any condition that stops your blood from clotting normally; any condition that decreases functioning of your immune system; surgery on your thyroid gland or parathyroid gland (small gland in the neck); surgery to remove part of your small intestine; problems with your stomach or intestine that make it difficult for your body to absorb nutrients; or thyroid or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. Denosumab injection may harm the fetus. You should not become pregnant while you are receiving denosumab injection and if receiving denosumab (Xgeva) for at least 5 months after your treatment. You should use a reliable method of birth control to prevent pregnancy while you are receiving denosumab injection and if receiving denosumab (Xgeva) for at least 5 months after your treatment. If you or your partner become pregnant while receiving denosumab injection, or within 5 months of your treatment with denosumab (Xgeva), call your doctor immediately.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving denosumab injection.

you should know that denosumab injection may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are being treated with denosumab injection. Talk to your doctor and dentist before having any dental treatments while you are receiving this medication. A dentist should examine your mouth and perform any needed treatments before you start treatment with denosumab injection. Be sure to brush your teeth, floss, and clean your mouth properly while you are being treated with denosumab injection.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

If you miss an appointment to receive an injection of denosumab, you should call your healthcare provider as soon as possible. The missed dose should be given as soon as it can be rescheduled. When denosumab injection (Prolia) is used for osteoporosis or bone loss, after you receive the missed dose, your next injection should be scheduled 6 months from the date of your last injection.

What side effects can this medication cause?

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

• red, dry, or itchy skin

• oozing or crusty blisters on skin

• peeling skin

• back pain

• pain in your arms

• muscle or joint pain

• nausea

• diarrhea

• headache

• runny nose

• sore throat

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• muscle stiffness, twitching, cramps, or spasms

• numbness or tingling in your fingers, toes, or around your mouth

• hives

• rash

• itching

• difficulty breathing or swallowing

• swelling of the face, throat, tongue, or lips

• dizziness

• fainting

• blurred vision

• fever or chills

• tiredness

• redness, tenderness, swelling or warmth of area of skin

• ear drainage or severe pain

• frequent or urgent need to urinate

• burning feeling when you urinate

• pain, numbness, swelling, or drainage from mouth, teeth, or jaw

• slow healing of the mouth or jaw

• severe abdominal pain

• ongoing pain that begins in the stomach area, but may spread to the back

• fast heart rate

Denosumab injection 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 denosumab injection. Denosumab injection may also cause broken bones to heal slowly and may impair bone growth and prevent teeth from coming in properly in children. Talk to your doctor about the risks of receiving denosumab injection.

Denosumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not shake denosumab injection. Store it in the refrigerator and protect it from light. Do not freeze. Denosumab injection can be kept at room temperature for up to 14 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

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 denosumab injection and to check your body's response to denosumab injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

Brand names

Prolia®

Xgeva®