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Pacritinib is an oral multi-target tyrosine kinase inhibitor. Compared with traditional JAK inhibitors, the significant advantage of Pacritinib is that it does not require dose adjustment due to thrombocytopenia, filling the treatment gap for high-risk MF patients.
Common name : Pacritinib
Trade name : VONJO™
Dosage form : oral capsule
Main ingredient : Each capsule contains 100mg of pacitinib citrate (equivalent to 100mg of base)
Excipients : microcrystalline cellulose, polyethylene glycol 8000 (PEG8000), magnesium stearate; capsule shell contains gelatin, titanium dioxide, iron oxide black, etc.
Myelofibrosis (MF) : It is used to treat adult patients with moderate-to-high-risk primary or secondary (post-polycythemia vera or essential thrombocythemia) myelofibrosis, and the platelet count is less than 50×10⁹/L.
Note: This indication is subject to accelerated approval based on spleen volume reduction, and further verification of clinical benefit is required.
Specifications : 100mg/capsule (120 capsules/bottle)
Characteristics : opaque hard capsule, with "Pacritinib 100mg" printed on the red cap and "C78837" printed on the gray body.
Regular dose of : 200mg orally, 2 times a day, before or after meals, swallow the whole tablet.
Missed dose handling : Skip the missed dose and take the next dose according to the originally planned time. It is prohibited to take double doses.
Discontinue before surgery: Discontinue it 7 days before elective surgery, and restart after bleeding has stopped.
Adverse reaction adjustment
Adverse reaction treatment measures
For grade 3/4 diarrhea , suspend the medication until it recovers to ≤ grade 1. When restarting, reduce the dose by 50% and use antidiarrheal drugs in combination.
Suspend the medication for severe thrombocytopenia , and reduce the dose by 50% after recovery; permanently discontinue the medication if recurrence occurs.
QTc>500ms : Suspend medication, and restart at the original dose after returning to ≤480ms within 1 week, otherwise reduce the dose.
For moderate to severe bleeding , the medication should be suspended and the dose reduced by 50% after recovery; for life-threatening bleeding, the medication should be permanently discontinued.
Adjustment of for special groups
for liver dysfunction: Moderate to severe (Child-PughB/C) is prohibited.
Renal insufficiency : eGFR <30mL/min is prohibited.
Monitoring requirements :
Baseline and regular inspections of blood routine, coagulation function, electrocardiogram, and liver function.
In case of diarrhea, promptly replenish fluids and use antidiarrheal drugs (such as loperamide).
Diet : No special restrictions, but you need to stay hydrated.
Vomiting : If vomiting is severe, consider administering the drug in divided doses or using antiemetics in combination.
Pregnant women : Use only when benefits >risks (animals show embryotoxicity).
Lactation period : Breastfeeding is prohibited within 2 weeks after stopping the drug.
Children : Safety has not been established.
U200c for the elderly: No dose adjustment is required, but adverse reactions need to be closely monitored.
Common (≥20%) : diarrhea (48%), thrombocytopenia (34%), nausea (32%), anemia (24%), peripheral edema (22%).
Severe but rare :
Hemorrhage (11% serious, 2% fatal), infection (including opportunistic infection), QT interval prolongation (3.8%), secondary malignancy (such as lymphoma).
Those allergic to paxtinib or excipients.
Combined use of strong CYP3A4 inhibitors/inducers (such as clarithromycin, rifampicin).
Moderate to severe liver insufficiency (Child-PughB/C) or eGFR<30mL/min.
CYP3A4 inhibitor/inducer : Strong drugs are prohibited, and moderate drugs should be avoided in combination (clarithromycin ↑AUC80%, rifampicin ↓AUC87%).
P-gp/BCRP/OCT1 substrate : Avoid combined use of sensitive substrates (such as digoxin, methotrexate).
Unopened : Store at room temperature (<30°C), protected from light in original packaging, valid for 36 months.
After opening : The bottle cap must be tightened to prevent moisture and light.
Manufacturer : CTIBioPharmaCorp. (USA)
Note : If severe diarrhea, bleeding or arrhythmia occurs during medication, seek medical attention immediately. Specific medication needs to be prescribed by your doctor.