This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.
Background and Date of Approval
Romosozumab is a humanised monoclonal antibody developed by Amgen Inc. and UCB Pharma. It was first approved by the U.S. Food and Drug Administration (FDA) on December 9, 2019. Romosozumab was introduced as a treatment option for osteoporosis in postmenopausal women who are at high risk of fractures.
Mechanism of Action of undefined
Romosozumab works by inhibiting sclerostin, a protein that negatively regulates bone formation. Sclerostin is produced by osteocytes and inhibits the activity of osteoblasts, the cells responsible for bone formation. By blocking sclerostin, Romosozumab promotes bone formation and reduces bone resorption, leading to increased bone mineral density and reduced fracture risk.
Uses of undefined
Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture. It is especially recommended for those who have a history of osteoporotic fractures or are at high risk of fractures and are not candidates for other osteoporosis treatments. It is used to reduce the risk of vertebral, non-vertebral, and hip fractures.
undefined Drug administaration and Dosage available
Romosozumab is administered via subcutaneous injection. The recommended dose is 210 mg once a month, given as two separate 105 mg injections in the upper arm, thigh, or abdomen. This monthly dosing regimen helps maintain effective levels of the drug in the body to provide ongoing therapeutic benefits.
Warnings, Precautions and Side Effects of undefined
Warnings
Romosozumab carries a warning for potential cardiovascular events. Patients with a history of cardiovascular disease should be closely monitored for signs of heart attack or stroke. Additionally, there is a risk of hypocalcemia, which requires monitoring and appropriate management.
Precautions
- Cardiovascular Health: Assess cardiovascular health before initiating treatment and monitor patients regularly for cardiovascular issues.
- Calcium Levels: Regularly check calcium levels and provide supplementation if necessary to manage hypocalcemia.
- Allergic Reactions: Monitor for severe allergic reactions and be prepared to manage them if they occur.
Side Effects
Common side effects of Romosozumab include:
- Injection site reactions (pain, redness, swelling)
- Headache
- Musculoskeletal pain
Serious side effects may include:
- Cardiovascular events such as myocardial infarction and stroke
- Severe allergic reactions
- Hypocalcemia (low calcium levels)
Word Of Advice
Before starting Romosozumab, ensure that patients are well-informed about the potential side effects and the need for regular monitoring. Emphasise the importance of adhering to the monthly injection schedule to achieve optimal therapeutic outcomes. Patients should be advised to report any unusual symptoms, particularly signs of cardiovascular distress or severe allergic reactions, to their healthcare provider immediately.
For more detailed information, consult the latest clinical guidelines and studies available through reputable medical sources.
Frequently Asked Question
References
Disclaimer
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