ライフサイエンスコーパス: Neoral

1 nd the delayed introduction of cyclosporine (Neoral).

2 e of rejection associated with conversion to Neoral.

3 lity by staggering administration of RAD and Neoral.

4 130) received tacrolimus, and 7,319 received Neoral.

5 uivalent and indistinguishable from those of Neoral.

6 in patients who received Gengraf compared to Neoral.

7 o evaluate interchangeability of Gengraf and Neoral.

8 profile, comparable to the safety profile of Neoral.

9 osage can be treated safely by conversion to Neoral.

10 ions were achieved in all patients with p.o. Neoral.

11 ulin, mycophenolate mofetil, prednisone, and Neoral.

12 was used slightly less in the Neoral group (Neoral: 10%; SIM: 12%).

13 oadministration in two transplant monkeys of Neoral (150/100 mg/kg/day) and SDZ RAD (1.5 mg/kg/day) c

14 Simultaneous administration (n=6) of Neoral (150/100 mg/kg/day; MTL: 217+/-16 ng/ml) and SDZ

15 loss, withdrawal, or death) occurred in the Neoral (45%) than the SIM recipients (58%) (P=0.015) and

16 ndications were randomized to receive either Neoral 5 mg/kg BDS or Tacrolimus 0.05 mg/kg BDS orally.

17 ransplantation), cyclosporine microemulsion (Neoral) 60 mg/kg/b.i.d. on days +1 to +3 with dose adjus

18 s treated with either drug alone (RAD 27+/-3/Neoral 815+/-67 ng/ml).

19 Neoral, a microemulsion formulation of cyclosporine, was

20 (e.g., mycophenolate mofetil, tacrolimus and neoral) acute rejection rates have been steadily decreas

21 randomly assigned to three treatment groups: Neoral alone (n=6), FK778 alone (n=7), or a combination

22 with median survival times of 14.5 days for Neoral alone, 7 days for FK778 alone, and 36 days for Ne

23 allograft rejection in 19 of 20 dogs: in the Neoral-alone group, four dogs were type IB, and two were

24 ian time, 3.6 days) and 17 patients received Neoral and 16 SIM (for both drugs, 10 mg/kg/day).

25 tion, acute rejection occurred in 34% of the Neoral and 47% of the SIM recipients (P=0.037).

26 grafts) were 95% and 88%, respectively, for Neoral and 96% and 89% for SIM.

27 In combination with Neoral and corticosteroids, RAD doses of 2 mg and 4 mg/d

28 n=6), FK778 alone (n=7), or a combination of Neoral and FK778 (n=7).

29 re type IB, and one was type IIB; and in the Neoral and FK778 group, three dogs were type IB, three w

30 A combination of Neoral and FK778 prolonged allograft survival in a robus

31 A combination of Neoral and FK778 significantly prolonged allograft survi

32 one, 7 days for FK778 alone, and 36 days for Neoral and FK778.

33 rved in dogs treated with the combination of Neoral and FK778.

34 Combining Neoral and HMR 279 resulted in a significant decrease in

35 ttributed to improved absorption of CsA from Neoral and less variability in whole blood CsA concentra

36 bination in comparison to the combination of Neoral and LFM in a stringent allogeneic rodent lung tra

37 R 3.60, confidence interval [CI] 2.03-6.39), Neoral and mycophenolate mofetil (AHR 2.09, CI 1.31-3.31

38 Neoral and rapamycin derivative (RAD) have complementary

39 as no difference in adverse events comparing Neoral and Sandimmune (P=NS).

40 Many studies comparing Neoral and Sandimmune have been conducted, and although

41 ate of graft loss was similar when comparing Neoral and Sandimmune in all analyses.

42 Neoral and Sandimmune were compared in all patients and

43 Publications comparing the use of Neoral and Sandimmune were reviewed for demographic vari

44 is was to compare the safety and efficacy of Neoral and Sandimmune.

45 trolled trial of simultaneously administered Neoral and SDZ RAD in transplant monkeys (target SDZ RAD

46 Initially identical Neoral and SIM doses were titrated, maintaining trough C

47 ed the efficacy, safety, and tolerability of Neoral and SIM in preventing acute rejection in de novo

48 rful nonsteroidal immunosuppressants such as Neoral and Tacrolimus, routine administration of steroid

49 ts on a stable regimen of cyclosporine (CsA; Neoral) and prednisone.

50 when used in combination with cyclosporine (Neoral) and steroids.

51 ination with cyclosporine for microemulsion (Neoral) and steroids.

52 ive therapy with cyclosporine microemulsion (Neoral) and steroids.

53 nce liquid chromatography/mass spectrometry (Neoral), and blinded histology assessment of the transpl

54 Nine of 50 patients (18%) were converted to Neoral, and 4 patients were converted to azathioprine as

55 ngly important in selection of tacrolimus or Neoral as primary immunosuppressant for renal-transplant

56 e microemulsion formulation of cyclosporine (Neoral) as compared with tacrolimus.

