Ibrutinib Emlutini IBRUTINIB140MG 90 capsules Approval No. 09 L 0701/16 Validity Date 27-6-2026 Export to China 3% customs VAT

Ibrutinib (trade name: Emlutini) is a targeted therapy drug, mainly used to treat various types of hematological malignancies, especially chronic lymphocytic leukemia (CLL) , small lymphocytic lymphoma (SLL) , mantle cell lymphoma (MCL) and some other B-cell related malignancies. The following is the basic information of Ibrutinib :

1. Drug classification :

• Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor . It blocks the B cell receptor signaling pathway by inhibiting BTK, thereby reducing the growth and spread of leukemia or lymphoma cells. BTK is a key enzyme in the B cell activation process and is involved in the activation and proliferation of immune cells.

2. Indications :

• Chronic lymphocytic leukemia (CLL) : For the treatment of adult patients with chronic lymphocytic leukemia, including those with 17p deletion.
• Small lymphocytic lymphoma (SLL) : Used to treat small lymphocytic lymphoma.
• Mantle cell lymphoma (MCL) : used to treat adult patients who have failed premenstrual therapy (such as chemotherapy, immunotherapy).
• Waldenström's Macroglobulinemia (WM) : For the treatment of patients with Waldenström's macroglobulinemia.
• Others : Ibrutinib is also approved for the treatment of some other B-cell-related malignancies and some relapsed, resistant lymphomas.

3. Usage and dosage :

• aldult :
  • Chronic lymphocytic leukemia (CLL) : The recommended dose is 420 mg (4 tablets) once daily , which can be taken before or after meals.
  • Small lymphocytic lymphoma (SLL) : The recommended dose is 420 mg once daily .
  • Mantle cell lymphoma (MCL) : The recommended dose is 560 mg (5 tablets) once daily , which can be taken before or after meals.
  • Waldenström macroglobulinemia (WM) : The recommended dose is 420 mg once daily .
• How to take : Ibrutinib should be swallowed whole and should not be chewed, crushed or split. The medication can be taken before or after meals, but should be taken at the same time every day.
• Dose Adjustment : If side effects occur, especially severe hematological toxicity, infection, or bleeding, the dose should be adjusted according to the doctor's advice.

4. Notes :

• Bleeding risk : Ibrutinib may increase the risk of bleeding, especially in patients taking anticoagulants or with a history of bleeding. Bleeding symptoms (such as abnormal bruising, bleeding, etc.) should be monitored during use.
• Cardiovascular disease : Ibrutinib may be associated with cardiovascular problems such as atrial fibrillation. Patients should be carefully monitored for cardiac symptoms such as palpitations, shortness of breath, and chest pain while using Ibrutinib.
• Infection : Ibrutinib may suppress immune system function and increase the risk of infection, especially when used long-term or in combination with chemotherapy. Patients should be regularly monitored for symptoms of infection (such as fever, cough, chills, etc.).
• Liver function monitoring : Ibrutinib may cause hepatic impairment, and liver function should be monitored regularly during treatment, especially in patients with abnormal liver function.
• Drug interactions : Ibrutinib is metabolized mainly through CYP3A enzymes, and certain drugs (such as strong CYP3A inhibitors or inducers) may affect its metabolism and increase or decrease its blood concentration. Therefore, when using Ibrutinib, avoid using it simultaneously with CYP3A inhibitors (such as ketoconazole) or inducers (such as rifampicin).

5. Side effects :

• Common side effects :
  • Hematological side effects : such as anemia, thrombocytopenia, leukopenia, infection, etc.
  • Bleeding events : such as subcutaneous hemorrhage, nosebleed, hematuria, etc.
  • Cardiovascular side effects : such as atrial fibrillation (especially in long-term treatment), hypertension, etc.
  • Digestive system reactions : nausea, diarrhea, loss of appetite, etc.
  • Fatigue, headache, joint pain, etc.
• Serious side effects :
  • Severe bleeding : may cause severe hematoma, gastrointestinal bleeding, etc., which requires immediate discontinuation of the drug and treatment measures.
  • Atrial fibrillation : This can cause serious heart problems, especially in people with a history of heart disease.
  • Hepatotoxicity : May cause abnormal liver function or jaundice, requiring discontinuation of the drug and appropriate treatment.
  • Infection : Due to the immunosuppressive effect, the risk of infection may be increased and requires prompt treatment.

6. Contraindications :

• Patients with hypersensitivity to Ibrutinib or any of its components are contraindicated.
• Not recommended for use in patients with severe hepatic impairment (Child-Pugh class C).
• It is contraindicated for patients with severe bleeding risk (such as active peptic ulcer, cerebral hemorrhage, etc.).

7. Pregnancy and lactation :

• Pregnancy : Ibrutinib is a Category C drug (possibly harmful to the fetus). The risk of using Ibrutinib during pregnancy has not been determined, and pregnant women should avoid using this drug. If you must use it during pregnancy, you should fully discuss the potential risks with your doctor.
• Lactation : It is not clear whether Ibrutinib is secreted into breast milk, so caution should be exercised when used during lactation, and it is best to discontinue or suspend breastfeeding.

8. Storage :

• Ibrutinib should be stored at room temperature (15°C to 30°C) away from moisture and direct sunlight. Keep the drug out of the reach of children.

9. Other matters needing attention :

• Monitoring : When using Ibrutinib, patients need to undergo regular blood tests , liver function tests , electrocardiograms and other related tests.
• Discontinuation management : If serious side effects occur, patients should follow the doctor's instructions to discontinue the medication and receive appropriate management.

Summarize:

Ibrutinib (Emlutini) is a targeted drug used to treat a variety of B-cell-related malignancies, especially chronic lymphocytic leukemia, mantle cell lymphoma, etc. It works by inhibiting Bruton's tyrosine kinase (BTK). When using Ibrutinib, regular monitoring of hematology, liver function, cardiovascular health, etc. is required. Patients should follow the doctor's instructions and adjust the dose according to their own conditions.

Please note : This description is for reference only. The specific treatment plan should be formulated according to the doctor's advice and the patient's specific situation. Before using Ibrutinib, patients should read the drug instructions in detail and consult a doctor.