MYEZOM - 2MG

                                      MYEZOM - 2MG

PRODUCT DETAILS

Trade name : Myezom

Active component : Bortezomib

Strength of the component : 2mg vial

Manufactured by : DR.Reddy's

Pack : 2mg Bortezomib containing vial in a carton

Dosage form : lyophilized powder

                                                                  Category : Anti-cancer drug; proteasome inhibitor

DEFINITION

Bortezomib is a drug sold under the brand name of Myezom 2mg which belongs to anti-neoplastic medicine, the main ingredient which is used as bortenat, which is available in the form of lyophilized powder Myezom 2mg is a prime benign proteasome inhibitor; proteasome is a biological structure that clefts the proteins Pharmacological grouped as: anti-neoplastic agent or proteasome inhibitor The drug is an prescription drug given under the supervision of pharmacist

PHARMACOKINETICS

Absorption:

The Myezom 2mg peak plasma level occurs as 509ng/ml

Distribution:

The Myezom 2mg has nearly 83% of human plasma protein binding.

Metabolism:

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

Excretion:

The half life period of Myezom 2mg occurs at 9 to 15 hours In single dose IV;

In adults:

Multiple myeloma :

Previously untreated multiple myeloma In the therapy: Myezom 2mg dose 1.3mg/m2 should be given as 3 to 5 seconds via IV bolus or subcutaneous by interacting with tablet melphalan and prednisolone for nine 6 weeks treatment cycles Myezom is taken for two times weekly, (day 1, 4, 8, 11, 22, 25, 29 and 32) for Cycles 1 over 4 Myezom is taken once a week (day 1, 8, 22, and 29) for Cycles 5 over 9 Duration of Myezom is 72 hours

In Relapse stage :

The usual dose of Myezom is 1.3mg/m2 should be given via 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) Schedule of Treatment 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)

Important points :

Myezom 2mg administrated alone or combination with dexamethasone therapy cycle require of Three week course

MECHANISM OF ACTION

The drug Myezom 2mg is a type of chymotrypsin like activity which is in form of unstable prohibitor of the 26S proteasome in human cells. The 26S proteasome is a group of protein that reduces the agglutinated proteins The various proteins are weakens by proteasome enzymes that make difficult to tumor cells persistence like cyclins, tumor suppressors, BCL-2 & cyclin dependent kinase inhibitors The functioning site of proteasome has Postglutamyl peptide hydrolysis activity Chymotrypsin like Trypsin like Prevention of these degenerations, sensitizes cells to apoptosis and cell arrest and leads to cell lysis

PRECAUTION & WARNING

While taking Myezom 2mg some adverse effects occurs care should be taken in the conditions like Cardiac toxicity Pulmonary toxicity like Acute Respiratory Distress Syndrome, pneumonitis, interstitial pneumonia, lung infiltration. Posterior reversible encephalopathy syndrome-stop the Myezom 2mg therapy Myezom 2mg 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 Gastrointestinal toxicity-fluid or electrolyte replacements have to take Thrombocytopenia and neutropenia Tumor lysis syndrome Hepatic toxicity Embryo fetal toxicity.

DRUG INTERACTION

Avoid interaction with st. Johns wort to decrease the exposure of Myezom 2mg while concomitant with CYP3A4 inhibitors: there is a chance of getting Myezom 2mg toxicity; so to reduce the dose of Myezom 2mg Interaction with Strong CYP3A4 inducers: decrease the exposure of Myezom 2mg while concomitant with melphalan-prednisone or dexamethasone alone No clinical effect on Myezom 2mg exposure.

CONTRAINDICATION

Myezom 2mg is administer through IV bolus or subcutaneous; whereas intrathecal administration is contraindicated to the patients who are receiving Bortezomib Hypersensitivity reaction occurs in patients who are contraindicated to Myezom 2mg, boron, boric acid or glycine

MISSED DOSE

Myezom 2mg is not a normal medicine used as anti-cancer drug; it is not to be self-medicated If a dose failed to take should consult with medical oncologist and followed the dosing schedules Avoid self administered Follow the advice given by physician and do not missed the cycles for course of therapy

SIDE EFFECTS

Most common side effects occurred after administration of Myezom 2mg includes; Burning, crawling, itching, numbness, prickling ; Chest pain ; Black tarry stools; Bleeding gums ; Blood in urine ; Blurred vision ; Body aches, dizziness, faintness, nerve pain, painful urination, pale skin, runny nose, sore throat, stuffy nose, swollen glands, sunken eyes, ulcer, dry mouth, Cough producing mucus, ear congestion, loss of voice

Less common side effects

Belching, bone pain, difficulty with moving & bowel movements, cold and shivering, loss of appetite, loss of taste, muscle cramps, muscle pain, stomach discomfort. Vomiting, loss of weight discomfort, increased sensitivity of pain & touch, irregular breathing, heart beats, swelling of peripheral organs, thickening of bronchial secretions






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