Frequently Asked Questions | IncyteCARES for JAKAFI or JAKAFI XR Skip to main content

IncyteCARES is a program for residents
of the United States and Puerto Rico.

About IncyteCARES

IncyteCARES is a support program for patients who are prescribed Incyte medications. Our team can help you understand your insurance coverage and medication costs and find savings and financial assistance options to fit your needs. You can speak one-on-one to an IncyteCARES representative who can help arrange delivery of your medicine, provide education about your condition, connect you with other organizations that provide counseling and help cover transportation costs, and more. Contact IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET with questions or to enroll.

Call us at 1-855-452-5234.

Our IncyteCARES team is available Monday through Friday, 8 AM–8 PM ET.

IncyteCARES is intended to help eligible patients who have been prescribed Incyte medications and who have trouble affording their out-of-pocket costs or who are facing other challenges in getting on and staying on their medication. Contact IncyteCARES to speak one-on-one to a representative to determine if you're eligible to enroll. Our team can be reached at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

IncyteCARES can help eligible patients understand their insurance coverage and costs for JAKAFI or JAKAFI XR and explore financial assistance and savings options to help reduce out-of-pocket costs. Our team can help coordinate delivery of medicine from a specialty pharmacy and arrange for a temporary supply of medicine if coverage is delayed. We can also help connect eligible patients with resources to help manage their condition day to day, including symptom trackers, counseling services, treatment education, transportation services, and more. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to speak one-on-one with a representative.

There are 3 ways to enroll in IncyteCARES.

  1. You can ask your Healthcare Professional to enroll you.
  2. You can call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET and speak to a representative to start the enrollment process.
  3. You can download an enrollment form, fill out your personal information yourself, and then take it to your Healthcare Professional to submit.

Visit How to Enroll to find out more or download an enrollment form.

No. Anyone can call IncyteCARES for general information.

Yes, any patient who has been prescribed JAKAFI or JAKAFI XR can enroll in IncyteCARES but may not be eligible to receive some of the services or support we offer. Contact IncyteCARES for more details and to determine if you're eligible. Our team can be reached at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET.

You must be a resident of the United States or Puerto Rico to be enrolled in the IncyteCARES Savings Program, Patient Assistance Program, or Temporary Access Program.

Uninsured patients may qualify for the IncyteCARES Patient Assistance Program if they are enrolled in IncyteCARES and meet certain criteria. Please call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET and speak with a representative to find out if you are eligible.

Yes, a caregiver may contact IncyteCARES on behalf of a patient to begin the enrollment process.

We can connect patients to nonprofit organizations that provide social and emotional support as well as information about other counseling services and support groups in their area. Please call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET and speak one-on-one with a representative to talk about the kinds of support that are available.

Enrollment in the IncyteCARES program lasts for one year. You can re-enroll each year (we'll remind you when it's time!) and can continue to be a part of the program for as long as you're taking JAKAFI or JAKAFI XR.

Filling Your Prescription

Yes. An IncyteCARES team member can help identify a specialty pharmacy that works with your insurance. You can choose to have your prescription shipped from that pharmacy to your home or to your Healthcare Professional’s office.

No, your medication cannot be shipped to your local pharmacy, but it can be shipped to your home or to your Healthcare Professional’s office.

No. Typically your specialty pharmacy will contact you each month to see if you would like a refill of your JAKAFI or JAKAFI XR. If you don’t receive this call, you can call your specialty pharmacy directly or contact IncyteCARES.

Call IncyteCARES about any insurance changes, and we can help you understand your new coverage. We can also determine if you are now, or are still, eligible for our IncyteCARES Savings Program or eligible for other forms of support, including our financial assistance programs. Your new insurance coverage may require you to use a different specialty pharmacy to fill your prescription. We can help you change pharmacies if needed and coordinate your medicine delivery from the new pharmacy.

Yes. You can always send prescriptions directly to a participating specialty pharmacy. Keep in mind, however, that IncyteCARES can offer helpful services, particularly if you don't have prescription drug coverage.

Check with your specialty pharmacy. It may provide a refill reminder service.

JAKAFI and JAKAFI XR prescriptions can be filled by these specialty pharmacies. Note that your insurance company may require you to use certain pharmacies to fill your prescription.

Talk to your Healthcare Professional about the best way to transition from JAKAFI to JAKAFI XR.

Financial Assistance Options

IncyteCARES offers savings and financial assistance options to help patients taking JAKAFI or JAKAFI XR with their out-of-pocket costs. With the IncyteCARES Savings Program, eligible patients with commercial prescription coverage can receive JAKAFI or JAKAFI XR for as little as $0, subject to certain limits.* For patients who are uninsured or underinsured, they may be eligible to receive JAKAFI or JAKAFI XR free of charge through the Patient Assistance Program.* Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to find out more.

*Terms and conditions apply. Terms of this program may change at any time. Read complete terms and conditions for the IncyteCARES Savings Program here.

With the IncyteCARES Savings Program, eligible patients with commercial prescription coverage can receive JAKAFI or JAKAFI XR for as little as $0, subject to certain limits.* Your actual savings may differ depending upon your insurance coverage. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to find out more.

