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Being diagnosed with cancer is devastating. Patients instantly have a lot of decisions to make when it comes to treatment plans and often don't think about how the cancer could impact their bones. However, it is important to know if your cancer has spread to your bones. Bone metastases or 'bone mets' occur when cancer cells from the original location of the tumor travel through the bloodstream or lymphatic system and begin to grow in the bone.
Ask your doctor how they are monitoring you for bone mets. If you have already been told you have bone mets, you are not alone. In the U.S., there are approximately 330,000 patients living with bone mets from solid tumors.
Certain types of cancer are more likely to spread to the bone. Bone mets are especially common in prostate, breast and lung cancer.
- About seven out of 10 men with advanced metastatic prostate cancer develop bone mets.
- Similarly, about seven out of 10 women with advanced metastatic breast cancer develop bone mets.
- In patients with advanced metastatic lung cancer, approximately four out of 10 develop bone mets.
Bone mets can cause bones to weaken, leading to fractures, as well as three other types of serious bone problems: a need for surgery to prevent or repair broken bones, a need for radiation treatments to the bone and pressure on the spinal cord (spinal cord compression). Additionally, once a patient experiences a serious bone problem, the likelihood of experiencing a second is greater. Even with these risks, of the 330,000 patients living with bone mets from solid tumors, more than 50 percent remain untreated for the prevention of serious bone problems. Fortunately, there are bone targeting medicines that can help prevent serious bone problems.
XGEVA® (denosumab)‎, a prescription medicine given, as a shot, once every four weeks in your doctor's office, is used to prevent pathologic fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with bone metastases from solid tumors. XGEVA® is not used to prevent these bone problems in patients with multiple myeloma.
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. 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®.
XGEVA® is the number one prescribed bone targeting medicine by oncologists to prevent serious bone problems in patients with bone mets from solid tumors. In studies of people with bone mets from breast cancer, prostate cancer, lung cancer, and other types of solid tumors or multiple myeloma, XGEVA® delayed serious bone problems for a median of 27.7 months. This was 8.2 months longer than another bone-targeting medicine, zoledronic acid, also known as ZA.
'Patients have a lot to think about when they are first diagnosed with metastatic cancer,' said Dr. Nancy Dawson, Director, Clinical Research, Lombardi Comprehensive Cancer Center, and Attending Oncologist, Prostate Cancer Research and Treatment Center, Georgetown University, Georgetown, MD. 'A bone scan tells us right away if there are metastases. In a head-to-head comparison, XGEVA® was shown to be better at preventing fractures and other serious bone problems longer than zoledronic acid, in patients whose solid tumor cancers had spread to bone.'
If you have been diagnosed with metastatic cancer that has spread to your bones, ask your doctor right away about your risk for serious bone problems and if XGEVA® might be right for you. Early discussion if you have bone mets is important so you can take steps to prevent serious bone problems.
Learn more about how XGEVA® can prevent serious bone problems in patients with solid tumors. For information about XGEVA®, and patient 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 important information you should know about XGEVA®?
XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking XGEVA® do not take Prolia®.
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 metastases, 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.
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. 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®.
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
- 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®?
- The most common side effects in patients receiving XGEVA® for the prevention of serious bone problems were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of XGEVA® was shortness of breath.
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.