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Aukelso (denosumab-kyqq) 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.
Aukelso is a type of medicine called a RANK ligand (RANKL) inhibitor. It works by blocking RANKL, a protein that helps activate 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.
Aukelso is biosimilar to Xgeva (denosumab), which means it is highly similar to Xgeva and has no clinically meaningful differences in safety, purity, or potency. Doctors prescribe Aukelso to help prevent skeletal-related events, which are serious bone problems linked to multiple myeloma.
Aukelso is given as an injection under the skin by a healthcare provider. It is usually given every four weeks.
Typical Dosing for Multiple Myeloma
The recommended dose of Aukelso 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 a clinical study of Aukelso for preventing skeletal-related events in people with multiple myeloma, the most common side effects occurred in 11 percent to 34 percent of people. These include:
Aukelso 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.
Biocon Biologics Inc., the manufacturer of Aukelso, offers My Biocon Biologics. This program offers support from specialists, including benefits investigations, prior authorization assistance, verification of patient-specific insurance coverage requirements, and help determining copay responsibilities.
To learn more, visit the Aukelso website or call 833-612-4626.
Before starting Aukelso, your doctor will check your calcium level. Any 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 denosumab products. Do not take Aukelso if you have had a serious allergic reaction to Aukelso or any of its ingredients. Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
You should also 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 Aukelso. Tell your dentist that you are taking Aukelso.
Keep good oral hygiene and avoid invasive dental procedures during treatment when possible.
Aukelso 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 FDA-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 Aukelso, talk with your doctor about the risks and benefits.
Aukelso can harm your baby if used during pregnancy. If you can become pregnant, your doctor should verify that you are not pregnant before starting Aukelso.
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 Aukelso?
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 treatment to bone, surgery to bone, or spinal cord compression. Overall survival was similar between people who received denosumab and those who received zoledronic acid.
In the same study, denosumab lowered urinary N-terminal telopeptide corrected for creatinine (uNTx/Cr), a marker of bone turnover, by about 75 percent by Week 5. These reductions were maintained at about 74 percent to 79 percent from Weeks 9 to 49 when treatment was given every four weeks.
How long does Aukelso take to work for multiple myeloma?
In a clinical study of people with newly diagnosed multiple myeloma, Aukelso lowered levels of uNTx/Cr, a marker of bone turnover, by about 75 percent by Week 5 when given every four weeks. Researchers used uNTx/Cr levels to measure changes in bone turnover during treatment with Aukelso.
Reductions in this marker were maintained during continued treatment. The clinical study data does not show when individuals may notice a benefit from treatment.
What tests or monitoring are needed with Aukelso for multiple myeloma?
Your doctor should check your calcium level before you start Aukelso. Any low calcium must be corrected before treatment begins.
Calcium levels should be monitored during treatment, especially during the first weeks after starting Aukelso. Your doctor may recommend calcium, magnesium, and vitamin D 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 examine your mouth and teeth before you start treatment. Good oral hygiene is important during treatment with Aukelso.
Tell your dentist that you are receiving Aukelso. Avoid invasive dental procedures when possible during treatment.
Contact your doctor if you develop symptoms involving your mouth or jaw, such as jaw pain or slow healing after dental work.
On MyMyelomaTeam, people share their experiences with multiple myeloma, get advice, and find support from others who understand.
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