*Terms and conditions apply. Terms of this program may change at any time. Read complete terms and conditions for the IncyteCARES Savings Program here.

To qualify for the Savings Program, patients must meet the following criteria:

  • Have commercial prescription drug coverage. Patients insured under federal or state government prescription drug programs—including Medicare Part B or D, Medicare Advantage, Medicaid, or TRICARE—are not eligible. Patients without prescription drug coverage are also not eligible
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for JAKAFI or JAKAFI XR for an FDA-approved use

Read complete terms and conditions for the IncyteCARES Savings Program here.

For more information, call IncyteCARES at 1-855-452-5234.

You can ask your prescribing Healthcare Professional, Specialty Pharmacist, or IncyteCARES to check your eligibility and enroll you in the program.

Read complete terms and conditions for the IncyteCARES Savings Program here.

For more information, call IncyteCARES at 1-855-452-5234.

Once your information is submitted for the IncyteCARES Savings Program, eligibility is determined right away. If you are eligible, a program member number is typically issued immediately. Your specialty pharmacy is often able to arrange this for you as they prepare your prescription. If your application is made by the IncyteCARES team, either you or our team can share this member number with your specialty pharmacy, so it can be applied to your prescription for JAKAFI or JAKAFI XR.

No. Your enrollment in the Savings Program will automatically renew each year. You do not need to re-enroll. You should, however, contact IncyteCARES if your prescription insurance plan changes, so we can update your information.

Eligible patients who do not have prescription drug insurance or have trouble affording their out-of-pocket costs for JAKAFI or JAKAFI XR may be able to receive their medication free of charge. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to speak one-on-one with an IncyteCARES representative about the criteria for eligibility.

The IncyteCARES Patient Assistance Program (PAP) helps eligible patients who do not have prescription drug insurance or have trouble affording their out-of-pocket costs. No purchase contingencies or other obligations apply.

To qualify, you must:*

  • Be confirmed as eligible for and enrolled in IncyteCARES
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for JAKAFI or JAKAFI XR for an FDA-approved use
  • Meet one of these 3 criteria:

Uninsured

    1. Have no prescription drug coverage and meet household income criteria

Underinsured

    1. text
    2. Have Medicare Part B, Medicare Part D, or Medicare Advantage and meet household income criteria
    3. Have any other type of prescription drug insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for JAKAFI or JAKAFI XR and meet household income criteria

For more information, call IncyteCARES at 1-855-452-5234.

*Terms and conditions apply. Terms of this program may change at any time.

Patients who are enrolled in an Alternate Funding Program (AFP) are not eligible to receive free drug.

Conditional approval for the Patient Assistance Program (PAP) is provided in 3 business days after we receive a patient's completed enrollment form. That means patients are approved for a supply of free medicine for 90 days. In the meantime, patients must send us proof of current household income. Eligible patients are fully approved for the PAP when proof of income criteria are confirmed.

You must document your current household income by submitting one of the following: your most recent federal income tax return, your most recent W-2 earnings statement from your employer, or one month of recent pay stubs.

Once we receive your completed PAP enrollment form, you will be given "conditional approval" for the program. This means patients are temporarily approved for the program, for up to 90 days, until we can review and evaluate the financial information (household size and current annual income) you must send to IncyteCARES.

Yes, if you are enrolled in the Patient Assistance Program (PAP), you need to re-enroll in IncyteCARES and reapply for PAP every year.

Understanding Insurance Coverage

Yes, once we have your prescription and insurance information, an IncyteCARES team member can help you understand your coverage and costs for your medication. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET if you have questions.

Once we receive your insurance information, we can research your coverage for JAKAFI or JAKAFI XR right away. In most cases, we’ll call you with this information within 3 business days. If there is a delay, we’ll notify you and/or your Healthcare Professional within that time frame.

Once you are enrolled in IncyteCARES, a team member will contact your insurance company to determine your coverage and whether prior authorization is required. If prior authorization is needed, we will notify your doctor and ensure that the required information is sent to your insurance company.

A team member will contact you after you are enrolled in IncyteCARES. They will review your insurance coverage for JAKAFI or JAKAFI XR with you and will also explain any savings or financial assistance programs for which you may be eligible. You can also call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to speak one-on-one to an IncyteCARES representative if you have questions.

Patients who have Medicare Part D or Medicaid may be eligible to receive JAKAFI or JAKAFI XR free of charge through the IncyteCARES Patient Assistance Program as long as they meet household income requirements and other criteria.* This program helps eligible patients who do not have prescription drug insurance or have trouble affording their out-of-pocket costs for their medication. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to find out more.

To learn more about how Medicare Part D can help you manage your out-of-pocket prescription costs, see the Information on Medicare Part D for IncyteCARES.

*Terms and conditions apply. Terms of this program may change at any time.

Many insurance plans require prior authorization before they will approve coverage for JAKAFI or JAKAFI XR. This means they require your Healthcare Professional to send them additional information about your condition and why JAKAFI or JAKAFI XR is being prescribed. Based on the additional details, they will determine coverage. In most cases, this extra step delays their coverage approval by just a few days. In the unusual event that your insurance company delays their coverage decision by more than a few business days, we may offer you a free short-term supply of JAKAFI or JAKAFI XR through our IncyteCARES Temporary Patient Assistance Program.

