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Biologic and immunologic agent
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Immunologic agent
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Active rheumatoid arthritis that has not responded adequately to one or more DMARDs; may be used alone or with methotrexate or DMARDs.
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Adults: inject SC into thigh or abdomen; rotate injection sites; supervise the first dose. 18 years or older: 40 mg every other week. May use with MTX, DMARDs, glucocorticoids, salicylates, NSAIDs or analgesics. Without MTX: may increase frequency to once weekly.
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CATEGORY B
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Injection site reactions, infections, headache, nausea, rash, abdominal pain, lymphoma, hypertension, neurological events, antibody formation, lupus-like syndrome
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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