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Maball 100mg and hyaluroni/dase 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). Maball 100mg injection 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. Maball 100mg is a type in a classification of drugs called monoclonal antibodies. Maball 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).

Pharmacokinetics:

Absorption: Not available
Distribution: volume of distribution is 3.1 L
Metabolism: Maball 100mg metabolized 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

Maball 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 Maball 100mg combination 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 Maball 100mg in 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 Maball 100mg infusion 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 :
Maball 100mg is administer with methotrexate combination Maball 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 Maball 100mg and may continue during and after the 4 week course with treatment of Maball 100mg drug. Safety and not established for subsequent infusion.

Pharmacology

Mechanism of action:
Maball 100mg is 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. Maball 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

Drug Interaction

Maball 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 Maball 100mg or any other medication informs 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 Maball 100mg do not take any vaccination or immunization without taking advice from doctors.

Avoid use of Maball 100mg if you are pregnant

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

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.

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.

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