What important information is included in the instructions for ibrutinib/Eco?

Ibrutinib, English generic name Ibrutinib, trade name IMBRUVICA, is an oral small molecule targeted drug widely used in the treatment of hematological tumors and immune-related diseases. As the first BTK inhibitor to enter clinical use, ibrutinib has been included in treatment guidelines in many countries and regions around the world. Its clinical experience is relatively mature and it has a clear positioning in a variety of B cell-related diseases.

1. Main scope of indications

Ibrutinib is mainly used for the treatment of a variety of B cell-derived diseases. First, in the fields of chronic lymphocytic leukemia and small lymphocytic lymphoma, the drug is suitable for adult patients, including those with high-risk genetic characteristics (such as 17p deletion). Second, in Waldenstrom's macroglobulinemia, ibrutinib is used for disease control in adult patients, especially those who require long-term oral treatment regimens. In addition, in terms of chronic graft-versus-host disease, ibrutinib has also been approved for use in patients who have failed previous systemic treatments. The applicable population covers adult and some pediatric patients, making it one of the few targeted drugs that can be used for this indication.

2. Medication Principles and Dosage Design

The administration method of ibrutinib is mainly once-daily oral administration, emphasizing regular and continuous medication. In the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia, adult patients are usually treated with a fixed-dose regimen that is continued until disease progression or intolerable adverse effects.

In the treatment of chronic graft-versus-host disease, the medication regimen emphasizes individualized management. Patients of different age groups have different dosage settings. When the disease is stable or immunosuppressive treatment is no longer needed, the decision to stop medication is based on the doctor's assessment. This flexible adjustment strategy reflects the characteristics of this drug in the management of immune-related diseases.

3. Clinical application of combination therapy

In some diseases, ibrutinib can be used not only as a single agent, but also in combination with other anti-tumor drugs. In the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, ibrutinib can be combined with monoclonal antibody drugs or combined with chemotherapy drugs to enhance the depth of treatment. On the day of co-medication, it is usually recommended to take ibrutinib first before other drugs to reduce the risk of drug interactions. In Waldenstrom's macroglobulinemia, ibrutinib can be used as a single agent or in combination with rituximab and other drugs. The specific regimen needs to be determined based on the patient's disease status and tolerance.

4. Medication management and precautions

Ibrutinib should be taken at a relatively fixed time every day, swallow the capsule whole, and avoid chewing, breaking or opening the capsule. If a dose is missed, it can be taken as soon as possible on the same day, but should not be made up by doubling the dose. Good medication compliance is crucial to maintaining stable efficacy, so patients should try to form a fixed medication habit during treatment and have regular follow-up visits.

5. Dose adjustment for special groups

Ibrutinib should be used with caution in patients with abnormal liver function. Patients with mild liver function impairment usually need to reduce the dose, and patients with moderate impairment need to further reduce the dosage. However, patients with severe liver function impairment are generally not recommended to use this drug. In patients with chronic graft-versus-host disease, if bilirubin is elevated, individualized dosage adjustment is required based on age and liver function to ensure treatment safety.

6. Overview of adverse reactions

There are certain differences in the adverse reactions of ibrutinib among different indications. More common reactions in hematological patients include gastrointestinal discomfort, fatigue, skin or bleeding-related manifestations, and blood cell count changes; while in chronic graft-versus-host disease treatment, infection-related symptoms or oral discomfort may also occur. Most adverse reactions can be alleviated through symptomatic treatment, dose adjustment or short-term intervention. Standardized monitoring is an important part of safe medication use.

7. Storage and use conditions

Ibrutinib should be stored at room temperature, away from high temperatures or moisture, and should be kept in its original packaging before use to ensure drug stability. Short-term temperature fluctuations usually do not affect the efficacy of the medicine, but long-term exposure to extreme environments is not recommended.

8. Fertility and medication safety

Considering the potential reproductive risks, female patients with childbearing potential should take effective contraceptive measures during treatment and for a period of time after stopping the drug; male patients should also use contraceptive management during treatment and after the last dose to reduce potential risks.

9. Brief description of the mechanism of action

From a mechanism perspective, ibrutinib forms an irreversible binding to the key site of Bruton's tyrosine kinase, blocking the conduction of the B cell receptor signaling pathway. This pathway plays an important role in the survival, migration and adhesion of B cells. By inhibiting this signaling axis, ibrutinib can interfere with the proliferation and survival of abnormal B cells, providing a molecular basis for the long-term control of related diseases.

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