Ibrutinib is a small molecule kinase inhibitor that inhibits the proliferation and survival of malignant B lymphocytes by blocking the B cell receptor (BCR) signaling pathway, while regulating the tumor microenvironment. It is used to treat various B cell malignancies and chronic graft-versus-host disease (cGVHD).

1、 Drug name

1. Common name: Ibrutinib

2. Product Name: IMBRUVICA

2、 Indications

1. Mantle cell lymphoma (MCL): Suitable for adult patients who have received at least one previous treatment.

2. Chronic lymphocytic leukemia (CLL): Suitable for adult patients who have received at least one previous treatment.

3、 Specifications and characteristics

140mg capsules.

4、 Main components

1. Active ingredient: Ibrutinib

2. Accessories: cross-linked carboxymethyl cellulose sodium, magnesium stearate, microcrystalline cellulose, sodium dodecyl sulfate; The capsule shell contains gelatin, titanium dioxide, and black ink.

5、 Usage and dosage

1. MCL: 560mg (4 140mg capsules) orally once daily.

2. CLL: 420mg (3 140mg capsules) orally once daily.

3. Usage: Swallow whole pill, do not open, crush or chew; Take it at a fixed time every day, either with food or on an empty stomach.

6、 Dose adjustment

1. Adverse reaction adjustment:

First occurrence of grade ≥ 3 non hematological toxicity or grade 4 hematological toxicity: Suspend medication and restart at the original dose after recovery.

Recurrence: MCL drops to 420mg/day, CLL drops to 280mg/day; The third occurrence will result in a further reduction of 140mg/day.

2. Combination use of CYP3A inhibitors: Strong inhibitors should be avoided or temporarily discontinued; Intermediate acting inhibitors need to be reduced to 140mg/day.

7、 Medication precautions

1. Missed dose: Take it as soon as possible on the same day and resume normal medication the next day. Do not take double the dose.

2. Dietary taboos: Avoid grapefruit, grapefruit juice, and Seville orange (which may increase blood drug concentration).

3. Monitoring requirements: Monthly blood routine examination; Regularly monitor kidney function, blood pressure, and signs of infection.

8、 Medication for special populations

1. Pregnant women: Prohibited, may cause fetal malformation, non hormonal contraceptive measures should be taken (during female medication and 4 weeks after discontinuation).

2. Breastfeeding period: Breastfeeding is prohibited during the medication period and within one week of discontinuation.

3. Liver injury: Patients with baseline liver injury should avoid using it.

4. Renal injury: mild to moderate without adjustment; Insufficient data for severe cases (CLcr<25mL/min).

9、 Adverse reactions

1. Common (≥ 20%):

MCL: thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema.

CLL: thrombocytopenia, diarrhea, bruising, neutropenia, upper respiratory tract infection.

2. Serious reactions: bleeding (48% MCL/63% CLL), infection (pneumonia, etc.), renal dysfunction, second primary malignant tumor (skin cancer, etc.).

10、 Contraindications

There are no clear contraindications, but it is contraindicated for those who are allergic to this product or excipients.

11、 Drug interactions

1. Strong CYP3A inhibitors (such as ketoconazole): Avoid combination therapy as blood drug concentrations may increase by 24 times.

2. Strong CYP3A inducers (such as rifampicin): Avoid combination therapy, otherwise the blood drug concentration may decrease by 10 times.

12、 Storage method

Store at room temperature (20 ° C-25 ° C) and allow short-term storage at 15 ° C-30 ° C; keep the original packaging sealed.

Ibrutinibinformation