Pacritinib Dosage

Medically reviewed by Drugs.com. Last updated on Aug 26, 2022.

Usual Adult Dose for Myelofibrosis

200 mg orally 2 times a day

Use: Treatment of patients with intermediate or high-risk primary or secondary (post-polycythemia vera OR post-essential thrombocythemia) myelofibrosis (MF) with a platelet count less than 50 times 10(9)/L (50 x 10(9)/L)

Renal Dose Adjustments

Estimated GFR (eGFR) 30 mL/min and over: Data not available
eGFR less than 30 mL/min: Not recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate and severe liver dysfunction (Child-Pugh B and C): Not recommended.

Dose Adjustments

Concomitant kinase inhibitor use: Prior to starting this drug, patients receiving treatment with other kinase inhibitor(s) should taper or discontinue the other kinase inhibitor(s) per manufacturer recommendations.

Planned surgical procedures/other interventions: This drug should be discontinued 7 days before the procedure/intervention, and then should be restarted only after hemostasis is reassured.

ADVERSE REACTIONS:
Diarrhea:

• New onset of diarrhea: Initiate antidiarrheal agent and/or encourage adequate oral hydration
• Grade 3 or 4 diarrhea: Administration should be held until diarrhea resolves to at least Grade 1 (or baseline), and then this drug should be restarted at the last given dose.
• The antidiarrheal regimen should be intensified, and fluid replacement should be provided.
• Recurrent diarrhea: Administration should be held until diarrhea resolves to at least Grade 1 (or baseline), and then this drug should be restarted at 50% of the last given dose once symptoms have resolved.
• Patients restarting treatment: Concomitant antidiarrheal treatment is required.

Hemorrhage:

• Moderate bleeding; intervention indicated: Administration should be held until hemorrhage resolves to at least Grade 1 (or baseline), and then this drug should be restarted at 50% of the last given dose once symptoms have resolved.
• Recurrent hemorrhage: Administration should be held until hemorrhage resolves, and then this drug should be restarted at 50% of the last given dose.
• Severe bleeding; invasive intervention, transfusion, and/or hospitalization indicated: Administration should be held until hemorrhage resolved, and then this drug should be restarted at 50% of the last given dose.
• Recurrent bleeding: Treatment should be discontinued.
• Life-threatening bleeding; urgent intervention indicated: Treatment should be discontinued.

QT prolongation:

• QT prolongation greater than 500 msec OR greater than 60 msec from baseline: Administration should be held.
• QT prolongation resolves to 480 msec (or baseline) within 1 week: Treatment should be restarted at the same dose.
• Time to resolution is more than 1 week: Treatment should be restarted at a lower dose.

Thrombocytopenia:

• Clinically significant worsening thrombocytopenia lasting greater than 7 days: Administration should be held, and then this drug should be restarted at 50% of the last given dose once symptoms have resolved.
• Recurrent thrombocytopenia: Administration should be held, and then this drug should be restarted at 50% of the last given dose once symptoms have resolved.

Precautions

CONTRAINDICATIONS:

• Patients concomitantly using strong CYP450 3A4 inducers or inhibitors

Safety and efficacy have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

Dialysis

eGFR less than 15 and hemodialysis: Not recommended.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• This drug may be taken without regard to meals
• Swallow the capsules whole; do not break, chew, or open the capsules.
• Missed dose: Patients should take the next prescribed dose at its scheduled time; extra doses should not be taken to replace the missed dose.

Storage requirements:

• Store below 30C (86F); keep in the original bottle to protect from light.

General:

• This drug was granted accelerated approval based on spleen volume reduction observed in clinical trials; continued approval may be contingent upon verified clinical benefit in confirmatory trials.

Monitoring:

• Cardiovascular: ECG (before and during treatment as necessary)
• Gastrointestinal: New/worsening diarrhea
• Hematologic: CBC and coagulation testing (before and during treatment as necessary)
• Immunologic: Signs/symptoms of infection

Patient advice:

• Patients should inform their healthcare providers that they are currently receiving treatment with this drug, especially if they are undergoing planned invasive or elective procedures.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer