phrotoxicity associated with high plasma concentrations of cyclosporine appear to be related to the neurological manifestations of cyclosporine toxicity.
In controlled studies, the nature, severity and incidence of the adverse events that were observed in 493 transplanted patients treated with cyclosporine (MODIFIED) were comparable with those observed in 208 transplanted patients who received Sandimmune® in these same studies when the dosage of the two drugs was adjusted to achieve the same cyclosporine blood trough concentrations.
Based on the historical experience with Sandimmune®, the following reactions occurred in 3% or greater of 892 patients involved in clinical trials of kidney, heart, and liver transplants.
|
|
|
Randomized Kidney Patients |
Cyclosporine Patients
Sandimmune® |
|
Body System |
Adverse Reactions |
|
|
|
|
|
Sandimmune®
(N = 227) % |
Azathioprine
(N = 228) % |
Kidney
(N = 705) % |
Heart
(N = 112) % |
Liver
(N = 75) % |
|
Genitourinary |
|
|
Renal Dysfunction |
32 |
6 |
25 |
38 |
37 |
|
Cardiovascular |
|
|
Hypertension |
26 |
18 |
13 |
53 |
27 |
|
|
Cramps |
4 |
< 1 |
2 |
< 1 |
0 |
|
Skin |
|
|
Hirsutism |
21 |
< 1 |
21 |
28 |
45 |
|
|
Acne |
6 |
8 |
2 |
2 |
1 |
|
Central Nervous System |
|
|
Tremor |
12 |
0 |
21 |
31 |
55 |
|
|
Convulsions |
3 |
1 |
1 |
4 |
5 |
|
|
Headache |
2 |
<1 |
2 |
15 |
4 |
|
Gastrointestinal |
|
|
Gum Hyperplasia |
4 |
0 |
9 |
5 |
16 |
|
|
Diarrhea |
3 |
< 1 |
3 |
4 |
8 |
|
|
Nausea/Vomiting |
2 |
< 1 |
4 |
10 |
4 |
|
|
Hepatotoxicity |
< 1 |
< 1 |
4 |
7 |
4 |
|
|
Abdominal Discomfort |
< 1 |
0 |
<1 |
7 |
