From the FDA Drug Label
XTANDI may cause serious side effects including:
- Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with XTANDI
- Bleeding problems
The FDA drug label does not directly answer the question regarding contraindications to open heart surgery, cardiopulmonary bypass, or bleeding with Xtandi (Enzalutamide). However, it does mention that heart disease and bleeding problems are potential side effects of XTANDI.
- Heart disease is a concern, and patients should be monitored for signs and symptoms of heart problems during treatment with XTANDI.
- Bleeding problems are also a potential side effect, but the label does not provide specific information about the risk of bleeding with open heart surgery, cardiopulmonary bypass, or other procedures. Based on the available information, it is not possible to determine if there are any contraindications to open heart surgery, cardiopulmonary bypass, or bleeding with Xtandi (Enzalutamide) 1 1.
From the Research
There are no specific contraindications for patients on Xtandi (enzalutamide) undergoing open heart surgery or cardiopulmonary bypass procedures, but caution is advised due to potential bleeding risks and interactions with anticoagulant medications. When considering open heart surgery or cardiopulmonary bypass for patients on Xtandi, it's essential to weigh the benefits against the potential risks, particularly those related to bleeding. The provided evidence does not directly address the interaction between Xtandi and bleeding risks in the context of open heart surgery or cardiopulmonary bypass. However, studies such as 2 suggest that antifibrinolytic agents like tranexamic acid can reduce postoperative bleeding in cardiac surgery, which might be relevant when managing patients on medications that could potentially increase bleeding risk.
Key Considerations
- Informing the surgical team about Xtandi use is crucial, as temporary discontinuation might be considered on a case-by-case basis, typically 1-2 weeks before major surgery if bleeding risk is a concern.
- Xtandi does not directly affect platelet function or coagulation factors, but its interactions with medications like warfarin require close monitoring of INR levels.
- Patients on Xtandi may have an increased risk of falls and fractures due to side effects like fatigue and dizziness, which could complicate post-surgical recovery.
- Resumption of Xtandi after surgery should be based on adequate wound healing and stabilization of the patient's condition, usually within 1-2 weeks post-procedure, as determined by the healthcare team.
Evidence Review
The most relevant study to the question of bleeding risk in cardiac surgery is 2, which demonstrates the efficacy of tranexamic acid in reducing postoperative bleeding. While this study does not specifically address Xtandi, it highlights the importance of managing bleeding risk in cardiac surgery. Other studies, such as 3, 4, and 5, provide insights into the management of bleeding in cardiac surgery but do not directly address the use of Xtandi.
Clinical Decision
Given the potential for increased bleeding risk and the importance of managing anticoagulation, healthcare providers should carefully assess the risk-benefit ratio for each patient on Xtandi undergoing open heart surgery or cardiopulmonary bypass. This assessment should consider the patient's overall health, the specific surgical procedure, and the potential for drug interactions. Close monitoring and management of bleeding risk, as well as careful consideration of when to resume Xtandi post-surgery, are critical components of care.