Vonjo Pacritinib 100 mg Capsule, 4,800-count — NDC 72482-100-12 (Billing 72482-0100-12)
This is a package of 4,800 capsules of Vonjo Pacritinib 100 mg Capsule from Sobi, Inc., marketed since Feb 2022 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72482-100-12 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72482 labeler · 100 product · 12 package
- Package marketed since
- Feb 28, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 4,800 EA per package
- Barcode (UPC-A, from the NDC)
- 3 7248210012 8
- Medicaid fills, this package
- 31 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 1, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 083108
- GCN: 51982
- HICL (First Databank): 047850
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 2595248
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Kinase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Pacritinib is used to treat adults with certain types of myelofibrosis (MF; a cancer of the bone marrow in which the bone marrow is replaced by scar tissue and causes decreased blood cell production). Pacritinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
Read the full MedlinePlus article ↗- Vonjo is used to treat a bone marrow disease called myelofibrosis — either the primary kind or a type that develops after another blood disorder. What makes it unique is that it's...
- What exactly is Vonjo used for, and why was it prescribed for me?
- You take Vonjo capsules twice a day — and the good news is you can take it with or without food, whichever is easier for you. Just swallow the capsules whole; don't open, crush, or...
- How do I take this medication, and does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pacritinib — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $215.63 | $1,035,004.80 / 4800 capsules |
| Medicare drug plans payPart D · Q2 2026 | $207.97 | $998,240.64 / 4800 capsules |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72482-0100-12 You're viewing this Main listing | 40 CARTON in 1 BOX / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE | 2022-02-28 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vonjo 100 mgthis 72482-0100-12 | Sobi, | 4800 capsules | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9573964 ↗ | Method of use | U-3332 | May 5, 2028 |
| US 9573964 ↗ | Method of use | U-3331 | May 5, 2028 |
| US 8153632 ↗ | Drug substance | U-3332 | Jan 17, 2029 |
| US 8153632 ↗ | Drug substance | U-3331 | Jan 17, 2029 |
| US 8980873 ↗ | Drug substance | U-3331 | Mar 25, 2030 |
| US 8980873 ↗ | Drug substance | U-3332 | Mar 25, 2030 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Feb 28, 2027 |
| ODE-397 | Orphan Drug Exclusivity (7-year) | Feb 28, 2029 |
Is there a generic version of VONJO 100 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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What does a patent or protection date mean here?
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Can a generic come out after the listed dates?
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Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VONJO 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).
VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage is 200 mg orally twice daily ( 2.1 ). May be taken with or without food ( 2.1 ).
2.1Recommended 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.
2.2Monitoring 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.
2.3Missed 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.
2.4Dose 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.
2.5Dose 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 1 b 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 1 b 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.
2.6Dosage Modification for Patients with Severe Hepatic Impairment T… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsule: 100 mg, oblong, size 0 hard gelatin capsule with an opaque scarlet cap printed with “Pacritinib 100 mg” and opaque gray body printed with “C78837”. Capsules: 100 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS VONJO is contraindicated in patients concomitantly using strong CYP3A4 inhibitors or inducers as these medications can significantly alter exposure to pacritinib, which may increase the risk of adverse reactions or impair efficacy [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.3 )] . Concomitant use of strong CYP3A4 inhibitors or inducers ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hemorrhage: Avoid use in patients with active bleeding and hold VONJO prior to any planned surgical procedures. May require dose interruption, dose reduction or permanent discontinuation depending on severity ( 5.1 ). Diarrhea: Manage significant diarrhea with anti-diarrheals, dose reduction, or dose interruption ( 5.2 ).
Thrombocytopenia: Manage by dose reduction or interruption ( 5.3 ). Prolonged QT Interval: Avoid use in patients with baseline QTc >480 msec. Interrupt and reduce VONJO dosage in patients who have a QTcF >500 msec.
Correct hypokalemia prior to and during VONJO administration ( 5.4 ). Major Adverse Cardiac Events (MACE): Risk may be increased in current/past smokers and patients with other cardiovascular risk factors. Monitor for signs, evaluate and treat promptly ( 5.5 ).
Thrombosis: Including deep venous thrombosis, pulmonary embolism, and arterial thrombosis may occur. Monitor for signs, evaluate and treat promptly ( 5.6 ). Secondary Malignancies: Lymphoma and other malignancies may occur.
Past/current smokers may be at increased risk ( 5.7 ). Risk of Infection: Delay starting VONJO until active serious infections have resolved. Observe for signs and symptoms of infection and manage promptly ( 5.8 ).
Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with VONJO ( 5.9 ).
5.1Hemorrhage Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 x 10 9 /L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 x 10 9 /L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm.
Due to hemorrhage, VONJO dose-reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively. Avoid use of VONJO in patients with active bleeding and hold VONJO 7 days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated [see Warnings and Precautions ( 5.3 )] .
Manage hemorrhage using treatment interruption and medical intervention [see Dosage and Administration ( 2.5 )] .
