Products
Romosozumab was approved for injection in the United States and EU in 2019 and in many countries in 2020 (Evenity).
Structure and properties
Romosozumab is a humanized Ig2 monoclonal antibody with a molecular mass of 149 kDa produced by biotechnological methods.
Effects
Romosozumab (ATC M05BX06) promotes bone formation and, to a lesser extent, additionally inhibits bone resorption. The effects are due to inhibition of the glycoprotein sclerostin, which is produced by osteocytes and inhibits osteoblast function, differentiation, proliferation, and survival. Sclerostin exerts its effects by binding to receptors on the surface of osteoblasts.
Indications
For the treatment of manifest osteoporosis in postmenopausal women at significantly increased risk of fracture.
Dosage
According to the SmPC. The drug is injected subcutaneously once a month. The maximum duration of therapy is 12 months.
Contraindications
- Hypersensitivity
- Hypocalcemia
- History of myocardial infarction or stroke in the patient.
For complete precautions, see the drug label.
Interactions
No study of interactions has been conducted
Adverse effects
The most common potential adverse effects include joint pain and headache and nasopharyngitis. The results of a clinical trial (comparison with alendronate) show an increased risk of serious cardiovascular events with romosozumab. Appropriate precautions must be observed.
