Bilprevda (Denosumab-Nxxp) for Multiple Myeloma

Bilprevda (denosumab-nxxp) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help prevent skeletal-related events, or serious bone problems, in people with multiple myeloma.

How Bilprevda Works and How It’s Taken

Bilprevda 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.

Bilprevda is a biosimilar to Xgeva (denosumab). This means it is highly similar to Xgeva and has no clinically meaningful differences in safety, purity, or effectiveness.

In multiple myeloma, Bilprevda may help lower the risk of bone damage and other serious bone problems. These include broken bones, the need for radiation or surgery to bone, and spinal cord compression.

Doctors prescribe Bilprevda to help prevent skeletal-related events, which are serious bone problems linked to multiple myeloma.

Bilprevda is given as an injection under the skin by a healthcare provider. It is usually given every four weeks. It may be given in the upper arm, upper thigh, or abdomen.

Typical Dosing for Multiple Myeloma

The recommended dose of Bilprevda 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.

Bilprevda Side Effects

In clinical studies of Bilprevda 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:

Diarrhea
Nausea
Anemia (low red blood cell count)
Back pain
Thrombocytopenia (low platelet count)
Peripheral edema (swelling, usually in the legs, ankles, or feet)
Hypocalcemia (low calcium levels)
Upper respiratory tract infection (such as a cold)
Rash
Headache

Serious Side Effects and Warnings

Bilprevda can cause serious side effects that may require immediate medical attention. These include:

Severe allergic reactions — Hypersensitivity, including anaphylaxis, can cause trouble breathing, swelling, hives, or low blood pressure.
Severe hypocalcemia — Dangerously low calcium levels can cause symptoms and have been fatal in some cases.
Severe hypophosphatemia — Dangerously low phosphate levels can occur during treatment.
Osteonecrosis of the jaw (ONJ) — Jawbone damage can cause jaw pain, tooth or gum infections, or sores that do not heal.
Atypical femoral fracture — An unusual thigh bone fracture may cause new or unusual thigh, hip, or groin pain.
Multiple vertebral fractures after stopping treatment — Broken bones in the spine have been reported after denosumab products were discontinued.
Embryo-fetal toxicity — Bilprevda can harm your baby if used during pregnancy.

Get medical help right away if you think you are having a serious reaction.

How To Save on Bilprevda

Organon offers The Organon Access Program for Bilprevda. The program may help eligible people understand insurance coverage and make Bilprevda more affordable.

Eligible people with private insurance may pay as little as $0. Not all people are eligible, and restrictions apply.

The Organon Access Program also offers insurance and coverage support, including help understanding whether Bilprevda is covered, estimating out-of-pocket costs, and determining whether insurance requirements such as prior authorization apply.

To learn more, visit The Organon Access Program for Bilprevda or call 855-459-9965.

What To Know Before Taking Bilprevda

Before starting Bilprevda, 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.

Do not take Bilprevda if you take Bildyos (denosumab). Bilprevda contains the same medicine as Bildyos.

Tell your doctor if you have any allergies to denosumab products. Do not take Bilprevda if you have had a serious allergic reaction to Bilprevda or any of its ingredients.

Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Talk with your doctor about Bilprevda’s risks and benefits as part of your overall multiple myeloma treatment plan.

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 Bilprevda. Tell your dentist that you are taking Bilprevda.

Keep good oral hygiene and avoid invasive dental procedures during treatment when possible.

Bilprevda 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 Bilprevda, talk with your doctor about the risks and benefits.

Bilprevda can harm your baby if used during pregnancy. If you can become pregnant, your doctor should verify that you are not pregnant before starting Bilprevda.

You should use effective birth control during treatment and for at least five months after your last dose.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Bilprevda?

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 also similar between the two groups.

In people with newly diagnosed multiple myeloma, denosumab lowered uNTx/Cr, a marker of bone turnover, by about 75 percent by Week 5. These reductions stayed at about 74 percent to 79 percent from Weeks 9 to 49 when treatment was given every four weeks.

How long does Bilprevda take to work for multiple myeloma?

In people with newly diagnosed multiple myeloma, Bilprevda lowered levels of uNTx/Cr, a marker of bone turnover, by about 75 percent by Week 5 when given every four weeks.

In the clinical study, uNTx/Cr levels were used to measure changes in bone turnover during treatment with Bilprevda.

What tests or monitoring are needed with Bilprevda for multiple myeloma?

Your doctor should check your calcium level before you start Bilprevda. Any low calcium must be corrected before treatment begins.

Calcium levels should be monitored during treatment, especially during the first weeks after starting Bilprevda. 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 Bilprevda.

Tell your dentist that you are receiving Bilprevda. 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. Your doctor may consider this monitoring along with the rest of your multiple myeloma treatment journey.