5.2Diarrhea VONJO caused diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm in a clinical trial. The median time to resolution in VONJO-treated patients was 2 weeks. The incidence of reported diarrhea decreased over time with 41% of patients reporting diarrhea in the first 8 weeks of treatment, 15% in Weeks 8 through 16, and 8% in Weeks 16 through 24.
Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm. In postmarketing reports, severe diarrhea leading to acute kidney injury and treatment discontinuation has been reported with VONJO.
Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose-modification. 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.
Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care [see Dosage and Administration ( 2.5 )] .
5.3Thrombocytopenia VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing moderate to severe thrombocytopenia (platelet count <100 x 10 9 /L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing severe thrombocytopenia (platelet c… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Diarrhea [see Warnings and Precautions ( 5.2 )] Thrombocytopenia [see Warnings and Precautions ( 5.3 )] Prolonged QT Interval [see Warnings and Precautions ( 5.4 )] Major Adverse Cardiac Events [see Warnings and Precautions ( 5.5 )] Thrombosis [see Warnings and Precautions ( 5.6 )] Secondary Malignancies [see Warnings and Precautions ( 5.7 )] Risk of Infection [see Warnings and Precautions ( 5.8 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.9 )] The most common (≥20% of patients) adverse reactions are diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Sobi, Inc. at (866) 773-5274 and www.VONJO.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. PERSIST-2 Trial The safety of VONJO was evaluated in the randomized, controlled PERSIST-2 trial [see Clinical Studies ( 14 )] . In PERSIST-2, key eligibility criteria included adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF with splenomegaly and a platelet count ≤100 × 10 9 /L.
Prior Janus associated kinase (JAK) inhibitor therapy was permitted. Patients received VONJO at 200 mg twice daily (n=106), 400 mg once daily (n=104), or best available therapy (BAT) (n=98). Forty-seven (44%) of the 106 patients treated with VONJO 200 mg twice daily had a baseline platelet count of <50 × 10 9 /L.
The 400 mg once daily dose could not be established to be safe, so further information on this arm is not provided. In PERSIST-2, among the 106 patients treated with VONJO 200 mg twice daily, the median baseline hemoglobin was 9.7 g/dL and the median drug exposure was 25 weeks. Fifty-four percent of patients were exposed for 6 months, and 18% were exposed for approximately 12 months.
Accounting for dose reductions, the average daily dose (mean relative dose intensity) and median daily dose (median relative dose intensity) were 380 mg (95%) and 400 mg (100%), respectively, for patients receiving VONJO twice daily. The median age of patients who received VONJO 200 mg twice daily was 67 years (range: 39 to 85 years), 59% were male, 86% were White, 3% were Asian, 2% were Native Hawaiian or Other Pacific Islander, 0% were Black, 9% did not report race, and 87% had an Eastern Cooperative Oncology Group performance status of 0 to 1.
Serious adverse reactions occurred in 47% of patients treated with VONJO 200 mg twice daily and in 31% of patients treated with BAT. The most frequent serious adverse reactions occurring in ≥3% patients receiving VONJO 200 mg twice daily were anemia (8%), thrombocytopenia (6%), pneumonia (6%), cardiac failure (4%), disease progression (3%), pyrexia (3%), and squamous cell carcinoma of skin (3%). Fatal adverse reactions occurred in 8% of patients receiving VONJO 200 mg twice daily and in 9% of patients treated with BAT.
The fatal adverse reactions among patients treated with VONJO 200 mg twice daily included events of disease progression (3%), and multiorgan failure, cerebral hemorrhage, meningorrhagia, and acute myeloid leukemia in <1% of patients each, respectively. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT. The most frequent reasons for permanent discontinuation in ≥2% of patients receiving VONJO 200 mg twice daily included anemia (3%) and thrombocytopenia (2%).
Drug interruptions due to an adverse react… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration of VONJO with moderate CYP3A4 inhibitors can increase the exposure to pacritinib. Monitor for increased adverse reactions of VONJO when administered with moderate CYP3A4 inhibitors ( 7.1 ). VONJO is an inhibitor of P-gp, BCRP, and CYP1A2 and an inducer of CYP3A4 and CYP2C19.
Monitor patients concomitantly receiving substrates of these transporters and enzymes, and adjust dose of the substrates as needed ( 7.2 ). VONJO may reduce the effectiveness of hormonal contraceptives ( 7.2 )
7.1Effect of Other Drugs on VONJO Strong and Moderate CYP3A4 Inhibitors Pacritinib is predominantly metabolized by CYP3A4. Concomitant use of VONJO with strong and moderate CYP3A4 inhibitors increases pacritinib exposure, which may increase the risk of exposure-related adverse reactions [see Clinical Pharmacology ( 12.3 )] Co-administration of VONJO with strong CYP3A4 inhibitors is contraindicated [see Contraindications ( 4 )]. 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 )] .
Concomitant use of VONJO with doses of fluconazole greater than 200 mg once daily has not been studied. Strong CYP3A4 Inducers Pacritinib is predominantly metabolized by CYP3A4. Concomitant use of VONJO with strong CYP3A4 inducers decreases pacritinib exposure, which may reduce efficacy of VONJO [see Clinical Pharmacology ( 12.3 )] .
