2018-03-21T18:01:01
(BPT) – This article is sponsored advertising content from Amgen, Inc.
Patients living with multiple myeloma and physicians who treat them are realizing the importance of not only treating the underlying disease, but also treating or preventing disease complications. One important area that sometimes gets overlooked is how multiple myeloma can impact the bones. Multiple myeloma is typically characterized by bone lesions, which often result in serious bone problems, defined as broken bones, the need for surgery (to prevent or repair broken bones), the need for radiation treatments to the bone, and pressure on the spinal cord (spinal cord compression).1,2
While still incurable, availability of new multiple myeloma treatment regimens have been shown to improve survival compared to recent standards-of-care. With these gains in survival, doctors and patients should be considering the importance of setting additional treatment goals to try to prevent some of the problems having multiple myeloma can bring, like fractures and other serious bone problems.3
March is Multiple Myeloma Awareness Month, which recognizes patients like Joshua Fine who are living with this life-threatening, incurable blood cancer that, as of 2014, affected an estimated 118,539 people in the U.S.4,5
Bone lesions were present at the time of Joshua’s diagnosis and, in his case, were an indication of the underlying disease.6
“After I was diagnosed with multiple myeloma, I experienced significant damage to my hip and had to begin using crutches. My doctor wanted to avoid surgery,” recalled Joshua. “We immediately discussed the importance of getting on a bone targeting agent to help protect my bones from further damage.”
Until recently, treatment options to prevent serious bone problems in patients with multiple myeloma were limited to bisphosphonates, most commonly given as an intravenous infusion.7 These are cleared by the body through the kidneys. Renal impairment (which means your kidneys are not working normally) is a common problem for patients with multiple myeloma.7 In fact, approximately 60 percent of all multiple myeloma patients have or will develop renal impairment over the course of the disease.8
There is a new bone targeting medicine available, called XGEVA® (denosumab), that is not cleared through the kidneys and can help prevent serious bone problems in patients with multiple myeloma.9 XGEVA®, a prescription medicine given as a shot once every four weeks in your doctor’s office, is 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.10
XGEVA® should not be used by women who are pregnant because it could harm the unborn baby. XGEVA® should not be used by people with low blood calcium levels (hypocalcemia). XGEVA® can cause low blood calcium levels, which in some cases could be life threatening. Patients with renal impairment are more likely to have problems with low calcium levels in their blood while taking XGEVA. Your doctor should check your blood calcium levels before you start and while on XGEVA®. Take calcium and vitamin D supplements as directed by your doctor while you are on XGEVA®. Please see the additional Important Safety Information at the end of this article to learn about risks to consider when talking to your doctor about starting XGEVA®.
In the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 newly diagnosed patients, XGEVA® was no worse at reducing the risk of having a serious bone problem than another drug called zoledronic acid, based on the time to first on-study serious bone problem (median 22.8 months vs. 24 months, respectively).10,11
Despite the risk of experiencing a serious bone problem, 36 percent of myeloma patients remain untreated for the prevention of bone problems.12 XGEVA® offers multiple myeloma patients protection from serious bone problems, with a convenient shot under the skin, instead of an intravenous infusion, providing patients with an alternative treatment option. Your doctor will check your blood before you start XGEVA® to make sure you do not have low calcium levels in your blood.10
“Since my diagnosis I have learned a lot about the effect multiple myeloma has on the body, especially the bones,” Joshua said. “I’m excited about the approval of XGEVA in multiple myeloma as it provides patients like me a new option that can help prevent serious bone problems.”
For more information about how XGEVA® can prevent serious bone problems in patients with multiple myeloma, and for support tools such as a list of questions for your doctor, visit http://www.xgeva.com/.
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)
Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth before you start, and while you are taking XGEVA®. Tell your dentist that you are taking XGEVA®. It is important for you to practice good mouth care during treatment with XGEVA®. In studies of patients with bone involvement, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.
Unusual thigh bone fracture
Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Risk of high calcium levels in patients who are still growing
Patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking XGEVA®, that can be serious.
Increased risk of broken bones in the spine after discontinuing XGEVA®
After your treatment with XGEVA® is stopped, your risk for breaking bones in your spine can increase, especially if you have a history of risk factors such as osteoporosis or prior fractures.
Possible harm to your unborn baby
You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby.
Tell your doctor if you:
- Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as XGEVA®
- Have symptoms of low blood calcium such as muscle stiffness or cramps
- Have symptoms of severe jaw bone problems such as pain or numbness
- Have ongoing pain or slow healing after dental surgery
- Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
- Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding
While taking XGEVA®, you should:
- Take good care of your teeth and gums and visit a dentist as recommended
- Tell your dentist that you are taking XGEVA®
- Tell your doctor if you plan to have dental surgery or teeth removed
- Talk to your doctor before you stop taking XGEVA® about your risk for broken bones in your spine.
- Women of child bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months after the last dose of XGEVA®
What are the possible side effects of XGEVA®?
In patients with bone metastases from solid tumors using XGEVA®, the most common side effects were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.
In multiple myeloma patients receiving XGEVA®, the most common side effects were diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction in multiple myeloma patients was pneumonia.
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–FDA1088.
Please see Full Prescribing Information.
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References
- Roodman GD. Pathogenesis of myeloma bone disease. Leukemia. 2009;23(3):435–441.
- Drake MT. Bone disease in multiple myeloma. Oncology (Williston Park). 2009;23 (14 Suppl 5):28-32.
- Rajkumar, SV, Moreau, P. Advances in biology and therapy. Nat Rev Clin Oncol. 2014; 11.
- Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives. Semin in Hematol. 2012; 49(3)(1),S16-S32.
- NCI SEER Cancer Stat Facts: Myeloma. www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed August 28, 2017.
- International Myeloma Working Group. International Myeloma Working Group (IMWG) Criteria for the Diagnosis of Multiple Myeloma. http://imwg.myeloma.org/international-myeloma-working-group-imwg-criteria-for-the-diagnosis-of-multiple-myeloma/. Accessed January 24, 2018.
- Terpos E, et al. International Myeloma Working Group recommendations for the treatment of multiple myeloma-related bone disease. J Clin Oncol. 2013;31(18):2347-57.
- Qian Y et al. Renal impairment and use of nephrotoxic agents in patients with multiple myeloma in the clinical practice setting in the United States. Cancer Med. 2017;6:1523-1530XGEVA® (denosumab) prescribing information, Amgen.
- Lewiecki EM. Denosumab: an investigational drug for the management of postmenopausal osteoporosis. Biologics: Targets & Therapy. 2008;2:645-653, 638-A-2.
- XGEVA® (denosumab) Prescribing information, Amgen.
- Raje 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 [published online ahead of print February 8, 2018]. Lancet Oncol. https://doi.org/10.1016/S1470-2045(18)30072-X.
- Kim, C., Hernandez, R. K., Cheng, P. C., Smith, J., Cyprien, L., & Liede, A. (2016). Bone Targeting Agent Treatment Patterns Among Patients with Multiple Myeloma Treated at Oncology Clinics Across the United States: Observations from Real-World Data. Blood. 128(22), 2364.
