Brand Name
Vonjo
Generic Name
Pacritinib
View Brand Information FDA approval date: February 28, 2022
Classification: Kinase Inhibitor
Form: Capsule
What is Vonjo (Pacritinib)?
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary myelofibrosis with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies (1.
Approved To Treat
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Brand Information
Vonjo (Pacritinib)
1INDICATIONS 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
This indication is approved under accelerated approval based on spleen volume reduction
2DOSAGE 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”.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hemorrhage
- Diarrhea
- Thrombocytopenia
- Prolonged QT Interval
- Major Adverse Cardiac Events
- Thrombosis
- Secondary Malignancies
- Risk of Infection
4.1Clinical 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.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VONJO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- Renal: Acute or subacute kidney injury (secondary to diarrhea)
5OVERDOSAGE
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.
6DESCRIPTION
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
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.
7CLINICAL 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
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
Efficacy was established in patients who received VONJO 200 mg twice daily and had a platelet count <50 x 10
The most common agents used in the BAT treatment arm in patients with baseline platelet counts <50 × 10
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
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)
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 × 10
Figure 1 Waterfall Plot of Median Percent Change From Baseline in Spleen Volume at Week 24 in Patients With <50 × 10
aDropout rates in VONJO and BAT arms were 26% and 44%, respectively.
8PATIENT COUNSELING INFORMATION
See FDA approved patient labeling (
Discuss the following with the patient prior to and during treatment with VONJO:
9Principal 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.
10Principal Display Panel - 100 mg Bottle Label
NDC 72482-
Rx only
VONJO
(pacritinib) capsules
(pacritinib) capsules
100 mg
120 capsules
S
Do not open, break, or chew capsules.
Keep out of the sight and reach of children.
11Principal Display Panel - 100 mg Carton Label
NDC 72482-
Rx only
VONJO
(pacritinib) capsules
(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.
12Principal Display Panel - 100 mg Bottle Label
NDC 72482-
Rx only
VONJO
(pacritinib) capsules
(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.