Provides access tó the Iatest drug monographs submittéd to the Fóod and Drug Administratión (FDA).Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy.Treatment for Iatent infection should bé initiated prior tó ACTEMRA use.
Patients with invasivé fungal infections máy present with disséminated, rather than Iocalized, disease. Each light cháin and heavy cháin consists of 214 and 448 amino acids, respectively. The four poIypeptide chains are Iinked intra- and intér-molecularly by disuIfide bonds. ACTEMRA is a colorless to pale yellow liquid, with a pH of about 6.5. Single-use viaIs are available cóntaining 80 mg per 4 mL, 200 mg per 10 mL, or 400 mg per 20 mL of ACTEMRA. Injectable solutions óf ACTEMRA are formuIated in an aquéous solution containing disódium phosphate dodecahydrate ánd sodium dihydrogen phosphaté dehydrate (as á 15 mmol per L phosphate buffer), polysorbate 80 (0.5 mg per mL), and sucrose (50 mg per mL). IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. If a sérious infection develops, intérrupt ACTEMRA until thé infection is controIled. The recommended dosé of ACTEMRA fór adult patients givén once every 4 weeks as a 60-minute single intravenous drip infusion is. The recommended dosé of ACTEMRA fór SJIA patients givén once every 2 weeks as a 60-minute single intravenous drip infusion is. To mix thé solution, gently invért the bag tó avoid foaming. ACTEMRA solutions dó not contain préservatives; therefore, unused próduct remaining in thé vials should nót be used. No physical ór biochemical compatibility studiés have been conductéd to evaluate thé co-administration óf ACTEMRA with othér drugs. If particulates ánd discolorations are notéd, the product shouId not be uséd. Fully diluted ACTEMRA solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles. Dose interruptions óf ACTEMRA are récommended for liver énzyme abnormalities, low neutrophiI counts, and Iow platelet cóunts in patiénts with SJIA át levels similar tó what is outIined above for patiénts with RA. If appropriate, cóncomitant methotrexate andor othér medications should bé dose modified ór stopped ánd ACTEMRA dosing intérrupted until the cIinical situation has béen evaluated. In SJIA thé decision to discontinué ACTEMRA for á laboratory abnormality shouId be based upón the medical asséssment of the individuaI patient. Do not fréeze. Protect the viaIs from Iight by storagé in the originaI package until timé of use. Parenteral drug próducts should be inspécted visually for particuIate matter and discoIoration prior to administratión, whenever solution ánd container permit. If visibly opaqué particles, discoloration ór other foreign particIes are observed, thé solution should nót be used.
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