ELIQUIS (Page 3 of 11)

Other Adverse Reactions

Hypersensitivity reactions (including drug hypersensitivity, such as skin rash, and anaphylactic reactions, such as allergic edema) and syncope were reported in <1% of patients receiving ELIQUIS.

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

The safety of ELIQUIS has been evaluated in 1 Phase II and 3 Phase III studies including 5924 patients exposed to ELIQUIS 2.5 mg twice daily undergoing major orthopedic surgery of the lower limbs (elective hip replacement or elective knee replacement) treated for up to 38 days.

In total, 11% of the patients treated with ELIQUIS 2.5 mg twice daily experienced adverse reactions.

Bleeding results during the treatment period in the Phase III studies are shown in Table 3. Bleeding was assessed in each study beginning with the first dose of double-blind study drug.

Table 3: Bleeding During the Treatment Period in Patients Undergoing Elective Hip or Knee Replacement Surgery
Bleeding Endpoint* ADVANCE-3Hip Replacement Surgery ADVANCE-2Knee Replacement Surgery ADVANCE-1Knee Replacement Surgery
* All bleeding criteria included surgical site bleeding. Includes 13 subjects with major bleeding events that occurred before the first dose of ELIQUIS (administered 12 to 24 hours post-surgery). Includes 5 subjects with major bleeding events that occurred before the first dose of ELIQUIS (administered 12 to 24 hours post-surgery).§ Intracranial, intraspinal, intraocular, pericardial, an operated joint requiring re-operation or intervention, intramuscular with compartment syndrome, or retroperitoneal. Bleeding into an operated joint requiring re-operation or intervention was present in all patients with this category of bleeding. Events and event rates include one enoxaparin-treated patient in ADVANCE-1 who also had intracranial hemorrhage. CRNM = clinically relevant nonmajor.

ELIQUIS2.5 mg po bid35±3 days

Enoxaparin 40 mg sc qd 35±3 days

ELIQUIS 2.5 mg po bid 12±2 days

Enoxaparin 40 mg sc qd 12±2 days

ELIQUIS 2.5 mg po bid 12±2 days

Enoxaparin 30 mg sc q12h 12±2 days

First dose 12 to 24 hours post surgery

First dose 9 to 15 hours prior to surgery

First dose 12 to 24 hours post surgery

First dose 9 to 15 hours prior to surgery

First dose 12 to 24 hours post surgery

First dose 12 to 24 hours post surgery

All treated

N=2673

N=2659

N=1501

N=1508

N=1596

N=1588

Major (including surgical site)

22 (0.82%)

18 (0.68%)

9 (0.60%)

14 (0.93%)

11 (0.69%)

22 (1.39%)

Fatal

0

0

0

0

0

1 (0.06%)

Hgb decrease ≥2 g/dL

13 (0.49%)

10 (0.38%)

8 (0.53%)

9 (0.60%)

10 (0.63%)

16 (1.01%)

Transfusion of ≥2 units RBC

16 (0.60%)

14 (0.53%)

5 (0.33%)

9 (0.60%)

9 (0.56%)

18 (1.13%)

Bleed at critical site§

1 (0.04%)

1 (0.04%)

1 (0.07%)

2 (0.13%)

1 (0.06%)

4 (0.25%)

Major+ CRNM

129 (4.83%)

134 (5.04%)

53 (3.53%)

72 (4.77%)

46 (2.88%)

68 (4.28%)

All

313 (11.71%)

334 (12.56%)

104 (6.93%)

126 (8.36%)

85 (5.33%)

108 (6.80%)

Adverse reactions occurring in ≥1% of patients undergoing hip or knee replacement surgery in the 1 Phase II study and the 3 Phase III studies are listed in Table 4.

Table 4: Adverse Reactions Occurring in ≥1% of Patients in Either Group Undergoing Hip or Knee Replacement Surgery
ELIQUIS, n (%) 2.5 mg po bid N=5924 Enoxaparin, n (%) 40 mg sc qd or 30 mg sc q12h N=5904

Nausea

153 (2.6)

159 (2.7)

Anemia (including postoperative and hemorrhagic anemia, and respective laboratory parameters)

153 (2.6)

178 (3.0)

Contusion

83 (1.4)

115 (1.9)

Hemorrhage (including hematoma, and vaginal and urethral hemorrhage)

67 (1.1)

81 (1.4)

Postprocedural hemorrhage (including postprocedural hematoma, wound hemorrhage, vessel puncture-site hematoma, and catheter-site hemorrhage)

54 (0.9)

60 (1.0)

Transaminases increased (including alanine aminotransferase increased and alanine aminotransferase abnormal)

50 (0.8)

71 (1.2)

Aspartate aminotransferase increased

47 (0.8)

69 (1.2)

Gamma-glutamyltransferase increased

38 (0.6)

65 (1.1)

Less common adverse reactions in ELIQUIS-treated patients undergoing hip or knee replacement surgery occurring at a frequency of ≥0.1% to <1%:

Blood and lymphatic system disorders: thrombocytopenia (including platelet count decreases)

Vascular disorders: hypotension (including procedural hypotension)

Respiratory, thoracic, and mediastinal disorders: epistaxis

Gastrointestinal disorders: gastrointestinal hemorrhage (including hematemesis and melena), hematochezia

Hepatobiliary disorders: liver function test abnormal, blood alkaline phosphatase increased, blood bilirubin increased

Renal and urinary disorders: hematuria (including respective laboratory parameters)

Injury, poisoning, and procedural complications: wound secretion, incision-site hemorrhage (including incision-site hematoma), operative hemorrhage

Less common adverse reactions in ELIQUIS-treated patients undergoing hip or knee replacement surgery occurring at a frequency of <0.1%:

Gingival bleeding, hemoptysis, hypersensitivity, muscle hemorrhage, ocular hemorrhage (including conjunctival hemorrhage), rectal hemorrhage

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