Enbrel - Side Effects & Drug Interactions

etanercept

• Enbrel - Drug Description
• Enbrel - Warnings & Precautions
• Enbrel - Clinical Pharmacology
• Enbrel - Overdosage & Contraindications
• Enbrel - Indications & Dosage
• Enbrel - Patient Info

ADVERSE REACTIONS

Adverse Reactions in Adult Patients with RA, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis

ENBREL® has been studied in 1442 patients with RA, followed for up to 80 months, in 157 patients with psoriatic arthritis for 6 months, in 222 patients with ankylosing spondylitis for up to10 months, and 1261 patients with plaque psoriasis for up to 15 months. In controlled trials, the proportion of ENBREL®-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied. The vast majority of these patients were treated with25 mg SC twice weekly. In plaque psoriasis studies, ENBREL® doses studied were 25 mg SC oncea week, 25 mg SC twice a week, and 50 mg SC twice a week.

Injection Site Reactions

In controlled trials in rheumatologic indications, approximately 37% of patients treated withENBREL® developed injection site reactions. In controlled trials in patients with plaque psoriasis,14% of patients treated with ENBREL® developed injection site reactions during the first 3 monthsof treatment. All injection site reactions were described as mild to moderate (erythema and/oritching, pain, or swelling) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given. In post-marketing experience, injection site bleeding and bruising have also been observed in conjunction with ENBREL®therapy.

Infections

In controlled trials, there were no differences in rates of infection among RA, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis patients treated with ENBREL® and those treated with placebo (or MTX for RA and psoriatic arthritis patients). The most common type of infection was upper respiratory infection, which occurred at a rate of approximately 20% among both ENBREL®-and placebo-treated patients in RA, psoriatic arthritis, and AS trials, and at a rate of approximately12% among both ENBREL®- and placebo-treated patients in plaque psoriasis trials in the first 3months of treatment.