Contraindications |
|
Severe hepatic impairment |
|
|
X |
|
Pregnancy |
|
|
X |
|
Current leflunomide treatment |
|
|
X |
|
Severe cardiovascular event (eg, myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, class III/IV heart failure) within the previous 6 months |
|
X |
|
|
History of or current Mobitz type II second- or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker |
|
X |
|
|
Baseline QTc interval ≥ 500 ms |
|
X |
|
|
Treatment with class Ia or III antiarrhythmic drugs |
|
X |
|
|
Warnings and precautions |
|
Atrioventricular block |
|
X |
|
|
Blood pressure increased |
|
X |
X |
|
Bone marrow disease; use not recommended |
|
|
X |
|
Bradyarrhythmia block |
|
X |
|
|
Hepatoxicity |
|
X |
X |
|
Hyperkalemia |
|
|
X |
|
Interstitial lung disease or worsening of pre-existing interstitial lung disease |
|
|
X |
|
Lung function decreased |
|
X |
|
|
Macular edema |
|
X |
|
|
Method for accelerated elimination of drug |
|
|
X |
|
Peripheral neuropathy |
|
|
X |
|
Acute renal failure |
|
|
X |
|
Concurrent use of immunosuppressive or immunomodulating therapies |
|
X |
X |
|
Severe immunodeficiency; use not recommended |
|
|
X |
|
White blood cell count decrease |
X |
X |
X |
|
Risk of infection |
|
X |
X |
|
Infections (severe, uncontrolled); use not recommended |
|
|
X |
|
Tuberculosis screening |
|
|
X |
|
Varicella zoster virus antibody testing/vaccination |
|
X |
|
|
Vaccination (live vaccines); use not recommended |
|
|
X |
|
Risk of malignancy |
|
|
X |
|
Skin reactions |
|
|
X |
|
Use in women of childbearing potential |
|
X |
X |
|
Flushing |
X |
|
|
|
Pregnancy |
Category C |
Category C |
Category X |
|
Breast-feeding |
Caution |
Not recommended |
Not recommended |