Product Description
Trastuzumab Lyophilized Powder
Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product.. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 7.15 mL (150 mg trastuzumab), at a pH of approximately 6.
Precise HER2 Targeting Cancer TherapyTrastuzumab is designed to specifically bind to the HER2 receptor on cancer cells, inhibiting tumor growth in HER2-positive breast and gastric cancers. This targeted approach offers a highly effective treatment option while minimizing damage to healthy cells. The product's high purity and robust manufacturing ensure consistent therapeutic outcomes.
Convenient Stable FormulationOffered as a stable lyophilized powder, Trastuzumab maintains its efficacy when stored properly under refrigeration. The formulation allows for ease of storage, extended shelf life of 24 months, and reconstitution according to clinical dosing needs, providing flexibility for medical providers and patients alike.
FAQ's of Trastuzumab Lyophilized Powder:
Q: How should Trastuzumab Lyophilized Powder be prepared and administered?
A: Reconstitute the vial with Sterile Water for Injection-7.2 mL for the 150 mg vial or 20 mL for the 440 mg vial-then further dilute the reconstituted solution in an infusion bag containing 0.9% Sodium Chloride. Administration is via intravenous infusion, with the first dose over 90 minutes and subsequent infusions over 30-90 minutes.
Q: What are the main indications for using Trastuzumab?
A: Trastuzumab is indicated for the treatment of HER2-positive breast cancer and HER2-positive gastric cancer, offering a targeted approach for these malignancies when prescribed by a qualified healthcare professional.
Q: When should cardiac monitoring be performed for patients receiving Trastuzumab?
A: Cardiac function should be evaluated before initiating Trastuzumab treatment and monitored regularly during therapy, as Trastuzumab poses a risk for cardiac toxicity. Patients with pre-existing heart conditions require extra caution and frequent assessment.
Q: Where should Trastuzumab Lyophilized Powder be stored prior to use?
A: The product must be stored at 2C-8C in a refrigerator, protected from light and not frozen. Proper storage ensures stability and preserves the therapeutic effectiveness of the lyophilized powder.
Q: What are the key benefits of Trastuzumab's lyophilized and recombinant formulation?
A: The lyophilized form provides stable long-term storage, while recombinant DNA technology ensures high purity and specificity for the HER2 receptor. This results in enhanced safety, efficacy, and consistency in cancer treatment.
Q: Is Trastuzumab suitable for all cancer patients?
A: Trastuzumab is only appropriate for patients with HER2-positive tumors, as determined by approved diagnostic tests. It is not suitable for individuals with hypersensitivity to trastuzumab or any of its excipients.