Denosumab (Injection)

Brand Name(s)

Xgeva, Prolia

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given under the skin of your upper arm, upper thigh, or stomach.
• A nurse or other trained health professional will give you this medicine.
• Prolia® is usually given once every 6 months. Xgeva? is usually given once every 4 weeks.
• Your doctor may also give you vitamin D and calcium supplements. Follow your doctor's instructions about how to take these medicines.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Before you start using Prolia®, make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer medicine.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Denosumab (den-OSE-ue-mab)

Prolia® treats osteoporosis (thinning of the bones) in women after menopause who have an increased risk for fractures. Prolia® is also used to treat bone loss in men and women who are receiving treatments for prostate and breast cancers. Xgeva? is used to prevent bone-related problems in patients with cancer.

Warnings While Using This Medicine

• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy surveillance program for patients receiving this medicine.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, anemia, blood clotting problems, cancer, eczema, a skin rash or infection, problems with absorbing food, gum or dental problems, or dentures that do not fit very well. Tell your doctor if you have an underactive parathyroid gland, or if you have had parathyroid surgery, thyroid surgery, or any mouth surgery.
• Prolia® contains denosumab which can also be found in Xgeva?. Patients using Prolia® should not receive Xgeva?.
• This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.
• Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor right away if you have a fever or chills; red, swollen skin; severe abdominal or stomach pain; or burning or painful urination.
• Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have any of the following symptoms that do not go away or get worse: blistering, crusting, irritation, itching, or reddening of the skin; cracked, dry, or scaly skin; rash; or swollen skin.
• It is important that you tell all of your doctors that you are using denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.
• The needle cover of the prefilled syringe of Prolia® contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Changes in how much or how often you urinate, or painful urination.
• Chest pain or a fast, uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Heavy feeling in the jaw.
• Loose teeth or problems with the teeth.
• Pain, swelling, or numbness in the mouth or jaw.
• Redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given.
• Severe bone, muscle, or back pain.
• Shortness of breath or trouble with breathing.
• Sudden and severe stomach pain, nausea, vomiting, and lightheadedness.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea.
• Headache.
• Heartburn, gas, or stomach pain.
• Lack or loss of strength.
• Mild back pain or joint pain.
• Mild rash or itching skin.
• Tiredness or weakness.
• Trouble sleeping.