Trade Name: BEVYXXA®
For which conditions is this drug approved? BEVYXXA is indicated for the prevention of venous thromboembolism (VTE) in adults who are hospitalized for an acute illness and are have risk factors for VTE. VTE is a blood clot in a vein. The BEVYXXA labeling contains a boxed warning to alert healthcare professional and patients about the potential severe side effect of epidural or spinal hematomas which may result in permanent paralysis and should be considered when scheduling patients for spinal procedures.
What is the mechanism of action? BEVYXXA is a factor Xa (FXa) inhibitor which helps prevent blood clotting.
How is BEVYXXA typically given (administered)? BEVYXXA is taken orally, once per day at the same time each day with food. If a dose is missed, talk to your doctor.
How are patients typically monitored? During treatment with BEVYXXA, at a minimum your healthcare provider will do blood tests to check your blood counts before you start treatment and at least every two weeks for the first 3 months during treatment to check for side effects.
What are the common (occur in 20% or more of patients) side effects of treatment with BEVYXXA?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BEVYXXA and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions, particularly if you have pathological bleeding or kidney impairment. Avoid using BEVYXXA if you are taking another anticoagulant. Tell your physicians or dentist that you are taking BEVYXXA prior to any surgical, medical or dental procedure and before any new drug is taken. If you are having a spinal procedure while on BEVYXXA, discuss the sign and symptoms of spinal or epidural hematomas. If you are pregnant, plant to become pregnant or are breastfeeding, talk to your doctor about the risks and benefits of BEVYXXA.
When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. If you have had a spinal procedure while on BEVYXXA, let your doctor know immediately if you experience numbness or weakness of the legs, or bowel or bladder dysfunction.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated: 12/31/2017
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