DENOCI Injection (Denosumab)

Bone is the third most frequent site of metastasis behind lung and liver. The overall incidence of bone metastasis is not known. The relative incidence of bone metastasis by type of tumor, in patients with advanced metastatic disease, is: 65-75% in BC; 65-75% in prostate; 60% in thyroid; 30-40% in lung; 40% in bladder; 20-25% in renal cell carcinoma, 70-95% in multiple myeloma and 14-45% in melanoma.

Around 64% patients with breast cancer & bone metastases, 49% patients with prostate cancer & bone metastases develop risk of bone complications or skeletal related events - SRE (i.e fractures, need for bone surgery, need for radiation treatments to bone, spinal cord compression). In multiple myeloma, around 19% patients present with hypercalcemia, 60% patients experience pathological fractures, and 70% patients experience bone lesions. Bone metastases also accounts for about 20% of cases of hypercalcaemia.

In tumor pathology, there is over production of RANKL by osteoblasts which binds to RANK expressed by osteoclast progenitors, resulting in maturation, function and survival of osteoclasts and thereby bone resorption. Bone resorption leads to calcium mobilization into extracellular fluid which then enters the circulation and cause hypercalcaemia.

DENOCI (Denosumab) is a fully human, IgG2 monoclonal, synthetic antibody that binds to RANKL with high affinity, preventing its interaction with RANK in a way that is similar to the natural endogenous inhibitor osteoprotegerin and thereby inhibits bone resorption and prevents SRE’s.

DENOCI is available as solution for injection by subcutaneous route only (120mg/1.7ml single use vials)

DENOCI is indicated in:

Multiple Myeloma and Bone Metastases from Solid Tumours

Prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

Hypercalcaemia of Malignancy

Treatment of hypercalcaemia of malignancy refractory to bisphosphonates therapy.

Bone is the third most frequent site of metastasis behind lung and liver. The overall incidence of bone metastasis is not known. The relative incidence of bone metastasis by type of tumor, in patients with advanced metastatic disease, is: 65-75% in BC; 65-75% in prostate; 60% in thyroid; 30-40% in lung; 40% in bladder; 20-25% in renal cell carcinoma, 70-95% in multiple myeloma and 14-45% in melanoma.

Around 64% patients with breast cancer & bone metastases, 49% patients with prostate cancer & bone metastases develop risk of bone complications or skeletal related events - SRE (i.e fractures, need for bone surgery, need for radiation treatments to bone, spinal cord compression). In multiple myeloma, around 19% patients present with hypercalcemia, 60% patients experience pathological fractures, and 70% patients experience bone lesions. Bone metastases also accounts for about 20% of cases of hypercalcaemia.

In tumor pathology, there is over production of RANKL by osteoblasts which binds to RANK expressed by osteoclast progenitors, resulting in maturation, function and survival of osteoclasts and thereby bone resorption. Bone resorption leads to calcium mobilization into extracellular fluid which then enters the circulation and cause hypercalcaemia.

DENOCI (Denosumab) is a fully human, IgG2 monoclonal, synthetic antibody that binds to RANKL with high affinity, preventing its interaction with RANK in a way that is similar to the natural endogenous inhibitor osteoprotegerin and thereby inhibits bone resorption and prevents SRE’s.

DENOCI is available as solution for injection by subcutaneous route only (120mg/1.7ml single use vials)

DENOCI is indicated in:

Multiple Myeloma and Bone Metastases from Solid Tumours

Prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

Hypercalcaemia of Malignancy

Treatment of hypercalcaemia of malignancy refractory to bisphosphonates therapy.

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