Osenvelt

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Osenvelt is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of 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. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Osenvelt is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Osenvelt is indicated for the treatment of 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 [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Osenvelt is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Dosage and administration 2 DOSAGE AND ADMINISTRATION Osenvelt should be administered by a healthcare provider. ( 2.1 ) Osenvelt is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. ( 2.1 ) Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.2 ) Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. ( 2.3 ) Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia. ( 2.2 , 2.3 ) Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. ( 2.4 ) 2.1 Important Administration Instructions Osenvelt should be administered by a healthcare provider. Osenvelt is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. 2.2 Multiple Myeloma and Bone Metastasis from Solid Tumors The recommended dose of Osenvelt is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3) ]. 2.3 Giant Cell Tumor of Bone The recommended dose of Osenvelt is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3) ]. 2.4 Hypercalcemia of Malignancy The recommended dose of Osenvelt is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. 2.5 Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Osenvelt is a clear, colorless to pale yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains particles or foreign particulate matter. Prior to administration, Osenvelt may be removed from the refrigerator and brought to room temperature up to 25°C (77°F) by standing in the original carton. This generally takes 15 to 30 minutes. Do not warm Osenvelt in any other way [see How Supplied/Storage and Handling (16) ]. Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-dose or entry. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Drug Products with Same Active Ingredient: Patients receiving Osenvelt should not receive other denosumab products concomitantly. ( 5.1 ) Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. ( 5.2 ) Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Osenvelt. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. ( 5.3 ) Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Osenvelt. Monitor for symptoms. Avoid invasive dental procedures during treatment with Osenvelt. ( 5.4 ) Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule