Ibrutinib Instructions

1. Indications

1.Chronic lymphocytic leukemia/Small lymphocytic lymphoma

Ibrutinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

2.Chronic lymphocytic leukemia17pDeleted small lymphocytic lymphoma

Ibrutinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.

3.Waldenström's macroglobulinemia

Ibrutinib is indicated for the treatment of adult patients with Waldenströmacroglobulinemia (WM).

4.Chronic graft-versus-host disease

Ibrutinib is indicated for the treatment of adult and pediatric patients 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more systemic therapies.

2. Usage and dosage

1.The recommended dose of ibrutinib for CLL/SLL is 420 mg orally once daily until disease progression or unacceptable toxicity occurs.

2.For CLL/SLL, ibrutinib is available as a single agent, in combination with rituximab or obinutuzumab, or with bendamustine and rituximab(BR)Combination medication.

3.For WM, ibrutinib can be used as a single agent or in combination with rituximab.

When ibrutinib is coadministered with rituximab or obinutuzumab, consider administering ibrutinib before rituximab or obinutuzumab on the same day.

4. The recommended dose of ibrutinibfor12years and oldercGVHD patients is420mg/days, the recommended dose for patients 1 years old to 12 years old and belowcGVHD is 240 mg/m2Orally once daily (The maximum dose is 420 mg) until cGVHD progression, recurrence of the underlying malignancy, or unacceptable toxicity. When a patient no longer requires treatment for cGVHD, ibrutinib should be discontinued, taking into account the individual patient's medical evaluation.

Three. Dosage form

Capsules: 70mg and 140mg.

Tablets: 140mg, 280mg and 420mg.

Oral suspension: 70mg/ml.

Four. Contraindications

None

5. Warnings and Precautions

1.Bleeding:Monitor and manage bleeding.

2.Infection:Monitor the patient's fever and infection, conduct timely assessment, and provide treatment.

3.Arrhythmia,Heart failure, and sudden death:Monitor for symptoms of arrhythmia and heart failure.

4.Hypertension:Monitor blood pressure and treat it.

5.Cytopenia:Check the complete blood count monthly.

6.Second primary malignant tumors:Other malignancies, including skin and other cancers, also occur in patients.

7.Tumor lysis syndrome:Assess baseline risk and take preventive measures, monitor and treatTLS.

8.Embryo-Fetal Toxicity:Can cause fetal harm. Inform women of reproductive potential of potential risks to the fetus and use effective contraceptive measures.

6. Adverse reactions

The most common adverse reactions (≥30%) in patients with cellular malignancies were thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea.

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, bleeding, nausea, abdominal pain, pneumonia, and headache.

7. Drug interactions

CYP3AInducers:Avoid use with strong CYP3Ainducing agents.

8. Use among specific groups of people

Breastfeeding: Breastfeeding is not recommended.

Liver Impairment: Patients with severe hepatic impairment should avoid use of ibrutinib. Reduce ibrutinib in patients with mild or moderate impairment.

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