GENGRAF ORAL SOLUTION(二十二)
|
0 |
Autonomic Nervous System |
|
Paresthesia |
3 |
0 |
1 |
2 |
1 |
|
Flushing |
< 1 |
0 |
4 |
0 |
4 |
Hematopoietic |
|
Leukopenia |
2 |
19 |
< 1 |
6 |
0 |
|
Lymphoma |
< 1 |
0 |
1 |
6 |
1 |
Respiratory |
|
Sinusitis |
< 1 |
0 |
4 |
3 |
7 |
Miscellaneous |
|
Gynecomastia |
< 1 |
0 |
< 1 |
4 |
3 |
Among 705 kidney transplant patients treated with cyclosporine oral solution in clinical trials, the reason for treatment discontinuation was renal toxicity in 5.4%, infection in 0.9%, lack of efficacy in 1.4%, acute tubular necrosis in 1.0%, lymphoproliferative disorders in 0.3%, hypertension in 0.3%, and other reasons in 0.7% of the patients.
The following reactions occurred in 2% or less of Sandimmune®-treated patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, muscle pain, peptic ulcer, thrombocytopenia, tinnitus.
The following reactions occurred rarely: anxiety, chest pain, constipation, depression, hair breaking, hematuria, joint pain, lethargy, mouth sores, myocardial infarction, night sweats, pancreatitis, pruritus, swallowing difficulty, tingling, upper GI bleeding, visual disturbance, weakness, weight loss.
Infectious Complications in Historical Randomized Studies in Renal Transplant Patients Using Sandimmune®
Complication |
Cyclosporine Treatment
(N = 227)
% of Complications |
Azathioprine with Steroids*
(N = 228)
% of Complications |
* Some patients also received ALG.
|
Septicemia |
5.3 |
4.8 |
Abscesses |
4.4 |
5.3 |
Systemic Fungal Infection |
2.2 |
3.9 |
Local Fungal Infection |
7.5 |
9.6 |
Cytomegalovirus |
4.8 |
12.3 |
Other Viral Infections |
15.9 |
18.4 |
Urinary Tract Infections |
21.1 |
20.2 |
Wound and Skin Infections |
7.0 |
10.1 |
Pneumonia |
6.2 |
9.2 |
Rheumatoid Arthritis
The principal adverse reactions associated with the use of cyclosporine in rheumatoid arthritis are renal dysfunction (see WARNINGS), hypertension (see PRECAUTI |