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Oziltus (denosumab-mobz) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to prevent bone problems, also called skeletal-related events, in people with multiple myeloma.
Oziltus is a type of medication called a RANK ligand (RANKL) inhibitor. It works by blocking a protein called RANKL, which helps turn on cells that break down bone.
In multiple myeloma, this may help lower bone damage and other bone problems. These include broken bones, the need for radiation or surgery to bone, and spinal cord compression.
Doctors prescribe Oziltus to help prevent skeletal-related events, which are serious bone problems linked to multiple myeloma.
Oziltus is given as an injection under the skin by a healthcare provider. It is usually given every four weeks.
The recommended dose of Oziltus for multiple myeloma is 120 milligrams injected under the skin every four weeks.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical trials described in the Oziltus prescribing information for the prevention of skeletal-related events in people with multiple myeloma, the most common side effects were reported by about 11 percent to 34 percent of people. These include:
Oziltus 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.
Amneal Pharmaceuticals, the manufacturer of Oziltus, offers the Amneal PATHways Patient Support Program. Eligible people with commercial insurance may pay as little as $0 per treatment with an Amneal Biosciences product through the Amneal PATHways Co-pay Assistance Card.
The Amneal PATHways Patient Support Program also provides enrolled people with a range of resources and services. Patient Access Specialists can provide support throughout treatment, explain benefits investigation results, discuss affordability options that may be available, and share program updates as needed.
To learn more, visit the Amneal Biosciences patient support website or call 866-426-6325.
Before starting Oziltus, your doctor will check your calcium level. Any low calcium must be corrected before treatment starts.
Tell your doctor if you have any allergies to Oziltus or any of its ingredients. Do not take Oziltus if you have had a serious allergic reaction to Oziltus or any of its ingredients.
Tell your doctor about all medications 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. You may have a higher risk of low calcium.
Your doctor should check your mouth and teeth before you start Oziltus. Tell your dentist that you are taking Oziltus.
Keep good oral hygiene and avoid invasive dental procedures during treatment when possible.
Oziltus is also FDA approved to treat adults and skeletally mature adolescents with a giant cell tumor of bone that cannot be removed by surgery or where surgery may cause severe 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 Oziltus, talk with your doctor about the risks and benefits.
Oziltus can harm your baby if used during pregnancy. If you can become pregnant, your doctor should verify that you are not pregnant before starting Oziltus.
You should 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 Oziltus?
In a study of 1,718 people with newly diagnosed multiple myeloma and bone lesions, denosumab worked about as well as another bone medicine called zoledronic acid at delaying the first skeletal-related event. A skeletal-related event is a serious bone problem, such as a broken bone, radiation or surgery to bone, or spinal cord compression.
Overall survival was also similar between the two groups.
Oziltus also lowered markers of bone breakdown by about 75 percent by week 5. These markers stayed lower, by about 74 percent to 79 percent, from weeks 9 to 49 when Oziltus was given every four weeks.
How long does Oziltus take to work for multiple myeloma?
In people with newly diagnosed multiple myeloma, Oziltus lowered markers of bone breakdown by about 75 percent by week 5 when given every four weeks.
Researchers measured this using uNTx/Cr, a laboratory marker linked to bone breakdown.
What tests or monitoring are needed with Oziltus for multiple myeloma?
Your doctor should check your calcium level before you start Oziltus. Any low calcium must be corrected before treatment begins.
Calcium levels should be monitored during treatment, especially during the first weeks after starting Oziltus. Your doctor may recommend calcium, magnesium, and vitamin D supplements if needed.
People with severe kidney problems or who are on dialysis have a higher risk of low calcium levels. In these individuals, calcium levels and calcium and vitamin D intake should be monitored closely.
Your doctor should also examine your mouth and teeth before treatment starts. Good dental care may help lower the risk of osteonecrosis of the jaw, a serious jaw problem linked to denosumab products.
Tell your dentist that you are taking Oziltus. Keep good oral hygiene and avoid invasive dental procedures during treatment when possible.
Contact your doctor if you have jaw pain, mouth sores, tooth problems, or slow healing after dental work.
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