Nivolumab 100mg 10mL Nivolumab Injection Gastrointestinal Cancer Treatment

Nabumab [drug name

align: inherit;">Trade name: OPDIVO/OPDIVO





The generic name: NAVULIZUMAB INJECTION
English name: Navulizumab Injection

Non-Small Cell Lung Cancer (NSCLC)

This product is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer. Epidermal Growth Factor Receptor (EGFR) mutation-negative and Anaplastic Lymphoma Kinase (ALK)-negative, as well as previously treated NSCLC with platinum-containing chemotherapy that has progressed or is intolerant.

Squamous Cell Carcinoma of the Head and Neck (SCCHN)


Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This product is indicated as a single agent for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) whose disease has progressed during or after treatment. Platinum-containing regimens whose tumors are positive for PD-L1 expression (defined as ≥1% of tumor cells expressing PD-L1).


This indication is based on an analysis of subjects with PD-L1-positive squamous cell carcinoma in the CheckMate 141 clinical study. head and neck cancer subjects analyzed in the CheckMate 141 clinical study that received conditional approval. Full approval for this indication is contingent upon the conduct of subsequent clinical trials to confirm the clinical benefit of the product in the Chinese population (see [Clinical Trials]).


Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma (GC, GEJC or EAC)

This product is indicated for the treatment of advanced or metastatic gastric, gastroesophageal-joint or esophageal adenocarcinoma (GC, GEJC or EAC)

Adenocarcinoma of the stomach or gastroesophageal junction


Adenocarcinoma of the stomach or gastroesophageal junction
This product is indicated for the treatment of patients with advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction who have received two or more prior systemic treatment regimens.

Malignant Pleural Mesothelioma (MPM)


This product is used in combination with ibritumomab for the treatment of adult patients with non-surgically resected primary non-epithelioid malignant pleural mesothelioma.


Based on the analysis of non-epithelioid malignant pleural mesothelioma subjects in the CheckMate 743 clinical study, this indication received favorable results. analysis in the CheckMate 743 clinical study in subjects with non-epithelioid malignant pleural mesothelioma, this indication received conditional approval. Full approval for this indication is subject to the conduct of a follow-up clinical trial to confirm the clinical benefit of the product in the Chinese population (see "Clinical Trials").

Dosage and Method of Administration


Patient choice

Patient choice
A positive PD-L1 assessment confirmed by a well-validated assay must be obtained prior to use of this product in patients with head and neck squamous cell carcinoma.

Recommended Dose



For monotherapy, the recommended dosage of this product is 3 mg/kg or a fixed dose of 240 mg by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity occurs.


[Adverse Reactions]
The most common adverse reactions (≥10%) were fatigue (28%), rash (16%), pruritus (13%), diarrhea (12%), neutropenia (12%), and nausea (11%) ) . Most adverse reactions were mild to moderate (grade 1 or 2).

Storage
Store at 2 to 8°C away from light, do not freeze.

See instruction manual [expiration date] for storage conditions of prepared solutions.