Xgeva

Xgeva

Generic Name: denosumab (den OH sue mab)

Brand Names: Prolia, Xgeva

What is Xgeva?

Xgeva (denosumab) is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Xgeva used to prevent bone fractures and other skeletal conditions in people with tumors that have spread to the bone. Xgeva is not for use in people with multiple myeloma (bone marrow cancer).

Xgeva may also be used for purposes not listed in this medication guide.

Important information about Xgeva

You should not receive Xgeva if you are allergic to denosumab, or if you have low levels of calcium in your blood (hypocalcemia).

Before you receive Xgeva, tell your doctor if you have kidney disease (or if you are on dialysis), a weak immune system, a history of hypoparathyroidism or thyroid surgery, a history of intestinal surgery; or if you are allergic to latex.

Serious infections may occur during treatment with Xgeva. Call your doctor right away if you have signs of infection such as: severe skin irritation; swelling or redness anywhere on your body; pain or burning when you urinate; severe stomach cramps, diarrhea, or vomiting; ear pain, trouble hearing; cough, feeling short of breath; purple or red spots under your skin; or fever, chills, night sweats, flu symptoms, or weight loss.

Some people using Xgeva have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Xgeva. You may need to stop using the medicine for a short time.

Before receiving Xgeva

You should not receive Xgeva if you are allergic to denosumab , or if you have low levels of calcium in your blood (hypocalcemia).

To make sure you can safely use Xgeva, tell your doctor if you have any of these other conditions:

kidney disease (or if you are on dialysis);

a weak immune system (caused by disease or by using certain medicines);

a history of hypoparathyroidism (decreased functioning of the parathyroid glands);

a history of thyroid surgery;

a history of surgery to remove part of your intestine; or

if you are allergic to latex.

FDA pregnancy category C. It is not known whether Xgeva will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, Xgeva may slow the production of breast milk. You should not breast-feed while receiving Xgeva.

See also: Xgeva pregnancy and breastfeeding warnings (in more detail)

Some people using Xgeva have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

How is Xgeva given?

Xgeva is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.

Xgeva is usually given once every 4 weeks. Follow your doctor's instructions.

Your doctor may have you take extra calcium and vitamin D while you are being treated with Xgeva. Take only the amount of calcium and vitamin D that your doctor has prescribed.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving Xgeva. You may need to stop using the medicine for a short time.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Xgeva injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Xgeva?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Xgeva side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Xgeva: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious infections may occur during treatment with Xgeva. Call your doctor right away if you have signs of infection such as:

severe itching, burning, rash, or dryness of the skin;

swelling, pain, tenderness, or redness anywhere on your body;

pain or burning when you urinate;

severe stomach cramps, diarrhea, vomiting;

ear pain or drainage, trouble hearing;

fever, chills, night sweats;

cough, feeling short of breath;

pinpoint purple or red spots under your skin; or

flu symptoms, weight loss.

Call your doctor at once if you have a serious side effect while using Xgeva, such as:

numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious Xgeva side effects may include:

feeling weak or tired;

constipation, diarrhea, mild nausea;

back pain, muscle or joint pain; or

pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Xgeva side effects (in more detail)

What other drugs will affect Xgeva?

Tell your doctor about all other medicines you use, especially:

drugs that weaken your immune system (such as cancer medicine or steroids);

cyclosporine (Neoral, Sandimmune, Gengraf);

sirolimus (Rapamune), tacrolimus (Prograf);

basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

mycophenolate mofetil (CellCept); or

azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).

This list is not complete and other drugs may interact with Xgeva. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Xgeva resources

Xgeva Side Effects (in More Detail)

Xgeva Use in Pregnancy & Breastfeeding

Xgeva Drug Interactions

Xgeva Support Group

0 Reviews for Xgeva - Add your own review/rating

Xgeva Prescribing Information (FDA)

Xgeva Advanced Consumer (Micromedex) - Includes Dosage Information

Xgeva MedFacts Consumer Leaflet (Wolters Kluwer)

Denosumab Professional Patient Advice (Wolters Kluwer)

Denosumab Monograph (AHFS DI)

Denosumab MedFacts Consumer Leaflet (Wolters Kluwer)

Prolia Prescribing Information (FDA)

Compare Xgeva with other medications

Hypercalcemia of Malignancy

Osteolytic Bone Metastases of Solid Tumors

Where can I get more information?

Your doctor or pharmacist can provide more information about Xgeva.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2011 Cerner Multum, Inc. Version: 6.01. Revision Date: 2/14/2011 4:13:38 PM.