Co-administration of VONJO with strong CYP3A4 inducers is contraindicated [see Contraindications ( 4 )].
7.2Effect of VONJO on Other Drugs CYP1A2 Substrates Pacritinib is an inhibitor of CYP1A2. VONJO increases the plasma concentrations of CYP1A2 substrates [see Clinical Pharmacology ( 12.3 )] ,which may increase the risk of adverse reactions from the CYP1A2 substrate. Monitor for CYP1A2 substrate related adverse reactions more frequently, unless otherwise recommended in the substrate Prescribing Information, when VONJO is used concomitantly with CYP1A2 substrates where minimal substrate concentration changes may lead to serious adverse reactions.
CYP2C19 Substrates Pacritinib is an inducer of CYP2C19. VONJO decreases the plasma concentrations of CYP2C19 substrates [see Clinical Pharmacology ( 12.3 )] , which may decrease the efficacy from the CYP2C19 substrate. Monitor the efficacy of CYP2C19 substrate more frequently, unless otherwise recommended in the substrate Prescribing Information, when VONJO is used concomitantly with CYP2C19 substrates where minimal substrate concentration changes may lead to diminished efficacy.
Dose adjustment of CYP2C19 substrates may be needed. CYP3A4 Substrates Pacritinib is an inducer of CYP3A4. VONJO decreases the plasma concentrations of CYP3A4 substrates [see Clinical Pharmacology ( 12.3 )] , which may decrease the efficacy from the CYP3A4 substrate.
Monitor the efficacy of CYP3A4 substrate more frequently, unless otherwise recommended in the substrate Prescribing Information, when VONJO is used concomitantly with CYP3A4 substrates where minimal substrate concentration changes may lead to diminished efficacy. Dose adjustment of CYP3A4 substrates may be needed. Hormonal Contraceptives Avoid concomitant use of VONJO with hormonal contraceptives except for intrauterine systems containing levonorgestrel.
The effectiveness of hormonal contraceptives, except for intrauterine systems containing levonorgestrel, may be reduced when used with VONJO. If contraception is needed or desired, an alternate contraceptive that is not affected by CYP3A4 inducers (e.g., an intrauterine system) or additional nonhormonal contraceptive (e.g., condoms) should be used when treated concomitantly with VONJO, and for 30 days after last dose of VONJO. P-gp Substrates Pacritinib is an inhibitor of P-gp.
VONJO increases the plasma concentrations of P-gp substrates [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ). Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), the recommended dosage is 100 mg twice daily ( 8.6 ). Renal Impairment: Avoid use in patients with eGFR <30 mL/min ( 8.7 ).
8.1Pregnancy Risk Summary There are no available data on VONJO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, administration of pacritinib to pregnant mice or rabbits at exposures that were considerably lower than those observed at the recommended human dose were associated with maternal toxicity and embryonic and fetal loss (see Data ) . Advise pregnant women of the potential risk to a fetus.
Consider the benefits and risks of VONJO for the mother and possible risks to the fetus when prescribing VONJO to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pacritinib was administered orally to pregnant mice at doses of 30, 100, or 250 mg/kg/day from gestation day 6 to gestation day 15. Pacritinib was also administered orally to pregnant rabbits at doses of 15, 30, or 60 mg/kg/day from gestation day 7 until gestation day 20.
In both species, pacritinib was associated with maternal toxicity, which resulted in post-implantation loss in mice, abortions in rabbits, and reduced fetal body weights in mice and rabbits at exposures 0.1 times (mice) and 0.3 times (rabbits) the exposure at the recommended human dose (AUC-based). In mice, the high dose was associated with an increased incidence of an external malformation (cleft palate) in the presence of maternal toxicity. In a pre- and post-natal development study in mice, pregnant animals were dosed with pacritinib from implantation through lactation at 30, 100, or 250 mg/kg/day.
Maternal toxicity was noted at 250 mg/kg and associated with increased gestation length and dystocia, lowered mean birth weights and neonatal survival, and transiently delayed startle response, learning, and memory development at weaning.
8.2Lactation Risk Summary There are no data on the presence of pacritinib in either human or animal milk, the effects on the breastfed child, or the effects on milk production. It is not known whether VONJO is excreted in human milk. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with VONJO, and for 2 weeks after the last dose.
8.3Females and Males of Reproductive Potential Infertility Males Pacritinib reduced male mating and fertility indices in BALB/c mice [see Nonclinical Toxicology ( 13.1 )]. Pacritinib may impair male fertility in humans.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of VONJO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
8.6Hepatic Impairment In patients with severe hepatic impairment [Child-Pugh C], the recommended dosage of VONJO is 100 mg twice daily. Dosage may be increased to 200 mg twice daily if the treatment is not effective after 12 weeks and there are no safety concerns. Monitor hepatically-impaired patients for adverse reactions and consider VONJO dose modifications based on safety and efficacy [see Dosage and Administration (2.5), Clinical Pharmacology ( 12.3 )].
No dose modification is recommended for patients with mild [Child-Pugh A] or moderate [Child-Pugh B] hepatic impairment [see Clinical Pharmacology ( 12.3 )… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on VONJO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, administration of pacritinib to pregnant mice or rabbits at exposures that were considerably lower than those observed at the recommended human dose were associated with maternal toxicity and embryonic and fetal loss (see Data ) . Advise pregnant women of the potential risk to a fetus.
