Vivitra - 440MG


Describes As


Vivitra 150mg injection consist a targeted cancer drug known as Trastuzumab, which is Pharmacologically grouped as humanized monoclonal antibody produced by recombinant DNA technology.
Vivitra 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 Vivitra 440mg which is involved in breast cancer treatment.
Vivitra 440mg vial with 858mg of lyophilized powder containing 150mg of Trastuzumab


Indication


The drug Vivitra 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:
Vivitra is administer into vein through IV infusion over 90 minutes
Do not administer IV push or bolus.
Duration of Vivitra is administratedin once every week or every 3 weeks.
Before starting treatment, patients should undergo biopsy to check Vivitra 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


Vivitra 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.
Vivitra 440mg is a intermediary of anti-body dependent cellular cytotoxicity.

Drug Interaction


Vivitra 440mg interaction with anthracycline after ending of Vivitra 440mg 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 Vivitra 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;
Vivitra 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 Vivitra 440mg treatment
Provide alternative therapy management
In serious condition, treatment should be discontinuing. Infusion reactions;
During Vivitra 440mg treatment some life-threatening infusion reactions are produced.
The manifestation due to infusion reactions should be monitored frequently
Delay the infusion of Vivitra 440mg treatment and Start the supportive measures by providing epinephrine, corticosteroids, diphenhydramine, bronchodilators, & oxygen.
In serious infusion reactions, Stop the Vivitra 440mg treatment permanently.
Patient should be treated with premedication before starting the infusion to overcome the such problem Embryo fetal damage;
Vivitra 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 Vivitra 440mg treatment.
During Vivitra 440mg treatment. Use with Caution. Therapy induced neutropenia;
Higher incidence of neutropenia occurs during Vivitra 440mg treatment.

Missed dose


If missed cycles of Vivitra 440mg treatment 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.
Consecutive Vivitra 440mg 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 Vivitra 440mg dose by higher than one week, then resume with re-storing dose of Vivitra 440mg such as weekly schedule is 4mg/kg; 3 weekly schedules is 8mg/kg should be administered over period of 90 minutes.

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.



Pregnancy and lactation


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


Storage


Vivitra 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 Vivitra 440mg diluted bag at 2oC to 8oC for 24 hours


Contraindication


No possible contraindicated occurs.
Infusion reactions are produced.
The patients are contraindicated to the component present in the Vivitra 150mg, Hence Hypersensitivity reactions are occurring.


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