ving ENBREL® may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving ENBREL® (see PRECAUTIONS: Immunosuppression).
It is recommended that JIA patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ENBREL® therapy. Patients with a significant exposure to varicella virus should temporarily discontinue ENBREL® therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Autoimmunity
Treatment with ENBREL® may result in the formation of autoantibodies (see ADVERSE REACTIONS: Autoantibodies) and, rarely, in the development of a lupus-like syndrome or autoimmune hepatitis (see ADVERSE REACTIONS: Adverse Reaction Information from Spontaneous Reports), which may resolve following withdrawal of ENBREL®. If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with ENBREL®, treatment should be discontinued and the patient should be carefully eva luated.
Drug Interactions
Specific drug interaction studies have not been conducted with ENBREL®. However, it was observed that the pharmacokinetics of ENBREL® was unaltered by concomitant methotrexate in rheumatoid arthritis patients.
In a study in which patients with active RA were treated for up to 24 weeks with concurrent ENBREL® and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with ENBREL® alone (0%) (see also WARNINGS). Two percent of patients treated concurrently with ENBREL® and anakinra developed neutropenia (ANC < 1 x 109/L).
In a study of patients with Wegener’s granulomatosis, the addition of ENBREL® to standard therapy (including cyclophosphamide) was associated with a higher incidence of non-cutaneous solid malignancies. The use of ENBREL® in patients receiving concurrent cyclophosphamide therapy is not recommended (see WARNINGS: Malignancies and ADVERSE REACTIONS: Malignancies).
Patients in a clinical study who were on established therapy with sulfasalazine, to which ENBREL® was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either ENBREL® or sulfasalazine alone. The clinical significance of this observation is unknown.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been conducted to eva luate the carcinogenic potential of ENBREL® or its effect on fertility. Mutagenesis studies were conducted in vitro and in vivo, and no evidence of mutagenic activity was observed.
Pregnancy (Category B)
Developmental toxicity studies have been performed in rats and rabbits at doses ranging from 60- to 100-fold higher than the human dose and have revealed no evidence of harm to the fetus due to ENBREL®. There are, however, no studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Registry: To monitor outcomes of pregnant women exposed to ENBREL®, a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972.
Nursing Mothers
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