New Treatment Option for Advanced Cancer and Rare Bone Tumor
A new treatment, Wyost, has been approved for use in adults and adolescents with advanced cancer that has spread to the bones, as well as for a rare bone tumor called giant cell bone tumor. This offers a potential option for patients who are not candidates for surgery or for whom surgery carries significant risks.
Wyost, a monoclonal antibody, works by targeting a protein called RANKL, which is crucial for the formation and activity of cells that break down bone. By blocking RANKL, Wyost reduces bone destruction caused by cancer and, in the case of giant cell bone tumors, can support replace tumor tissue with healthy bone.
How Wyost Works
The medication, denosumab, specifically binds to RANKL, reducing the number and function of osteoclasts – cells responsible for bone resorption. This process diminishes the bone damage caused by cancer. In patients with giant cell bone tumors, Wyost inhibits or eliminates the giant cells that contribute to bone breakdown, promoting the growth of dense, healthy bone tissue in place of the tumor.
Dosage and Administration
The recommended dosage of Wyost is a 120 mg injection administered every four weeks via subcutaneous injection – typically in the thigh, abdomen, or upper arm – by a healthcare professional. For patients with giant cell bone tumors, additional 120 mg doses are given on days 8 and 15 of the first month of treatment.
Contraindications and Precautions
Wyost should not be used in individuals with a known hypersensitivity to any of its components, severe untreated low calcium levels, or unhealed wounds from dental surgery.
The treatment is not recommended during pregnancy or for women who are planning to become pregnant and are not using contraception. Women are advised to avoid pregnancy during treatment and for at least five months after stopping Wyost. Breastfeeding is similarly discouraged during treatment.
Potential Side Effects
Common side effects associated with Wyost include low calcium levels, diarrhea, difficulty breathing, and musculoskeletal pain. Other observed side effects include increased sweating, low phosphate levels, dental extractions, and osteonecrosis of the jaw.
Drug Interactions
Currently, no drug interaction studies have been conducted with Wyost. However, clinical trials have shown that the medication’s pharmacokinetic and pharmacologic properties were not altered when used alongside chemotherapy, hormone therapy, or after previous exposure to intravenous bisphosphonates.
Patients should not receive Wyost concurrently with bisphosphonates.
Monitoring and Follow-Up
Prior to initiating treatment, any existing low calcium levels should be corrected. Calcium levels should be monitored before the first injection, then two weeks later, and whenever symptoms of low calcium appear. Additional monitoring is recommended for patients with risk factors for hypocalcemia or based on their clinical status.
After stopping treatment, patients should be monitored for signs of high calcium levels, and calcium and vitamin D levels should be regularly assessed.
To prevent osteonecrosis of the jaw, a dental examination, including preventative care, and an individual risk-benefit assessment are recommended before starting Wyost. The possibility of osteonecrosis of the external ear canal should also be considered in patients experiencing ear symptoms, such as chronic ear infections.
Storage Information
- Store in the refrigerator between 32°F and 46°F (2°C and 8°C).
- Keep the container in the outer packaging, protected from light.
- Once removed from the refrigerator, Wyost can be stored at room temperature (up to 77°F or 25°C) for up to 30 days.
Important Patient Information
- Daily supplementation with at least 500 mg of calcium and 400 IU of vitamin D is recommended for all patients, unless hypercalcemia is present.
- Maintaining good oral hygiene and having regular dental checkups is crucial. Any oral symptoms, such as tooth mobility, pain, swelling, or non-healing ulcers, should be reported immediately.
- Patients should report any new or unusual pain in the thigh, hip, or groin due to the risk of incomplete atypical femoral fracture.
- Patients should receive the patient information leaflet and product information card provided by their doctor.
HAS Recommendation
The level of medical service provided (SMR) for Xgeva is applicable to Wyost.
Prescription Details
- Schedule I controlled substance.
- Prescription is limited to physicians specializing in oncology, as well as specialists and services in oncology and rheumatology.
Technical Specifications
Wyost, injectable solution 120 mg, 1.7 ml vial.
Schedule I, 100% Social Security reimbursement, €154.65 (excluding dispensing fees), CIP: 3400930305874.
Sandoz: +33 1 49 64 48 00
