Xgeva

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

What is Xgeva?

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.

Xgeva 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).

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.

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

Important information about Xgeva

Do not use Xgeva if you are pregnant. It could harm the unborn baby.

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.

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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 kidney disease or if you are on dialysis.

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

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

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 Xgeva 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 this medicine.

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.

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

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. If you keep your medication at home, store it in the original container in a refrigerator. Protect from light and do not freeze.

You may take the medicine out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

After you have taken Xgeva out of the refrigerator, you may keep it at room temperature and use it within 14 days. Store in the original container away from heat and light. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

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.

Call your doctor at once if you have a serious side effect such as:

• numbness or tingly feeling around your mouth or in your fingers or toes, fast or slow heart rate, muscle cramps or contraction, overactive reflexes; or

• trouble breathing.

Less serious Xgeva side effects may include:

• feeling weak or tired;

• diarrhea, nausea; or

• headache.

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?

There may be other drugs that can 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.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Xgeva.