Vonjo Generic Name & Formulations
Legal Class
Rx
General Description
Pacritinib 100mg; caps.
Pharmacological Class
Kinase inhibitor.
How Supplied
Caps—120
Manufacturer
Generic Availability
NO
Vonjo Indications
Indications
Treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50×109/L.
Vonjo Dosage and Administration
Adult
Swallow whole. 200mg twice daily. Dose modification for adverse reactions: see full labeling.
Children
Not established.
Vonjo Contraindications
Contraindications
Concomitant with strong CYP3A4 inhibitors (eg, clarithromycin) or inducers (eg, rifampin).
Vonjo Boxed Warnings
Not Applicable
Vonjo Warnings/Precautions
Warnings/Precautions
Risk of hemorrhage. Avoid use in those with active bleeding. Discontinue treatment 7 days prior to elective surgery or invasive procedures; restart only after hemostasis is assured. Control preexisting diarrhea prior to initiation. Interrupt or reduce dose if significant diarrhea occurs despite optimal supportive care. Preexisting moderate to severe thrombocytopenia. Interrupt treatment if clinically significant worsening of thrombocytopenia develops lasting for more than 7 days. Risk of prolonged QT interval; avoid use if baseline QTc >480msec. Correct hypokalemia prior to and during treatment. Perform CBCs (including WBC differential, platelets), coagulation testing, baseline ECG prior to initiation and monitor as indicated during therapy. Increased risk of MACE, thrombosis, lymphoma, and other malignancies; monitor. Consider the risks/benefits esp. in patients with known malignancy, cardiovascular risk factors, or current/past smokers. Increased risk of serious infections (eg, bacterial, mycobacterial, fungal, or viral); delay starting therapy until active serious infections have resolved. Monitor for infection during treatment. Renal impairment (eGFR <30mL/min), moderate or severe hepatic impairment: avoid. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Vonjo Pharmacokinetics
See Literature
Vonjo Interactions
Interactions
See Contraindications. Avoid concomitant drugs with significant potential for QTc prolongation. Potentiated by moderate CYP3A4 inhibitors; avoid. Antagonized by moderate CYP3A4 inducers; avoid. Potentiates sensitive substrates of CYP1A2, CYP3A4, P-gp, BCRP, or OCTI; avoid.
Vonjo Adverse Reactions
Adverse Reactions
Diarrhea, thrombocytopenia, nausea, anemia, peripheral anemia, vomiting, dizziness, pyrexia, epistaxis, dyspnea, pruritus, upper RTI, cough; serious cardiovascular events.
Vonjo Clinical Trials
See Literature
Vonjo Note
Not Applicable
Vonjo Patient Counseling
See Literature