MYEZOM - 3.5MG



Description


Myezom 3.5mg belongs to class of anti-cancer medicine, which is in the form of lyophilized powder A first beneficial proteasome inhibitor is known as Myezom 3.5mg; proteasome is a cellular structure which breaks the proteins


Indication


Myezom 3.5mg is mainly indicated for the treatment of :
Multiple myeloma
Mantle cell lymphoma

Dosage and administration


Myezom (lyophilized powder form) is reconstituted by using 0.9% sodium chloride (NS) Myezom should be reconstituted in 3.5ml NS The route of administration is IV bolus Intrathecal not use for administration In adults:

Key points


Partially, 72 hours should be passing between following doses of Myezom




Important points


Myezom should be used alone or combination with dexamethasone Three week course is considered as therapy cycle A minimum 72 hours should slip away between constant doses of Myezom

Pharmacokinetic


Absorption


Myezom 3.5mg has good absorption The Myezom 3.5mg has peak plasma level occurs as 509ng/ml

Distribution


The Myezom 3.5mg has human plasma protein binding occurs as nearly 83%

Metabolism


Hepatically Myezom 3.5mg is metabolized with the help of cytochrome P 450 enzymes 3A4, 2C19, & 1A2 by oxidation Major metabolic pathway: deboronation to form 2-deboronated metabolites which are inactive as 26S proteasome inhibitors.

Elimination


The half life period occurs at 9 to 15 hours for single dose IV dosing: 40 to 193 hours for Multiple 1mg/m2 dosing: 76 to 108 hours for Multiple 1.3mg/m2

Mantle cell lymphoma


The Myezom recommended dose for untreated mantle cell lymphoma is; 1.3mg/m2 of Myezom administered as IV bolus given as two times weekly by combining with rituximab, cyclophospahmide, doxorubicin and tablet prednisolone for two weeks (day I, IV, VIII & XI) followed rest period of 10 days (day II through 21). In Relapse stage: The usual dose of Myezom is 1.3mg/m2 administered as IV bolus or subcutaneous two times for two weeks (day I, IV, VIII & XI) followed by 10 day rest period (day II through 21) The treatment continued for above 8 cycles may be taken for once weekly for 4 weeks (day 1, 8, 15 & 22), followed by 13 day rest (days 23 through 35)

Multiple myeloma


In the therapy of previously untreated multiple myeloma: 1.3mg/m2 of dose should be administered as 3 to 5 seconds through IV bolus or subcutaneous by combining with tablet melphalan and prednisolone for nine 6 weeks therapy cycles Cycles 1 over 4, Myezom is taken for two times weekly, (day 1, 4, 8, 11, 22, 25, 29 and 32) Cycles 5 over 9, Myezom is taken once a week (day 1, 8, 22, and 29)

In Relapse stage


The usual dose of Myezom is 1.3mg/m2 should be administered through IV bolus or subcutaneous as two times for two weeks (day1, 4, 8, and 11) followed by a ten day rest course (day 12 through 21) Treatment schedule increased above 8 cycles may be taken once weekly for 4 weeks (day 1, 8, 15, and 22), followed by 13 day rest (day 23 over 35)

Mechanism of action


Pharmacological category: anti-neoplastic agent or proteasome inhibitor Myezom 3.5mg is a type of chymotrypsin like activity unpredictable inhibitor of the 26S proteasome in human cells. The 26S proteasome is a big protein multiplex which degraded the accompany proteins The functioning site of proteasome has Chymotrypsin like Trypsin like Postglutamyl peptide hydrolysis activity The 26S proteasome enzyme recede assorted proteins which demanding to tumor cells survival like cyclins, tumor suppressors, BCL-2 & cyclin dependent kinase inhibitors Prevention of these degenerations, sensitizes cells to apoptosis and cell arrest


Drug interaction


Strong CYP3A4 inhibitors: there is a chance of getting Myezom 3.5mg toxicity; so to reduce the dose of Myezom 3.5mg while concomitant with CYP3A4 inhibitors Strong CYP3A4 inducers: decrease the exposure of Myezom 3.5mg Avoid concomitant with st. Johns wort to decrease the exposure of Myezom 3.5mg No clinical effect on Myezom 3.5mg exposure while concomitant with melphalan-prednisone or dexamethasone alone

Side effects


Most common side effects occurred after administration of Myezom includes; Black tarry stools Bleeding gums Blood in urine Blurred vision Body aches Burning, crawling, itching, numbness, prickling Chest pain Cough producing mucus, dizziness, faintness, nerve pain, painful urination, pale skin, runny nose, sore throat, stuffy nose, swollen glands, sunken eyes, ulcer, dry mouth, ear congestion, loss of voice Less common side effects: irregular breathing , Swelling of peripheral organs ,Dilated veins, discomfort, increased sensitivity of pain & touch, , heart beats, , thickening of bronchial secretions loss of appetite, Muscle cramps Belching, bone pain, difficulty with moving & bowel movements, cold and shivering, , loss of taste, , muscle pain, stomach discomfort. Vomiting, loss of weight

Precaution


While taking Myezom 3.5mg some adverse effects occurs care should be taken in the conditions like Myezom 3.5mg leads to peripheral neuropathy like burning sensation, hyperesthesia, hypoesthesia, paresthesia, neuropathic pain Manage postural Hypotension by altering the antihypertensive agents, hydration, and administration of mineralocorticoids or sympathomimetics Cardiac toxicity Pulmonary toxicity like Acute Respiratory Distress Syndrome, pneumonitis, interstitial pneumonia, lung infiltration Posterior reversible encephalopathy syndrome-stop the Myezom 3.5mg therapy Gastrointestinal toxicity-fluid or electrolyte replacements have to take Thrombocytopenia and neutropenia Tumor lysis syndrome Hepatic toxicity Embryo fetal toxicity

Pregnancy and lactation


Myezom 3.5mg is not recommended in pregnancy condition, it causes harm to fetus Breast feeding is not recommended

Storage


Myezom 3.5mg vial should be stored at 20 oC to 25oC (68oF to 77oF) excursion between 15 oC to 30oC (59oF to 86oF) Keep away from light and heat



Missed Dose


Myezom 3.5mg is not a normal medicine used as anti-cancer drug; it is not to be self-medicated.Please consult with physician and do not missed the cycles for course of therapy


Missed Dose


If patient fail to take the dose of Myezom 3.5mg, must consult with medical oncologist and followed the dosing schedules.Do not self administered


Contraindication


Hypersensitivity reaction occurs in patients who are contraindicated to Myezom 3.5mg, boron, boric acid or glycine Myezom 3.5mg is given through IV bolus or subcutaneous; whereas intrathecal administration is contraindicated to the patients who are receiving Myezom 3.5mg


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