Enfiera - 500mg



Prescribed For


Enfiera 500mg is indicated for the treatment for patients suffering with certain types of Non-Hodgkin’s Lymphoma. Enfiera 500mg is indicated for the treatment for patients suffering with chronic Lymphocytic Leukemia


Pharmacology


Rituximab belongs type of monoclonal antibody which aims the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab intercedes B-cell lysis. Potential mechanisms of cell lysis contain complement dependent cytotoxicity (CDC) and antibody dependent cell intercede cytotoxicity (ADCC). B cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and along with chronic synovitis. In this setting, B cells may be work 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.





Pharmacokinetic


Absorption: Not available
Distribution: volume of distribution is 3.1 L
Metabolism: Enfiera 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 polyangiitis is 23 days.

Dosage & Administration


Enfiera 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 up to 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 up to 100 mg/hr. increments at intervals of 30 min and max of 400 mg/hr.
Premedication with corticosteroids must be considered, if Enfiera 500mg 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, Up to 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Enfiera 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.
CHRONIC LYMPHOCYTIC LEUKEMIA:
Before starting of FC chemotherapy, dose recommended is 375 mg/m2 followed 100 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 Enfiera 500mg 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 :
Enfiera 500mg is administer with methotrexate combination
Enfiera 500mg administrating as two doses 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 initiate within 14 days before or with the starting of Enfiera 500mg and may continue during and after the 4-week course with treatment of Enfiera 500mg drug.
Safety and not established for subsequent infusion.
ADMINISTRTION:
Take an Enfiera 500mg amount and diluted to final concentration of 1 mg/ml up to 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 Enfiera 500mg then seek immediately to the emergency department or poison control help line. Please consult the doctor for further clarification.

Precautions


Concerning your history of drug used which include in prescription, non-prescription, vitamins & supplements, nutritional products just inform the doctor.
While using Enfiera 500mg do not take any vaccination or immunization without taking advice from doctors.
Allergic condition against Enfiera 500mg or any other medication inform your doctor.
Avoid use of Enfiera 500mg if you are pregnant because it will harm the baby unborn, while using Enfiera 500mg cause correct birth control to prohibit pregnancy and for at least 2 weeks after your treatment ends. Enfiera 500mg may affect the ability to have children in women. Inform your doctor if you planning to pregnant.

Side Effects


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

Drug Interaction


Enfiera 500mg 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.

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 doses at a same time.

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


Pregnancy Category C: The drug has no sufficient and well controlled studies in humans, using in pregnant women benefits by warrant use of the drug.


Lactation


It is unknown whether Enfiera 500mg passes into breast milk, avoid breast-feed while on Enfiera 500mg treatment. . Women should not breast feed during Enfiera 500mg treatment and 12 months following last dose.


Contraindication


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


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