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Xbryk (denosumab-dssb) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help prevent skeletal-related events in adults with multiple myeloma.
Xbryk is a type of medicine called a RANK ligand inhibitor. It works by blocking a protein called RANKL, which helps control the cells that break down bone.
In people with multiple myeloma who have bone problems, this helps reduce bone breakdown and lower the risk of bone-related complications.
Doctors prescribe Xbryk when a person with multiple myeloma needs help preventing skeletal-related events. These bone problems can include broken bones, radiation treatment to bone, surgery to bone, and spinal cord compression.
Xbryk is a biosimilar to Xgeva. This means it is made from living cells and is designed to work like the original medicine. The FDA requires biosimilars to have no meaningful differences from the original medicine in safety or effectiveness.
Xbryk is given as an injection under the skin by a healthcare provider. It is given every four weeks. It may be given in the upper arm, upper thigh, or abdomen.
The recommended dose of Xbryk for multiple myeloma is 120 milligrams given as an injection under the skin every four weeks. Calcium and vitamin D may also be given to help treat or prevent low calcium levels.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Xbryk for preventing skeletal-related events in people with multiple myeloma, the most common side effects occurred in about 11 percent to 34 percent of people. These include:
Xbryk can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Before you start Xbryk, your doctor will check your calcium level. Low calcium must be corrected before treatment starts. Your doctor may also recommend calcium and vitamin D to help treat or prevent low calcium levels.
Tell your doctor if you have any allergies to Xbryk or any of its ingredients. Do not take Xbryk if you have had a serious allergic reaction to Xbryk or any of its ingredients.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Tell your doctor if you have kidney problems or are on dialysis because you may have a higher risk of low calcium levels.
Your doctor should check your mouth and teeth before you start Xbryk. Keep your mouth clean, and tell your dentist you are taking Xbryk. Avoid invasive dental procedures during treatment when possible.
Xbryk is also FDA-approved to treat adults and skeletally mature adolescents, meaning teens whose bones have stopped growing. It may be used for giant cell tumor of bone that cannot be removed by surgery or when surgery could cause serious problems. It is also approved to treat hypercalcemia of malignancy that did not respond to bisphosphonate therapy.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Xbryk, talk with your doctor about the risks and benefits.
Xbryk can harm a fetus. If you can become pregnant, your doctor will check that you are not pregnant before treatment. Use effective birth control during treatment and for at least five months after your last dose.
These answers are fact-checked by our editorial staff.
How effective is Xbryk?
In a clinical study of 1,718 people with newly diagnosed multiple myeloma and bone lesions, denosumab was shown to be similar to zoledronic acid in delaying the first skeletal-related event. A skeletal-related event is a serious bone problem, such as a broken bone, radiation therapy to bone, surgery to bone, or spinal cord compression.
Overall survival was similar between the two treatment groups.
Denosumab also reduced levels of a marker of bone breakdown called uNTx/Cr by about 75 percent by week 5. These reductions were maintained throughout the study, with levels remaining about 74 percent to 79 percent below baseline from weeks 9 through 49 when denosumab was given every four weeks.
How long does Xbryk take to work for multiple myeloma?
Xbryk starts affecting bone turnover early in treatment. In a clinical study of denosumab in people with newly diagnosed multiple myeloma, a bone marker called uNTx/Cr went down by about 75 percent by week 5. These reductions were maintained through at least 49 weeks of treatment.
Because people respond differently to treatment, there is no set time frame for when someone may notice a difference.
What tests or monitoring are needed with Xbryk for multiple myeloma?
Your doctor should check your calcium levels during Xbryk treatment. This is especially important during the first weeks after starting treatment. Low calcium levels must be corrected before Xbryk begins.
Your doctor may give you calcium, magnesium, and vitamin D as needed. These can help treat or prevent low calcium levels.
Before starting Xbryk, your doctor should check your mouth and teeth. You may also need preventive dental care. During treatment, your doctor should watch for symptoms of osteonecrosis of the jaw, which is a serious jaw problem.
If you can become pregnant, your doctor should check that you are not pregnant before you start Xbryk.
On MyMyelomaTeam, people share their experiences with multiple myeloma, get advice, and find support from others who understand.
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