度伐利尤单抗(Imfinzi)的中文说明书

Imfinzi is a PD-L1 inhibitor developed by AstraZeneca, a world-renowned pharmaceutical company. It is used in the treatment of many types of cancer and shows broad anti-cancer potential.

The indications for Imfinzi (Imfinzi) include specific patients with non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma and endometrial cancer. It has been approved by the FDA for the treatment of the following cancers in adults:

1. Non-small cell lung cancer (NSCLC)

(1) Non-small cell lung cancer with no known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement and resectable (tumor ≥4 cm and/or positive lymph nodes). It is used as neoadjuvant therapy in combination with platinum-containing chemotherapy, and durvalumab monotherapy is continued as adjuvant therapy after surgery.

(2) Patients with unresectable stage III non-small cell lung cancer did not progress after receiving concurrent platinum-based chemotherapy and radiotherapy. Imrvalumab is used as a single agent.

(3) Metastatic non-small cell lung cancer without sensitizing EGFR mutations or ALK genomic tumor abnormalities. Immobilumab and temtumumab are used in treatment regimens in combination with platinum-based chemotherapy.

2. Small cell lung cancer (SCLC)

(1) Used in combination with the chemotherapy drug etoposide and carboplatin or cisplatin, for patients whose cancer has spread within the lungs or to other parts of the body.

(2) As a single agent, it is suitable for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after receiving concurrent platinum-based chemotherapy and radiotherapy (cCRT).

3. Biliary tract cancer (including cholangiocarcinoma and gallbladder cancer)

Used in combination with the chemotherapy drugs gemcitabine and cisplatin, for patients whose cancer has spread to nearby tissues or other parts of the body.

4. Hepatocellular carcinoma (unresectable)

Durvalumab and temselimumab are used in combination.

5. Endometrial cancer

If the cancer has spread (late stage) or recurred, and the test shows that the tumor is mismatch repair-deficient (dMMR) endometrial cancer, durvalumab and carboplatin combined with paclitaxel are used, followed by durvalumab monotherapy.

6. Bladder cancer

Bladder cancer that has infiltrated the muscle layer. Durvalumab was used as neoadjuvant therapy in combination with gemcitabine and cisplatin, and durvalumab alone was continued as adjuvant therapy after radical cystectomy.

Side effects of Imfinzi

1. Common side effects

(1) When used as a single agent

When Imfinzi is used as a single agent for stage III non-small cell lung cancer, common side effects include cough, rash, dyspnea, fatigue, cold symptoms (respiratory tract infection), and lung inflammation (pneumonia).

(2) When used in combination

When used in combination with other drugs, common side effects of durvalumab may include nausea, constipation, loss of appetite, feeling weak or tired, bone or muscle pain, cough, difficulty breathing, colds Symptoms (such as nasal congestion, sneezing, sore throat), abdominal pain, fever, itchy skin, rash, painful urination, hair loss, vomiting, neuroinflammation (leading to symptoms such as numbness, weakness, tingling or burning sensation), abnormal blood tests (including decreased magnesium, increased ALT and increased AST). Side effect profiles depend on the specific combination treatment regimen.

(3) When used in combination with carboplatin and paclitaxel

Immune-mediated hypothyroidism was reported in 14% of patients who received durvalumab in combination with carboplatin and paclitaxel. Some patients experienced symptom relief, but all required endocrine therapy.

2. Serious side effects

Call your doctor immediately if:

Chest pain, new or worsening cough, difficulty breathing,

Severe stomach pain, diarrhea, bloody or tarry stools,

New or worsening rash, itching, or blisters,

Fever, flu-like symptoms,

Pain during urination or a burning sensation when urinating,

Other organ problems, such as changes in mood or behavior, stiff neck, confusion, sore or red eyes, vision problems,

Liver problems, such as loss of appetite, upper abdominal pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes),

Kidney problems, such as reduced or no urine production, red or pink urine, swelling of the feet or ankles ,

Transplant rejection, such as rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near the transplanted organ,

Signs of a hormone disorder, such as unusual headache, dizziness or extreme tiredness, hoarseness or deepening of voice, increased appetite or thirst, increased urine output, constipation, vomiting, hair loss, feeling cold, weight gain or loss.

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Common adult doses of imfinzi (Imfinzi)

1. Small cell lung cancer

(1) 30 kg and below

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20 mg/kg intravenously every 3 weeks (21 days) in combination with chemotherapy for 4 cycles, followed by 10 mg/kg intravenously every 4 weeks as monotherapy until disease progression or unacceptable toxicity.

