YuTuo (Zimberelimab Injection) – cHL | HongKong DengYue Medicine

Zimberelimab Injection Application Scope

• Relapsed or refractory classical Hodgkin lymphoma (r/r cHL): Adult patients who have failed at least two lines of systemic chemotherapy. This approval was granted based on the objective response rate (ORR) and duration of response (DOR) from a single-arm trial.

• Recurrent or metastatic cervical cancer: Patients with recurrent or metastatic cervical cancer whose disease has progressed after at least one line of platinum-based chemotherapy and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).

  

Zimberelimab Injection Characteristics

• Ingredients: Zimberelimab

• Properties:​ Clear to slightly opalescent, colorless to slightly yellow liquid for injection

• Packaging Specification:​ 120 mg/4 mL × 12 vial/bottle

• Storage:​  Store at 2-8°C. Do not freeze. Keep the vial in the original outer carton to protect from light

• Expiry Date: Please refer to the expiration date printed on the vial and packaging

• Executive Standard: National Drug Standards of China.

• Approval Number: National Drug Approval Number S20210034

• Date of Revision: The latest revision date should be checked on the approved package insert

• Manufacturer: Wuxi Biologics Co., Ltd

Guidelines for the Use of Zimberelimab Injection

• Dosage and Administration:

  • Recommended Dose: 240 mg administered intravenously every 2 weeks until disease progression or unacceptable toxicity.

  • Administration:

    • Administer via intravenous infusion over no less than 45 minutes. Do not administer as an intravenous push or bolus injection.

    • Prior to administration, the vial must be allowed to reach room temperature (≤25°C).

    • Aseptically withdraw 4 mL (120 mg) from each of two vials (total 240 mg dose) and dilute into an intravenous bag containing either 0.9% Sodium Chloride Injection or 5% Glucose Injection to achieve a final concentration of 2.4 mg/mL.

  • Missed Dose: If a dose is missed, administer it as soon as possible. Subsequent doses should be rescheduled according to the prescribed interval (every 2 weeks) based on the date of the last administered dose. Decisions should be made under a physician’s guidance

• Adverse Reactions:

  • Common Adverse Reactions: Anemia, hypothyroidism, decreased white blood cell count, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), fever, hyperbilirubinemia, rash, decreased neutrophil count, proteinuria

  • Serious Adverse Reactions: Immune-related adverse reactions (irAEs) can be severe or fatal and may involve any organ system, including pneumonitis, colitis, hepatitis, endocrinopathies (such as thyroid disorders, adrenal insufficiency, type 1 diabetes), nephritis, and severe skin reactions. Other serious reactions include severe infections and infusion-related reactions.

• Contraindications: Hypersensitivity to the active substance or any excipient

• Precautions:

  • Immune-Related Adverse Reactions (irAEs): irAEs may occur during or after treatment discontinuation. Monitor patients closely. Most irAEs are manageable with corticosteroids and/or treatment modification (dose delay or discontinuation) according to established guidelines.

  • Infusion-Related Reactions: Monitor for signs during and after infusion. Interrupt or slow the infusion rate or discontinue based on severity.

  • Special Populations:

    • Hepatic or Renal Impairment: Not recommended in patients with moderate or severe hepatic or renal impairment. Use with caution in patients with mild impairment.

    • Elderly: Use with caution due to limited data.

    • Pregnancy and Breastfeeding: Based on its mechanism, may cause fetal harm. Effective contraception is recommended during and for several months after treatment. Discontinue breastfeeding during treatment and for at least 5 months after the last dose.

    • Pediatric Use: Safety and effectiveness have not been established.

Zimberelimab Injection Interactions

• Formal drug-drug interaction studies have not been conducted. As a monoclonal antibody, zimberelimab is not metabolized by cytochrome P450 enzymes; interactions with drugs that are substrates, inducers, or inhibitors of these enzymes are unlikely.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.