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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 a variety of B cell malignancies and chronic graft-versus-host disease (cGVHD).
1. Generic name: Ibrutinib
2. Trade name: IMBRUVICA
1. Mantle cell lymphoma (MCL): Applicable to adult patients who have received at least one previous treatment.
2. Chronic lymphocytic leukemia (CLL): Applicable to adult patients who have received at least one previous treatment.
140mg capsule .
1. Active ingredient: Ibrutinib
2. Excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate; capsule shell contains gelatin, titanium dioxide and black ink.
1. MCL : 560mg (4 140mg capsules) orally once a day.
2. CLL : 420mg (3 140mg capsules) taken orally once a day.
3. How to take : Swallow the tablet whole, do not open, crush or chew it; take it at a fixed time every day, with food or on an empty stomach.
1. Adverse reaction adjustment :
For the first occurrence of ≥ grade 3 non-hematological toxicity or grade 4 hematological toxicity: suspend the medication and restart at the original dose after recovery.
Reoccurrence: MCL dropped to 420mg/day, CLL dropped to 280mg/day; for the third occurrence, the dose was further reduced to 140mg/day.
2. Combined use of CYP3A inhibitors with : Strong inhibitors need to be avoided in combination or medication should be suspended; moderate inhibitors need to be reduced to 140mg/day.
1. If you miss a dose of : take it as soon as possible on the same day, and resume normal medication the next day. Do not take double dose of .
2. Dietary taboos : Avoid grapefruit, grapefruit juice and Seville orange (may increase blood concentration).
3. Monitoring requirements : Check blood routine every month; regularly monitor kidney function, blood pressure and signs of infection.
1. Pregnant women : contraindicated, may cause fetal malformation, non-hormonal contraceptive measures are required (for women during medication and 4 weeks after discontinuation).
2. Lactation period : Breastfeeding is prohibited during medication and within 1 week of discontinuation of medication.
3. Liver injury : Avoid use in patients with baseline liver injury.
4. Kidney injury : Mild to moderate, no adjustment is required; severe (CLcr<25mL/min) data is insufficient.
1. Common (≥20%) :
MCL: thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, and peripheral edema.
CLL: thrombocytopenia, diarrhea, bruising, neutropenia, upper respiratory tract infection.
2. Severe reactions : bleeding (48% MCL/63% CLL), infection (pneumonia, etc.), renal function damage, second primary malignant tumor (skin cancer, etc.).
There are no clear contraindications, but it is prohibited for those who are allergic to this product or excipients.
1. Strong CYP3A inhibitor (such as ketoconazole): avoid combined use, otherwise the plasma concentration may increase 24 times.
2. Strong CYP3A inducer (such as rifampicin): avoid combined use, otherwise the plasma concentration may be reduced by 10 times.
Save at room temperature (20°C-25°C), short-term storage at 15°C-30°C is allowed; keep the original packaging sealed.