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Vonjo

pacritinib
JAK2/FLT3 InhibitorFDA Approved 2022CTI BioPharma
Route
IV
Half-Life
~12 hrs
FDA Approved
2022
Manufacturer
CTI BioPharma
1. Indications and Usage

Adults with intermediate or high-risk myelofibrosis with platelet count below 50x10^9/L.

2. Dosage and Administration

200 mg orally twice daily with or without food.

3. Dosage Forms and Strengths

Capsules: 100 mg

4. Contraindications

Concomitant use of strong CYP3A4 inhibitors or inducers.

5. Warnings and Precautions
  • Hemorrhage: Assess bleeding risk; withhold for Grade 3+ bleeding.
  • Diarrhea: Dose interrupt if Grade 3+.
  • Thrombocytopenia: Monitor CBCs.
  • QTc Prolongation: Monitor ECGs.
  • Major Adverse Cardiac Events: Reported with JAK inhibitors.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (48%), Thrombocytopenia (34%), Nausea (32%), Anemia (24%), Peripheral Edema (18%), Vomiting (16%)

Diarrhea
48%
Thrombocytopenia
34%
Nausea
32%
Anemia
24%
Peripheral Edema
18%
Vomiting
16%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Contraindicated.
Strong CYP3A4 Inducers: Contraindicated.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Pacritinib inhibits JAK2 (including V617F) and FLT3. Unlike ruxolitinib, it has limited JAK1 activity, potentially causing less immunosuppression and myelosuppression in cytopenic patients.

Pharmacokinetics

Tmax: 4-8 hours. Protein binding: >99%. Metabolized by CYP3A4.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
  • PERSIST-2 — Pacritinib vs BAT in myelofibrosis with platelets <100K. Phase III, n=311.
Additional Resources
FDA-Approved Tumor Types

Consult the prescribing information for complete indication details and associated tumor types.

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Vonjo. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Vonjo (pacritinib) approved for?

Vonjo (pacritinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Vonjo (pacritinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Vonjo (pacritinib) work?

Pacritinib inhibits JAK2 (including V617F) and FLT3. Unlike ruxolitinib, it has limited JAK1 activity, potentially causing less immunosuppression and myelosuppression in cytopenic patients.

What are the most common side effects?

Diarrhea (48%), Thrombocytopenia (34%), Nausea (32%), Anemia (24%), Peripheral Edema (18%), Vomiting (16%) Diarrhea 48% Thrombocytopenia 34% Nausea 32% Anemia 24% Peripheral Edema 18% Vomiting 16%