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sharon paula Hermab 150mg Injection - Trastuzumab
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Hermab 150mg injection

Hermab 150mg injection consist a targeted cancer drug known as Trastuzumab, which is Pharmacologically grouped as humanized monoclonal antibody produced by recombinant DNA technology.

Hermab 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 Hermab 150mg which is involved in breast cancer treatment.

Hermab 150mg vial with 858mg of lyophilized powder containing 150mg of Trastuzumab .

 

Indication

The drug Hermab 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:

• 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:

Hermab is administer into vein through IV infusion over 90 minutes

Do not administer IV push or bolus.

Duration of Hermab is administratedin once every week or every 3 weeks.

Before starting treatment, patients should undergo biopsy to check Hermab 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

Hermab 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.

Hermab 150mg is a intermediary of anti-body dependent cellular cytotoxicity.

 

Drug Interaction

Hermab 150mg interaction with anthracycline after ending of Hermab 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 Hermab 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;

Hermab 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 Hermab 150mg treatment

Provide alternative therapy management

In serious condition, treatment should be discontinuing.

Infusion reactions;

During Hermab 150mg treatment some life-threatening infusion reactions are produced.

The manifestation due to infusion reactions should be monitored frequently

Delay the infusion of Hermab 150mg treatment and Start the supportive measures by providing epinephrine, corticosteroids, diphenhydramine, bronchodilators, & oxygen.

In serious infusion reactions, Stop the Hermab 150mg treatment permanently.

Patient should be treated with premedication before starting the infusion to overcome the such problem, Embryo fetal damage;

Hermab 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 Hermab 150mg treatment.

During Hermab 150mg treatment. Use with Caution. Therapy induced neutropenia;

Higher incidence of neutropenia occurs during Hermab 150mg treatment.

 

Missed dose

If missed cycles of Hermab 150mg treatment by one week or less, then the repeated maintenance dose (weekly schedule: 2mg/kg; 3 weekly schedules: 6mg/kg) administer as soon as probably.

Until the next planned cycle, the patient does not take interval.

Consecutive Hermab 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 Hermab 150mg dose by higher than one week, then resume with re-storing dose of Hermab 150mg 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.



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