Consider the benefits and risks of VONJO for the mother and possible risks to the fetus when prescribing VONJO to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pacritinib was administered orally to pregnant mice at doses of 30, 100, or 250 mg/kg/day from gestation day 6 to gestation day 15. Pacritinib was also administered orally to pregnant rabbits at doses of 15, 30, or 60 mg/kg/day from gestation day 7 until gestation day 20.
In both species, pacritinib was associated with maternal toxicity, which resulted in post-implantation loss in mice, abortions in rabbits, and reduced fetal body weights in mice and rabbits at exposures 0.1 times (mice) and 0.3 times (rabbits) the exposure at the recommended human dose (AUC-based). In mice, the high dose was associated with an increased incidence of an external malformation (cleft palate) in the presence of maternal toxicity. In a pre- and post-natal development study in mice, pregnant animals were dosed with pacritinib from implantation through lactation at 30, 100, or 250 mg/kg/day.
Maternal toxicity was noted at 250 mg/kg and associated with increased gestation length and dystocia, lowered mean birth weights and neonatal survival, and transiently delayed startle response, learning, and memory development at weaning.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of VONJO did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage may lead to gastrointestinal toxicities, myelosuppression, blurred vision, dizziness, worsening performance status, and sepsis. There is no known antidote for overdose with VONJO. Hemodialysis is not expected to enhance the elimination of VONJO.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Pacritinib is an oral kinase inhibitor with activity against wild type Janus associated kinase 2 (JAK2), mutant JAK2V617F, FMS-like tyrosine kinase 3 (FLT3), and interleukin 1 receptor associated kinase-1 (IRAK1) which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Pacritinib is also an inhibitor of activin A receptor, type 1/activin receptor like-kinase 2 (ACVR1/ALK2). MF is often associated with dysregulated JAK2 signaling.
At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib has higher inhibitory activity for JAK2 compared to JAK3 and tyrosine kinase 2 (TYK2). Pacritinib exhibits inhibitory activity against additional cellular kinases, such as colony stimulating factor 1 receptor (CSF1R), of which the clinical relevance in myelofibrosis is unknown.
12.2Pharmacodynamics Pacritinib inhibited the phosphorylation of signal transducer and activator of transcription 5 (STAT5) protein in a dose-dependent manner (ex vivo) in expanded erythroid progenitor cells derived from healthy subjects. Administration of single doses of 400 mg pacritinib resulted in modest inhibition of interleukin-6-induced STAT3 phosphorylation in whole blood derived from healthy subjects. Cardiac Electrophysiology In a 24-week study of 54 patients with MF treated with VONJO 200 mg twice daily, the maximum mean (90% confidence interval) change in QTcF from baseline was 11 (90% CI: 5-17) msec.
12.3Pharmacokinetics Pacritinib steady-state mean (CV%) C max is 8.4 mg/L (32.4%) and AUC 0-12 is 95.6 mg×h/L (33.1%) following administration of VONJO 200 mg twice daily in patients with MF. Pharmacokinetics of pacritinib increases in a less than dose-proportional manner. VONJO 200 mg twice daily accumulates 386% and reaches steady-state within a week.
Absorption Pacritinib achieves C max within approximately 4 to 5 hours post-dose. Effect of Food There was no significant effect of food on the pharmacokinetics of pacritinib following oral administration of VONJO 200 mg with a high-fat meal. Distribution The median (range) apparent volume of distribution of pacritinib at steady state is 229 L (156 to 591 L) in patients with MF taking 200 mg twice daily.
Plasma protein binding of pacritinib is approximately 98.8%. Metabolism Pacritinib is predominantly metabolized by the CYP3A4 isozyme. Pacritinib is the major circulating component and the pharmacologic activity is mainly attributed to the parent molecule.
Two major metabolites, M1 and M2, in human whole plasma represent 9.6% and 10.5% of parent drug exposure, respectively. Elimination The mean apparent clearance at steady-state (CV%) of pacritinib is
2.09L/h (33.1%), and mean effective half-life (CV%) is 27.7 hours (17.0%). Excretion Following a single oral administration of radiolabeled pacritinib 400 mg in healthy adult subjects, 87% of the radioactivity was recovered in feces, and 6% was recovered in urine. No unchanged drug was excreted in feces and 0.12% of unchanged drug was excreted in urine.
Specific Populations No clinically significant differences in the pharmacokinetics of pacritinib were observed based on age, sex, body weight, or race. Patients With Renal Impairment Pacritinib C max and AUC were similar in subjects with eGFR 30 to 89 mL/min, as estimated by the MDRD study equation, compared to subjects with eGFR ≥90 mL/min. The C max and AUC increased approximately 30% in subjects with eGFR 15 to 29 mL/min and eGFR <15 mL/min on hemodialysis.
