Biceltis (Tastuzumab)

DESCRIPTION

Biceltis injection be expressed by a targeted cancer drug known as Trastuzumab, which is Pharmacologically classify as humanized monoclonal antibody produced by recombinant DNA technology. Biceltis helps to decrease the rate of reactivation & mortality.
One of the epidermal growth factor receptors 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 Biceltis which is involved in breast cancer treatment.
Biceltis vial with 858mg of lyophilized powder containing 440mg of Trastuzumab.

INDICATION

The drug Biceltis is used for the treatment of Supportive treatment for breast cancer

The drug Biceltis is used for the treatment of Advanced breast cancer

The drug Biceltis is used for the treatment of Advanced gastric cancer.

MECHANISM OF ACTION

Biceltis 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.

Biceltis is a intermediary of anti-body dependent cellular cytotoxicity.

 PHARMACOKINETICS

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

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 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:
Biceltis is administer into vein through IV infusion over 90 minutes
Do not administer IV push or bolus.
Duration of Biceltis is administrated in once every week or every 3 weeks.
Before starting treatment, patients should undergo biopsy to check Biceltis is the right regimenthe infusion solution should be compatible to polyvinyl chloride or polyethylene bags.
After dilution, the infusion bag should be stored at 2°C to 8°C for not more than 24 hours before use.

PRECAUTIONS

Embryo fetal damage;
Biceltis is contraindicated to pregnancy period
Avoid becoming pregnancy during this therapy.
Use efficient contraceptives during treatment
Cardiomyopathy;
Biceltis receiving patients have increased risk of exposing to cardiac disorders.
Provide alternative therapy management
In serious condition, treatment should be discontinuing
Pulmonary toxicity;
Some serious fatal cases of pulmonary toxicity occur during Biceltis treatment.
Infusion reactions;
During Biceltis treatment some life-threatening infusion reactions are produced.
In serious infusion reactions, Stop the Biceltis treatment permanently.
Patient should be treated with premedication before starting the infusion to overcome the such problem,
During Biceltistreatment. Use with Caution.
Therapy induced neutropenia;
Higher incidence of neutropenia occurs during Biceltis 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, Dyspnea, 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.

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 Biceltis treatment.

Biceltis interaction with anthracycline after ending of Biceltis 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.

CONTRAINDICATIONS

Probably no contraindicated occurs.

The patients are contraindicated to the component present in the Biceltis, Hence Hypersensitivity reactions are occurring. Infusion reactions are produced.

PREGNANCY & LACTATION

Biceltis pregnancy category is D: Biceltis should not suggest during pregnancy condition.

Breast feeding should not be recommended.

STORAGE 

Biceltis 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 Biceltis diluted bag at 2°C to 8°C for 24 hours.

MISSED DOSE

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