What key information does the durvalumab (durvalumab) package insert contain? What should you pay attention to when using it?

Durvalumab (Durvalumab) is an immune checkpoint inhibitor and a monoclonal antibody drug. It enhances the immune response of T cells by inhibiting the binding of programmed cell death protein 1 (PD-1) and its ligand PD-L1, thereby activating the body's immune system to fight against tumor cells. This drug is used to treat certain types of cancer, especially non-small cell lung cancer (NSCLC) and bladder cancer. The following is the key information in the durvalumab drug package insert and matters needing attention when using it.

1. Drug efficacy and indications

Durvalumab is mainly used to treat the following cancer types:

Advanced or metastatic non-small cell lung cancer (NSCLC): used for patients with positive PD-L1 expression, especially after failure of other chemotherapy regimens;

Locally advanced or metastatic bladder cancer: used as a single agent or in combination with chemotherapy to treat patients with metastatic bladder cancer, especially those who have a certain response to chemotherapy;

Other Indications: Durvalumab may also be used in clinical trials to treat other types of tumors, but its main approved indications remain lung and bladder cancer.

2. Usage and dosage

Durvalumab is usually administered intravenously, and the exact usage and dosage will vary based on the cancer type and the patient's clinical condition. Common dosage schedules are:

Adult dosage: In the treatment of non-small cell lung cancer, the usual dose of durvalumab is 150 mg once every two weeks. For patients with bladder cancer, the usual recommended dose is 10 mg/kg every two weeks.

Administration: This drug should be administered by intravenous infusion, usually over 60 minutes. During the treatment process, patients need to receive infusions under the supervision of medical personnel to observe possible allergic reactions.

3. Common adverse reactions

The use of durvalumab may cause some adverse reactions, which are often related to activation of the immune system. Common adverse reactions include:

Fatigue: This is one of the most common side effects and patients may experience ongoing fatigue and weakness.

Skin reactions: such as rash, itching, etc.;

Immune-related adverse reactions: including pneumonia, hepatitis, endocrine dysfunction (such as hyperthyroidism or hypothyroidism), etc. Immune-related adverse reactions can be serious or even life-threatening and require prompt treatment.

Gastrointestinal reactions: nausea, vomiting, diarrhea and other symptoms.

Therefore, patients need to undergo regular physical examinations when using this drug to monitor whether these adverse reactions occur, especially immune-related reactions.

4. Contraindications and Precautions

Contraindications: There are certain contraindications to the use of durvalumab, which mainly include patients who are allergic to the drug or any of its components. In the event of severe allergic reactions, difficulty breathing, etc., the use of this drug should be stopped immediately.

Immune-related reactions: Because the drug's mechanism is to enhance the activity of the immune system, it may cause the immune system to attack normal tissues, leading to inflammation and organ damage. During treatment, patients should be closely observed for abnormal symptoms in the lungs, liver, intestines or endocrine system.

Pregnancy and Lactation: The safety of durvalumab during pregnancy has not been fully established and its use should be avoided in pregnant women. If used during pregnancy, it may affect the health of the fetus. In addition, it is unclear whether durvalumab is excreted in breast milk, and nursing women should use this drug with caution.

5. Long-term use and monitoring

When using durvalumab for a long time, patients need to undergo regular examinations of immune function, liver and kidney function, lung function, etc., in order to detect possible immune system-related adverse reactions as early as possible. Doctors often adjust the dose based on the patient's response or temporarily stop treatment until side effects subside.

In summary, the application of durvalumab in cancer treatment provides new hope for patients, but due to its side effects and immune-related adverse reactions, patients need to be cautious during use, strictly follow medical instructions, and conduct regular examinations.

Reference materials:https://www.imfinzi.com/