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Biologic and immunologic agent
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Immunologic agentIndications:Moderately-to severely-active rheumatoid arthritis, Active systemic juvenile idiopathic arthritis
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1. Adults: RA: Give once every 4 weeks as a 60-minutes IV infusion. Initially 4mg/kg, may increase to 8mg/kg based on clinical response. 2. Children: SJIA: < 2yrs: not recommended. กร2yrs: Give once every 2 weeks as a 60-minute IV infusion. <30kg: 12 mg/kg. กร30 kg: 8mg/kg.
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Category C
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Upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, infusion reactions(may be severe and fatal), neutropenia, thrombocytopenia, gastrointestinal perforations, increased lipids
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HERE!
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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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