Patients With Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of pacritinib was studied in subjects with normal or impaired hepatic function at 200 mg VONJO twice daily for 14 days. The geometric mean AUC of total pacritinib decreased in subjects with moderate [Child-Pugh B, n=8] or severe hepatic impairment [Child-Pugh C, n=6] compared to subjects with normal hepatic function (n=11… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Pacritinib is an oral kinase inhibitor with activity against wild type Janus associated kinase 2 (JAK2), mutant JAK2V617F, FMS-like tyrosine kinase 3 (FLT3), and interleukin 1 receptor associated kinase-1 (IRAK1) which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Pacritinib is also an inhibitor of activin A receptor, type 1/activin receptor like-kinase 2 (ACVR1/ALK2). MF is often associated with dysregulated JAK2 signaling.
At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib has higher inhibitory activity for JAK2 compared to JAK3 and tyrosine kinase 2 (TYK2). Pacritinib exhibits inhibitory activity against additional cellular kinases, such as colony stimulating factor 1 receptor (CSF1R), of which the clinical relevance in myelofibrosis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied VONJO is supplied in the following strength and package configuration: Strength NDC Number Description Capsules per Bottle 100 mg 72482-100-12 Hard, oblong, opaque, gelatin capsule with scarlet cap and gray body, printed with “Pacritinib 100 mg” on the cap and “C78837” on the body 120
16.2Storage Store at room temperature, below 30°C (86°F). Keep the bottle tightly closed and protect from light. Store in original package. Dispense in original package or in a light-resistant container.
📦 Storage and Handling ▾
16.2Storage Store at room temperature, below 30°C (86°F). Keep the bottle tightly closed and protect from light. Store in original package. Dispense in original package or in a light-resistant container.
📋 Description ▾
11 DESCRIPTION VONJO contains pacritinib citrate, a kinase inhibitor with the chemical name (2E,16E)-11-[2-(pyrrolidin-1-yl)ethoxy]-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2,4,6,8,10,12(26),16,21,23-decaene citrate and a molecular weight of 664.7 as citrate salt and 472.59 as a free base. The molecular formula is C 28 H 32 N 4 O 3 •C 6 H 8 O 7 and the structural formula is: VONJO capsule is for oral administration. Each capsule contains 100 mg of pacritinib equivalent to 140.65 mg of pacritinib citrate and the inactive ingredients are microcrystalline cellulose NF, polyethylene glycol 8000 (PEG 8000) NF, and magnesium stearate NF.
The gelatin capsule is bovine derived. The capsule shell contains gelatin, titanium dioxide, black iron oxide, erythrosine, red iron oxide, and printing ink containing shellac, propylene glycol, titanium dioxide, sodium hydroxide, and povidone. image description
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA approved patient labeling ( Patient Information ). Discuss the following with the patient prior to and during treatment with VONJO: Current therapy with another kinase inhibitor Advise patients who are currently taking a kinase inhibitor that they must taper or discontinue their current kinase inhibitor therapy according to the package insert for that drug prior to starting VONJO. Hemorrhage Advise patients that VONJO can cause hemorrhage and instruct them to consult their healthcare provider right away if bleeding occurs.
Advise patients about how to recognize bleeding and of the urgent need to report any unusual bleeding to their healthcare provider. Patients should urgently seek emergency medical attention for any bleeding that cannot be stopped [see Warnings and Precautions ( 5.1 )] . Diarrhea Advise patients that VONJO can cause diarrhea.
Advise patients to stay hydrated while taking VONJO and to inform their healthcare provider if they experience diarrhea. Instruct patients to initiate antidiarrheal medication promptly at the first onset of symptoms (increase in frequency or change in consistency of bowel movements [loosening]) after starting VONJO. Advise patients to urgently seek emergency medical attention if diarrhea becomes severe [see Warnings and Precautions ( 5.2 )] .
Thrombocytopenia Advise patients that VONJO can cause thrombocytopenia, and of the need to monitor complete blood counts before and during treatment [see Warnings and Precautions ( 5.3 )] . Prolonged QT Interval Advise patients to consult their healthcare provider immediately if they feel faint, lose consciousness, or have signs or symptoms suggestive of arrhythmia. Advise patients with a history of hypokalemia of the importance of monitoring their electrolytes [see Warnings and Precautions ( 5.4 )] .
Major Adverse Cardiac Events (MACE) Advise patients that events of major adverse cardiac events (MACE) including myocardial infarction, stroke, and cardiovascular death, have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which VONJO is not indicated. Advise patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions ( 5.5 )] .
Thrombosis Advise patients that events of deep vein thrombosis and pulmonary embolism have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which VONJO is not indicated. Advise patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions ( 5.6 )] . Secondary Malignancies Advise patients, especially current or past smokers and patients with a known secondary malignancy (other than a successfully treated NMSC), that lymphoma and other malignancies (excluding NMSC) have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which VONJO is not indicated [see Warnings and Precautions ( 5.7 )] .
Infections Advise patients that treatment with another JAK-inhibitor has increased the risk of serious infections in patients with myeloproliferative neoplasms and that serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Inform patients of the signs and symptoms of infection and to report any such signs and symptoms promptly [see Warnings and Precautions ( 5.8 )] . Nausea and Vomiting Advise patients that nausea and vomiting may occur during treatment with VONJO.
