Osenvelt (Denosumab-Bmwo) for Myeloma

Overview
Osenvelt is approved by the U.S. Food and Drug Administration (FDA) to prevent skeletal-related events in people with multiple myeloma and in those with bone metastases from solid tumors. Skeletal-related events include bone fractures, spinal cord compression, and the need for radiation or surgery due to bone complications. Osenvelt is a biosimilar, meaning it is highly similar to an already approved biologic drug, Xgeva (denosumab), with no significant clinical differences in safety or effectiveness. Osenvelt is also known by its drug name, denosumab-bmwo.

Osenvelt is a RANK ligand (RANKL) inhibitor. It works by blocking RANKL, a protein involved in bone breakdown, to help strengthen bones and reduce the risk of fractures in patients with multiple myeloma.

How do I take it?
Prescribing information states that Osenvelt is given as a subcutaneous (under the skin) injection in the upper arm, upper thigh, or abdomen. For multiple myeloma, the recommended dose is one injection every four weeks. People should take calcium and vitamin D as recommended to help prevent low calcium levels. Osenvelt should be administered exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Osenvelt include fatigue, diarrhea, nausea, anemia (low red blood cell count), back pain, thrombocytopenia (low platelet count), peripheral edema (swelling in the limbs), hypocalcemia (low calcium levels), upper respiratory tract infection, rash, and headache.

Rare but serious side effects may include severe symptomatic hypocalcemia, osteonecrosis of the jaw (bone damage in the jaw), atypical femoral fractures (unusual thigh bone fractures), hypersensitivity reactions such as anaphylaxis (severe allergic reaction), multiple vertebral fractures after stopping treatment, and potential harm to an unborn fetus if taken during pregnancy. 

For more information about this treatment, visit:

FDA Approves Osenvelt — Drugs.com