How do you Characterize a Biosimilar?
|Primary Structure||Higher Order Structure||Post-Translation Modification||Product-Related Substances/Impurities||Biologic Activity|
|Amino acid sequence||Disulfide bridge||Glycoforms||High molecular weight protein||Fab, HER2 receptor binding|
|Intact mass||Secondary structure||Sialylation||Low molecular weight protein||Fab blockade|
|Tertiary structure||Aglycosylated, thioether-bridged fragments||Fc-gamma III receptor binding|
|Deamidation, charge variant|
HertrazTM 150 mg is reconstituted with 7.2 mL bacteriostatic water for injection (BWFI) and HertrazTM 440 mg should be reconstituted with 20 mL of BWFI. Reconstituted HertrazTM concentrate contains approximately 21 mg/mL of Trastuzumab. Calculate the volume of the 21 mg/mL reconstituted HertrazTM solution needed, withdraw this amount from the vial and add it to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. Do not use Dextrose (5%) solution.
Dosage and Administration
HertrazTM should be administered as intravenous infusion and not as an intravenous push or bolus. For HER2-positive positive breast cancer, administer at either initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly after beginning one week of initial dose, or initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 minutes IV infusion every three weeks after beginning three weeks of initial dose. For Metastatic Gastric Cancer (MGC), administer initial dose of 8 mg/kg, then 6 mg/kg every three weeks after beginning three weeks of initial dose.
Patients who are hypersensitive to Trastuzumab, murine proteins, or to any other component of HertrazTM or suffering from severe dyspnoea at rest due to complications of advanced malignancy, and are requiring supplementary oxygen therapy.
Trastuzumab for Injection (r-DNA Origin)
List of Excipients
TM Hertraz a white to pale yellow lyophilised powder.
Hertraz™ reconstituted with BWFI, as supplied, is stable for 28 days after reconstitution when stored refrigerated at 2°C-8°C (36ºF-46°F).
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