Instruct them on how to manage nausea and vomiting and to immediately inform their healthcare provider if nausea/vomiting become severe. Symptom Exacerbation Following Interruption or Discontinuation of Treatment with VONJO Inform patients that after discontinuation of treatment, signs and symptoms fr… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Pacritinib steady-state mean (CV%) C max is 8.4 mg/L (32.4%) and AUC 0-12 is 95.6 mg×h/L (33.1%) following administration of VONJO 200 mg twice daily in patients with MF. Pharmacokinetics of pacritinib increases in a less than dose-proportional manner. VONJO 200 mg twice daily accumulates 386% and reaches steady-state within a week.
Absorption Pacritinib achieves C max within approximately 4 to 5 hours post-dose. Effect of Food There was no significant effect of food on the pharmacokinetics of pacritinib following oral administration of VONJO 200 mg with a high-fat meal. Distribution The median (range) apparent volume of distribution of pacritinib at steady state is 229 L (156 to 591 L) in patients with MF taking 200 mg twice daily.
Plasma protein binding of pacritinib is approximately 98.8%. Metabolism Pacritinib is predominantly metabolized by the CYP3A4 isozyme. Pacritinib is the major circulating component and the pharmacologic activity is mainly attributed to the parent molecule.
Two major metabolites, M1 and M2, in human whole plasma represent 9.6% and 10.5% of parent drug exposure, respectively. Elimination The mean apparent clearance at steady-state (CV%) of pacritinib is
2.09L/h (33.1%), and mean effective half-life (CV%) is 27.7 hours (17.0%). Excretion Following a single oral administration of radiolabeled pacritinib 400 mg in healthy adult subjects, 87% of the radioactivity was recovered in feces, and 6% was recovered in urine. No unchanged drug was excreted in feces and 0.12% of unchanged drug was excreted in urine.
Specific Populations No clinically significant differences in the pharmacokinetics of pacritinib were observed based on age, sex, body weight, or race. Patients With Renal Impairment Pacritinib C max and AUC were similar in subjects with eGFR 30 to 89 mL/min, as estimated by the MDRD study equation, compared to subjects with eGFR ≥90 mL/min. The C max and AUC increased approximately 30% in subjects with eGFR 15 to 29 mL/min and eGFR <15 mL/min on hemodialysis.
Patients With Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of pacritinib was studied in subjects with normal or impaired hepatic function at 200 mg VONJO twice daily for 14 days. The geometric mean AUC of total pacritinib decreased in subjects with moderate [Child-Pugh B, n=8] or severe hepatic impairment [Child-Pugh C, n=6] compared to subjects with normal hepatic function (n=11) due to reduced plasma protein binding. The geometric mean AUC of unbound pacritinib, the pharmacologically relevant parameter, was similar in healthy subjects compared to subjects with moderate hepatic impairment and increased by 23% in subjects with severe hepatic impairment (see Table 6).
Table 6 Steady-State Pharmacokinetic Changes in Pacritinib at 200 mg VONJO BID: Subjects with Moderate / Severe Hepatic Impairment vs. Normal Hepatic Function Hepatic impairment Ratio (90% CI) of pacritinib exposure 1 Unbound C max Unbound AUC 0-tau Moderate impairment (Child-Pugh B) 1.06 (0.72, 1.58) 1.05 (0.69, 1.60) Severe impairment (Child-Pugh C) 1.24 (0.93, 1.65) 1.23 (0.91, 1.66) Notes: AUC 0-tau = Area under the curve from zero to tau post-dose after 14 days twice daily dosing with VONJO 200 mg; CI = Confidence Interval; C max = Maximum plasma concentration.
1 Ratios for C max and AUC compare exposure of unbound pacritinib in subjects with hepatic impairment vs normal hepatic function following administration of VONJO 200 mg BID for 14 days. Drug Interactions Effects of Other Drugs on the Pharmacokinetics of VONJO The effect of co-administered drugs on the exposure of pacritinib is shown in Table 7 and Table 8. Table 7 Change in Pharmacokinetics of Pacritinib Following Administration of a Single 400 mg Dose VONJO in the Presence of Co-administered Drugs Co-administered Drug Regimen of Co-administered Drug Ratio (90% CI) of pacritinib exposure 1 C max AUC 0-t Clarithromycin (strong CYP3A4 inhibitor) 500 mg every 12 hours fo… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pacritinib inhibited the phosphorylation of signal transducer and activator of transcription 5 (STAT5) protein in a dose-dependent manner (ex vivo) in expanded erythroid progenitor cells derived from healthy subjects. Administration of single doses of 400 mg pacritinib resulted in modest inhibition of interleukin-6-induced STAT3 phosphorylation in whole blood derived from healthy subjects. Cardiac Electrophysiology In a 24-week study of 54 patients with MF treated with VONJO 200 mg twice daily, the maximum mean (90% confidence interval) change in QTcF from baseline was 11 (90% CI: 5-17) msec.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES PERSIST-2 The efficacy of VONJO in the treatment of patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF was established in the PERSIST-2 trial. PERSIST-2 enrolled patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF with splenomegaly and a platelet count ≤100 × 10 9 /L. Both JAK2 naïve patients and patients with prior JAK2 inhibitor therapy were included.
