|
ONS), headache, gastrointestinal disturbances and hirsutism/hypertrichosis.
In rheumatoid arthritis patients treated in clinical trials within the recommended dose range, cyclosporine therapy was discontinued in 5.3% of the patients because of hypertension and in 7% of the patients because of increased creatinine. These changes are usually reversible with timely dose decrease or drug discontinuation. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced without dose reduction or discontinuation.
The Following Adverse Events Occurred in Controlled Clinical Trials
Cyclosporine (MODIFIED)/Sandimmune® Rheumatoid Arthritis Percentage of Patients with Adverse Events ≥ 3% in any Cyclosporine Treated Group
|
|
|
Studies
651+652+2008 |
Study
302 |
Study
654 |
Study
654 |
Study
302 |
Studies
651+652
+2008 |
Body
System |
Preferred Term |
Sandimmune®†
(N = 269) |
Sandimmune®
(N = 155) |
Methotrexate
& Sandimmune®
(N = 74) |
Methotrexate
& Placebo
(N = 73) |
Cyclosporine
(MODIFIED)
(N = 143) |
Placebo
(N = 201) |
|
† Includes patients in 2.5 mg/kg/day dose group only.
* NOS = Not Otherwise Specified.
|
|
Autonomic Nervous System Disorders |
|
|
Flushing |
2% |
2% |
3% |
0% |
5% |
2% |
|
Body As A Whole - General Disorders |
|
|
Accidental Trauma |
0% |
1% |
10% |
4% |
4% |
0% |
|
|
Edema NOS* |
5% |
14% |
12% |
4% |
10% |
< 1% |
|
|
Fatigue |
6% |
3% |
8% |
12% |
3% |
7% |
|
|
Fever |
2% |
3% |
0% |
0% |
2% |
4% |
|
|
Influenza-like symptoms |
< 1% |
6% |
1% |
0% |
3% |
2% |
|
|
Pain |
6% |
9% |
10% |
15% |
13% |
4% |
|
|
Rigors |
1% |
1% |
4% |
0% |
3% |
1% |
|
Cardiovascular Disorders |
|
|
Arrhythmia |
2% |
5% |
5% |
6% |
|
