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Name of Drug:RITUXANClinical Policy REM: Risk Evaluation Management Description of biologic:Rituxan is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen.Box warnings and Precautions:Rituxan infusions can cause serious, including fatal infusion reactions. Severe mucocutaneous reactions can occur in addition to HBV reactivation.Adverse reactions:Infusion reactionsSever mucocutaneous reactionsHBV reactivationPMLTLSInfectionsCardiac arrhythmiasRenal toxicityBowel obstruction and PerforationMechanism of Action:Rituxan is a monoclonal antibody that targets CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, Rituxan mediates B-cell lysis.Indications and usage: Rheumatoid Arthritis RA, Granulomatosis with Polyangiitis GPAHalf Life of drug:Half life is dose dependent After two doses of Rituxan in RA pts the half life is 18 days.After four doses of Rituxan in GPA pts the half life is 23 days.Storage and Stability:Rituxan vials should be refrigerated at 20C- 80C(360F – 460F)Contraindications: Refer to LabelScreenings/Labs:Hepatitis screenPPDFor RA patients non-live vaccines should be administered at least 4 weeks prior to a course of Rituxan as needed.Dosage Forms & Strengths:100 mg/ 10 ml in a single dose vial500 mg/ 50 ml in a single dose vialCalculating total volume:For RA patients administer Rituxan as 2-1000mg intravenous infusions separated by two weeks.For GPA patients administer Rituxan as 375mg/m2 intravenous infusions once weekly for four weeks. Utilize mixing table below for volume totals.Mixing table:BSAm2RituxanmgRituxanmlNS/D5WmlTotalml1.348849741231.452553801331.556356841401.660060901501.763864961601.8675681021701.9713711071782.0750751331882.1788791191982.282583125208Preparation and Administration:Administer ordered antihistamines and corticosteroids in ordered doses, 30 mins. Prior to start of infusion.Withdraw a volume of 0.9%NaCl equal to the volume for Rituxan required for the patients’ dose from the infusion bag.Withdraw the amount of Rituxan for intravenous infusion from vial(s) and add slowly to the Sodium Chloride infusion bag. Gently invert the gab to mix.Administer the initial infusion beginning at a rate of 50 mg /hr and increasing by 50 mg/hr very 30 mins. to a maximum rate of 400 mg /hr in the absence of infusion toxicity. Subsequent infusions should be administered at a rate of 100mg /hr increasing by 100mg /hr every 30 mins. to a maximum rate of 400mg /hr in the absence of infusion toxicity.If particulates and discolorations are noted, the product should not be used.Documentation:Weight Vital signs pre infusion and every 30 mins until infusion completion and 30 mins. post infusion.Total dose administeredStart and stop times of infusionWastage if applicable ................
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