Product Description
1. General Characteristics
- Brand/Generic: Serplulimab (INN), often marketed as Hetronifly or Zerpidio.
- Dosage Form: Sterile concentrate for solution for infusion (intravenous drip).
- Drug Class: Immune checkpoint inhibitor (recombinant humanized anti-PD-1 monoclonal antibody).
- Mechanism: It blocks the PD-1 receptor on T-cells, preventing cancer cells from deactivating the immune system and helping the body destroy tumor cells.
- Appearance: Colourless to slightly yellow, and clear to slightly opalescent liquid.
- Concentration: \(10\text{ mg/ml}\).
- Packaging: Typically supplied in a single-use clear glass vial containing \(10\text{ ml}\) of concentrate (totaling \(100\text{ mg}\) of serplulimab).
3. Composition & Excipients
- Active Ingredient: Serplulimab (produced in Chinese hamster ovary cells via recombinant DNA technology).
- Inactive Ingredients/Excipients: Sodium, polysorbate 80 (E 433), and Water for Injections.
- pH Range: 5.2 to 5.8.
4. Preparation & Administration
- Dilution: Must be aseptically diluted in \(0.9\%\) Sodium Chloride injection before use.
- Administration: Administered strictly via intravenous (IV) infusion (typically over 30 to 60 minutes).
- Storage: Must be refrigerated continuously between \(2^{\circ}\text{C}\) and \(8^{\circ}\text{C}\) (\(36^{\circ}\text{F}\) to \(46^{\circ}\text{F}\)) and protected from light.
- Used primarily as a first-line treatment for aggressive malignancies, such as extensive-stage small cell lung cancer (ES-SCLC).
- Often prescribed in combination with chemotherapy (such as carboplatin and etoposide).