Trasturel 150mg injection consist a targeted cancer drug known as Trastuzumab, which is Pharmacologically grouped as humanized monoclonal antibody produced by recombinant DNA technology, it helps to reduce the rate of reactivation & mortality
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Trasturel 150mg injection
1. Trasturel 150mg injection
Trasturel 150mg injection consist a targeted cancer drug known as
Trastuzumab, which is Pharmacologically grouped as humanized
monoclonal antibody produced by recombinant DNA technology.
Trasturel 150mg 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 150mg which is involved in breast cancer treatment.
Trasturel 150mg vial with 858mg of lyophilized powder containing
150mg of Trastuzumab
Indication
The drug Trasturel 150mg 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:
2. • 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;
3. 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 150mg 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 150mg is a intermediary of anti-body dependent cellular
cytotoxicity.
Drug Interaction
4. Trasturel 150mg interaction with anthracycline after ending of Trasturel
150mg treatment may have a chance of getting cardiac problem. This
side effects occur because of Transtuzumab great disaster period is
depends on population PK analysis. Do not take anthracycline treatment
for 7 months after stopping the Trasturel 150mg 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 150mg 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 150mg treatment
Provide alternative therapy management
In serious condition, treatment should be discontinuing. Infusion
reactions;
During Trasturel 150mg treatment some life-threatening infusion
reactions are produced.
The manifestation due to infusion reactions should be monitored
frequently
Delay the infusion of Trasturel 150mg treatment and Start the supportive
measures by providing epinephrine, corticosteroids, diphenhydramine,
bronchodilators, & oxygen.
5. In serious infusion reactions, Stop the Trasturel 150mg treatment
permanently.
Patient should be treated with premedication before starting the infusion
to overcome the such problem, Embryo fetal damage;
Trasturel 150mg 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
150mg treatment.
During Trasturel 150mg treatment. Use with Caution. Therapy induced
neutropenia;
Higher incidence of neutropenia occurs during Trasturel 150mg
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 150mg dose by higher than one week,
then resume with re-storing dose of Trasturel 150mg such as weekly
schedule is 4mg/kg; 3 weekly schedules is 8mg/kg should be
administered over period of 90 minutes.
6. Side Effects
The most common adverse effects;
Cardiomyopathy, Infusion reactions, Embryo fetal toxicity, Pulmonary
toxicity, Chemotherapy induced neutropenia. The most common side
effects;
Hypertension, Influenza, Dyspnae, URI, Rhinitis, Pharyngolaryngeal
pain, Sinusitis, Epitasis, Pulmonary hypertension, Dizziness, Decrease
LVEF, Palpitations, Arrhythmia, Cardiac failure, Cough, Interstitial
pneumonitis, Diarrhea/constipation, Nausea, vomiting, Dyspepsia,
Autoimmune thyroiditis, Neutropenia, Hypokalemia, Anemia,
Thrombocytopenia, Febrile neutropenia, Renal failure, Abdominal pain,
Arthralgia, Back pain, Bone pain, Headache, Paresthesia, Rash,, Nail
disorders, Pruritus, Pyrexia, Chills, Edema, Asthenia, Sudden death.
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