Instructions for Necitumumab

1. Name: Necitumumab, Necitumumab, PORTRAZZA

2. Indications:

Necitumumab is suitable for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin.

Limitations of Use: Nexituzumab is not indicated for the treatment of non-squamous non-small cell lung cancer.

3. Usage and dosage:

1. Recommended dosage:

The recommended dose of oxetuzumab is 800 mg as a 60-minute intravenous infusion on days 1 and 8 of each 3-week cycle, followed by an infusion of gemcitabine and cisplatin. Treatment with oxetuzumab is continued until disease progression or unacceptable toxicity occurs.

2. Preoperative medication:

For patients who have had a previous Grade 1 or 2 infusion-related reaction (IRR)Precede all subsequent nesituzumab infusions with diphenhydramine hydrochloride (or equivalent); For patients with secondary Grade 1 or 2 IRR, premedicate all subsequent infusions with diphenhydramine hydrochloride (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each nexituzumab infusion.

3. Dosage modification:

(1)Infusion-related reaction(IRR):

For Grade 1 IRR, reducenexituzumabinfusion rateby 50%; withhold infusion for Grade 2 IRR until signs and symptoms resolve to grade 0 or 1; for all subsequent infusions, resume oxituzumab at a 50% reduced rate; for grade 3 or 4 IRR, permanently discontinue oxituzumab.

(2) Skin toxicity:

For grade 3 or acneiform rashwithhold nesituzumab until symptoms resolve to ≤ grade 2, then continue nesituzumab at a reduced dose of 400 mg for at least 1 treatment cycle. If symptoms do not worsen, the dose can be increased to 60 in subsequent cycles0mg and 800mg. If Grade 3 rash or acneiform rash does not resolve to Grade ≤ 2 within 6 weeks, adverse reactions worsen or become intolerable at doses of 400 mg, patients develop Grade 3 skin induration/fibrosis or Grade 4 skin toxicity, permanently discontinue Nexituzumab.

4. Adverse reactions:

The most common adverse reactions (all grades) observed in patients treated with nestuzumab were ≥15% and ≥2% more frequent than gemcitabine and cisplatin alone, respectively, and included rash, vomiting, diarrhea, and acneiform dermatitis. The most common serious adverse events that occurred in ≥2% of patients treated with nesituzumab compared with patients who received gemcitabine and cisplatin alone were venous thromboembolic events (including pulmonary embolism), rash, and vomiting.

5. Storage:

Before using nexituzumab , store vials in a refrigerator at 2 to 8°C (36 to 46°F). Store vials in outer carton to protect from light. Do not freeze or shake vial. Store diluted infusion solution nesituzumab for no more than 24 hours and at room temperature (max 25°C [77°F]) for no more than 4 hours.

6. Special groups:

1. Women: Based on its mechanism of action, nesituzumab can cause fetal harm when used in pregnant women; therefore, it is recommended that women of reproductive potential use effective contraception during treatment with nesituzumab and within three months after the last dose; lactating women should not breastfeed during treatment with nesituzumab and within three months after the last dose.

7. Mechanism of action:

Nexituzumab is a recombinant humanlgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands. EGFR expression and activation are associated with malignant progression, induction of angiogenesis, and inhibition of apoptosis. Binding of nexituzumab induces the internalization and degradation of EGFR in vitro. In vitro, binding of nexituzumab also resulted inantibody-dependent cellular cytotoxicity (ADCC) of EGFR-expressing cells. In in vivo studies using xenograft models of human cancers, including non-small cell lung cancer, administration of nexituzumab in combination with gemcitabine and cisplatin to implanted mice resulted in increased antitumor activity compared to mice receiving gemcitabine and cisplatin alone.

The generic drug of Nexituzumab has not yet been approved for marketing in China, and therefore it has not been included in medical insurance. Listed overseasSpecifications of the German version of the generic drug of Nexituzumab800mg/50ml per box may cost more than 10,000 yuan (the price may fluctuate due to the exchange rate), which is relatively expensive. Currently, there are no generic drugs of Nexituzumab on the market. For more drug information and specific prices, please consult Yaode Medical Consultant.