How to manage a patient on Eliquis (apixaban) for pulmonary embolism who develops rectal bleeding after receiving FOLFIRINOX (folinic acid, fluorouracil, irinotecan, oxaliplatin) chemotherapy?

From the Guidelines

For a patient on apixaban (Eliquis) for pulmonary embolism who develops rectal bleeding after FOLFIRINOX chemotherapy, temporarily discontinue apixaban and seek urgent medical evaluation. The patient should be assessed for hemodynamic stability, with vital signs monitoring and laboratory tests including complete blood count, coagulation studies, and renal function, as suggested by the 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants 1.

Assessing Bleed Severity

To determine the severity of the bleed, assess for factors such as bleeding at a critical site, hemodynamic instability, or clinically overt bleeding with hemoglobin decrease ≥2 g/dL or administration of ≥2 units RBCs, as outlined in the 2020 ACC guidelines 1.

Management of Bleeding

If the bleeding is severe, consider reversal with andexanet alfa or prothrombin complex concentrate, and provide local therapy/manual compression, as well as supportive care and volume resuscitation 1. For mild bleeding, holding apixaban for 1-2 days may be sufficient given its relatively short half-life of 12 hours.

Reassessing Anticoagulation

Once bleeding resolves, reassess the risk-benefit ratio of anticoagulation, considering options such as resuming apixaban at a reduced dose, switching to a different anticoagulant like low molecular weight heparin, or considering an inferior vena cava filter if anticoagulation must be withheld long-term. The bleeding likely results from FOLFIRINOX-induced mucositis combined with apixaban's anticoagulant effect, and close coordination between oncology and hematology is essential, with ongoing monitoring for both recurrent bleeding and thrombotic events, as cancer patients face elevated risks for both complications. The use of bevacizumab in FOLFIRINOX chemotherapy may also increase the risk of bleeding, as noted in the NCCN clinical practice guidelines in oncology 1.

From the FDA Drug Label

5 WARNINGS AND PRECAUTIONS 5.2 Bleeding Apixaban tablets increases the risk of bleeding and can cause serious, potentially fatal, bleeding

The patient on Eliquis (apixaban) for pulmonary embolism who develops rectal bleeding after receiving FOLFIRINOX chemotherapy should be managed with caution.

• Discontinue apixaban: The drug label recommends discontinuing apixaban in patients with active pathological bleeding 2.
• Assess bleeding: Evaluate the severity of the rectal bleeding and monitor the patient closely for signs of worsening bleeding.
• Consider alternative anticoagulation: If apixaban is discontinued, consider coverage with another anticoagulant to reduce the risk of thrombotic events 2.
• Restart apixaban with caution: Once the bleeding is controlled, apixaban can be restarted, but with careful monitoring for signs of bleeding 2.

Note: The management of rectal bleeding in a patient on apixaban requires careful consideration of the risk of thrombotic events and the risk of bleeding. The decision to discontinue or restart apixaban should be made on a case-by-case basis, taking into account the individual patient's risk factors and clinical presentation.

From the Research

Management of Rectal Bleeding in a Patient on Eliquis for Pulmonary Embolism

• The patient is on Eliquis (apixaban) for pulmonary embolism and has developed rectal bleeding after receiving FOLFIRINOX chemotherapy.
• The management of rectal bleeding in this patient should take into account the risk of bleeding associated with apixaban, as well as the potential risks and benefits of continuing or discontinuing anticoagulation therapy 3, 4.
• A study on the risk factors for bleeding in cancer patients treated with apixaban for venous thromboembolism found that age above 74 years, body mass index (BMI) below 21.7, and hemoglobin at baseline below 10.5 for females and 11.1 for males were associated with an increased risk of clinically relevant bleeding 4.
• Another study suggested that the use of apixaban may be beneficial in the management of chronic disseminated intravascular coagulation, with improvements in DIC parameters and clinical symptoms 5.
• However, there is limited evidence on the management of rectal bleeding in patients on apixaban, and the decision to continue or discontinue anticoagulation therapy should be made on a case-by-case basis, taking into account the individual patient's risk factors and clinical circumstances 6, 7.

Considerations for Anticoagulation Therapy

• The patient's platelet count should be monitored closely, as thrombocytopenia may increase the risk of bleeding 6.
• The use of dose-adjusted low molecular weight heparin (LMWH) may be considered as an alternative to apixaban, particularly in patients with a high risk of bleeding 6.
• The patient's renal function should also be monitored, as apixaban is renally cleared and may accumulate in patients with impaired renal function 7.

Monitoring and Follow-up

• The patient should be closely monitored for signs and symptoms of bleeding, as well as for any changes in their clinical condition 3, 4.
• Regular follow-up appointments should be scheduled to assess the patient's response to treatment and to adjust their anticoagulation therapy as needed 7, 5.