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Ikgdar-500mg

PRODUCT DETAILS

Brand name : Ikgdar
Composition : Rituximab
Strength : 500mg
Manufactured by : Emcure Pharmaceutical Ltd
Dosage form : injection

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Ikgdar 500mg is a anticancer medicine which prevents the growth and spread of cancer cells in the body, the main ingredient which is used as rituximab. Ikgdar 500mg will help to prevent the Non- Hodgkin’s lymphoma or chronic lymphocytic and with combination with another anticancer drugs like methotrexate is used for rheumatoid arthritis symptoms in adult treatment. Ikgdar 500mg with steroid regimen combination is given for the treatment of some rare disorders which cause blood vessels and other tissues inflammation in the body.

INDICATIONS

Ikgdar 500mg and hyaluronidase human injection are given alone or combination with another drugs to treat certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia (cancer start in WBC). Ikgdar 500mg injection combination with methotrexate (Otrexup, Rasuvo, Xatmep, others) is also indicated for the treatment rheumatoid arthritis symptoms in adults that have been already treated with a some type of regimen knowns as tumor necrosis factor (TNF) inhibitor. Ikgdar 500mg is a type in a classification of drugs called monoclonal antibodies. Ikgdar 500mg is used to killing cancer cells to treat NHL , CLL, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis by inhibiting the activity of the immune system parts that can injury the joints, veins, and other blood vessels and cause organs (heart and lungs) damage.

Ikgdar injection is usually used to administrate only via intravenous infusion not by IV push or bolus.
BEFORE EACH INFUSION THE DRUG IS PREMEDICATE :
First infusion: Starting treatment rate of 50 mg/hr is administer , in not showing infusion toxicity, rate raised up to 50 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Successive infusion: initial at rate of 100 mg/hr, in not showing infusion toxicity, rate raised upto 100 mg/hr increments at intervals of 30 min and max of 400 mg/hr. While combination with CHOP chemotherapy the injection Ikgdar has not been given. Hence Premedication with corticosteroids must be considered.
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 500mg 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 dose 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
CHRONIC LYMPHOCYTIC LEUKEMIA :
Before starting of FC chemotherapy, dose recommended is 375 mg/m2 followed 500 mg/m2 on day 1 of 2-6 cycles every 28 days.

PHARMACOKINETICS

Absorption:
Not available
Distribution:
volume of distribution is 3.1 L There are no human plasma level
Metabolism:
Ikgdar 500mg metabolized by human antimurine antibody production.
Elimination:
not available The drug elimination of half life of NHL is 22 days and for RA is 18.0 days, GPA and microscopic polyangitis is 23 days.

MECHANISM OF ACTION

Ikgdar 500mg is a type of class called as monoclonal antibody. A new type of "targeted" cancer treatment and an integral part of the body's immune system. Naturally the body fused to antibodies in along with an antigen which has entered the body and attack the antigen for destruction by the immune system. Monoclonal antibiotics which only targeted by an essential cells only, they may cause less toxicity to healthy cell and it is prescribed treatment given only for cancers in which antigens (and the respective antibodies) have been already identified. Ikgdar injection works by linking to the CD20 antigen on normal and malignant B-cells. Hence natural immune security of body are initiated to attach and kill the marked B-cells. Young cells (stem cells) in the bone marrow which will develop into the various cell types and do not have the CD20 antigen. After treatment CD20 antigen allows healthy B-cells to multiply.

ADMINISTRTION

Take an amount Ikgdar 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.

DOSAGE

COMPONENT OF ZEVALIN FOR TREATMENT OF NHL :
The dose 250 mg/m2 of Ikgdar 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. RHEUMATOID ARTHRITIS When combination of Ikgdar injection with methotrexate is administrated. Ikgdar injection given as two dose of 100mg IV infusion 2 weeks separated. When glucocorticoids administered as methylprednisolone 100mg IV Subsequent course based on clinical evaluation must administer every 24 weeks, but not early than every 16 weeks.
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 subsequent infusion.

PRECAUTIONS

Allgeric condition against Ikgdar 500mg 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. While using Ikgdar 500mg do not take any vaccination or immunization without taking advice from doctors. Avoid use of Ikgdar 500mg if you are pregnant. It will harm the baby unborn, while using Ikgdar 500mguse correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends. Ikgdar 500mg may affect the ability to have children in women. Inform your doctor if you planning to pregnant. It is unknown whether Ikgdar 500mg passes into breast milk , avoid breast-feed while on Ikgdar 500mg treatment.

MISSED DOSE

If a dose missed then have the drug soon you remembered, if next dose time reach then leave the missed dose and follow the normal schedule. Do not have 2 dose at a same time. Please consult with doctor for further details.

DRUG INTERACTION

Ikgdar 500mg drug interaction has limited data is available at present.Interation with fludarabine or cyclophosphamide have no effects in pharmacokinetics in CLL patients.Ikgdar combination with methotrexate had no effects in pharmacokinetics.

STORAGE

Store the drug at 2℃ – 3℃ Keep away from the childerns.Use the drug before expiry date. Protected from direct sunlight and Do not freeze or shake. Discard the unused drug by asking the advice from doctor or pharmacist.

SIDE EFFECTS

Common effects: fever and chills (flu lik symptoms) Less common side effects: Weakness; nausea ; headache; cough ; dyspnea ; pharyngitis

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