Prescription medicine
Pacritinib Brand names: Vonjo
Pacritinib (Vonjo) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pacritinib FDA label on DailyMed (effective July 30, 2026, Sobi, Inc.); the NDA 208712 record on Drugs@FDA; every pacritinib label on DailyMed.
Highlights of the record
FDA label of July 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L.
Forms and strengths
- 100 mg
Capsule.
On the market
- Earliest approval on file
- February 28, 2022 Vonjo, Sobi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 25, 2030 Vonjo capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,964 through July 30, 2026
What is pacritinib used for?
From the label: indications and usageVONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Vonjo), Sobi, Inc., effective July 30, 2026 (SPL set 4b5ab444-0e1a-4984-99db-76ad11a298ee), via openFDA; the full label on DailyMed
Is there a generic for pacritinib (Vonjo)?
No generic pacritinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Vonjo capsules: the compound patent runs to March 25, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pacritinib label say about other medicines?
The pacritinib label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Measure serum digoxin concentrations before initiating concomitant use with VONJO and continue monitoring serum digoxin concentrations as recommended in the Prescribing Information for digoxin [see Clinical Pharmacology ( 12.3 )]. |
| Fluconazole | drug interactions | Monitor patients concomitantly receiving moderate CYP3A4 inhibitors (e.g., fluconazole) for increased adverse reactions and consider VONJO dose modifications based on safety [see Dosage and Administration ( 2.5 )]. |
| Levonorgestrel | drug interactions | Hormonal Contraceptives Avoid concomitant use of VONJO with hormonal contraceptives except for intrauterine systems containing levonorgestrel. |
| Loperamide | warnings and precautions | Upon initiation of therapy, prescribe an anti-diarrheal medication (e.g., loperamide), and instruct patients to treat diarrhea promptly at the first onset of symptoms (change in frequency or consistency of bowel movements) after starting VONJO. |
| Rosuvastatin | drug interactions | Rosuvastatin: The dose of rosuvastatin should not exceed 20 mg once daily when concomitantly used with VONJO [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (Vonjo), Sobi, Inc., effective July 30, 2026 (SPL set 4b5ab444-0e1a-4984-99db-76ad11a298ee), via openFDA; the full label on DailyMed
What do FAERS reports show for pacritinib?
The FDA Adverse Event Reporting System holds 2,964 reports that list pacritinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 339 are coded as a death and 546 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,102, against a median of 3 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pacritinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other