Patients were randomized 1:1:1 to receive VONJO 400 mg once daily, VONJO 200 mg twice daily, or best available therapy (BAT). BAT agents could be used alone, in combinations, sequentially, and intermittently, as clinically indicated by standards of care. BAT included any physician-selected treatment for MF and may have included ruxolitinib, hydroxyurea, glucocorticoids, erythropoietic agents, immunomodulatory agents, mercaptopurine, danazol, interferons, cytarabine, melphalan.
BAT also included no treatment (“watch and wait”) or symptom-directed treatment without MF-specific treatment. In this trial, 311 patients were randomized to receive VONJO 400 mg once daily (n=104), VONJO 200 mg twice daily (n=107), or BAT (n=100). The VONJO dose of 400 mg once daily was not established as safe and is not an approved dosage regimen.
The demographic characteristics of the efficacy population were median age of 68 years (range 32 to 91), 55% male, 86% Caucasian, and 14% non-Caucasian. The VONJO and BAT treatment arms were well balanced with respect to age, gender, race, ethnicity, body mass index, and geographic region. Sixty-eight percent of patients had primary MF, 20% had post-polycythemia vera MF, and 12% had post-essential thrombocythemia MF.
Forty-six percent and 51% of patients in the VONJO and BAT treatment arms, respectively, had received prior ruxolitinib therapy. The median baseline hemoglobin level was 9.5 g/dL and 23% of patients were red blood cell (RBC) transfusion dependent at study entry. The median baseline platelet count was 55 × 10 9 /L; 45% of patients had a platelet count <50 × 10 9 /L.
Patients had a baseline median spleen length of 14 cm assessed by magnetic resonance imaging (MRI) or computerized axial tomography (CAT). Efficacy was established in patients who received VONJO 200 mg twice daily and had a platelet count <50 x 10 9 (N=31). The most common agents used in the BAT treatment arm in patients with baseline platelet counts <50 × 10 9 /L (N=32) were ruxolitinib (39%), watchful waiting (32%), and hydroxyurea (26%).
Spleen Volume Reduction The efficacy of VONJO in the treatment of patients with primary or secondary MF was established based upon the proportion of patients in the efficacy population receiving VONJO 200 mg twice daily or BAT achieving ≥35% spleen volume reduction from baseline to Week 24 as measured by magnetic resonance imaging or computed tomography. Efficacy results for spleen volume reduction in patients with a platelet count <50 × 10 9 /L are presented in Table 11 Table 11 Percentage of Patients Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 in the Phase 3 Study, PERSIST-2 (Efficacy Population) Patient Population VONJO 200mg Twice Daily N=31 Best Available Therapy N=32 Baseline Platelets <50 × 10 9 /L 9 (29.0%) 1 (3.1%) 95% Confidence Interval (CI) 14.2, 48.0 0.1,
16.2Difference (VONJO-BAT) 95% CI 25.9 (4.3,44.5) A waterfall plot of the percentage of change in spleen volume from baseline to Week 24 is presented in Figure 1 for the PERSIST-2 patients with baseline platelet counts <50 × 109/L. The median reduction in spleen volume for patients with a platelet count <50 × 109/L was 27.3% for patients in the VONJO 200 mg twice daily group compared to 0.9% in the BAT group. Figure 1 Waterfall Plot of Median Percent Change From Baseline in Spleen Volume at Week 24 in Patients With <50 × 109/L Platelet Counts in PERSIST-2a aDropout rates in VONJO and BAT arms were 26% a… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Pacritinib was not carcinogenic in the 6-month Tg.rasH2 transgenic mouse model. Pacritinib was not carcinogenic in a 2-year carcinogenicity study in rats at 0.004 times and 0.014 times, in males and females, respectively, the recommended human dose (AUC-based). Pacritinib exposures achieved in mice and rats during the carcinogenicity assessments were considerably lower than the exposure observed at the recommended human dose.
Pacritinib was not mutagenic in a bacterial mutagenicity assay (Ames test) or clastogenic in vitro in a chromosomal aberration assay (Chinese hamster ovary cells) or in vivo in a micronucleus test in mice. In a fertility study in male BALB/c mice, pacritinib was administered for at least 70 days prior to cohabitation with untreated partners. Pacritinib had no effects at any dose level on uterine implantation, macroscopic findings, reproductive organ weights, and sperm evaluations.
At 213.4 mg/kg/day (3.0 times, the recommended human dose, based on body surface area), reduced mating and fertility indices were observed in male BALB/c mice. In a fertility and early embryonic development study in CD-1 mice, no effects on male or female reproductive performance, including assessments of mating, fertility, estrous cyclicity, and intrauterine survival, were observed at doses up to 250 mg/kg/day (3.0 times, the recommended human dose, based on body surface area).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Pacritinib was not carcinogenic in the 6-month Tg.rasH2 transgenic mouse model. Pacritinib was not carcinogenic in a 2-year carcinogenicity study in rats at 0.004 times and 0.014 times, in males and females, respectively, the recommended human dose (AUC-based). Pacritinib exposures achieved in mice and rats during the carcinogenicity assessments were considerably lower than the exposure observed at the recommended human dose.
