BOMYNTRA 70 mg/mL
Denosumab · INJECTION · Fresenius Kabi USA, LLC
BOMYNTRA is a injection containing denosumab at 70 mg/mL, taken subcutaneous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- BOMYNTRA
- Generic Name
- Denosumab
- NDC Code (Product)
65219-670- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 70 mg/mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761398
- Drug Class
- RANK Ligand Inhibitor [EPC]
- Marketing Start
- 06/30/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bomyntra 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 Bomyntra 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 Bomyntra 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 Bomyntra is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Bomyntra should be administered by a healthcare provider. ( 2.1 ) Bomyntra 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 Bomyntra should be administered by a healthcare provider. Bomyntra is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. 2.2 Multiple Myeloma and Bone Metastasis from Soli…
Contraindications
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 Bomyntra [see Warnings and Precautions ( 5.3 )] . 4.2 Hypersensitivity Bomyntra is contraindicated in patients with known clinically significant hypersensitivity to denosumab products [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] .
Adverse Reactions
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 fatigue/asthenia, hypophosphatemia, and nausea. ( 6.1 ) Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. ( 6.1 ) Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and p…
Frequently Asked Questions
What is BOMYNTRA used for?
BOMYNTRA contains Denosumab. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is BOMYNTRA a controlled substance?
BOMYNTRA is not classified as a controlled substance by the DEA.
What is the generic name for BOMYNTRA?
The generic name for BOMYNTRA is Denosumab. There are 10 other brand versions of Denosumab.
What is the NDC code for BOMYNTRA 70 mg/mL?
The NDC (National Drug Code) for BOMYNTRA 70 mg/mL is 65219-670, listed by Fresenius Kabi USA, LLC.