Zercepac 420 mg Powder for concentrate for solution for infusion Vial

Product Overview

Zercepac 420 mg Powder for concentrate for solution for infusion is a prescription-only biosimilar medicine, meticulously developed by Accord Healthcare. It contains the active ingredient trastuzumab, a targeted therapy designed for the specific treatment of HER2-positive cancers. This includes HER2-positive early breast cancer, metastatic breast cancer, and HER2-positive metastatic gastric or gastro-oesophageal junction adenocarcinoma. Zercepac works by selectively binding to the HER2 protein, which is often overexpressed in these aggressive cancer cells. This binding action helps to inhibit cancer cell growth and survival, offering a vital therapeutic option. Administration of Zercepac is strictly performed by qualified healthcare professionals in a clinical setting, ensuring patient safety and optimal efficacy.

Benefits of Use

• Targets and inhibits the growth of HER2-positive cancer cells.
• Effective in the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
• Offers a biosimilar alternative to originator trastuzumab, potentially improving access to critical cancer treatment.

How to Use

Zercepac 420 mg is a Prescription Only Medicine (POM) and its preparation and administration must be carried out by a qualified healthcare professional. Patients should not attempt to self-administer this medication. The general steps for its use are:

1. The Zercepac vial contains powder for concentrate for solution for infusion.
2. The powder is first reconstituted with sterile water for injection, following specific guidelines.
3. The reconstituted solution is then further diluted into a suitable infusion solution.
4. The final prepared solution is administered intravenously (into a vein) to the patient.
5. The infusion typically lasts over a period ranging from 30 to 90 minutes.
6. Your doctor will determine the precise dosage and duration of your treatment, tailored to your specific medical condition, body weight, and how you respond to the therapy.
7. Throughout the treatment, regular monitoring for potential side effects and the efficacy of the treatment is crucial.

Caution & Warnings

• Cardiotoxicity: Zercepac can potentially cause serious heart problems, including a reduction in heart function. Regular cardiac monitoring, both during and after treatment, is essential to detect and manage any issues promptly.
• Infusion-Related Reactions: Patients may experience various reactions during or shortly after the infusion. These can include fever, chills, headache, and shortness of breath. In rare cases, severe and life-threatening reactions may occur.
• Pulmonary Toxicity: There have been reports of lung problems, such as interstitial pneumonitis, associated with trastuzumab treatment.
• Embryo-Foetal Toxicity: Zercepac is known to cause significant harm to an unborn baby. Women who are of childbearing potential must use highly effective contraception during treatment and continue for at least 7 months following the last dose.
• Administration: This medication must only be administered under the direct supervision of a physician who has extensive experience in the administration of anticancer agents.
• Do not self-administer this product under any circumstances.
• It is imperative to report any new or worsening symptoms to your healthcare provider immediately.

Ingredients

• Active Ingredient: Trastuzumab 420 mg
• Excipients: L-histidine, alpha,alpha-trehalose dihydrate, polysorbate 20 (please refer to the patient information leaflet for the complete and exact list of excipients, as formulations may vary slightly).

Product Details

• Product Name: Zercepac 420 mg Powder for concentrate for solution for infusion
• Strength: 420 mg
• Dosage Form: Powder for concentrate for solution for infusion
• Manufacturer: Accord Healthcare
• Storage: Store in a refrigerator between 2°C and 8°C (36°F and 46°F). It is important to keep the vial in its original outer carton to protect the contents from light. Do not freeze the product.
• Legal Status: Prescription Only Medicine (POM)