Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars - Seite 2

Bone is the third most frequent site for metastatic tumors.² Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.³

Wyost 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).^8,9 Wyost is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.¹

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Hypocalcemia and known clinically significant hypersensitivity to denosumab products.

WARNINGS AND PRECAUTIONS
Same Active Ingredient: Patients receiving Wyost should not receive other denosumab products concomitantly. Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Wyost. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Wyost. Monitor for symptoms. Avoid invasive dental procedures during treatment with Wyost. Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Wyost treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.