Denosumab

Pronunciation: den-OH-sue-mab
Generic Name: Denosumab
Brand Name: Xgeva

Denosumab is used for:

Preventing certain bone-related events in patients who have a certain type of tumor that has spread to the bones (bone metastases).

Denosumab is a receptor activator of nuclear factor-kappa B (RANK) ligand inhibitor. It works by decreasing the formation, function, and survival of certain bone cells (osteoclasts) that are responsible for slowing bone loss. Decreased osteoclast activity helps to reduce the risk of bone-related events in patients with cancer that has spread to the bone.

Do NOT use Denosumab if:

• you are allergic to any ingredient in Denosumab


• you have multiple myeloma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Denosumab:

Some medical conditions may interact with Denosumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney problems or you are on dialysis


• if you have low blood calcium levels, cannot take daily calcium or vitamin D supplements, or plan to have dental surgery or teeth removed

Some MEDICINES MAY INTERACT with Denosumab. However, no specific interactions with Denosumab are known at this time.

Ask your health care provider if Denosumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Denosumab:

Use Denosumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Denosumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Denosumab at home, a health care provider will teach you how to use it. Be sure you understand how to use Denosumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Denosumab is a colorless to pale yellow solution that may contain a very small amount of clear to white particles. Do not use Denosumab if it contains many particles or any foreign matter. Do not use it if the solution is cloudy or discolored, or if the vial is cracked or damaged.


• Do not vigorously shake Denosumab.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Denosumab, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Denosumab.

Important safety information:

• Talk to your doctor about taking a calcium or vitamin D supplement while you use Denosumab.


• Tell your doctor or dentist that you take Denosumab before you receive any medical or dental care, emergency care, or surgery.


• Denosumab may cause jaw bone problems in some patients. Your risk may be greater if you have had a tooth removed, or a history of poor dental hygiene or use of a dental appliance. Your risk may also be greater if you have had certain dental procedures. Talk to your doctor about having a dental exam before you start to use Denosumab. Ask your doctor any questions you may have about dental treatment while you use Denosumab.


• Proper dental care is important while you are taking Denosumab. Brush and floss your teeth and visit the dentist regularly.


• If you have dental surgery while you are using Denosumab, contact your doctor if you have persistent pain or slow healing of the mouth or jaw after the surgery.


• Lab tests and medical exams, including blood calcium levels and dental exams, may be performed while you use Denosumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Denosumab should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Denosumab may affect bone growth and tooth development in children.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Denosumab while you are pregnant. It is not known if Denosumab is found in breast milk. Do not breast-feed while taking Denosumab.

Possible side effects of Denosumab:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough; pain, numbness, swelling, or drainage from the jaw, mouth, or teeth; shortness of breath; symptoms of low blood calcium levels (eg, muscle spasms, twitches, or cramps; burning, numbness, or tingling in your fingers, toes, or around your mouth); symptoms of low blood phosphate levels (eg, new or worsening loss of appetite, muscle weakness or pain, seizures); ulcers of the gums.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Denosumab side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Denosumab:

Denosumab is usually handled and stored by a health care provider. If you are using Denosumab at home, store Denosumab as directed by your pharmacist or health care provider. Keep Denosumab out of the reach of children and away from pets.

General information:

• If you have any questions about Denosumab, please talk with your doctor, pharmacist, or other health care provider.


• Denosumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Denosumab. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Denosumab resources

• Denosumab Side Effects (in more detail)
• Denosumab Use in Pregnancy & Breastfeeding
• Denosumab Drug Interactions
• Denosumab Support Group
• 0 Reviews for Denosumab - Add your own review/rating

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