The innovation is a biosimilar trastuzumab that was designed and produced in-house by the company. Although trastuzumab has side effects such as flu-like symptoms (such as fever, chills and mild pain), nausea, diarrhea, an association with cardiac dysfunction (in 2-7% of cases), and a contraindication with anthracycline chemotherapy, this biosimilar variant has shown reduced occurrence of such side effects.
The product is available in two variants:
• A single-dose vial containing 60 or 150 mg of Trastuzumab
• 440 mg/21 ml multi-dose vials
It can be administered in an outpatient setting. The recommended loading dose is 4mg/kg as a 90-minute intravenous infusion along with 175 mg/m2/ dose on day 1 of therapy.
The weekly maintenance dose is 2 mg/kg over 30 minutes if the first dose was well tolerated on days 1, 8, and 15 except for day 1 of the first cycle.