Denosumab-bmwo
Generic Name: denosumab-bmwo
Brand Names:
Osenvelt
11 DESCRIPTION Denosumab-bmwo is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bmwo has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Osenvelt (denosumab-bmwo) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use.
Overview
11 DESCRIPTION Denosumab-bmwo is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bmwo has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Osenvelt (denosumab-bmwo) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use.
Uses
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.
Dosage
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.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.2) ] Hypocalcemia [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fracture [see Warnings and Precautions (5.5) ] Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons [see Warnings and Precautions (5.6) and Use in Specific Populations (8.4) ] Multiple vertebral fractures (MVF) following treatment discontinuation [see Warnings and Precautions (5.7) ] Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were f...
Warnings
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. 4 CONTRAINDICATIONS Hypocalcemia ( 4.1 ) Known clinically significant hypersensitivity to denosumab products ( 4.2 ) 4.1 Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with Osenvelt [see Warnings and Precautions (5.3) ].
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are insufficient data with denosumab products use in pregnant women to inform any drug associated risks for adverse developmental outcomes.
Storage
Storage and Handling Store Osenvelt refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Prior to administration, Osenvelt may be allowed to reach room temperature up to 25°C (77°F) in the original carton.
Frequently Asked Questions
What is Denosumab-bmwo used for?▼
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.
What are the side effects of Denosumab-bmwo?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.2) ] Hypocalcemia [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fracture [see Warnings and Precautions (5.5) ] Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons [see Warnings and Precautions (5.6) and Use in Specific Populations (8.4) ] Multiple vertebral fractures (MVF) following treatment discontinuation [see Warnings and Precautions (5.7) ] Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were f...
Can I take Denosumab-bmwo during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action, denosumab products can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are insufficient data with denosumab products use in pregnant women to inform any drug associated risks for adverse developmental outcomes.
What are the important warnings for Denosumab-bmwo?▼
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. 4 CONTRAINDICATIONS Hypocalcemia ( 4.1 ) Known clinically significant hypersensitivity to denosumab products ( 4.2 ) 4.1 Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with Osenvelt [see Warnings and Precautions (5.3) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.