1.64, 3.49)
p < 0.001
A summary of major and CRNM bleeding events by dose is shown in Table 2 and Table 3.
Table 2: Summary of Adjudicated Major, CRNM, Major or CRNM Bleeding Events through 7 Days after Discontinuation for Patients Receiving 80 mg
Parameter BEVYXXA 80 mg
(N=2,986)
n (%) Enoxaparin
40 mg
(N=2,991)
n (%)
Major 15 (0.50) 16 (0.53)
RR (95% CI) 0.94 (0.47, 1.90)
Clinically Relevant Non-Major (CRNM) 66 (2.21) 33 (1.10)
RR (95% CI) 2.00 (1.32, 3.03)
Major or CRNM 81 (2.71) 49 (1.64)
RR (95% CI) 1.66 (1.17, 2.35)
Table 3: Summary of Adjudicated Major, CRNM, Major or CRNM Bleeding Events through 7 Days after Discontinuation for Patients Receiving 40 mg
Severe Renal Impairment Concomitant use of P-gp Inhibitor
Parameter BEVYXXA 40 mg
(N=150)
n (%) Enoxaparin 20 mg
(N=125)
n (%) BEVYXXA 40 mg
(N=542)
n (%) Enoxaparin 40 mg
(N=527)
n (%)
Major 3 (2.00) 1 (0.80) 6 (1.11) 4 (0.76)
RR (95% CI) 2.5 (0.26, 23.74) 1.46 (0.41, 5.14)
Clinically Relevant Non-Major (CRNM) 6 (4.00) 2 (1.60) 20 (3.69) 3 (0.57)
RR (95% CI) 2.5 (0.51, 12.17) 6.5 (1.94, 21.68)
Major or CRNM 9 (6.00) 3 (2.40) 26 (4.80) 7 (1.33)
RR (95% CI) 2.5 (0.69, 9.04) 3.6 (1.58, 8.25)
The most common adverse reactions occurring in ≥ 2% of patients are shown in Table 4.
Table 4: Adverse Reactions in APEX Occurring in ≥ 2% of Patients
Adverse Reaction BEVYXXA
N=3,716
n (%) Enoxaparin
N=3,716
n (%)
Bleeding-Related (all sources)
Epistaxis 58 (2) 24 (1)
Hematuria 62 (2) 28 (1)
Non Bleeding Adverse Reaction
Urinary Tract Infection 123 (3) 87 (2)
Constipation 110 (3) 102 (3)
Hypokalemia 93 (3) 84 (2)
Hypertension 89 (2) 80 (2)
Headache 74 (2) 59 (2)
Nausea 67 (2) 56 (2)
Diarrhea 64 (2) 61 (2)
Other Adverse Reactions
Hypersensitivity reactions: one patient experienced a serious adverse reaction of moderate hypersensitivity
7 DRUG INTERACTIONS
7.1 Inhibitors of P-gp
BEVYXXA is a substrate of P-gp and concomitant use of P-gp inhibitors (e.g., amiodarone, azithromycin, verapamil, ketoconazole, clarithromycin) results in an increased exposure of BEVYXXA [see CLINICAL PHARMACOLOGY (12.3)].
Reduce the dose of BEVYXXA for patients receiving or starting concomitant P-gp inhibitors [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.4), CLINICAL PHARMACOLOGY (12.3)].
7.2 Anticoagulants, Antiplatelets, and Thrombolytics
Co-administration of anticoagulants, antiplatelet drugs, and thrombolytics may increase the risk of bleeding. Promptly eva luate any signs or symptoms of blood loss if patients are treated concomitantly with anticoagulants, aspirin, other platelet aggregation inhibitors, and/or NSAIDs [see WARNINGS AND PRECAUTIONS (5.1)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no data with the use of BEVYXXA in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery (see CLINICAL CONSIDERATIONS) |
