lucibru ibrutinib tablets 140mg

[Product Name] Ibrutinib Tablets

[English Name] Ibrutinib Tablets

[Other Names] Yike / Ibrutinib / Imbruvica / Ibrutix / Ibrunib

[Specification] 140 mg/tablet; 120 tablets/box.

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

[Indications]

Ibrutinib tablets are a kinase inhibitor indicated for the treatment of:

1. Adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.

2. Adult patients with Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL).

3. Adult patients with CLL / SLL with 17p deletion.

4. Adult patients with Waldenström’s Macroglobulinemia (WM).

5. Adult patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

6. Adult and pediatric patients aged 1 year and older with Chronic Graft-versus-Host Disease (cGVHD) who have failed one or more lines of systemic therapy.

[Dosage and Administration]

1. MCL and MZL: 560 mg orally once daily.

2. CLL/SLL and WM: 420 mg orally once daily.

3. cGVHD:

① Patients aged 12 years and older: 420 mg orally once daily.

② Patients aged 1 year to less than 12 years: 240 mg/m² orally once daily (maximum dose of 420 mg).

4. Do not cut, crush, or chew the tablets.

[Contraindications] None.

[Warnings and Precautions]

Hemorrhage: Monitor for and manage bleeding.

Infections: Monitor patients for fever and infections; evaluate and treat promptly.

Cardiac Arrhythmias, Cardiac Failure, and Sudden Death: Monitor for and manage symptoms of cardiac arrhythmias and cardiac failure.

Hypertension: Monitor blood pressure and treat.

Cytopenias: Check complete blood counts monthly.

Second Primary Malignancies: Other malignancies, including skin cancers and other cancers, have occurred in patients.

Tumor Lysis Syndrome (TLS): Assess baseline risk and take appropriate prophylactic measures. Monitor for and treat TLS.

Embryo-Fetal Toxicity: May cause harm to the fetus. Women of reproductive potential are advised to be aware of the potential risks to the fetus and to use effective contraception.

[Adverse Reactions]

The most common (≥30%) adverse reactions in patients with B-cell malignancies (MCL, CLL/SLL, WM, and MZL) are: thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, and bruising.

The most common (≥20%) adverse reactions in adult or pediatric patients with cGVHD are: fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache.

[Drug Interactions]

CYP3A Inhibitors: Modify the LuciBru dosage as directed.

CYP3A Inducers: Avoid co-administration with strong CYP3A inducers.

[Use in Specific Populations]

Lactation: Breastfeeding is not recommended.

Hepatic Impairment: Avoid the use of LuciBru in patients with severe hepatic impairment. For patients with mild or moderate impairment, reduce the LuciBru dosage.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.