Multikinase inhibitors
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Vonjo Dosage

Drug Detail:Vonjo (Pacritinib)

Generic Name: Pacritinib 100mg

Dosage Form: capsule

Drug Class: Multikinase inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

The recommended dosage of VONJO is 200 mg orally twice daily. VONJO may be taken with or without food.

Swallow capsules whole. Do not open, break, or chew capsules.

Patients who are on treatment with other kinase inhibitors before the initiation of VONJO must taper or discontinue according to the prescribing information for that drug.

Monitoring for Safety

Perform a complete blood count (CBC; including white blood cell count differential and platelet count), coagulation testing (prothrombin time, partial thromboplastin time, thrombin time, and international normalized ratio) and a baseline electrocardiogram (ECG), prior to starting VONJO, and monitor as clinically indicated while the patient is on treatment.

Missed Dose

If a dose of VONJO is missed, the patient should take the next prescribed dose at its scheduled time. Extra capsules should not be taken to make up for the missed dose.

Dose Interruption for Planned Surgical Procedures or Other Interventions

Discontinue VONJO 7 days prior to elective surgery or invasive procedures because of the risk of hemorrhage and restart only after hemostasis is assured.

Dose Modification for Adverse Reactions

Dose modifications for diarrhea, thrombocytopenia, hemorrhage, and prolonged QT interval are described in Table 1, Table 2, Table 3, and Table 4 respectively. See Warning and Precautions (5.1, 5.2, 5.3, and 5.4) for additional risk minimization recommendations.

Dose levels for VONJO are as follows: 200 mg twice daily (initial starting dose), 100 mg twice daily (first dose reduction), 100 mg once daily (second dose reduction). Discontinue VONJO in patients unable to tolerate a dose of 100 mg daily.

Table 1 Dosage Modification for Diarrhea
Toxicity Management/Action

a Increase of at least 7 stools per day over baseline, or hospitalization indicated, or severe increase in ostomy output over baseline, or if limiting self care.

b Increase of <4 stools per day over baseline or mild increase in ostomy output compared to baseline.
New onset of diarrhea
  • Initiate anti-diarrheal medications.
  • Encourage adequate oral hydration.
Grade 3 or 4 a
  • Hold VONJO until the diarrhea resolves to Grade 1b or lower or baseline. Restart VONJO at the last given dose.
  • Intensify anti-diarrheal regimen. Provide fluid replacement.
  • If diarrhea recurs, hold VONJO until the diarrhea resolves to Grade 1b or lower or baseline. Restart VONJO at 50% of the last given dose once the toxicity has resolved.
  • Concomitant antidiarrheal treatment is required for patients restarting VONJO.
Table 2 Dose Modification for Thrombocytopenia
Worsening Thrombocytopenia Action
For clinically significant worsening of thrombocytopenia that lasts more than 7 days
  • Hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.
  • If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.
Table 3 Dose Modification for Hemorrhage
Toxicity Action
Moderate bleeding; intervention indicated
  • Hold VONJO until hemorrhage resolves. Restart VONJO at the last given dose.
  • If hemorrhage recurs, hold VONJO until resolution then restart at 50% of the last given dose.
Severe bleeding; transfusion, invasive intervention, or hospitalization indicated
  • Hold VONJO until hemorrhage resolves.
  • Restart VONJO at 50% of the last given dose.
  • If bleeding recurs, discontinue VONJO.
Life-threatening bleeding; urgent intervention indicated.
  • Discontinue VONJO.
Table 4 Dose Modification for Prolonged QT Interval
Toxicity Action
QTc prolongation >500 msec or >60 msec from baseline
  • Hold VONJO.
  • If QTc prolongation resolves to £480 msec or baseline within 1 week, restart VONJO at the same dose.
  • If time to resolution is greater than 1 week, restart VONJO at a reduced dose.
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