Cosibelimab-Ipdl|Cutaneous Squamous Cell Carcinoma | HongKong DengYue Medicine

  • Generic Name / Brand Name: Cosibelimab-ipdl / UNLOXCYT
  • Indications: Cutaneous Squamous Cell Carcinoma
  • Dosage Form: ​Solution
  • Specification: 300 mg/5 mL

Cosibelimab-Ipdl Application Scope

Treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or curative radiation.

cosibelimab-ipdl

Cosibelimab-Ipdl Characteristics

  • Ingredients: Active ingredient: Cosibelimab-ipdl, a fully human IgG1 monoclonal antibody targeting PD-L1.

  • Properties: Blocks the interaction between PD-L1 and its receptors PD-1 and B7.1, enhancing anti-tumor immune response. Also induces antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.

  • Packaging Specification: Supplied as a solution for intravenous infusion.

  • Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.

  • Expiry Date: Refer to the product labeling for specific expiration information.

  • Executive Standard: Approved by the U.S. Food and Drug Administration (FDA).

  • Approval Number: Biologics License Application (BLA) number 761297.

  • Date of Revision: December 2024.

  • Manufacturer: Checkpoint Therapeutics, Inc.

Guidelines for the Use of Cosibelimab-Ipdl

  • Dosage and Administration: Administer 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.

  • Adverse Reactions:

    • Common (≥10%): Fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, urinary tract infection.

    • Serious: Immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, myocarditis, and others.

  • Contraindications: None listed. However, caution is advised in patients with a history of severe hypersensitivity reactions to monoclonal antibodies.

  • Precautions:

    • Monitor for signs of immune-mediated adverse reactions.

    • Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment.

    • Withhold or permanently discontinue treatment based on the severity of adverse reactions.

Cosibelimab-Ipdl Interactions

  • Drug Interactions: No formal drug interaction studies have been conducted. However, concomitant use with immunosuppressive agents may diminish the efficacy of cosibelimab-ipdl.

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
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