TRASTUREL - 440MG

Describes As :
Trasturel 440mg injection consist a targeted cancer drug known as Trastuzumab, which is
Pharmacologically grouped as humanized monoclonal antibody produced by recombinant DNA
technology.

Trasturel 440mg helps to reduce the rate of reactivation & mortality. One of the epidermal
growth factor receptor is known as human epidermal growth factor receptor 2 (HER2) plays vital
role in breast cancer.

This factor is responsible for cell replication. An FDA approved product Trasturel
440mg which is involved in breast cancer treatment. Trasturel 440mg vial with 858mg of
lyophilized powder containing 150mg of Trastuzumab.

Indication :
The medication Trasturel 440mg is indicated for the treatment of following conditions:
Supportive treatment for breast cancer Advanced breast cancer Advanced gastric cancer.

Dosage & Administration :

Breast cancer Metastatic HER2-Overexpressing:
• Over a 90 minute, 4mg/kg alone or with combination of paclitaxel in initial dose.
• Over 30 minutes, 2mg /kg once in a week for maintenance dose.
• Duration of therapy for initial and maintenance dose until disease progression.
Adjuvant regimen for HER2 over expressing Breast cancer:
52 weeks of treatment total schedules as follows:
• Combination With paclitaxel or docetaxel, overa 90 minute, 4mg/kg IV then over 30 minutes,
2mg /kg for 12 weeks or combination with Carboplatin/ docetaxel for 18 weeks one week
following the last weekly dose.
• Over 30 to 90 minutes, 6mg/kg IV for every 3 weeks.
Esophageal carcinoma or gastric cancer for adult dose:
• 8mg/kg IV over 90 minutes as initial dose
• 6mg/kg IV over 30 to 90 minutes for every 3 weeks as maintenance dose
• Duration of therapy for initial and maintenance dose until disease progression.
Administration:
Trasturel is administer into vein through IV infusion over 90 minutes
Do not administer IV push or bolus.
Duration of Trasturel is administratedin once every week or every 3 weeks.
Before starting treatment, patients should undergo biopsy to check Trasturel is the right regimen
the infusion solution should be compatible to polyvinyl chloride or polyethylene bags.
After dilution, the infusion bag should be stored at 2oC to 8oC for not more than 24 hours before
use.
Over dosage :
Maximum dose of Trastuzumab is more than 8mg/kg as a single dose.
In case of over dosage condition, patient must be;
Provide with supportive measures
Monitor the signs & symptoms due to over dosage .

Pharmacokinetic :
Distribution:
Volume of distribution: 44 mL/kg as trastuzumab; 3.13 L as trastuzumab emtansine.
Metabolism:
As trastuzumab emtansine: which Undergoes deconjugation and catabolism through proteolysis
in cellular lysosomes.
Excretion:
Terminal Elimination half-life is 6 days (weekly dosing); 16 days (3 weekly regimen); approx 4
days as trastuzumab emtansine.
Elimination of drug includes clearance of IgG through the reticuloendothelial system.

Mechanism :
Trasturel 440mg is a type of monoclonal antibody which targeting the HER2, provoke a
resistant mediate reaction which causes disguise and down regulation of HER2. HER2 pathway
is specific for cell proliferation, joining of Transtuzumab to the site of HER2 causes prevention
of this activity. This joining leads to antibody mediated and leads to HER2 positive cells break
down. Trasturel 440mg is a intermediary of anti-body dependent cellular cytotoxicity.

Drug Interaction :
Do not take anthracycline treatment for 7 months after stopping the Trasturel 440mg treatment.
In some phenomenal condition, patient should get anthracycline, in that situation patient’s
cardiac function should be checked carefully with regular intervals.

Safety Precautions :
Cardiomyopathy;
Trasturel 440mg receiving patients have increased risk of exposing to cardiac disorders.
To overcome the problem by;
Monitoring cardiac functions regularly
Avoid using anthracycline drug after Trasturel 440mg treatment
Provide alternative therapy management
In serious condition, treatment should be discontinuing. Infusion reactions;
During Trasturel 440mg treatment some life-threatening infusion reactions are produced.
The manifestation due to infusion reactions should be monitored frequently
Delay the infusion of Trasturel 440mg treatment and Start the supportive measures by
providing epinephrine, corticosteroids, diphenhydramine, bronchodilators, & oxygen.
In serious infusion reactions, Stop the Trasturel 440mg treatment permanently.
Patient should be treated with premedication before starting the infusion to overcome the such
problem, Embryo fetal damage;
Trasturel 440mg is contraindicated to pregnancy period.
Avoid becoming pregnancy during this therapy.
Use efficient contraceptives during treatment Pulmonary toxicity;
Some serious fatal cases of pulmonary toxicity occur during Trasturel 440mg treatment.
During Trasturel 440mg treatment. Use with Caution. Therapy induced neutropenia;
Higher incidence of neutropenia occurs during Trasturel 440mg treatment.

Missed dose :
If missed cycles of Trasturel 150mgtreatment by one week or less, then the repeated maintenance
dose (weekly schedule: 2mg/kg; 3 weekly schedule: 6mg/kg) administer as soon as probably.
Until the next planned cycle the patient does not take interval.
ConsecutiveTrasturel 150mg maintenance dose should be taken in 7 days or 21 days next confer
to the weekly or 3 weekly schedules.
If patient missed to take Trasturel 440mg dose by higher than one week, then resume with re-
storing dose of Trasturel 440mg such as weekly schedule is 4mg/kg; 3 weekly schedules is
8mg/kg should be administered over period of 90 minutes.

Pregnancy and lactation :

Trasturel 440mg pregnancy category is D
Trasturel 440mg should not suggest during pregnancy condition.
Breast feeding should not be recommended.

Storage :
Trasturel 440mg vials should be stored at refrigerator temperature of 2oC to 8oC. Keep the vial
away from heat & light. After reconstitution, vial should be stored at 2oC to 8oC for 28 days.
Stored Trasturel 440mg diluted bag at 2oC to 8oC for 24 hours..

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