Brand name : Biceltis
Composition : Trastuzumab
Strength : 440mg
Manufactured by : Emcure
Pack : two vials in a container; one vial containing drug Trastuzumab 1.0ml& one vial containing bacteriostatic water.
Biceltis is a group of medicines which belongs to anti neoplastic medication. Biceltis is a chemotherapy drug. It is recommended that Biceltis be administered under the guidance of a qualified physician experienced in the use of cancer chemotherapeutic agents.
The injection Biceltis is used alone or combination with other medicine for the treatment in patients who suffering from metastatic breast cancer.
The drug also indicated with combination of other medicine for the treatment of certain types of stomach or esophagus cancer in some persons.
Different type of breast cancer cells has a higher than normal level of a protein called HER2 (human epidermal growth factor receptor 2) on their surface. These HER2 receptors get signals which stimulate the tumor cells to develop and reproduce. But breast cancer cells with too many HER2 receptors can Choice too many growth signals and so start developing and proliferating too much and too fast.
Biceltis acts by adhere itself to the HER2 receptors on the surface of breast cancer cells and stopping them from collecting growth signals. By stopping the signals, Biceltis can slow or inhibit the growth of the breast cancer and the drug is an immune targeted therapy. In addition to inhibiting HER2 receptors, Trastuzumab can also help to fight against breast cancer by attentive the immune system to damage the cancer cells onto which it is attached.
The injection Biceltis should not mix with other drugs and do not administer as an intravenous push or bolus.
Trastuzumab should not be substitute for or with ado-Trastuzumab emtansine
Adjuvant treatment, breast cancer:
The drug given according to one of the following doses and schedules for a 52 weeks total of trastuzumab treatment:
During combination with paclitaxel, docetaxel, or docetaxel /Carboplatin:
Starting dose of 4 mg/kg as an IV (intravenous infusion) over 90 minutes followed at 2 mg/kg as an IV(intravenous infusion) over 30 minutes weekly during treatment of chemotherapy given with paclitaxel or docetaxel for first 12 weeks or 18 weeks (docetaxel/carboplatin) The Biceltis dose for One week following the last weekly administers Trastuzumab at 6 mg/kg as an IV (intravenous infusion) over 30 to 90 minutes every three weeks.
The injection given as a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens:
For an intravenous infusion over 90 minutes: Initial dose at 8 mg/kg
Successive doses at 6 mg/kg over 30 to 90 minutes every three weeks as an intravenous infusion.
Adjuvant treatment stretching beyond one year is not recommended.
Metastatic Treatment, Breast Cancer:
Biceltis administrated alone or in combination with paclitaxel, at a starting dose of 4 mg/kg as a 90-minute intravenous infusion continued by successive once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease development.
Metastatic Gastric Cancer:
Biceltis administrated at a starting dose of 8 mg/kg as a 90-minute IV intravenous infusion continued by successive doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease development.
Embryo fetal damage
Biceltis is contraindicated to pregnancy period. Avoid becoming pregnancy during this therapy. Use efficient contraceptives during treatment
Patient getting Biceltis injection have increased risk of exposing to cardiac disorders. Provide alternative therapy management In serious condition, treatment should be discontinuing
Some serious fatal cases of pulmonary toxicity occur during Biceltis treatment.
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.
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 Trastuzumab great disaster period is depends on population PK analysis.
Probably no contraindicated occurs.
The patients are contraindicated to the component present in the Biceltis, Hence Hypersensitivity reactions are occurring.
Store the drug at 2℃ to 8℃ (refrigerator temperature) Protected the vial away from heat & light Stored at 2℃ to 8℃ for 28 days after reconstitution Stored Biceltis diluted bag at 2℃ to 8℃ for 24 hours.
The drug Missing doses can decrease their usefulness and raises the probability of developing drug resistance, that makes this drug lose their potency. For best results, it is important to accept each scheduled dose of Trastuzumab medication as instructed. If you miss a dose, leave the missed dose and continue with your regular dosing schedule. Do not have two doses to make up for a missed one. If you are not sure about what to do after missing a dose, the take advice with doctor or pharmacist.
Common side effects:
Redness at injection site (IV)
Mild skin rash
Serious side effects:
Sudden unexplained weight gain
Easy bruising or bleeding
Fast or pounding heartbeat