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Table 2 Concentration–time profiles for rivaroxaban in different patient populations observed in clinical studies [Bayer HealthCare Pharmaceuticals and Janssen Research & Development, LLC; data on file]

From: Rivaroxaban and other novel oral anticoagulants: pharmacokinetics in healthy subjects, specific patient populations and relevance of coagulation monitoring

Indication and rivaroxaban dose

VTE prevention:

DVT treatment:

Prevention of stroke in patients with AF and CrCl ≥50 ml/min:

Prevention of stroke in patients with AF and CrCl <50 ml/min:

Prevention of CV events in patients with ACS:

10 mg od

15 mg bid for 3 weeks followed by 20 mg od

20 mg od

15 mg od

2.5 mg bid

Time after dosing (hours)

Concentration, μg/l (5/95 percentile)

Concentration, μg/l (5/95 percentile)

Concentration, μg/l (5/95 percentile)

Concentration, μg/l (5/95 percentile)

Concentration, μg/l (5/95 percentile)

1

111 (75.1–177)

235 (164–361)

216 (152–316)

189 (134–281)

41.3 (23.5–65.9)

2

122 (90.6–195)

270 (189–419)

250 (177–361)

219 (157–317)

44.1 (26.7–69.5)

3

114 (82.3–186)

259 (180–405)

246 (172–361)

216 (153–317)

42.0 (25.9–66.4)

4

102 (75.8–164)

237 (161–369)

232 (157–349)

205 (141–309)

38.7 (23.3–63.3)

5

90.7 (62.2–143)

213 (145–339)

215 (140–333)

191 (127–297)

35.2 (20.2–59.1)

6

80.2 (51.8–125)

191 (123–311)

198 (123–318)

177 (111–286)

31.7 (17.4–55.5)

9

55.2 (30.5–96.0)

137 (71.3–240)

155 (81.9–276)

141 (74.9–254)

22.8 (10.4–45.2)

12

37.8 (15.2–76.1)

97.8 (42.9–190)

121 (53.4–242)

112 (50.0–225)

16.2 (6.11–36.6)

18

17.9 (4.85–49.9)

50.0 (16.0–124)

73.5 (22.0–187)

70.4 (21.9–180)

−

24

8.54 (1.36–37.2)

25.6 (5.93–86.9)

44.7 (9.02–147)

44.4 (9.42–143)

−

  1. Plasma concentrations given as geometric mean values with 90% prediction intervals (5/95 percentiles). Values given to 3 significant figures.
  2. ACS acute coronary syndrome, AF atrial fibrillation, bid twice daily, CrCl creatinine clearance, CV cardiovascular, DVT deep vein thrombosis, od once daily, VTE venous thromboembolism.