Penpulimab Injection Application Scope

Penpulimab is a humanized anti-PD-1 monoclonal antibody used in immunotherapy for various cancers.

It is indicated mainly for the treatment of recurrent or metastatic nasopharyngeal carcinoma and other solid tumors, either as monotherapy or in combination with chemotherapy agents.

Penpulimab Injection Characteristics

Ingredients: Penpulimab, a humanized monoclonal antibody targeting the PD-1 receptor.
Properties:
Penpulimab binds to the PD-1 receptor on T cells, preventing interaction with its ligands, PD-L1 and PD-L2.
Packaging Specification: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.
Storage: Refrigerate at 2–8 °C; do not freeze; protect from light.
Expiry Date: 36 months from the date of manufacture.
Executive Standard: Meets FDA, EMA, ICH Q6B, and European Pharmacopoeia standards for monoclonal antibodies.
Approval Number: FDA-approved in April 2025; NMPA-approved in August 2021.
Date of Revision: 2025‑01 (or insert latest label update date).
Manufacturer: Akeso Biopharma Co., Ltd., Zhongshan, Guangdong, China.

Guidelines for the Use of Penpulimab Injection

Dosage and Administration:
- Recommended Dose:
  - Combination therapy: 200 mg intravenously over 60 minutes every 3 weeks, in combination with gemcitabine and cisplatin or carboplatin, until disease progression or a maximum of 24 months.
  - Monotherapy: 200 mg intravenously over 60 minutes every 2 weeks, until disease progression or a maximum of 24 months.
Adverse Reactions:
- Common Adverse Reactions
  - Hypothyroidism
  - Fever
  - Elevated alanine aminotransferase levels
  - Decreased white blood cell count
  - Rash
- Serious Adverse Reactions:
  - Immune-mediated pneumonitis
  - Immune-mediated colitis
  - Hepatitis
  - Nephritis
  - Skin reactions
  - Endocrinopathies
  - Infusion-related reactions
  - Cytopenias
Contraindications: None
Precautions:
- Immune-mediated Adverse Reactions: Monitor for signs and symptoms of immune-mediated adverse reactions. Discontinue use if reactions occur.
- Infusion-related Reactions: Monitor during and after infusion.
- Pregnancy and Lactation: Use only if potential benefit justifies the risk. Inform healthcare provider if pregnant or breastfeeding.

Penpulimab Interactions

May interact with other immunosuppressive therapies. Monitor for potential interactions.

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.