Mabtas - 100mg


Prescribed For


Mabtas 100mg 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). Mabtas 100mginjection is also used with methotrexate (Otrexup, Rasuvo, Xatmep, others) for the treatment rheumatoid arthritis symptoms in adults that have been already treated with a some type of regimen known as tumor necrosis factor (TNF) inhibitor. Mabtas 100mg is a type in a classification of drugs called monoclonal antibodies. Mabtas 100mg is used to killing cancer cells to treat NHL , CLL, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis by stopping the activity of the part of the immune system that will damage the joints, veins, and other blood vessels and cause damage to organs (heart and lungs).


Pharmacokinetic


Absorption: Not available
Distribution: volume of distribution is 3.1 L
Metabolism: Mabtas 100mgmetabolized by human antimurine antibody production.
Elimination : not available The half life of NHL is 22 days and for RA is 18.0 days, GPA and microscopic polyangitis is 23 days.






Dosage & Administration


Mabtas 100mg is recommended to administer only through intravenous infusion not by IV push or bolus. PREMEDICATE BEFORE EACH INFUSION
First infusion:
initially rate of 50 mg/hr is given , in not showing infusion toxicity, rate raised upto 50 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Successive infusion: 100 mg/hr initiated rate , in not showing infusion toxicity, rate raised upto 100 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Premedication with corticosteroids must be considered, if Mabtas 100mgcombination with CHOP chemotherapy is not given.
LOW GRADE OR FOLLICULAR NON-HODGKINS LYMPHOMA:
Dose is 375 mg/m2 as an IV infusion. Once weeks for 4 or 8 doses administrated for Relapsed treatment Relapsed Retreatment for once weekly for 4 doses administrated. Untreated Previously: given on day 1 of each cycle of chemotherapy, upto 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Mabtas 100mgin combination with chemotherapy completed then administer 8weeks for 12 doses as a single agent. Once weekly for 4 dose 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 upto 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. COMPONENT OF ZEVALIN FOR TREATMENT OF NHL:
Prior to the administration of Indium-111-(In-111-) Zevalin and Yttrium-90- (Y-90-) Zevalin administer Mabtas 100mginfusion about 250 mg/m2 within 4 hours Before to Rituxan and Y-90- Zevalin administrate Rituxan and In-111-Zevalin 7–9 days.
RHEUMATOID ARTHRITIS
Mabtas 100mg is administer with methotrexate combination Mabtas 100mg administrating as two dose of 100mg IV infusion 2 weeks separated. When glucocorticoids administered as methyl prednisolone 100mg IV Subsequent course based on clinical evaluation should administer every 24 weeks, but not early than every 16 weeks.
GRANULOMATOSIS POLYANGITIS AND MICROSCOPIC POLYANGITIS
Weekly once for 4 weeks administer Dose of 375 mg/m2 IV infusion While Glucocorticoids combination with methylprednisolone by dose of 1000 mg IV/ day given for 1- 3 days and purse by oral prednisone 1 mg/kg/day are recommended for the treatment of symptoms of serious vasculitis . This drug should intiate within 14 days before or with the starting of Mabtas 100mgand may continue during and after the 4 week course with treatment of Mabtas 100mg drug. Safety and not established for subsequent infusion.

Pharmacology


Mechanism of action: Mabtas 100 mgis a type of class called as monoclonal antibody and which is a new type of "targeted" cancer treatment and an integral part of the body's immune system. Naturally the body build antibodies in along with to an antigen which has entered the body and attach to the antigen for destruction by the immune system. An essential cells only aimed by monoclonal antibiotics, they may leads to less toxicity to healthy cell and it is usually treatment recommended only for cancers in which antigens (and the respective antibodies) have been already identified. Mabtas 100mg works by linking to the CD20 antigen on normal and malignant B-cells. Hence the body's essential immune security are initiated to attack and kill the marked B-cells. Stem cells i.eyoung cells in the bone marrow which will grow into the various cell types and do not have the CD20 antigen. After treatment,CD20 antigen allows healthy B-cells to multiply

Administration


Take an Mabtas 100mg amount 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). Invert gently the bag and mix the solution. Dispose unused drug left in vial. OVERDOSAGE: If the patients had high dose of Mabtas 100mg then seek immediately to the emergency department or poison control help line. Please consult the doctor for further clarification.

Drug Interaction


Mabtas 100mg drug interaction has limited data is available at present. Combination with fludarabine or cyclophosphamide has no effects in pharmacokinetics in CLL patients. Combination with methotrexate had no effects in pharmacokinetics.

Side Effects


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

Precautions


Allgeric condition against Mabtas 100mg or any other medication inform your doctor. Concerning your past history of drug used which include in prescription, non-prescription, vitamins &supplements , nutritional products just inform the doctor. While using Mabtas 100mgdo not take any vaccination or immunization without taking advice from doctors.

Avoid use of Mabtas 100mg if you are pregnant


It will harm the baby unborn, while using Mabtas use correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends. Mabtas 100mg may affect the ability to have children in women. Inform your doctor if you planning to pregnant. It is unknown whether Mabtas 100mgpasses into breast milk , avoid breast-feed while on Mabtas 100mg treatment.

Lactation


Mabtas 100mg excreted into human milk is unknown. Due to the drug belongs to large protein molecule, no information is available. Women should not breast feed during Mabtas 100mg treatment and 12 months following last dose.

Storage


Store at 20C – 30C Use the drug before expiry date Protected from direct sunlight Do not freeze or shake. Keep away from the childerns Discard the unused drug by asking the advice from doctor or pharmacist.



Pregnancy


CategoryC : animal studies reproduction shown an adverse effect on the fetus. The drug has no sufficient and well controlled studies in humans, using in pregnant women benefits by warrant use of the drug.


Missed dose


If a dose missed to take at the time then have it suddenly before next dose timing, if time reach for next dose, then skip missed dose and continue and continue the regular schedule. Do not have 2 dose at a same time.


Contraindication


Hypersensitivity or murine proteins. Active severe infectons in rheumatoid arthritis Uncontrolled cardiac disease.


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