Ikgdar 100Mg Injection

1. Ikgdar 100mg Ikgdar 100mg is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Ikgdar has an approximate molecular weight of 145 kD. Ikgdar has a binding affinity for the CD20 antigen of approximately 8.0 nm. Ikgdar is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product. Ikgdar 100mg is an anticancer medicine which prevents the growth and spread of cancer cells in the body. Ikgdar 100mg with steroid regimen combination is given for the treatment of some rare disorders which cause blood vessels and other tissues inflammation in the body. IKGDAR 100MG INDICATED FOR Ikgdar 100mg and hyaluronidase human injection are used as alone or concomitant use with other drugs to treat some types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia (cancer start in WBC). Ikgdar 100mg injection concomitant use with methotrexate (Otrexup, Rasuvo, Xatmep, others) is also used for the treatment rheumatoid arthritis symptoms in adults that have been already treated with some type of drug knowns as tumor necrosis factor (TNF) inhibitor. Ikgdar 100mg is a type in a classification of drugs called monoclonal antibodies. Ikgdar 100mg is indicated to killing cancer cells to treat NHL, CLL, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis by preventing the activity of the immune system parts which can injury the joints, veins, and other blood vessels and cause organs (heart and lungs) damage. MECHANISM OF ACTION Rituximab (Ikgdar 100mg) is belonging to a classification monoclonal antibody which aim the CD20 antigen declare on the surface of pre-B and mature B-lymphocytes. Upon connecting to CD20, rituximab

2. intercedes B-cell lysis. Probably mechanisms of cell lysis contain complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC). B cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and analog to chronic synovitis. In this setting, B cells may be action at multiple sites in the autoimmune/inflammatory process, involving through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T-cell activation, and/or proinflammatory cytokine production. DOSAGE AND ADMINISTRATION Ikgdar 100mg injection is generally used to given only via intravenous infusion not by IV push or bolus. Prior to Each Infusion the Drug Is Premedicate First infusion: Initial treatment rate of 50 mg/hr is administer, in not showing infusion toxicity, rate increased up to 50 mg/hr. increments at intervals of 30 min and max of 400 mg/hr. Successive infusion: starting at rate of 100 mg/hr., in not showing infusion toxicity, rate increased up to 100 mg/hr. increments at intervals of 30 min and max of 400 mg/hr. While consolidation with CHOP chemotherapy the injection Ikgdar has not been given. Hence Premedication with corticosteroids must be considered. CHRONIC LYMPHOCYTIC LEUKEMIA Prior to starting of FC chemotherapy, dose usual given is 375 mg/m2 followed 500 mg/m2 on day 1 of 2-6 cycles every 28 days. RHEUMATOID ARTHRITIS When combination of Ikgdar 100mg injection with methotrexate is administrated. Ikgdar injectiongiven as two doses of 100mg IV infusion 2 weeks separated. When glucocorticoids administered as methylprednisolone 100mg IV

3. Subsequent course based on clinical evaluation must administer every 24 weeks, but not early than every 16 weeks. LOW GRADE OR FOLLICULAR NON-HODGKINS LYMPHOMA The drug Dose is 375 mg/m2 as an IV infusion. Once weeks for 4 or 8 doses administrated for Relapsed treatment Once weekly for 4 doses administrated for Retreatment for relapsed. Previously untreated: administer on day 1 of each cycle of chemotherapy, up to 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Ikgdar 100mg in combination with chemotherapy completed then administer 8weeks for 12 doses as a single agent. Once weekly for 4 doses at intervals of 6 months and max of 16 doses for Non – progression (following CVP chemotherapy completion 6 – 8 cycles): On day 1 each cycle of chemotherapy up to 8 infusions for Diffuse Large B- cell NHL COMPONENT OF ZEVALIN FOR TREATMENT OF NHL The dose 250 mg/m2 of Ikgdar 100mg injection within 4 hours prior to the administration of Indium-111-(In-111-) Zevalin and Yttrium-90- (Y- 90-) Zevalin. 7–9 days before to Rituxan and Y-90- Zevalin administrate Rituxan and In-111-Zevalin. GRANULOMATOSIS POLYANGITIS AND MICROSCOPIC POLYANGITIS Ikgdar injection administer Dose of 375 mg/m2 IV infusion weekly once for 4 weeks. When Glucocorticoids given with methylprednisolone by dose of 1000 mg IV/ day for 1- 3 days and purse by oral prednisone 1 mg/kg/day are recommended for the treatment of symptoms of serious vacuities. This drug should initiate within 14 days before or with the starting of Ikgdar injection and may continue during and after the 4 week course with treatment of Ikgdar injection drug. Safety and not established for

4. subsequent infusion. ADMINISTRTION Take an amount Ikgdar 100mg injection is administer and diluted to final concentration of 1 mg/ml upto 4 mg/ml as infusion (containing either 0.9% Nacl or 5% dextrose in water). Gently Invert the bag and mix the solution. Discard unused drug left in vial. OVERDOSAGE If over dose occurs seek immediately to the emergency department or poison control help line. please consult the doctor for further clarification. COMMON EFFECTS Fever and chills (flu lik symptoms) LESS COMMON SIDE EFFECTS Weakness; nausea; headache; cough;dyspnea ; pharyngitis PRECAUTIONS Allergic condition against Ikgdar 100mg or any other medication inform your doctor. Information about past medical history used which include in prescription, non-prescription, vitamins & supplements, nutritional products just inform the doctor. Avoid use of Ikgdar 100mg if you are pregnant. It will harm the baby unborn, while using Ikgdar 100mg use correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends. It is unknown whether Ikgdar 100mg passes into breast milk, avoid breast- feed while on Ikgdar 100mg treatment. While using Ikgdar 100mg do not take any vaccination or immunization without taking advice from doctors.