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Generic Name
Denosumab
Brand Names
Ospomyv, Jubbonti, Bomyntra, Xgeva, Osenvelt, Xtrenbo, Conexxence, Bosaya, Oziltus, Boncresa, Denosumab-BMWO, WYOST, ENOBY, Aukelso, Bilprevda, Stoboclo, Bildyos
FDA approval date: June 05, 2010
Classification: RANK Ligand Inhibitor
Form: Injection
What is Ospomyv (Denosumab)?
Enoby is a RANK ligand inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture.
Approved To Treat
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Brand Information
OSPOMYV (denosumab)
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
- Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m
- The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients
- Prior to initiating Ospomyv in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Ospomyv in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD
1DOSAGE FORMS AND STRENGTHS
- Injection: 60 mg/mL clear, colorless to slightly yellow solution in a single-dose prefilled syringe.
2CONTRAINDICATIONS
Ospomyv is contraindicated in:
- Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Ospomyv
- 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
- 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
3ADVERSE REACTIONS
The following serious adverse reactions are discussed below and also elsewhere in the labeling:
- Severe Hypocalcemia and Mineral Metabolism Changes
- Hypersensitivity
- Osteonecrosis of the Jaw
- Atypical Subtrochanteric and Diaphyseal Femoral Fractures
- Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
- Serious Infections
- Dermatologic Adverse Reactions
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 patient incidence ≥ 10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.
3.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
3.2Postmarketing Experience
Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of denosumab products:
- Drug-related hypersensitivity reactions: anaphylaxis, rash, urticaria, facial swelling, and erythema
- Hypocalcemia: severe symptomatic hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases
- Musculoskeletal pain, including severe cases
- Parathyroid hormone (PTH): Marked elevation in serum PTH in patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis
- Multiple vertebral fractures following treatment discontinuation
- Cutaneous and mucosal lichenoid drug eruptions (e.g. lichen planus-like reactions)
- Alopecia
- Vasculitis (e.g. ANCA positive vasculitis, leukocytoclastic vasculitis)
- Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
4DESCRIPTION
Denosumab-dssb is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-dssb has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Ospomyv (denosumab-dssb) injection is a sterile, preservative-free, clear, colorless to slightly yellow solution for subcutaneous use.
Each single-dose prefilled syringe contains1 mL solution of 60 mg denosumab-dssb, 0.28 mg histidine, 3.81 mg histidine hydrochloride monohydrate, 0.1 mg polysorbate 20, 44 mg sorbitol, and Water for Injections. The pH is 5.2.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
6PRINCIPAL DISPLAY PANEL - 60 mg/mL Syringe Carton
NDC 83457-012-10
OSPOMYV™
60 mg/mL
Injection
1 x 60 mg/mL Single-dose Prefilled Syringe
Rx only
Single-dose Prefilled Syringe. Discard unused portion.
Ospomyv should be administered by a healthcare
ATTENTION: Dispense the accompanying
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