Packaging Size90 Capsules/Bottle
TreatmentChronic Lymphocytic Leukemia（CLL）,Small Lymphocytic Lymphoma（SLL）,Mantle Cell Lymphoma（MCL）,Waldenström Macroglobulinemia（WM）,Marginal Zone Lymphoma（MZL）,Graft vs Host Disease（cGVHD）
ManufacturerSaiLin Biopharmaceutical (Laos) Co., Ltd
YSTOBLASTIC LYMPHOMA: SCHLEBULAR LYMPHOMA (MCL) THAT HAS RECEIVED AT LEAST ONE PREVIOUS TREATMENT, ACCELERATED APPROVAL FOR THIS ADAPTATION IS BASED ON ORR. CONTINUED APPROVAL OF THE ADAPTATION MAY DEPEND ON A DESCRIPTION AND CONFIRMATION OF THE CLINICAL BENEFITS OF A DEFINITIVE TRIAL.
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/MICROLYMOCYTE LYMPHOMA (SLL): IBUTINIB IS SUITABLE FOR ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/MICROLYMOCYTE LYMPHOMA.
Chronic lymphocytic leukemia (CLL)/small lymphocyte lymphoma (SLL) with 17p deletion: ibutinib is suitable for adult patients with 17p-deficient chronic lymphocytic leukemia/micro-lymphocytic lymphoma.
● Waldenström macroglobulinemia (WM): ibutinib is indicated for adult patients with Fahrenhet macroglobulinemia.
PERIPHERAL LYMPHOMA: FOR MARGINAL LYMPHOMA (MZL) THAT HAS ALREADY RECEIVED SYSTEMIC THERAPY AND HAS RECEIVED AT LEAST ONE ANTI-CD20 TREATMENT, ACCELERATES APPROVAL OF THIS ADAPTATION BASED ON ORR. CONTINUED APPROVAL OF THE ADAPTATION MAY DEPEND ON A DESCRIPTION AND CONFIRMATION OF THE CLINICAL BENEFITS OF A DEFINITIVE TRIAL.
Chronic graft-versus-host disease: Used to treat chronic graft-versus-host disease (cGVHD) after failure of first-line or multi-line systemic therapy.
【dosage and administration method】
1. method of administration
taken orally, once a day, near the same time each day, swallowed with a glass of water, without opening, crushing or chewing the capsule.
MCL and MZL: Recommended doses are once daily, 560 mg (4 140 mg capsules) orally until disease progresses or toxic intolerance is tolerated.
CLL/SLL and WM: Recommended doses are once daily, 420 mg (3 capsules of 140 mg capsules) orally until disease progression or toxic intolerance.
● WHEN ELUTINIB IS COMBINED WITH FENDAMUSTINE AND RITUXIMAB FOR TREATMENT OF CLL/SLL (ADMINISTERED FOR 6 WEEKS, (PLEASE READ THIS BOOK CAREFULLY, AS REQUIRED OR UNDER THE DIRECTION OF A DOCTOR)
each cycle is 28 days), recommended once daily, 420 mg (3 capsules of 140 mg capsules) orally until the disease progresses or toxic intolerance.
cGVHD: Recommended once daily, 420 mg (3 capsules of 140 mg capsules) orally until the disease progresses, a malignant tumor recurs, or is toxic intolerant. When a patient no longer requests cGVHD treatment, ibutinib should stop the medical evaluation of individual patients .
3. dosage specifications
● bulging sac, 140 mg.
4. contraindications: none.
【warnings and precautions】
patients taking this drug have had fatal bleeding events. bleeding events of grade 3 or above (intrafacial bleeding (including subdural hemorrhoids), gastrointestinal bleeding, hematuria, and postoperative bleeding) can account for 6%. and about half of patients will have any level of bleeding events, including small events such as ecchymosis and bleeding spots.
the mechanism of bleeding is not very clear now.
Taking erutinib in patients receiving antiplatelet or anticoagulant therapy may increase the risk of bleeding, and patients should be monitored for signs of bleeding.
Depending on the type of surgery and the risk of bleeding, the pros and cons should be weighed and the use of elutinib should be suspended at least 3 to 7 days before and after surgery.
infection: treatment with erutinib can present with fatal and non-fatal infections (including bacterial, viral, or fungal). about 14% to 29% of patients develop ≥ grade 3 infection. during the use of ibutinib, several cases of progressive multi- lesion leukoencephalopathy and pneumocystis yeeri pneumonia have been reported. for patients at increased risk of opportunistic infections, preventive measures are considered according to standards of care. During treatment, the patient's fever and infection should be assessed and appropriate treatment should be carried out.
● HEMOLENIA: GRADE 3 OR 4 ATTENIA THAT OCCURS DURING TREATMENT INCLUDES NEUTROPENIA (13% TO 29%), THROMBOCYTOPENIA (5% TO 17%), AND ANEMIA (0 TO 13%) BASED ON LABORATORY-MONITORED DATA FROM MONOTHERAPY FOR B- CELL MALIGNANT TUMORS.
whole blood cell counts should be monitored every month.
atrial agitation: approximately 6% to 9% of treated patients develop atrial and atrial flavouring, especially those with risk factors for heart disease, patients with high blood pressure, acute infections, and patients with a prior history of atrial flare. patients are regularly monitored for this aspect. if the patient has symptoms of irregular heart rhythm, such as palpitations, dizziness, difficulty breathing, etc., the patient should be monitored by an electrocardiogram. the necessary interventions must be made for atrial support, and if this symptom persists , it is necessary to take into account the benefits and risks of treatment with this drug in a balanced manner, and then adjust the dose as needed, see [dosage and usage (2.3)].
● high blood pressure: about 6% to 17% of patients develop high blood pressure during treatment, and the median onset time is 4.6 months (0.03 to 22 months). monitoring of new and uncontrolled high blood pressure during treatment is required. appropriate adjustment of existing anti-hypertensive drugs and/or initiation of anti-hypertensive therapy.
the second primary malignant tumor: about 3% to 16% of patients develop other malignant tumors, including non-skin cancer (1% to 4%).
tumor lysis syndrome: this symptom is rare. Baseline conditions (eg, high tumor load) can be assessed and appropriate preventive measures can be taken before use. if it occurs, it should be monitored tightly and appropriate treatment measures taken.
● embryonic and fetal toxicity: according to animal test results, pregnant women taking erutinib can cause damage to the fetus. ibutinib, used during tissue and organ formation in pregnant mice and rabbits, causes fetal toxicity in embryos, including malformations, with drug exposures 2 -20 times greater than reported in patients with blood tumors. women are advised not to become pregnant during the period of taking this drug and for more than one month after stopping the drug. if the drug is taken during pregnancy or becomes pregnant during the drug , the patient should be advised of the potential harm of this drug to the fetus.
includes: bleeding, infection, cytopenia, atrial atrium, high blood pressure, a second primary malignant tumor, tumor
dissolve the syndrome.
shade, dry cool areas.
The above information comes from the network.