TM Owner Sobi, Inc.
Vonjo 100mg Capsule
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Indications & Clinical Uses
- Vonjo 100 mg capsules contain pacritinib, an oral kinase inhibitor.
- In the United States it is approved for adults with intermediate or high-risk primary or secondary myelofibrosis who have a platelet count below 50 x 10^9/L.
- This use was approved under accelerated approval based on spleen volume reduction, so continued approval depends on further evidence.
- The usual dose is 200 mg (two 100 mg capsules) twice daily, and a specialist prescribes and monitors it.
- Vonjo is marketed in the US by Sobi, Inc. (the label holder listed on the current label).
- It is not authorised in the European Union; the EMA record shows only a 2017 application (Enpaxiq) that the company withdrew.
Side Effects
- The most common side effects (20% or more of patients) are diarrhoea (about 48%), low platelet count or thrombocytopenia (about 34%), nausea (about 32%), anaemia (about 24%) and swelling of the legs or hands, called peripheral oedema (about 20%).
- Serious effects can occur: bleeding (serious in about 11% and fatal in about 2% of patients in the label), blood clots in veins or arteries, serious bacterial, fungal or viral infections, changes in heart rhythm (QT prolongation), new cancers including lymphoma, and major cardiovascular events such as heart attack or stroke.
- The label carries no boxed warning.
- Report bleeding, black stools, chest pain, fever, severe diarrhoea or fainting to your healthcare provider straight away.
Precautions & Warnings
- Your platelet count and heart rhythm (QTc) are checked before and during treatment; the label advises against starting with a baseline QTc above 480 msec.
- Vonjo is contraindicated with strong CYP3A4 inhibitors or inducers.
- Treatment is held for 7 days before planned surgery because of bleeding risk.
- Diarrhoea should be treated early with anti-diarrhoeal medicine and dose changes as directed.
- People who smoke or have cardiovascular risk factors face higher risks of heart events and cancer.
- Avoid use if kidney function is severely reduced (eGFR below 30 mL/min); severe liver impairment (Child-Pugh C) needs a lower starting dose of 100 mg twice daily.
- Avoid pregnancy, as animal studies showed embryo loss and fetal harm.
- Do not breastfeed during treatment and for 2 weeks after the last dose.
- Hormonal contraceptives may work less well, so use another method.
Avoid Interactions
- Increase the effect or toxicity: strong CYP3A4 inhibitors must not be used with Vonjo (contraindicated), and moderate CYP3A4 inhibitors call for closer monitoring.
- Vonjo can raise blood levels of medicines carried by P-glycoprotein and BCRP, and it inhibits CYP1A2, so sensitive medicines may need monitoring.
- Reduce efficacy: strong CYP3A4 inducers must not be used because they lower Vonjo exposure (contraindicated).
- Vonjo itself induces CYP3A4 and CYP2C19, which can lower levels of medicines broken down by those enzymes, including hormonal contraceptives, which may become less effective.
- Tell your healthcare provider about every prescription medicine, over-the-counter medicine, herbal product and supplement you take, and check before starting any new one.
References
Frequently Asked Questions
Vonjo (pacritinib) treats adults with intermediate or high-risk primary or secondary myelofibrosis whose platelet count is below 50 x 10^9/L. It was approved in the US under accelerated approval based on spleen volume reduction. A specialist prescribes it, and it is not authorised in the EU.
Take Vonjo (pacritinib) 200 mg, which is two 100 mg capsules, by mouth twice daily, with or without food. Swallow the capsules whole. Your prescriber may change the dose if you have severe liver impairment or side effects such as diarrhoea or low platelets.
Common Vonjo side effects are diarrhoea (about 48%), low platelets (34%), nausea (32%), anaemia (24%) and swelling (20%). Serious ones include bleeding, blood clots, infections and heart rhythm changes. Seek urgent help for bleeding that will not stop, black stools, chest pain or fainting. There is no boxed warning.
Do not take Vonjo (pacritinib) with strong CYP3A4 inhibitors or inducers; the label contraindicates them. Hormonal contraceptives may work less well, so use another method. Smoking raises the risk of heart events and lymphoma. Tell your prescriber about all medicines and supplements before starting anything new.
If you miss a dose of Vonjo (pacritinib), skip it and take the next dose at the usual time. Do not take extra capsules to make up for the missed dose. Keep the bottle tightly closed, protected from light and stored below 30°C.
Avoid becoming pregnant on Vonjo (pacritinib), because animal studies showed embryo loss and fetal harm. Hormonal contraceptives may be less effective, so use another method. Do not breastfeed during treatment and for 2 weeks after the last dose. Your platelet counts and heart rhythm are also monitored during treatment.
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