You need to enable JavaScript to run this app.
This site is intended for US residents only.

Not all MF treatments are tailored to patients with low platelet counts—but VONJO is.

Low platelet counts (less than 50 x 109/L) can be caused by the MF treatment you’re currently taking, or by changes in your MF. To manage those changes, doses may have to be lowered in order to lessen the risk of making low platelet counts worse. However, with VONJO, you have a therapy that’s tailored to your type of MF from the start by treating the disease while managing low platelet counts.

How does VONJO work?

MF develops when changes (mutations) take place in blood stem cells. When these mutations send more signals than normal along various signaling pathways, it causes inflammation in the bone marrow. As a result, that bone marrow becomes scarred and unable to create normal amounts of blood cells. The resulting scar tissue may lead to complications such as low red blood cells (anemia), low platelets (thrombocytopenia), weakness, and tiredness. It can also cause the spleen to enlarge as it works harder to take over blood cell production.

Some of the mutations specific to your MF may be related to Janus kinase (JAK) proteins, such as JAK1 and JAK2. The JAK2 mutation is found in more than half of people with MF (approximately 50%-60%), but there may be more mutations involved in your MF. In some people, both JAK2 and IRAK1 (interleukin-1 receptor-associated kinase 1) mutations may be changing how the body sends signals for blood cell production.

VONJO is believed to inhibit (interrupt) more than one of the overactive signals (JAK2 and IRAK1) that may be driving MF. However, VONJO does not significantly inhibit JAK1, which is important because sparing that signaling pathway may help reduce the chance of worsening platelet counts. VONJO is approved for use in people with low platelet counts.

How is VONJO different than other FDA-approved therapies for MF?

When people have MF, overactive signaling in the JAK and IRAK pathways can cause chronic inflammation within the body and various related symptoms.

VONJO is believed to inhibit (interrupt) JAK2 and IRAK1 within these pathways to help address the inflammation and reduce MF-related symptoms, including an enlarged spleen. However, some FDA-approved therapies for MF inhibit JAK1, which may result in worsening platelet counts. VONJO is different than these therapies in that it does not inhibit JAK1.*

Infographic showing how the JAK pathway and IRAK pathway act while taking VONJO
*VONJO is believed to reduce signaling of JAK2 and IRAK1; however, the clinical relevance of IRAK1 is unknown. VONJO does not reduce signaling of JAK1.

In a clinical trial, spleen volume reduction was measured in patients with MF and low platelet counts (less than 50 x 109/L).

hex 29
hex 38
Spleen volume reduction by more than 35%:

10x more patients (29%) had a spleen volume reduction on VONJO than those receiving best available therapy (3%).

Any spleen volume reduction:

More patients (83%) reduced spleen size on VONJO than those receiving best available therapy (56%).

In the best available therapy group, most patients (39%) were on ruxolitinib. Other options included monitoring without treatment (32% of patients) and hydroxyurea (26% of patients).

Talk with your doctor before you start taking VONJO and set up some treatment goals.

Tell your doctor about all your medical conditions before taking VONJO, including if you:

  • Smoke or were a smoker in the past
  • Have had any other cancers
  • Have had a blood clot, heart attack, other heart problems, or stroke
  • Have an infection
  • Have diarrhea or commonly have loose stools
  • Have nausea or vomiting
  • Have liver or kidney problems
  • Have active bleeding, have had severe bleeding, or plan to have surgery. You should stop taking VONJO 7 days before any planned surgery or invasive procedures (such as heart catheterization, stent placement in a coronary artery in your heart, or a procedure for varicose veins)

Talking about pregnancy or fertility while on VONJO.

Tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if VONJO will harm your unborn baby or if it passes into breast milk. You should not breastfeed during treatment and for two weeks after your last dose of VONJO. Talk to your doctor about the best way to feed your baby during this time.

VONJO may affect fertility in males. You may have problems fathering a child. Talk to your doctor if this is a concern for you.

Taking VONJO along with other medications.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VONJO with certain other medicines may affect the amount of VONJO in your blood, and may increase your risk of side effects or affect how well VONJO works.

Know the medicines you take. Keep a list of the medicines you take to show your doctor and pharmacist when you get a new medicine.

If you take other kinase inhibitors (eg, ruxolitinib), carefully follow your doctor’s instructions about how to slowly decrease (taper) your dose or stop the other kinase inhibitor medicines before you begin taking VONJO.

Find out how VONJO fits into your daily schedule as a treatment tailored to your type of MF.

Taking VONJO
Taking VONJO

What is VONJO® (pacritinib) approved for?

VONJO is a prescription medicine used to treat adults with certain types of myelofibrosis (MF) who have a platelet count below 50 × 109/L.

It is not known if VONJO is safe and effective in children.

This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

VONJO can cause serious side effects, including:

Bleeding. VONJO may cause severe bleeding, which can be serious and, in some cases, may lead to death. Avoid taking VONJO if you are bleeding. If you develop bleeding, stop VONJO and call your healthcare provider. Your healthcare provider will do a blood test to check your blood cell counts before you start VONJO and regularly during your treatment with VONJO. Tell your healthcare provider right away if you develop any of these symptoms: unusual bleeding, bruising, and fever. You will need to stop taking VONJO 7 days before any planned surgery or invasive procedure (such as a heart catheterization, stent placement in a coronary artery in your heart, or a procedure for varicose veins). Your healthcare provider should tell you when you can start taking VONJO again.

