From the Guidelines
Gross hematuria while on Eliquis (apixaban) is a medical emergency that requires immediate attention, and the patient should be treated with andexanet alfa, a specific reversal agent for apixaban, as recommended by the 2020 ACC expert consensus decision pathway 1. When a patient on Eliquis presents with gross hematuria, it is crucial to consider the potential for a serious bleeding complication. The patient should contact their healthcare provider or go to the emergency room right away.
Key Considerations
- Do not stop taking Eliquis without medical guidance, as this could increase the risk of blood clots.
- While waiting for medical care, document when the bleeding started, its severity, and any associated symptoms like pain or clots.
- Eliquis is an anticoagulant that inhibits Factor Xa in the blood clotting cascade, which reduces clot formation but can increase bleeding risk.
- Potential causes of hematuria while on Eliquis include urinary tract infections, kidney stones, trauma, or underlying conditions like tumors.
Management
- The patient's doctor will likely perform tests including urinalysis, imaging studies, and possibly adjust their anticoagulation therapy.
- They may temporarily pause Eliquis depending on the bleeding severity and the reason the patient is taking the medication.
- According to the 2020 ACC expert consensus decision pathway, andexanet alfa is the recommended reversal agent for apixaban, with a low-dose or high-dose regimen depending on the timing of the last dose and the severity of the bleeding 1.
- Maintaining good hydration and avoiding activities with high injury risk while on anticoagulants can help reduce complications.
Reversal Agent
- Andexanet alfa is a specific reversal agent for apixaban, and its use is recommended in cases of major bleeding, such as gross hematuria 1.
- The dosing of andexanet alfa depends on the timing of the last dose of apixaban and the severity of the bleeding, with a low-dose regimen (400 mg IV bolus followed by 4 mg/min infusion for up to 120 minutes) or a high-dose regimen (800 mg IV bolus followed by 8 mg/min infusion for up to 120 minutes) 1.
From the FDA Drug Label
Hematuria (including respective laboratory parameters) Common adverse reactions (≥1%) were ... hematuria Adverse reactions occurring in ≥1% of patients in the AMPLIFY study are listed in Table 6 Apixaban N=2676 n (%) ... Hematuria 46 (1.7)
Gross Hematuria is a type of bleeding that can occur while on apixaban (Eliquis).
- The FDA drug label lists hematuria as a possible adverse reaction, occurring in 1.7% of patients in the AMPLIFY study 2.
- The label also mentions that bleeding reactions are a common adverse reaction to apixaban, and that hematuria is one of the specific types of bleeding that can occur 3.
- However, the label does not provide specific information on the incidence of gross hematuria.
- Given the available information, it is reasonable to conclude that gross hematuria is a possible adverse reaction to apixaban, but the exact incidence is not specified.
From the Research
Gross Hematuria while on Eliquis
- Gross hematuria is defined as the presence of blood in the urine, either on voiding or in a catheterized specimen 4
- The causes of gross hematuria include a wide spectrum of conditions, such as calculus, trauma, tumors, vascular, and miscellaneous causes 4
- In patients on anticoagulant therapy, gross hematuria can be a significant issue, and a thorough evaluation of the urinary tract should be conducted to identify any underlying pathological lesions 5
Evaluation of Gross Hematuria
- CT urography is a useful technique for evaluating gross hematuria, and it can be used alone for this task 4, 6
- The evaluation of gross hematuria should include an unenhanced scan, the nephrographic phase, and the excretory phase to detect various conditions such as renal parenchymal diseases, urothelial diseases, and calculus disease 4
- Other imaging modalities, such as ultrasound, intravenous urography, magnetic resonance imaging, retrograde ureterography, and pyelography, can also be used to evaluate gross hematuria 4
Anticoagulants and Gross Hematuria
- Anticoagulants, such as Eliquis, can increase the risk of gross hematuria, and medication with these drugs has a significant impact on the clinical course of gross hematuria 7, 8
- Drug-drug interactions can also lead to adverse clinical events or greater drug toxicity, and critical evaluation of medication and interdisciplinary counseling are recommended for patients with gross hematuria and urinary tract disease 7
- The risk of urological etiology of hematuria is lower in patients on oral anticoagulants, especially when INR >4, however, it is not zero 8