Patient information: uses, side effects, how to take - Vonjo

What is VONJO?

VONJO is a prescription medicine used to treat adults with certain types of myelofibrosis who have a platelet count below 50 x 10 ⁹/L.

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

Before taking VONJO, tell your healthcare provider about all of your medical conditions, including if you:

have active bleeding, have had severe bleeding, or plan to have surgery or invasive procedures. You should stop taking VONJO 7 days before any planned surgery or invasive procedures. See “What are the possible side effects of VONJO?”
have diarrhea or commonly have loose stools
have had a blood clot, heart attack, other heart problems, or stroke
have a history of low blood levels of potassium. It is important that you get blood tests done during treatment with VONJO to monitor your body salts (electrolytes).
smoke or were a smoker in the past
have had any other cancers. See “What are the possible side effects of VONJO?”
have an infection. See “What are the possible side effects of VONJO?”
have nausea or vomiting
have liver or kidney problems
are pregnant or plan to become pregnant. It is not known if VONJO will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if VONJO passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your last dose of VONJO. Talk to your healthcare provider about the best way to feed your baby during this time.

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 or the other medicines in your blood and may increase your risk of side effects or affect how well VONJO works.

Especially tell your healthcare provider if you take hormonal contraceptives (birth control). Hormonal birth control methods, except for intrauterine systems containing levonorgestrel may not work during treatment with VONJO and for 30 days after your last dose. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VONJO.

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.

How should I take VONJO?

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 stop treatment with VONJO, symptoms of your condition may return. See “What are the possible side effects of VONJO?”
If you take other kinase inhibitors, carefully follow your healthcare provider's instructions about how to slowly decrease (taper) your dose or stop the other kinase inhibitor medicines before you begin taking VONJO.
VONJO is usually taken by mouth 2 times each day.
Swallow VONJO capsules whole. Do not open, break, or chew capsules.
You can take VONJO with or without food or drink.
Take your VONJO doses at about the same time every day.
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.
If you miss a dose of VONJO, skip the dose and just take your next dose at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.
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.

What are the possible side effects of VONJO?

VONJO can cause serious side effects including:

Bleeding.VONJO can cause severe bleeding, which can be serious and, in some cases may lead to death.
Stop taking VONJO and tell your healthcare provider right away if you develop any of these symptoms: unusual bleeding, bruising, and fever. Get medical help right away for any bleeding that you cannot stop.
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). Dehydration can lead to kidney problems. Tell your healthcare provider if you develop diarrhea during treatment with VONJO. Drink plenty of fluids to help prevent dehydration. Your healthcare provider will prescribe an anti-diarrheal medicine before you start VONJO. You should start taking the anti-diarrheal medicine right away if you get any symptoms of diarrhea, including any changes in consistency (such as loose stools) or increase in the number of daily bowel movements, during treatment with VONJO. Get emergency medical help right away if your diarrhea becomes severe.
Worsening low platelet counts.
Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. 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 have happened, especially in those who have cardiovascular risk factors and who are current or past smokers taking another Janus Kinase (JAK)-inhibitor to treat rheumatoid arthritis.

Get emergency help right away if you have any symptoms of a heart attack or stroke during treatment with 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
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 for rheumatoid arthritis and may be life-threatening.

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
shortness of breath or 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. 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 o vomiting
aches o weakness
fever o painful skin rash or blisters
nausea
Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment with VONJO. Do not interrupt or stop treatment with VONJO without talking to your healthcare provider. If you need to stop treatment with VONJO, your healthcare provider may give you instructions for slowly stopping treatment. Tell your healthcare provider right away if you get any of the following signs and symptoms after stopping treatment with VONJO:
fever o weakness
trouble breathing o night sweats
feeling dizzy or lightheaded o pain in your left upper stomach (abdomen) area or left shoulder

The most common side effects of VONJO include:

low platelet counts
nausea and vomiting
low red blood cell counts (anemia)
swelling of your ankles, legs, and feet

Your healthcare provider will do blood tests and an electrocardiogram (ECG) before you start treatment with VONJO and as needed during treatment to check for side effects.

Your healthcare provider may change your dose or how often you take VONJO, temporarily stop or permanently stop treatment with VONJO if you have certain side effects.

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 of the possible side effects with VONJO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VONJO?

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.

Keep VONJO and all medicines out of the reach of children.

General information about the safe and effective use of VONJO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VONJO for a condition for which it was not prescribed. Do not give VONJO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VONJO that is written for health professionals.

What are the ingredients in VONJO?

Active ingredient: pacritinib

Inactive ingredients: microcrystalline cellulose, polyethylene glycol 8000 (PEG 8000), and magnesium stearate. The capsule shell contains gelatin, titanium dioxide, black iron oxide, erythrosine, red iron oxide, and printing ink containing shellac, propylene glycol, titanium dioxide, sodium hydroxide, and povidone.

Manufactured and Marketed by: Sobi Inc., 77 4th Ave, FL 3, Waltham, MA, 02451

For more information call (866) 773-5274 or go to www.VONJO.com.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2026

Vonjo (Pacritinib): Uses, Side Effects and Dosage