Vonjo

About Vonjo(Pacritinib)

• Pacritinib, marketed under the brand name. On February 28, 2022, the U.S. Food and Drug Administration (FDA) granted approval for Pacritinib, 
• Vonjo, is an anti-cancer drug specifically designed for the treatment of myelofibrosis. Pacritinib is classified as a macrocyclic protein kinase inhibitor, it predominantly targets Janus kinase 2 (JAK2) and Fms-like tyrosine kinase 3 (CD135). 
• This kinase inhibitor is indicated for adults with intermediate or high-risk primary or secondary myelofibrosis (post-polycythemia vera or post-essential thrombocythemia) presenting with a platelet count below 50 × 10^9/L.
• Myelofibrosis, a rare form of bone marrow cancer, disrupts the regular production of blood cells in the body. This condition results in significant scarring within the bone marrow, contributing to profound anemia. 

Strength: 

The capsule is available as Vonjo 100 mg. 

Recommended Dosage:

Conduct a comprehensive blood analysis, including a complete blood count (CBC) with white blood cell count differential and platelet count. Perform coagulation tests such as prothrombin time, partial thromboplastin time, thrombin time, and international normalized ratio. Additionally, obtain a baseline electrocardiogram (ECG) before initiating Vonjo and monitor as clinically necessary throughout the course of treatment.

• The prescribed dosage for Vonjo is 200 mg orally administered twice daily. It can be taken with or without food. 
• It is essential to swallow the capsules whole, and they should not be opened, broken, or chewed.

Important:

In the event of a missed dose of Vonjo capsule, the patient should take the next prescribed dose at the scheduled time. Avoid taking additional capsules to compensate for the missed dose. If elective surgery or invasive procedures are planned, discontinue Vonjo 7 days prior due to the risk of hemorrhage and resume only after ensuring hemostasis.

Warnings & Precautions

• Avoid concurrent use of potent CYP3A4 inhibitors or inducers. 
• The concurrent administration of Vonjo may impact the concentration of drugs acting as substrates for P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), or organic cation transporter 1 (OCT1). It is advisable to avoid using Vonjo in conjunction with medications that are sensitive substrates for these transporters.
• Exercise caution with Vonjo capsule, especially in patients prone to bleeding, requiring surgical procedures, or experiencing significant diarrhea. 
• Thrombocytopenia concerns should be addressed through dose adjustments, and vigilance is required in patients with a prolonged QT interval. 
• Monitor for major adverse cardiac events and thrombosis, particularly in individuals with a smoking history or cardiovascular risk factors. 
• Additionally, stay vigilant for secondary malignancies, especially in those with a smoking background, and be cautious about infection risks, ensuring resolution before initiating Vonjo. 
• Always prioritize patient safety and promptly manage any observed complications or adverse effects.

Common Vonjo Side Effects:

• Diarrhea,
• Thrombocytopenia
• Nausea
• Anemia
• Peripheral edema
• Dizziness
• Headache
• Fatigue
• Constipation
• Stomach pain
• Loss of appetite
• Muscle pain
• Difficulty sleeping
• Mouth sores
• Skin rash
• Hair loss
• Low red blood cell

Use in Specific Population

• For individuals who are pregnant or planning pregnancy, the potential impact of Vonjo on the unborn baby remains unknown. 
• No data is available on the presence of pacritinib in human or animal milk, its effects on the breastfed child, or its impact on milk production. Due to the potential for severe adverse reactions in the breastfed child, patients are advised against breastfeeding during Vonjo treatment and for a period of 2 weeks after the last dose.
• Regarding reproductive potential, pacritinib has shown a reduction in male mating and fertility indices in mice, suggesting a potential impairment of male fertility in humans. 
• The safety and efficacy of Vonjo in pediatric patients have not been established, and studies did not include a sufficient number of subjects aged 65 and over to determine if they respond differently. 
• Specific caution is advised for individuals with hepatic impairment, recommending avoidance of moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C). 
• Additionally, in cases of renal impairment where the estimated glomerular filtration rate (eGFR) is below 30 mL/min, use of Vonjo should be avoided.

Storage and Handling

• Store Vonjo at room temperature, below 86°F (30°C).
• Store Vonjo in the original package.
• Keep the bottle tightly closed to protect Vonjo from light. 
• Protect Vonjo from direct light exposure and prevent freezing. 
• Keep the medicine away from pets and children.