CANMAB - 440MG


Describes As


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


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.






Indication Of Canmab


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

Mechanism Of Canmab


Canmab 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 Trastuzumab to the site of HER2 causes prevention of this activity. This joining leads to antibody mediated and leads to HER2 positive cells break down. Canmab is a intermediary of anti-body dependent cellular cytotoxicity.

Drug Interaction


Canmab interaction with anthracycline after ending of Canmab 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 Canmab 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 :
Canmab receiving patients have increased risk of exposing to cardiac disorders. To overcome the problem by; Monitoring cardiac functions regularly Avoid using anthracycline drug after Canmab treatment Provide alternative therapy management In serious condition, treatment should be discontinue.
Infusion reactions :
During Canmab treatment some life threatening infusion reactions are produced. The manifestation due to infusion reactions should be monitored frequently Delay the infusion of Canmab treatment and Start the supportive measures by providing epinephrine, corticosteroids, diphenhydramine, bronchodilators, & oxygen. In serious infusion reactions, Stop the Canmab treatment permanently. Patient should be treated with premedication before starting the infusion to overcome the such problem,
Embryo fetal damage :
Canmab 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 Canmab treatment. During Canmab treatment.use with Caution.
Therapy induced neutropenia :
Higher incidence of neutropenia occurs during Canmab treatment.

Pregnancy and lactation


Canmab pregnancy category is D Canmab should not suggest during pregnancy condition. Breast feeding should not be recommended.

Missed dose


If missed cycles of Canmab 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 Canmab 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 Canmab dose by higher than one week, then resume with re-storing dose of Canmab 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.This are the most common trastuzumab side effects.



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


Storage


Canmab 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 Canmab 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 Canmab, Hence Hypersensitivity reactions are occurs.


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