Anikeke Penpulimab Injection

1. Indications and Usage
Relapsed or Refractory Classical Hodgkin Lymphoma (cHL):
Indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have received at least two prior lines of systemic chemotherapy.
Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC):
Indicated in combination with paclitaxel and carboplatin for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Dose: 200 mg administered intravenously every 2 weeks.
Duration: Continue until disease progression or unacceptable toxicity.
Preparation:
Dilute the required volume into a sterile infusion bag containing 0.9% Sodium Chloride Injection. The final concentration should range from 1.0 to 5.0 mg/mL.
Administration:
Infuse over 60 minutes. For patients who cannot tolerate 60-minute infusion, the duration may be extended to 120 minutes.
3. Mechanism of Action
PD-1 Blockade:
Penpulimab is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor.
Immune Activation:
It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby reversing PD-1 pathway-mediated immune inhibition and restoring anti-tumor immunity.
4. Safety and Warnings
Immune-Mediated Adverse Reactions (IMARs):
Penpulimab can cause severe or life-threatening IMARs in any organ system, including pneumonitis, hepatitis, nephritis, and endocrinopathies (e.g., hypothyroidism). Monitor patients closely.
Embryo-Fetal Toxicity:
May cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for at least 5 months after the last dose.
Infusion-Related Reactions:
Monitor patients for signs of infusion reactions during administration.
5. Adverse Reactions
Most Common:
Hypothyroidism, increased ALT/AST (transaminases), rash, anemia, and pyrexia.
6. Drug Interactions
Immunosuppressants:
Systemic corticosteroids and other immunosuppressive drugs may interfere with the efficacy of Penpulimab.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Penpulimab.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light.