Pacritinib was not mutagenic in a bacterial mutagenicity assay (Ames test) or clastogenic in vitro in a chromosomal aberration assay (Chinese hamster ovary cells) or in vivo in a micronucleus test in mice. In a fertility study in male BALB/c mice, pacritinib was administered for at least 70 days prior to cohabitation with untreated partners. Pacritinib had no effects at any dose level on uterine implantation, macroscopic findings, reproductive organ weights, and sperm evaluations.
At 213.4 mg/kg/day (3.0 times, the recommended human dose, based on body surface area), reduced mating and fertility indices were observed in male BALB/c mice. In a fertility and early embryonic development study in CD-1 mice, no effects on male or female reproductive performance, including assessments of mating, fertility, estrous cyclicity, and intrauterine survival, were observed at doses up to 250 mg/kg/day (3.0 times, the recommended human dose, based on body surface area).
📄 Patient Package Insert ▾
PATIENT INFORMATION VONJO (VON-joh) (pacritinib) capsules What is VONJO? VONJO is a prescription medicine used to treat adults with certain types of myelofibrosis who have a platelet count below 50 x 10 9 /L. It is not known if VONJO is safe and effective in children.
Before taking VONJO, tell your healthcare provider about all of your medical conditions, including if you: have active bleeding, have had severe bleeding, or plan to have surgery or invasive procedures. You should stop taking VONJO 7 days before any planned surgery or invasive procedures. See “ What are the possible side effects of VONJO? ” have diarrhea or commonly have loose stools have had a blood clot, heart attack, other heart problems, or stroke have a history of low blood levels of potassium.
It is important that you get blood tests done during treatment with VONJO to monitor your body salts (electrolytes). smoke or were a smoker in the past have had any other cancers. See “ What are the possible side effects of VONJO? ” have an infection. See “What are the possible side effects of VONJO?” have nausea or vomiting have liver or kidney problems are pregnant or plan to become pregnant.
It is not known if VONJO will harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if VONJO passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose of VONJO.
Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VONJO with certain other medicines may affect the amount of VONJO or the other medicines in your blood and may increase your risk of side effects or affect how well VONJO works.
Especially tell your healthcare provider if you take hormonal contraceptives (birth control). Hormonal birth control methods, except for intrauterine systems containing levonorgestrel may not work during treatment with VONJO and for 30 days after your last dose. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VONJO.
Know the medicines you take. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you get a new medicine. How should I take VONJO?
Take VONJO exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking VONJO without first talking to your healthcare provider. If you stop treatment with VONJO, symptoms of your condition may return.
See “What are the possible side effects of VONJO?” If you take other kinase inhibitors, carefully follow your healthcare provider's instructions about how to slowly decrease (taper) your dose or stop the other kinase inhibitor medicines before you begin taking VONJO. VONJO is usually taken by mouth 2 times each day. Swallow VONJO capsules whole.
Do not open, break, or chew capsules. You can take VONJO with or without food or drink. Take your VONJO doses at about the same time every day.
If you notice any change in how often you have bowel movements, if they become softer or you have diarrhea, start taking an antidiarrheal medicine (for example, loperamide) as soon as you notice changes, as directed by your healthcare provider. If you miss a dose of VONJO, skip the dose and just take your next dose at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.
If you take too much VONJO, call your healthcare provider or go to the nearest emergency room right away and take your bottle of VONJO with you. What are the possible side effects of VONJO? VONJO can cause serious side effects including: Bleeding.
VONJO can cause severe bleeding, which can be serious and, in some cases may lead to death. Stop taking VONJO and tell your healthcare provider right away if you develop any of these symptoms: unusual bleeding, bruisin… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions ( 5.9 ) 11/2024 Warnings and Precautions ( 5.2 ) 08/2025 Dosage and Administration ( 2.6 ) 10/2025 Warnings and Precautions ( 5.9 ) 03/2026
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - 100 mg Carton Label NDC 72482- 100 -12 Rx only VONJO® (pacritinib) capsules 100 mg 120 capsules Swallow capsules whole. Do not open, break, or chew capsules. Keep out of the sight and reach of children. image description
Principal Display Panel - 100 mg Bottle Label NDC 72482- 100 -12 Rx only VONJO ® (pacritinib) capsules 100 mg 120 capsules Swallow capsules whole. Do not open, break, or chew capsules. Keep out of the sight and reach of children. image description
Principal Display Panel - 100 mg Carton Label NDC 72482- 100 -12 Rx only VONJO ® (pacritinib) capsules 100 mg 120 capsules Swallow capsules whole. Do not open, break, or chew capsules. Keep out of the sight and reach of children. image description
Principal Display Panel - 100 mg Bottle Label NDC 72482- 100 -12 Rx only VONJO ® (pacritinib) capsules 100 mg 120 capsules Swallow capsules whole. Do not open, break, or chew capsules. Keep out of the sight and reach of children. image description
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