Osenvelt (Denosumab-Bmwo) for Multiple Myeloma

Osenvelt (denosumab-bmwo) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for preventing skeletal-related events in adults with multiple myeloma.

How Osenvelt Works and How It’s Taken

Osenvelt is a type of medication called a RANK ligand inhibitor. It works by blocking RANKL, a protein that helps break down bone. In multiple myeloma, Osenvelt helps lower the risk of serious bone problems called skeletal-related events.

Doctors prescribe Osenvelt to adults with multiple myeloma to help prevent skeletal-related events, such as broken bones or other bone complications. By targeting this pathway, Osenvelt may help manage the risk of bone complications.

Osenvelt is given as an injection under the skin, typically once every four weeks. It is given by a healthcare provider in a healthcare setting, such as a clinic.

Typical Dosing for Multiple Myeloma

The recommended dose of Osenvelt is 120 milligrams given once every four weeks as an injection under the skin in the upper arm, upper thigh, or abdomen.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Osenvelt Side Effects

In clinical trials of Osenvelt for preventing skeletal-related events (bone complications) in people with multiple myeloma, the most common side effects occurred in about 11 percent to 34 percent of people. They 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

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

Severe allergic reactions, including anaphylaxis — These can cause trouble breathing, swelling of the face or throat, hives, or low blood pressure.
Severe hypocalcemia — Dangerously low calcium levels can be life-threatening.
Osteonecrosis of the jaw — Jawbone damage can cause jaw pain, infection, or slow healing in the mouth.
Atypical femur fracture — This unusual thigh bone fracture may cause new or unusual thigh, hip, or groin pain.
Multiple vertebral fractures after stopping treatment — More than one broken bone in the spine can occur after Osenvelt is discontinued.
Embryo-fetal toxicity — This medication may harm your baby if you are pregnant.

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

How To Save on Osenvelt

Celltrion USA, the manufacturer of Osenvelt, offers the Celltrion CARES Co-pay Program. Eligible people with commercial insurance may pay as little as $0 out of pocket for each dose.

To learn more, visit the Osenvelt financial assistance page, or call 877-81CONNC (877-812-6662).

What To Know Before Taking Osenvelt

Before starting Osenvelt, your doctor will check your calcium level. If your calcium is low, it must be treated first and brought up to a normal range before you receive Osenvelt. Do not take Osenvelt if you have low blood calcium.

Tell your doctor if you have any allergies to denosumab-bmwo or any ingredients in Osenvelt. Do not take Osenvelt if you have had a serious allergic reaction to denosumab-bmwo or any denosumab product.

Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, and supplements. If you receive Osenvelt, you should not receive other denosumab products at the same time.

Before taking Osenvelt, tell your doctor if you:

Take other denosumab products
Have low blood calcium
Cannot take daily calcium and vitamin D supplements
Take medicines that can lower blood calcium
Have a planned dental surgery or tooth removal

Osenvelt is also FDA approved to treat:

Adults and adolescents whose bones have stopped growing with giant cell tumor of bone that cannot be removed with surgery, or when surgery could cause severe complications
High blood calcium caused by cancer (hypercalcemia of malignancy) that has not improved after treatment with bisphosphonates

If you are pregnant, planning to become pregnant, or breastfeeding while taking Osenvelt, talk with your doctor about the risks and benefits. If you can become pregnant, your doctor should check if you are pregnant before you start Osenvelt, and you should use effective birth control during treatment and for at least five months after your last dose. It is unknown if Osenvelt passes into breast milk. Do not breastfeed during treatment with Osenvelt.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Osenvelt?

In a study of people with newly diagnosed multiple myeloma, Osenvelt helped delay the amount of time to a first serious bone problem. Also, bone markers that show bone breakdown dropped by about 75 percent by week 5 and stayed lower through week 49 with Osenvelt 120 milligrams every four weeks.

How long does Osenvelt take to work?

It is unknown how quickly Osenvelt starts to work for individuals with multiple myeloma. In studies, a bone turnover marker called uNTx/Cr decreased by about 75 percent by week 5, showing that bone breakdown slowed during treatment.

What tests or monitoring are needed with Osenvelt?

Before starting Osenvelt, your healthcare provider will check your calcium level and treat it if it is low. Your calcium should also be checked during treatment, especially in the first few weeks. You may need to take calcium and vitamin D to help keep your levels normal.

A dental exam is recommended before starting treatment, and you should take good care of your teeth during treatment.