About Acute Graft-Versus-Host Disease


What is acute graft-versus-host disease?

Acute graft-versus-host disease (GVHD) is a serious complication that may affect people who have had a stem cell transplant using cells from a donor. This type of procedure is called an allogeneic (AL-oh-geh-NAY-ik) stem cell transplant. During an allogeneic stem cell transplant, a patient’s cells are replaced with donor cells. (Figure A)

Acute GVHD occurs when donor cells (called the graft) attack the organs and tissues of the patient who received them (or the host). That’s why the condition is known as graft-versus-host disease. (Figure B)

Although acute GVHD can occur any time after transplant, it is commonly diagnosed within the first few months. Your Transplant Team relies on a combination of factors—including your symptoms and what organs are affected—to diagnose acute GVHD.


Graphic describes how acute graft-versus-host disease occurs when donor cells (called the graft) attack the organs and tissues of the patient who received them (or the host).

What parts of the body are affected by acute GVHD?

Acute GVHD mainly affects the skin, liver, and gastrointestinal tract (stomach, intestines, and colon). Patients may experience symptoms or other health problems in any of these organs because of acute GVHD.


What are the symptoms and signs of acute GVHD?

The following are all common symptoms and signs of acute GVHD. If you or a loved one notice that you are experiencing any new or worsening symptoms, contact your Transplant Team right away. Taking action early with acute GVHD can make a difference in your recovery and health.

Icon depicting the skin

Skin

Faint to severe sunburn-like rash (can appear anywhere, may cover entire body) | Blistering and peeling skin

Gastrointestinal tract icon

Gastrointestinal tract
(stomach, intestines, colon)

Diarrhea | Abdominal pain | Nausea | Vomiting | Bloating | Blood in the stool

Liver icon

Liver

Effects identified by blood tests | Few outward signs, but may include: yellowing of skin or eyes (jaundice); pain in the upper part of your belly; dark, tea-colored urine

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Already taking Jakafi? IncyteCARES is a patient support program for people taking Jakafi that offers ongoing education and resources

If you and your Healthcare Professional decide that Jakafi is right for you, the registered nurses of IncyteCARES can help eligible patients understand their insurance coverage and financial assistance options, access possible travel cost assistance, plus provide ongoing education and support resources.

IncyteCARES: Connecting to Access, Reimbursement, Education and Support

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INDICATIONS AND USAGE

INDICATIONS AND USAGE

Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.

Jakafi is used to treat adults with certain types of myelofibrosis.

Jakafi is also used to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, and headache; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB) or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had skin cancer, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

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.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.