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Pitobrutinib is a new generation BTK inhibitor that provides an important treatment option for patients with drug-resistant B cell malignancies, but requires strict monitoring of liver function and infection risk.
1. Generic name :Pirtobrutinib (Pirtobrutinib)
2. Trade name : b>JAYPIRCA™
3. Dosage form : Oral film-coated tablets
4. Main ingredient : Each tablet contains 50 mg or 100 mg of pitobrutinib (active ingredient).
Relapsed or refractory mantle cell lymphoma (MCL) : For the treatment of adult patients with relapsed or refractory MCL who have received at least two previous systemic therapies (including a BTK inhibitor). This indication is based on accelerated approval and requires further verification of clinical benefit.
1. Specifications :50mg (blue arc-shaped triangular tablet, engraved with "Lilly50" and "6902"); 100mg (blue round tablet, engraved with "Lilly100" and "7026").
2. Packaging : 30 tablets/bottle (50mg) or 60 tablets/bottle (100mg), equipped with child-safe bottle cap.
1. Recommended dose : 200mg orally, once a day until disease progression or intolerable toxicity.
2. How to take : Swallow the whole tablet with food or on an empty stomach. Take the medicine at a fixed time every day.
3. Treatment of missed doses : If you miss a dose for more than 12 hours, skip it and take it as originally planned the next day; there is no need to take another dose after vomiting.
1. First reduction of : 100mg once a day;
2. Second reduction of : 50mg once a day;
3. Permanent discontinuation of : Unable to tolerate the 50mg dose.
4. Adjustment basis :
(1), severe renal impairment (eGFR15-29mL/min) : Reduce the dose to 100mg once a day;
< b>(2), combined with the strong CYP3A inhibitor : Reduce the dose by 50 mg;
(3), combined with the moderate CYP3A inducer : increase to 300 mg once a day (when the original dose is 200 mg).
1. Infection risk : 17% of patients develop ≥ grade 3 infections, which require monitoring and preventive use of anti-infective drugs.
2. Bleeding risk : 2.4% of patients suffered from severe bleeding, so avoid combined use of anticoagulant drugs.
3. High blood sugar monitoring : Regularly detect fasting blood sugar, and diabetic patients need to strengthen management.
4. Skin cancer risk : 3.8% of patients develop non-melanoma skin cancer, so sun protection is recommended.
1. Pregnant women: : Disabled (animal experiments show embryotoxicity).
2. Lactation : Breastfeeding is prohibited during treatment and within 1 week of drug withdrawal.
3. Renal insufficiency : Severe renal damage requires dose reduction.
4. U200c for the elderly: No dose adjustment is required, but adverse reactions need to be monitored more closely.
1. Common (≥20%) : Fatigue (27%), musculoskeletal pain (26%), diarrhea (20%), bruise (20%).
2. Severe reactions :Pneumonitis (14%), neutropenia (16%), hemorrhage (3.1%).
There are no absolute contraindications, but avoid combined use of strong CYP3A inducers (such as rifampicin).
1. Strong CYP3A inhibitor (such as itraconazole): needs to be reduced;
2. Sensitive CYP2C8/2C19 substrate (such as repaglinide): may increase the toxicity of the latter.
Save at room temperature (20-25°C). The original bottle should be protected from light and moisture.
Note : If severe infection, bleeding or arrhythmia occurs, seek medical attention immediately. Blood routine and liver function need to be monitored regularly during treatment.