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The recommended dosage of pacritinib is 200 mg, administered orally twice daily. Pacritinib may be taken with or without food.
Swallow the capsules whole. Do not open, break, or chew the capsules.
Patients receiving treatment with other kinase inhibitors prior to initiating pacritinib therapy must gradually reduce the dose or discontinue the medication in accordance with the prescribing information of that drug.
Before the initiation of pacritinib therapy, complete blood count (including differential leukocyte count and platelet count), coagulation function tests (prothrombin time, activated partial thromboplastin time, thrombin time, and international normalized ratio) and baseline electrocardiogram should be performed. Monitoring should be repeated during treatment based on clinical indications.
If a dose of pacritinib is missed, the patient should take the regular dose at the next scheduled time. An extra capsule should not be taken to make up for the missed dose.
Due to the risk of bleeding, discontinue pacritinib 7 days prior to elective surgery or invasive procedures. Treatment may be resumed only after hemostasis is confirmed.
Dosage adjustments for diarrhea, thrombocytopenia, hemorrhage, and QTc interval prolongation are described below, respectively. For additional risk minimization recommendations, refer to Warnings and Precautions.
The dosage levels of pacritinib are as follows: 200 mg twice daily (initial starting dose), 100 mg twice daily (first dose reduction), 100 mg once daily (second dose reduction). Patients who cannot tolerate the dosage of 100 mg once daily should discontinue pacritinib.
For newly developed diarrhea, antidiarrheal medications should be initiated promptly, and adequate oral fluid replacement should be encouraged.
For Grade 3 or 4 diarrhea (defined as an increase of at least 7 bowel movements per day from baseline, or requiring hospitalization, or a severe increase in ostomy output from baseline, or impairing the ability of self-care), pacritinib should be suspended until diarrhea resolves to Grade 1 (defined as an increase of fewer than 4 bowel movements per day from baseline, or a mild increase in ostomy output from baseline) or below, or returns to baseline levels, then resume pacritinib at the last administered dose. Meanwhile, the antidiarrheal regimen should be intensified and fluid replacement should be continued.
If diarrhea recurs, suspend pacritinib until diarrhea resolves to Grade 1 or below, or returns to baseline levels, then resume pacritinib at 50% of the last administered dose after the toxicity resolves. Patients resuming pacritinib need to continue antidiarrheal treatment concurrently.
For clinically significant worsening of thrombocytopenia that persists for more than 7 days, suspend pacritinib. After the toxicity resolves, resume pacritinib at 50% of the last administered dose. If the toxicity recurs, suspend pacritinib again and resume at 50% of the last administered dose after the toxicity resolves.
For moderate hemorrhage (requiring intervention), suspend pacritinib until bleeding stops, then resume at the last administered dose. If hemorrhage recurs, suspend pacritinib until the condition resolves, then resume at 50% of the last administered dose.
For severe hemorrhage (requiring blood transfusion, invasive intervention, or hospitalization), suspend pacritinib until bleeding stops, then resume at 50% of the last administered dose. If hemorrhage recurs, discontinue pacritinib permanently.
For life-threatening hemorrhage (requiring emergency intervention), discontinue pacritinib permanently.
In cases of QTc interval prolongation > 500 ms or an increase of > 60 ms from baseline, suspend pacritinib. If the QTc interval prolongation resolves to ≤ 480 ms or baseline levels within 1 week, resume pacritinib at the same dose. If the resolution takes more than 1 week, resume pacritinib at a reduced dose.
For patients with severe hepatic impairment (Child-Pugh Class C), the recommended dosage of pacritinib is 100 mg twice daily. If there is no clinical response after 12 weeks of treatment and no safety concerns, the dosage may be increased to 200 mg twice daily; continuous safety monitoring is required.
FDA，2025.10
