Overview
EVENITY (romosozumab-aqqg) is a humanized monoclonal antibody specifically designed to inhibit the activity of the protein sclerostin. sclerostin, a regulatory factor in bone metabolism, plays a crucial role in regulating bone formation and preventing bone resorption. By blocking the function of sclerostin, EVENITY enhances bone formation in both trabecular and cortical bone surfaces, leading to an increase in bone mass and improved bone structure and strength. Consequently, Evenity is a potential novel treatment option for postmenopausal women with osteoporosis.
Indication and Usage
EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for骨折. It is also approved for use in certain females who have failed or are intolerant to other available osteoporosis therapies. Notably, EVENITY is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or any component of its formulation.
Dosage Form and Administration
EVENITY is given as a subcutaneous injection in a prefilled syringe. The recommended dose of EVENITY is 210mg administered subcutaneously in the abdomen, thigh, or upper arm. Patients should receive two separate injections 1 month apart for a complete course of treatment, totaling 210mg of EVENITY.
Storage and Handling
EVENITY must be stored at 2°C to 8°C (36°F to 46°F) in the original carton in order to preserve its integrity. Once removed from the refrigerator, EVENITY should be kept at room temperature up to 25°C (77°F) for a maximum of 30 days. Any samples that have been removed from the refrigeration should be discarded if not used within this timeframe.
Patient Information
EVENITY is a prescription drug that must be administered under the guidance of a healthcare provider. It is not advised for use in children and individuals with a history of low blood calcium levels, allergies to romosozumab or its components, or previous serious allergic reactions to the drug.
Side Effects
EVENITY is generally well-tolerated; however, it may cause potential serious side effects, including:
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Increased risk of heart attack, stroke, and cardiovascular death: Evenity may increase the risk of heart attack, stroke, and death from a cardiovascular (heart or blood vessel) problem. Symptoms may include chest pain or pressure, shortness of breath, feeling light-headed or dizzy, headache, numbness or weakness in the face, arm, or legs, difficulty talking, changes in vision, or loss of balance and coordination.
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Hypocalcemia: Evenity may lower blood calcium levels and requires treatment before initiating therapy.
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Osteonecrosis of the jaw (ONJ): This condition may rare and is associated with tooth extraction and/or local infection with delayed healing.
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Atypical subtrochanteric and diaphyseal femoral fractures: These fractures may occur without a clear trauma history and typically result in significant morbidity.
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Immunogenicity: Anti-romosozumab-aqqg antibodies may develop in some patients, although their clinical significance is not fully understood.
Contraindications
EVENITY is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or any component(s) of the product formulation.
Precautions
EVENITY is contraindicated in patients with hypercalcemia, severe kidney diseases, and individuals at high risk for developing hypocalcemia.
Use in Specific Populations
- Pregnant women: Use of EVENITY in pregnant women is contraindicated.
- Breastfeeding women: Use of EVENITY in breastfeeding women is contraindicated.
Overdose Information
There are no known overdoses of EVENITY.
Adverse Reactions
Please see "Adverse Events" and "临床药理学" sections in the reference information for detailed information on common and serious adverse reactions associated with Evenity.
Storage and Handling
EVENITY should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and used within a maximum of 30 days after removal from the refrigerator.
More About EVENITY
EVENITY (romosozumab-aqqg) is a prescription drug used in the treatment of osteoporosis in postmenopausal women at high risk for骨折. However, its safety and efficacy in other patient populations remain to be established. Additional studies are necessary to determine the effects of Evenity on bones, risk reduction on fracture, and potential long-term effects in various clinical scenarios.
References
- Evenity (romosozumab-aqqg) Injection (20mg/mL) – Prescribing Information
- FDA – Labeling:Romosozumab-Aqqg (Evenity)
- Evenity (Romosozumab-aqqg) Injection (10mg/mL) – Prescribing Information
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