OSPOMYV 60 mg/mL
denosumab · INJECTION, SOLUTION · Cordavis Limited
OSPOMYV is a injection, solution containing denosumab at 60 mg/mL, taken subcutaneous. Manufactured by Cordavis Limited.
Key Facts
- Brand Name
- OSPOMYV
- Generic Name
- denosumab
- NDC Code (Product)
83457-012- Manufacturer
- Cordavis Limited
- Strength
- 60 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761392
- Drug Class
- RANK Ligand Inhibitor [EPC]
- Marketing Start
- 10/10/2025
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 Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Ospomyv is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies (14.1) ] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Ospomyv is indica…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Pregnancy must be ruled out prior to administration of Ospomyv. ( 2.1 ) Before initiating Ospomyv in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) Ospomyv should be administered by a healthcare provider. ( 2.3 ) Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.3 ) Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. ( 2.3 ) 2.1 Pregnancy Testing Prior to Initiation of Ospomyv Pregnancy must be ruled out prior to administration of Ospomyv. Perform pregnancy testing in all females of reproductive potential prior to administration of Ospomyv. Based on findings in animals, denosumab products can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1 , 8.3) ] . 2.2 Laboratory Testing in Patients with Advanced Chronic Kidney Disease Prior to Initiation of Ospomyv In patients with advanced chronic kidney disease [i.e., es…
Contraindications
4 CONTRAINDICATIONS Ospomyv is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Ospomyv [see Warnings and Precautions (5.1) ] . Pregnant women: Denosumab products may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Ospomyv [see Use in Specific Populations (8.1) ] . Patients with hypersensitivity to denosumab products: Ospomyv is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) ] . Hypocalcemia ( 4 , 5.1 ) Pregnancy ( 4 , 8.1 ) Known hypersensitivity to denosumab products ( 4 , 5.3 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and also elsewhere in the labeling: Severe Hypocalcemia and Mineral Metabolism Changes [see Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation [see Warnings and Precautions (5.6) ] Serious Infections [see Warnings and Precautions (5.7) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions reported with denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. The most common adverse reactions reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. The most common (per patien…
Frequently Asked Questions
What is OSPOMYV used for?
OSPOMYV contains denosumab. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is OSPOMYV a controlled substance?
OSPOMYV is not classified as a controlled substance by the DEA.
What is the generic name for OSPOMYV?
The generic name for OSPOMYV is denosumab. There are 11 other brand versions of denosumab.
What is the NDC code for OSPOMYV 60 mg/mL?
The NDC (National Drug Code) for OSPOMYV 60 mg/mL is 83457-012, listed by Cordavis Limited.