57 = NS), with 80% for Tacrolimus and 73.5% for Neoral at 30 months.

58 ultaneously (n=8); or (D) RAD at 2.5 mg/kg + Neoral at 7.5 mg/kg (n=6) staggered 6 hr apart.

59 oral doses: (A) RAD at 2.5 mg/kg (n=9); (B) Neoral at 7.5 mg/kg (n=8); (C) RAD at 2.5 mg/kg + Neoral

60 l at 7.5 mg/kg (n=8); (C) RAD at 2.5 mg/kg + Neoral at 7.5 mg/kg simultaneously (n=8); or (D) RAD at

61 3) Staggered administration of RAD+Neoral avoided the pharmacokinetic interactions that cau

62 s demonstrated equivalent graft survival for Neoral compared with tacrolimus (66.9% versus 65.9%, res

63 cyclosporine (including separate analysis of Neoral) compared directly with tacrolimus, for the risk

64 y was necessary in 36% of patients receiving Neoral, compared with 13% of Tacrolimus patients (P = NS

65 idence intervals (CI) for the Gengraf versus Neoral comparison at steady state (day 28 vs. day 14) we

66 transplant recipients taking stable doses of Neoral completed a multicenter study.

67 nts from Sandimmune (cyclosporin A [CsA]) to Neoral (CsA-microemulsion [CsA-ME]), a dose conversion r

68 , TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF.

69 2 mg, or 4 mg/day of RAD in combination with Neoral (cyclosporine, USP MODIFIED) and corticosteroids.

70 psies in monkeys treated with vehicle (n=4), Neoral (day 1-7: 150 mg/kg/day; day 8-28: 100 mg/kg/day;

71 me milligram-for-milligram dosing regimen of Neoral during period III (days 29-35).

72 ter conversion, and showed that cyclosporin (Neoral) exhibited significantly less interpatient and in

73 entrate formulation of cyclosporine A (CsA) (Neoral) exhibits more uniform pharmacokinetics than the

74 nitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported

75 loss was 10.0% for tacrolimus and 10.6% for Neoral; for living donor recipients these figures were 6

76 nd mycophenolate mofetil (MMF, n=18) or CsA (Neoral formulation) and MMF (n=18).

77 n combination with either cyclosporine (CsA; Neoral formulation) or tacrolimus (TAC).

78 n=6); V, 10 mg/kg/day LFM plus 7.5 mg/kg/day Neoral given simultaneously (n=13); and VI, 10 mg/kg/day

79 VI, 10 mg/kg/day HMR 279 plus 7.5 mg/kg/day Neoral given simultaneously (n=6).

80 tory rejection was used slightly less in the Neoral group (Neoral: 10%; SIM: 12%).

81 he SIM group compared with only three in the Neoral group (P=0.027).

82 occurred in 9 of 17 patients (52.90%) in the Neoral group and in 9 of 16 patients (56.3%) in the SIM

83 derate/severe rejection did not occur in the Neoral group in this early period.

84 ents in the SIM group and no patients in the Neoral group required treatment with OKT3 for steroid-re

85 There were more episodes of rejection in the Neoral group, but there were no differences in bacterial

86 25 patients) or microemulsion cyclosporine (Neoral) (group 2, 24 patients).

87 and graft survival rates in the Prograf and Neoral groups at 18 months were 72 and 68% and 67 and 64

88 onotherapy) and completely clear (both RAD + Neoral groups) on day 21.

89 However, patients treated with Neoral had a lower incidence of moderate/severe histolog

90 apsule, an AB-rated generic cyclosporine for Neoral, has been shown to be bioequivalent in previous s

91 e present report was to evaluate the role of Neoral in OLTX recipients with neurotoxic complication w

92 f is well tolerated and interchangeable with Neoral in stable renal transplant recipients.

93 e microemulsion formulation of cyclosporine (Neoral) in comparison with Sandimmune (SIM) in the treat

94 sive efficacy of microemulsion cyclosporine (Neoral) in rodent heart transplantation.

95 Neoral is a microemulsion formulation of cyclosporine th

96 Neoral is a microemulsion formulation of cyclosporine.

97 Neoral is a safe and efficacious drug in the treatment o

98 been conducted, and although most state that Neoral is the superior cyclosporine formulation, results

99 Clinically, cyclosporine (CSA, Neoral) is titrated to concentrations, and not to pharma

100 .8 years; 17 men, 6 women) were converted to Neoral (mean 35+/-41 days after OLTX).

101 Tacrolimus or Neoral monotherapy after liver transplantation provides

102 At postoperative day 21, the Neoral monotherapy and the combination groups showed no

103 Grafts were mildly opacified (Neoral monotherapy) and completely clear (both RAD + Neo

104 us + azathioprine (AZA) versus cyclosporine (Neoral) + mycophenolate mofetil (MMF) versus tacrolimus

105 All patients received cyclosporine (Neoral), mycophenolate mofetil (CellCept, MMF), and cort

106 roid taper with randomization of patients to Neoral (N) or Tacrolimus (FK) is the basis of this repor

107 pients who either received Gengraf (n=88) or Neoral (n=100) in a single-center, retrospective review.

