Friday, October 21, 2016

Xgeva



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


Xgeva 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).


Xgeva 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 Xgeva if:


  • you are allergic to any ingredient in Xgeva

  • you have multiple myeloma

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



Before using Xgeva:


Some medical conditions may interact with Xgeva. 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 Xgeva. However, no specific interactions with Xgeva are known at this time.


Ask your health care provider if Xgeva 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 Xgeva:


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


  • Xgeva is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Xgeva at home, a health care provider will teach you how to use it. Be sure you understand how to use Xgeva. 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.

  • Xgeva is a colorless to pale yellow solution that may contain a very small amount of clear to white particles. Do not use Xgeva 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 Xgeva.

  • 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 Xgeva, contact your doctor right away.

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



Important safety information:


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

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

  • Xgeva 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 Xgeva. Ask your doctor any questions you may have about dental treatment while you use Xgeva.

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

  • If you have dental surgery while you are using Xgeva, 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 Xgeva. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Xgeva should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Xgeva 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 Xgeva while you are pregnant. It is not known if Xgeva is found in breast milk. Do not breast-feed while taking Xgeva.


Possible side effects of Xgeva:


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: Xgeva 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 Xgeva:

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


General information:


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

  • Xgeva 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 Xgeva. 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 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 Consumer Overview

  • Denosumab Professional Patient Advice (Wolters Kluwer)

  • Denosumab Monograph (AHFS DI)

  • Prolia Consumer Overview

  • Prolia Prescribing Information (FDA)



Compare Xgeva with other medications


  • Hypercalcemia of Malignancy
  • Osteolytic Bone Metastases of Solid Tumors

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