Ibrutinib is for adult patients with mantle cell lymphoma (MCL) who have received at least one prior treatment. 3% customs VAT for export to China

Ibrutinib Tablets (LuciBru) Simple Instructions

Please use under the guidance of a physician

Product Name: LuciBru

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Ibrutinib tablets

English name: Ibrutinib tablets

Drug approval number: 07 L 1141/24

 

【Indications】

LuciBru is a kinase inhibitor indicated for the treatment of:

1. Adult patients with mantle cell lymphoma (MCL) who have received at least one treatment.

2. Adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

3. Adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.

4. Adult patients with Waldenström macroglobulinemia (WM).

5. Adult patients with marginal zone lymphoma (MZL) who require systemic treatment and have received at least one anti-CD20-based therapy.

6. Adults and children aged 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more systemic therapies.

 

【Usage and Dosage】

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

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

3. cGVHD:

①. Patients 12 years and above: take orally once daily, 420 mg each time.

②. Patients aged 1 to under 12 years: Orally once daily, 240 mg/m2 (maximum dose is 420 mg).

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

 

【Specification】

140mg/tablet, 120 tablets/box.

 

【 Contraindications 】

none

 

【 Warnings and Precautions 】

• Bleeding: Monitor and manage bleeding.

•Infection: Monitor patients for fever and infection, and evaluate and treat promptly.

•Arrhythmias, Heart Failure, and Sudden Death: Monitor for symptoms of arrhythmias and heart failure and manage them.

• Hypertension: Monitor blood pressure and treat.

•Cytopenia: Check complete blood count monthly.

•Second primary malignancies: Other malignancies have also occurred in patients, including skin cancer and other cancers.

• Tumor lysis syndrome (TLS): Assess baseline risk and take preventive measures. Monitor and treat TLS.

• Embryo-fetal toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

 

【Adverse Reactions】

•The most common adverse reactions (≥30%) 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 adverse reactions (≥20%) in adults or children with cGVHD were: fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle cramps, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache.

【Drug Interactions】

•CYP3A inhibitors: Modify LuciBru dose as directed.

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

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

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

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.