108 ollowing treatment groups: II, 7.5 mg/kg/day Neoral (n=6); III, 10 mg/kg/day LFM (n=6); IV, 10 mg/kg/

109 with a similar dose reduction algorithm for Neoral (Neo) was included for comparison.

110 The newer formulations of cyclosporine, Neoral (Novartis Pharmaceuticals; Basle, Switzerland), a

111 Group C received cyclosporine A (CsA) (Neoral, Novartis, Basel, Switzerland) and sirolimus with

112 cals, Basel, Switzerland), and cyclosporine (Neoral, Novartis, East Hanover, NJ).

113 f renal transplant recipients receiving CsA (Neoral; Novartis, Basel, Switzerland).

114 Subjects then switched from Neoral on a milligram-for-milligram basis to Gengraf dur

115 cadaveric kidney recipients (n=293) received Neoral or SIM twice daily for 12 months.

116 ore undergoing primary OLT to receive either Neoral or SIM.

117 r renal-transplant patients receiving either Neoral or tacrolimus with MMF and steroids, with no sign

118 nt immunosuppression "ab initio" with either Neoral or Tacrolimus, and no routine or maintenance ster

119 as 10.2% vs. 44.4% in the group converted to Neoral (P< or =0.04, Cox-Mantel test).

120 was 85% for Tacrolimus patients, and 78% for Neoral patients (P = NS), with 80% for Tacrolimus and 73

121 on for 87% of Tacrolimus patients and 64% of Neoral patients.

122 ry for 60% of Tacrolimus patients and 40% of Neoral patients.

123 As compared to patients who received Neoral, patients who received Gengraf were significantly

124 Combination therapies of Neoral plus HMR 279 or Neoral plus LFM were most success

125 bination therapies of Neoral plus HMR 279 or Neoral plus LFM were most successful in preventing histo

126 e therapy with cyclosporine A microemulsion (Neoral) plus the macrolide SDZ RAD 40-0 (2-hydroxyethyl)

127 at combined treatment of LFM or HMR 279 plus Neoral potentiates the immunosuppressive efficacies of t

128 Neoral reduced the incidence of acute rejection compared

129 Subjects continued their Neoral regimen during period I (days 1-14).

130 2.5 years was 73 and 62% for Tacrolimus and Neoral, respectively (P = NS).

131 Co-administration of LFM plus Neoral resulted in significantly higher LFM trough level

132 It begins with the newest formulation (Neoral, Sandoz Pharmaceuticals, East Hanover, NJ, USA) o

133 mbination of orally administered SDZ RAD and Neoral showed excellent immunosuppressive efficacy in a

134 ic studies showed cyclosporin in the form of Neoral showed less inter- and intrapatient variability t

135 (1) Administration of RAD + Neoral suppressed lung rejection more effectively than t

136 > or =250 microg/L) were reached faster with Neoral than SIM (P=0.0017).

137 was allocated to a patient receiving initial Neoral therapy and its mate allocated to a patient recei

138 ished trials, the data seem to indicate that Neoral therapy is preferred because of a lower rejection

139 als, the incidence of rejection was lower in Neoral-treated de novo and stable patients (P<0.05).

140 mmune-treated de novo liver transplants than Neoral-treated de novo liver transplants (P<0.00001).

141 The incidence of rejection was lower in Neoral-treated de novo renal, liver, and cardiac transpl

142 d studies, there were more adverse events in Neoral-treated patients (P<0.05), whereas in open-labele

143 In our Neoral-treated sample population, Cmax was associated wi

144 However, there were more adverse events in Neoral-treated stable patients (P<0.00001).

145 Neoral use was associated with more adverse events in bl

146 Neoral use was not associated with increased nephrotoxic

147 h), and AUC) were indistinguishable from the Neoral values in stable renal allograft recipients.

148 administration of the microemulsion (CsA-ME; Neoral) versus the corn oil-based (CsA-GC; Sandimmune) g

149 an increased risk of new-onset gout: use of Neoral (vs.

150 eric donor patients taking tacrolimus versus Neoral was 1.02 (95% confidence interval [CI] 0.8-1.3),

151 Neoral was replaced with a generic cyclosporine formulat

152 nts studied, the combination of HMR 279 plus Neoral was tolerated best as assessed by percentage of w

153 liver transplant patients from Sandimmune to Neoral, we conducted a prospective trial involving 54 pa

154 In addition, we conclude that TAC and CsA (Neoral), when combined with MMF, yield similar, low acut

155 re 3-year graft survival using tacrolimus or Neoral with mycophenolate mofetil (MMF) and steroids.