Aidixi Disitamab Vedotin For Injection

1. Indications and Usage
Locally Advanced or Metastatic Gastric Cancer (GC/GEJC):
Indicated for the treatment of adult patients with HER2-overexpressing (IHC 2+ or 3+), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who have received two or more prior systemic chemotherapy regimens.
Urothelial Cancer (UC):
Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously been treated with a PD-1 or PD-L1 inhibitor.
Breast Cancer (BC):
Indicated for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer with liver metastases who have received prior trastuzumab and a taxane.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
For Gastric Cancer: 2.5 mg/kg administered intravenously once every 2 weeks (Q2W).
For Urothelial Cancer / Breast Cancer: 2.0 mg/kg administered intravenously once every 2 weeks (Q2W).
Administration Instructions:
Infusion Time: Administer via intravenous drip over approximately 60 minutes (range 30-90 minutes).
Premedication: Not routinely required but monitor for infusion reactions.
3. Mechanism of Action
ADC Technology:
Disitamab vedotin is an antibody-drug conjugate targeting HER2.
Payload Release:
Upon binding to HER2 on tumor cells, the drug is internalized and degraded in lysosomes, releasing the active cytotoxic payload MMAE (monomethyl auristatin E). MMAE binds to tubulin, inhibiting its polymerization, which leads to cell cycle arrest and apoptosis.
4. Safety and Warnings
Peripheral Neuropathy:
May cause sensory neuropathy (numbness, hypoesthesia). Monitor for new or worsening neurological symptoms. Dose interruption or reduction is recommended for Grade ≥ 2 neuropathy.
Ocular Toxicity:
Monitor for signs of ocular toxicity (e.g., blurred vision, dry eye).
Infusion-Related Reactions:
Monitor patients during and after infusion for signs of anaphylaxis or infusion reactions (fever, chills, dyspnea).
5. Adverse Reactions
Most Common:
Elevated transaminases (ALT/AST), decreased white blood cell count, decreased neutrophil count, sensory neuropathy, fatigue, alopecia, nausea, and decreased appetite.
6. Drug Interactions
P-gp Inhibitors:
Avoid concomitant use of strong P-glycoprotein (P-gp) inhibitors, as they may increase the exposure of MMAE and the risk of toxicity.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Disitamab Vedotin (Available in 60 mg vials).
Storage:
Store in a refrigerator at 2-8°C in the original carton to protect from light. Do not freeze.