Trazumab 440mg (Trastuzumab)

DESCRIPTION

Trazumab 440mg injection be expressed by a targeted cancer drug known as Trastuzumab, which is Pharmacologically classify as humanized monoclonal antibody produced by recombinant DNA technology. Trazumab 440mg helps to decrease 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 Trazumab 440mg which is involved in breast cancer treatment. Trazumab 440mg vial with 858mg of lyophilized powder containing 440mg of Trastuzumab

INDICATION

The drug Trazumab 440mg is used for the treatment of Supportive treatment for breast cancer The drug Trazumab 440mg is used for the treatment of Advanced breast cancer The drug Trazumab 440mg is used for the treatment of Advanced gastric cancer

MECHANISM OF ACTION

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

DOSAGE MANAGEMENT

DOSAGE MANAGEMENT

Adjuvant regimen for HER2 over expressing Breast cancer:

52 weeks of treatment total schedules as follows: Combination With paclitaxel or docetaxel ,over a 90 minutes, 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.

BREAST CANCER METASTATIC HER2-OVEREXPRESSING:

Over a 90 minutes, 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.

ADMINISTRATION

Trazumab 440mg is administer into vein through IV infusion over 90 minutes Do not administer IV push or bolus. Duration of Trazumab 440mg is administrated in once every week or every 3 weeks. Before starting treatment, patients should undergo biopsy to check Trazumab 440mg 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.

PRECAUTION

EMBRYO FETAL DAMAGE

Trazumab 440mg is contraindicated to pregnancy period. Avoid becoming pregnancy during this therapy. Use efficient contraceptives during treatment

CARDIOMYOPATHY

Trazumab 440mg receiving patients have increased risk of exposing to cardiac disorders. Provide alternative therapy management In serious condition, treatment should be discontinue

PULMONARY TOXICITY

Some serious fatal cases of pulmonary toxicity occur during Trazumab 440mg treatment.

INFUSION REACTIONS

During Trazumab 440mg treatment some life threatening infusion reactions are produced. In serious infusion reactions, Stop the Trazumab 440mg treatment permanently. Patient should be treated with premedication before starting the infusion to overcome the such problem, During Trazumab 440mg treatment.use with Caution.

THERAPY INDUCED NEUTROPENIA

Higher incidence of neutropenia occurs during Trazumab 440mg treatment.

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
1Rash
Nail disorders
Pruritus
Pyrexia
Chills
Edema
Asthenia
Sudden death

DRUG INTERACTION

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

CONTRAINDICATION

Probably no contraindicated occurs. The patients are contraindicated to the component present in the Trazumab 440mg , Hence Hypersensitivity reactions are occurs. Infusion reactions are produced.

PREGNANCY & LACTATION

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

STORAGE

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

MISSED DOSE

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