What is VONJO® (pacritinib) approved for?

VONJO is a prescription medicine used to treat adults with certain types of myelofibrosis (MF) who have a platelet count below 50 × 109/L.

It is not known if VONJO is safe and effective in children.

This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

VONJO can cause serious side effects, including:

Bleeding. VONJO may cause severe bleeding, which can be serious and, in some cases, may lead to death. Avoid taking VONJO if you are bleeding. If you develop bleeding, stop VONJO and call your healthcare provider. Your healthcare provider will do a blood test to check your blood cell counts before you start VONJO and regularly during your treatment with VONJO. Tell your healthcare provider right away if you develop any of these symptoms: unusual bleeding, bruising, and fever. You will need to stop taking VONJO 7 days before any planned surgery or invasive procedure (such as a heart catheterization, stent placement in a coronary artery in your heart, or a procedure for varicose veins). Your healthcare provider should tell you when you can start taking VONJO again.

Diarrhea. Diarrhea is common with VONJO, but can also be severe, and cause loss of too much body fluid (dehydration). Tell your healthcare provider if you have diarrhea and follow instructions for what to do to help treat diarrhea. Drink plenty of fluids to help prevent dehydration. Your healthcare provider may change your dose of VONJO if you have severe diarrhea.

If you notice any change in how often you have bowel movements, if they become softer or you have diarrhea, start taking an antidiarrheal medicine (for example, loperamide) as soon as you notice changes, as directed by your healthcare provider.

Worsening low platelet counts. Your healthcare provider will do blood tests to check your blood counts before you start taking VONJO and during treatment with VONJO.

Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before you start VONJO and during treatment with VONJO, as needed. If you have a history of low blood potassium, it is important that you get your blood tests done as ordered by your healthcare provider to monitor your body salts (electrolytes) in your blood. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.

Increased risk of major cardiovascular events such as heart attack, stroke, or death in people who have cardiovascular risk factors and who are current or past smokers have happened in some people taking another Janus associated kinase (JAK) inhibitor to treat rheumatoid arthritis. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking VONJO, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw; pain or discomfort in your arms, back, neck, jaw, or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; feeling lightheaded; weakness in one part or on one side of your body; or slurred speech.

Increased risk of blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in some people taking another JAK inhibitor and may be life-threatening. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with VONJO, including: swelling, pain, or tenderness in one or both legs; sudden, unexplained chest pain; or shortness of breath/difficulty breathing.

Possible increased risk of new (secondary) cancers. People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers, except non-melanoma skin cancer. The risk of new cancers is further increased in people who smoke or who smoked in the past.

Risk of infection. People who have certain blood cancers and take another JAK inhibitor have an increased risk of serious infections. Infections are common with VONJO, but people who take VONJO may also develop serious infections, including bacterial, mycobacterial, fungal, and viral infections. If you have a serious infection, your healthcare provider may not start you on VONJO until your infection is gone. Your healthcare provider will monitor you and treat you for any infections that you get during treatment with VONJO. Tell your healthcare provider right away if you develop any of the following symptoms of infection: chills, aches, fever, nausea, vomiting, weakness, painful skin rash, or blisters.

The most common side effects of VONJO include: nausea, vomiting, low red blood cell count (anemia), and swelling of your ankles, legs, and feet.

VONJO may affect fertility in males. You may have problems fathering a child. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects with VONJO. Call your doctor for medical advice about side effects.

Before taking VONJO, tell your healthcare provider if you:
  • smoke or were a smoker in the past
  • have had previous medical conditions such as any other cancers, blood clot, heart attack, other heart problems, stroke, infection, diarrhea, commonly loose stools, nausea, vomiting, liver problems, or kidney problems
  • have active bleeding, have had severe bleeding, or plan to have surgery. You should stop taking VONJO 7 days before any planned surgery or invasive procedures (such as a heart catheterization, stent placement in a coronary artery in your heart, or a procedure for varicose veins)
  • are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if VONJO will harm your unborn baby or if it passes into breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose of VONJO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VONJO with certain other medicines may affect the amount of VONJO in your blood and may increase your risk of side effects or affect how well VONJO works. Know the medicines you take. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you get a new medicine.

Take VONJO exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking VONJO without first talking to your healthcare provider. If you take other kinase inhibitors, carefully follow your healthcare provider’s instructions about how to slowly decrease (taper) your dose and stop the other kinase inhibitor medicines before you begin taking VONJO. Take VONJO two times daily, with or without food, at about the same time of day. Swallow VONJO capsules whole—do not open, break, or chew capsules. If you take too much VONJO, call your healthcare provider or go to the nearest emergency room right away and take your bottle of VONJO with you. If you miss a dose, skip it, and take your next dose at your regular time—do not take 2 doses at the same time to make up for the missed dose. Your healthcare provider may change your dose or how often you take it, temporarily stop, or permanently stop treatment if you have certain side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.