Multiple myeloma and serious bone problems

Multiple Myeloma

MULTIPLE MYELOMA may have weakened my bones but
I still push forward
1,2

XGEVA® helps protect against serious bone problems3

XGEVA® is a prescription medicine used to prevent serious bone problems in patients with multiple myeloma.3

Serious bone problems are defined as3:

  • Broken bones (fractures)
  • The need for bone surgery
  • Radiation treatments for bone pain
  • Pressure on the spinal cord (spinal cord compression)

For people with multiple myeloma,
XGEVA® helps provide the protection you seek from serious bone problems3

In the largest international trial ever done to evaluate the prevention of serious bone problems in multiple myeloma,4

XGEVA® was found to delay serious bone problems for a median of 22.8 months3

The study included 1,718 adults with multiple myeloma and compared XGEVA® with zoledronic acid (ZA). In this study, XGEVA® was found to be no worse than ZA in delaying time to first on-study serious bone problem (median 22.8 months compared with 24 months for ZA).3

Explore XGEVA® in other cancer types

Important Safety Information


Do not take XGEVA® if you have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive XGEVA®. XGEVA® can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.

Do not take XGEVA® if you are allergic to denosumab or any of the ingredients of XGEVA®. Serious allergic reactions have happened in people who take XGEVA®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.

What is the most important information you should know about XGEVA®?

Do not take XGEVA® if you take Prolia. XGEVA® contains the same medicine as Prolia® (denosumab).

Severe jaw bone problems (osteonecrosis)

Unusual thigh bone fracture

Risk of high calcium levels in patients with Giant Cell Tumor of Bone and in patients who are still growing

Increased risk of broken bones in the spine after discontinuing XGEVA®

Possible harm to your unborn baby

Tell your doctor if you:

While taking XGEVA®, you should:

What are the possible side effects of XGEVA®?

These are not all the possible side effects of XGEVA®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information.

Indication

XGEVA® is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.

References:
  1. Heusschen R, Muller J, Duray E, et al. Molecular mechanisms, current management and next generation therapy in myeloma bone disease. Leuk Lymphoma. 2018;59(1):14-28.
  2. Kyle RA, Gertz MA, Witzig TE, et al. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003;78(1):21-33.
  3. XGEVA® (denosumab) prescribing information, Amgen.
  4. Raje N, Terpos E, Willenbacher W, et al. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018:19(3):370-381.