Meiyouheng Becotatug Vedotin for Injection

1. Indications and Usage
Locally Advanced or Metastatic Nasopharyngeal Carcinoma (NPC):
Becotatug Vedotin is indicated for the treatment of adult patients with locally advanced or metastatic nasopharyngeal carcinoma who have received prior platinum-based chemotherapy and PD-1 inhibitor therapy.
2. Dosage and Administration
Recommended Dosage:
Standard Dose: 2.2 mg/kg administered as an intravenous infusion every 3 weeks.
Dose Reduction: For patients who have experienced unacceptable toxicity, doses can be reduced to 1.8 mg/kg and then to 1.4 mg/kg.
Administration Instructions:
Infuse through an intravenous line with a 0.2 micron or 0.22 micron inline filter.
Do not administer as an intravenous push or bolus.
Do not mix or co-administer with other drugs in the same infusion line.
3. Mechanism of Action
Antibody-Drug Conjugate (ADC):
Becotatug Vedotin is an anti-CD166 antibody conjugated to monomethyl auristatin E (MMAE).
Physiological Effect:
Becotatug Vedotin binds to CD166 (Activated Leukocyte Cell Adhesion Molecule), which is overexpressed on tumor cells. The ADC is internalized and MMAE is released intracellularly.
4. Safety and Warnings
Peripheral Neuropathy:
Peripheral neuropathy may occur. Monitor patients for signs of neuropathy (numbness, tingling, or pain in the hands or feet). Dose delays or reductions may be required.
Infusion-Related Reactions:
Monitor patients during infusions. Interrupt or slow the rate of administration if severe reactions occur.
Reproductive Toxicity:
May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.
5. Adverse Reactions
Most Common:
Peripheral neuropathy, anemia, fatigue, nausea, vomiting, alopecia, and rash.
6. Drug Interactions
No Specific Interactions:
No formal drug interaction studies have been conducted.
7. Pharmaceutical Information
Storage:
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake.