penpulimab-kcqx

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Indications

  • in combination with either cisplatin or carboplatin & gemcitabine for first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma
  • as a single agent for the treatment of adults with metastatic non-keratinizing nasopharyngeal carcinoma with disease progression on or after platinum-based chemotherapy & at least one other prior line of therapy

Contraindications

  • Embryo-Fetal Toxicity

Dosage

  • 200 mg IV over 60 minutes every 2-3* weeks until disease progression or a maximum of 24 months

* every 2 weeks as single agent

* every 3 weeks with either cisplatin or carboplatin & gemcitabine

Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.

Adverse effects

  • serious or fatal immune-mediated reactions can occur in any organ of the body
  • most common (> 20%)
    • in combination with either cisplatin or carboplatin & gemcitabine:
      • nausea, vomiting, hypothyroidism, constipation, decreased appetite, weight loss, cough, COVID-19 infection, fatigue, rash, pyrexia
    • as single agent (> 20%)
      • anemia, hypothyroidism

Mechanism of action

More general terms

References

  1. HIGHLIGHTS OF PRESCRIBING INFORMATION PENPULIMAB-KCQX injection, for intravenous use https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761258s000lbl.pdf