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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
3. English name: Ibrutinib
Ibrutinib is a kinase inhibitor used to treat the following patients:
1. Mantle cell lymphoma (MCL) who have received at least one treatment in the past.
2. Chronic lymphocytic leukemia (CLL) that has received at least one type of treatment in the past.
1. Specifications: 140 mg/capsule.
2. Characteristics: capsule.
1. Active ingredient: ibrutinib.
2. Inactive ingredients: The contents of the capsule include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide and black ink.
1. Recommended dose for mantle cell lymphoma (MCL): 560 mg orally once daily (i.e. four 140 mg capsules).
2. Recommended dosage for chronic lymphocytic leukemia (CLL): 420 mg orally once daily (i.e. three 140 mg capsules).
3. How to take: Take the whole tablet with water at about the same time every day. Do not open, break or chew capsules.
4. Treatment of missed doses: If you miss a dose at the scheduled time, you can take it as soon as possible on the same day, and resume the normal medication time the next day. A double dose should not be taken on the same day to make up for a missed dose.
1. Adjustment for adverse reactions: ibrutinib treatment should be interrupted for any grade 3 or above non-hematological toxicity, grade 3 or above neutropenia accompanied by infection or fever, or grade 4 hematological toxicity.
2. Adjustments due to drug interactions: simultaneous use with strong or moderate CYP3A inhibitors should be avoided. For strong CYP3A inhibitors that must be used short-term (≤7 days), consider interrupting ibrutinib during inhibitor use. For moderate CYP3A inhibitors that must be used, the ibrutinib dose should be reduced to 140 mg once daily.
1. Medication time: once a day, at a fixed time.
2. Dietary effects: Taking it with food will increase the exposure of ibrutinib by approximately 2 times. Grapefruit, grapefruit juice, and Seville oranges (commonly used in jam) should be avoided because they contain moderate CYP3A inhibitors.
3. Treatment of missed doses: Take the missed dose as soon as you remember it on the day, and take the medicine as originally planned the next day without taking double the dose.
4. Monitoring requirements: Monitor complete blood count every month during treatment; monitor renal function (creatinine level) and maintain adequate fluids; closely monitor signs of bleeding and symptoms of infection.
1. Pregnant women: Based on animal data, it may cause fetal harm. Women are advised to avoid becoming pregnant during treatment.
2. Breastfeeding women: It is unclear whether ibrutinib is secreted with human milk. Due to the potential for serious adverse effects, the decision to discontinue breastfeeding or discontinue medication should be weighed.
3. Pediatric patients: Safety and effectiveness have not been established.
4. Elderly patients: In MCL and CLL studies, no overall difference in effectiveness was observed with younger patients, but the incidence of certain adverse events (such as cardiac events, infections, gastrointestinal events) was higher in elderly patients.
5. Patients with renal impairment: Patients with mild to moderate renal impairment do not need to adjust the dosage. There are insufficient data in patients with severe renal impairment.
6. Patients with liver damage: Ibrutinib is metabolized in the liver, and patients with liver damage are expected to have significantly increased exposure. Use should be avoided in patients with baseline hepatic impairment.
1. The most common adverse reactions (≥20%) in patients with mantle cell lymphoma include: thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting, and decreased appetite.
2. The most common adverse reactions (≥20%) in patients with chronic lymphocytic leukemia include: thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory tract infection, fatigue, musculoskeletal pain, rash, fever, constipation, peripheral edema, joint pain, nausea, stomatitis, sinusitis, and dizziness.
3. Serious adverse reactions include: bleeding, infection, bone marrow suppression, nephrotoxicity, and second primary malignant tumors.
There are no clear contraindications, but it is prohibited for those who are allergic to this product or excipients.
1. CYP3A inhibitors: Avoid co-administration with strong or moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, the dose of ibrutinib needs to be reduced. Monitor more closely for signs of toxicity during concurrent use.
2. CYP3A inducers: Avoid combination with strong CYP3A inducers, as they will significantly reduce the plasma concentration of ibrutinib.
Store at room temperature 20°C to 25°C (68°F to 77°F); short-distance transportation allowed within 15°C to 30°C (59°F to 86°F). Keep in original packaging.