Enbrel Warnings & Precautions - etanercept

[etanercept]

WARNINGS

INFECTIONS

IN POST-MARKETING REPORTS, SERIOUS INFECTIONS AND SEPSIS, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH THE USE OF ENBREL®. MANY OF THE SERIOUS INFECTIONS HAVE OCCURRED IN PATIENTS ON CONCOMITANT IMMUNOSUPPRESSIVE THERAPY THAT, IN ADDITION TO THEIR UNDERLYING DISEASE, COULD PREDISPOSE THEM TO INFECTIONS.

RARE CASES OF TUBERCULOSIS (TB) HAVE BEEN OBSERVED IN PATIENTS TREATED WITH TNF ANTAGONISTS, INCLUDING ENBREL®. PATIENTS WHO DEVELOP A NEW INFECTION WHILE UNDERGOING TREATMENT WITH ENBREL® SHOULD BE MONITORED CLOSELY. ADMINISTRATION OF ENBREL® SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS INFECTION OR SEPSIS. TREATMENT WITH ENBREL® SHOULD NOT BE INITIATED IN PATIENTS WITH ACTIVE INFECTIONS INCLUDING CHRONIC OR LOCALIZED INFECTIONS.

PHYSICIANS SHOULD EXERCISE CAUTION WHEN CONSIDERING THE USE OF ENBREL® IN PATIENTS WITH A HISTORY OF RECURRING INFECTIONS OR WITH UNDERLYING CONDITIONS WHICH MAY PREDISPOSE PATIENTS TO INFECTIONS, SUCH AS ADVANCED OR POORLY CONTROLLED DIABETES (see PRECAUTIONS and ADVERSE REACTIONS: Infections).

IN A 24-WEEK STUDY OF CONCURRENT ENBREL® AND ANAKINRA THERAPY,THE RATE OF SERIOUS INFECTIONS IN THE COMBINATION ARM (7%) WASHIGHER THAN WITH ENBREL® ALONE (0%). THE COMBINATION OF ENBREL®AND ANAKINRA DID NOT RESULT IN HIGHER ACR RESPONSE RATES COMPAREDTO ENBREL® ALONE (see CLINICAL STUDIES: Clinical Response and ADVERSEREACTIONS: Infections). CONCURRENT THERAPY WITH ENBREL® ANDANAKINRA IS NOT RECOMMENDED.

Neurologic Events

Treatment with ENBREL® and other agents that inhibit TNF have been associated with rare casesof new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases of transverse myelitis, optic neuritis, multiple sclerosis, and new onset or exacerbation of seizure disorders have been observed in association with ENBREL® therapy. The causal relationship to ENBREL®therapy remains unclear. While no clinical trials have been performed evaluating ENBREL®therapy in patients with multiple sclerosis, other TNF antagonists administered to patients with multiple sclerosis have been associated with increases in disease activity.7, 8 Prescribers should exercise caution in considering the use of ENBREL® in patients with preexisting or recent-onset central nervous system demyelinating disorders (see ADVERSE REACTIONS).