(2) More than 30 kg

1500 mg intravenously every 3 weeks (21 days) in combination with chemotherapy for 4 cycles, followed by 1500 mg intravenously every 4 weeks as monotherapy until disease progression or unacceptable toxicity.

2. Biliary tract cancer

(1) 30 kg and below

Inject 20 mg/kg intravenously every 3 weeks (21 days) in combination with chemotherapy for up to 8 cycles, followed by intravenous injection of 20 mg/kg every 4 weeks as monotherapy until disease progression or unacceptable toxicity.

(2) Over 30 kg

1500 mg intravenously every 3 weeks (21 days) in combination with chemotherapy for up to 8 cycles, followed by 1500 mg intravenously every 4 weeks as monotherapy until disease progression or unacceptable toxicity.

3. Unresectable hepatocellular carcinoma

(1) Less than 30 kilograms

On day 1 of cycle 1, combined with temsilimumab 4 mg/kg at a dose of 20 mg/kg, followed by durvalumab monotherapy every 4 weeks.

(2) 30 kg and above

On day 1 of cycle 1, combined with tirvalumab 300 mg at a dose of 1500 mg, followed by tirvalumab monotherapy every 4 weeks.

4. Endometrial cancer

(1) 30 kg and below

Combined with carboplatin and paclitaxel 15 mg/kg every 3 weeks (21 days) for a total of 6 cycles, followed by durvalumab 20 mg/kg monotherapy every 4 weeks until disease progression or unacceptable toxicity.

(2) More than 30 kg

1120 mg combined with carboplatin and paclitaxel every 3 weeks (21 days) for 6 cycles, followed by durvalumab 1500 mg monotherapy every 4 weeks.

5. Common dosages for adults with non-small cell lung cancer

For detailed dosage information for non-small cell lung cancer and muscle-invasive bladder cancer, please see the detailed dosage instructions for durvalumab.

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Precautions before taking imfinzi (Imfinzi)

1. Allergy

This infusion drug should not be used if you are allergic to imfinzi or any inactive ingredients.

2. Tell your doctor about your history of other medical conditions

To make sure this drug is safe for you, tell your doctor if you have an active infection or if you have ever had:

An organ transplant or stem cell transplant (recent or planned); lung disease or breathing problems; liver disease; radiation therapy to the chest area; autoimmune diseases such as lupus, ulcerative colitis, or Crohn's disease.

3. Pregnancy

Impartumab may harm your unborn baby. Effective contraception should be used to prevent pregnancy while using this medication and for at least 3 months after the last dose. If pregnant, tell your doctor.

4. Breastfeeding

Do not breastfeed while using this medication and for at least 3 months after the last dose.

Precautions after taking imfinzi (Imfinzi)

1. Infusion-related reactions

If an infusion-related reaction occurs, depending on the severity of the reaction, it may be necessary to slow down the infusion rate, interrupt the infusion, or permanently discontinue the drug.

2. Complications of allogeneic hematopoietic stem cell transplantation

Patients who have received or plan to receive allogeneic hematopoietic stem cell transplantation may suffer from fatal and other serious complications before and after treatment with PD-1/PD-L1 blocking antibodies.

3. Embryo-fetal toxicity

This drug may cause harm to the fetus. Women of reproductive potential should be informed of the potential risks to the fetus and should use effective contraception.

Imfinzi administration method

1. Imfinzi is administered by intravenous infusion, usually once every 2, 3 or 4 weeks. Medical staff inject the patient.

2. Durvalumab must be administered slowly, and the infusion takes about 1 hour to complete.

3. If you miss your injection appointment, please call your doctor for guidance.

Strengths of imfinzi (Imfinzi)

500 mg/10 ml (50 mg/ml) single-dose vial solution.

120 mg/2.4 ml (50 mg/ml) single-dose vial solution.

Imfinzi Overdose

Imfinzi is administered by healthcare professionals in a medical setting, so overdose is unlikely.

Imfinzi Drug Interactions

Other drugs may interact with Imfinzi, including prescription drugs, over-the-counter drugs, vitamins, and herbal products. Tell your doctor about all the medicines you currently take and any medicines you start or stop taking.

Main ingredients of Imfinzi

Active ingredients: Imfinzi

Inactive ingredients of Imfinzi: L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, polysorbate 80, water for injection.