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denosumab

Pronunciation

Generic Name: denosumab (Xgeva) (den OH sue mab)
Brand Name: Xgeva

What is denosumab (Xgeva)?

Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

The Xgeva brand of denosumab is 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 is also used to treat giant cell bone tumor in adults and teenagers with fully matured bone structure.

This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

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

What is the most important information I should know about Xgeva?

This medication guide provides information about the Xgeva brand of denosumab. Prolia is another brand of denosumab used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.

Slideshow: Flashback: FDA Drug Approvals 2013

You should not receive denosumab if you have low levels of calcium in your blood (hypocalcemia).

What should I discuss with my healthcare provider before receiving Xgeva?

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

While you are receiving Xgeva, you should not use Prolia, another brand of denosumab.

To make sure Xgeva is safe for you, tell your doctor if you have kidney disease (or if you are on dialysis).

Denosumab may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, gum infection, or slow healing after dental work.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

FDA pregnancy category D. Do not use denosumab if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of denosumab on the baby.

It is not known whether denosumab passes into breast milk or if it could harm a nursing baby. However, this medication may slow the production of breast milk. You should not breast-feed while receiving denosumab.

How is Xgeva given?

Denosumab 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 denosumab. 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 denosumab. You may need to stop using the medicine for a short time.

Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have a dental exam before you begin treatment with Xgeva. Follow your doctor's instructions.

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: itching, rash, hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or unusual pain in your thigh, hip, or groin;

  • fast or slow heart rate, trouble breathing; or

  • low levels of calcium in your blood (hypocalcemia)--numbness or tingly feeling around your mouth or in your fingers or toes, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

  • feeling weak or tired;

  • nausea;

  • headache, back 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: Side effects (in more detail)

Denosumab dosing information

Usual Adult Dose for Osteoporosis:

Prolia(R): 60 mg subcutaneously once every 6 months

Comments:
-If a dose is missed, the injection should be administered as soon as the patient is available. Thereafter, injections should be scheduled every 6 months from the date of the last injection.

Uses:
-Treatment of postmenopausal women with osteoporosis at high risk for fracture
-Treatment to increase bone mass in men with osteoporosis
-Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer
-Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer

Usual Adult Dose for Giant Cell Tumor of Bone:

Xgeva (R): Initial dose: 120 mg subcutaneously on Days 8 and 15 of the first month of therapy in the upper arm, upper thigh, or abdomen
Maintenance dose: 120 mg subcutaneously every 4 weeks in the upper arm, upper thigh, or abdomen

Comments:
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors:

Xgeva(R): 120 mg subcutaneously every 4 weeks

Comments:
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Prevention of skeletal-related events in patients with bone metastases from solid tumors

What other drugs will affect Xgeva?

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about denosumab (Xgeva).
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.01. Revision Date: 2014-09-04, 1:40:26 PM.

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