Pacritinib (Vonjo) is a kinase inhibitor primarily indicated for the treatment of patients with specific types of myelofibrosis. As a therapeutic drug with special safety risks, its use must strictly comply with prescribing guidelines.

Indications for Pacritinib (Vonjo)

Core Therapeutic Scope

(1) Pacritinib is indicated for the treatment of adult patients with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) and a platelet count below 50×10⁹/L.

(2) This indication is granted under accelerated approval based on the reduction in spleen volume; confirmatory trials may be required subsequently to verify clinical benefits.

Usage Restrictions

(1) Second-line Treatment Positioning: Due to safety risks, it is generally used only in patients who have had an inadequate response to two or more drugs for MF treatment.

(2) Contraindications: Concomitant use with strong CYP3A4 inhibitors or inducers is prohibited; it is contraindicated in patients with active bleeding.

(3) Special Monitoring: The drug must be obtained through the Risk Evaluation and Mitigation Strategy (REMS) program. During treatment, regular monitoring of complete blood count, electrocardiogram (ECG), and other parameters is required.

Dosage Form, Strength, and Properties of Pacritinib (Vonjo)

Basic Parameters

(1) Dosage Form: Oral hard capsules.

(2) Strength: 100 mg per capsule (an opaque, oval capsule with a scarlet cap printed with "Pacritinib 100mg" and a gray body printed with "C78837").

(3) Appearance: The contents are a white to off-white powder.

Formulation Components

(1) Active Ingredient: Pacritinib citrate (each capsule contains 100 mg of pacritinib, equivalent to 140.65 mg of pacritinib citrate).

(2) Excipients: Microcrystalline cellulose, polyethylene glycol 8000, magnesium stearate, etc.

Precautions for Use

(1) Capsules must be swallowed whole; do not open, break, or chew them.

(2) Administration is not affected by food intake, but the drug should be taken at a fixed time each day.

Storage Methods for Pacritinib (Vonjo)

Unopened Storage

(1) Temperature: Store at room temperature (below 30°C/86°F).

(2) Light Protection: Keep in the original packaging to protect from light, and ensure the bottle cap is tightly closed.

(3) Prohibited Handling: Do not freeze or expose to humid environments.

Handling After Opening

(1) Stability: Use within the expiration date after opening the bottle.

(2) Moisture Protection: Immediately close the bottle cap tightly after each dose is taken.

Transportation Requirements

The drug must be transported in its original packaging to avoid exposure to extreme temperatures and light.