Please contact IncyteCARES if your insurance coverage changes or is lost or if you have a life-changing event such as a job loss or other change in household income. We can determine any changes in your coverage for JAKAFI or JAKAFI XR or your out-of-pocket costs. We can also find out if your specialty pharmacy is still within network for your insurer and can communicate any changes to them. If you need to change specialty pharmacies, we can help with that as well.

If your coverage is denied, IncyteCARES can help you and your doctor file an appeal. If your appeal decision is delayed beyond a few business days, we may be able to offer you a free short-term supply of your medication through the Temporary Patient Assistance Program if you are eligible. If your appeal is unsuccessful, we can assess your eligibility for free medication through the Patient Assistance Program.

When you first enroll in IncyteCARES, we can do a benefit verification for both JAKAFI XR and JAKAFI. If coverage for JAKAFI XR is denied, IncyteCARES will contact your Healthcare Professional to discuss whether JAKAFI is covered. If your Healthcare Professional decides that JAKAFI is right for you, IncyteCARES will work with them to update your enrollment.

Copay adjustment programs are used by health insurance companies—mostly for specialty medications that have drug manufacturer copay savings programs. Health plans use adjustment programs to offset what they pay for a medication rather than allow the manufacturers’ savings program to be applied to the patient's out-of-pocket costs and deductibles as it was intended to be.

As drug manufacturers attempt to create programs to subsidize out-of-pocket costs for patients, the payers reduce the value of these programs by exhausting such funds while also requiring the patient to pay their deductibles and coinsurance up to their out-of-pocket maximums to obtain their medications.

Copay adjustment programs may vary in name, but traditionally they are called copay accumulators or maximizers. Patients may often have difficulty knowing if their health insurance program includes accumulators and maximizers. In some cases, patients are offered reduced costs if they enroll in a particular program.

The most common types of copay adjustment programs are accumulators and maximizers. These programs are designed to exclude the use of manufacturer copay savings programs from counting toward patients’ annual deductibles and out-of-pocket costs, such as copays. Alternative funding programs may also impact patients’ deductibles and out-of-pocket costs.

  • An accumulator adjustment program is used by the plan/pharmacy benefit managers (PBMs) to prevent manufacturers’ copay savings from being applied to deductibles and maximum out-of-pocket cost. That means that the value of the copay savings program goes directly to the plan rather than being subtracted from the patient’s annual deductible or out-of-pocket expenses. Once the full value of the copay savings is used, the patient is still responsible for their full or remaining deductible and out-of-pocket cost
  • A maximizer adjustment program is used to adjust the patient’s copay responsibility to match the maximum value of the manufacturer’s savings program. Generally, the value is divided over the year, a shorter specified period of time determined by the plan, or the number of months a patient is on the product within a calendar year to extract the full value of the copay savings program. For plans to use maximizers, the insurance company deems the specialty drug nonessential so that they are not limited to the Affordable Care Act (ACA) maximums
  • Alternate funding programs (AFPs) are not medical insurance, but they can be used by health plans to deny or delay patients’ access to specialty medications. AFPs operate in agreement on behalf of the health plan to exclude certain specialty products from the patient’s prescription drug benefit. AFPs then coordinate with the patient’s enrollment into the drug manufacturer’s foundation or Patient Assistance Program (PAP). AFPs may create challenges and delays for starting or staying on therapy due to the PAP’s enrollment processes and timelines. AFPs may prevent a patient from moving through their insurance out-of-pocket requirements in the way the patient would have if the medication had been included in the insurer’s prescription drug benefit

First, take look at your plan details. The explanation of benefits (EOB) report is a good place to start.

Your health insurance company can provide your EOB upon request. The document should describe how to meet your deductible and out-of-pocket maximum. You can also ask your employer if your plan includes these programs.

Next, review your insurance plan’s Pharmacy Limitations and Exclusions or Schedule of Benefits statement.

Be on the lookout for terms like “manufacturer,” “copay card,” “coupon,” and “discount.” These keywords can help you find the restrictions or limitations for financial assistance you may receive from drug manufacturers.

You can contact a customer service agent from your insurance company who may help you find out if the plan you are enrolled in (or are considering) has a copay adjustment program that could change your out-of-pocket costs.

Straightforward questions to ask include:

  • Does this health plan have an accumulator or maximizer program?
  • How does it impact me?
  • What are my options for handling gaps in coverage that may occur?
  • Am I required to enroll, or may I opt out?
  • If I can opt out, can I do so at any time of the year or only during open enrollment?

Need Help?

Our IncyteCARES team is available Monday through Friday, 8 AM–8 PM ET

Our IncyteCARES team is available
Monday through Friday,
8 AM–8 PM ET

Call us at 1-855-452-5234

Expand section Close section

WHAT IS JAKAFI OR JAKAFI XR?

JAKAFI® or JAKAFI XR™ (ruxolitinib) is a prescription medication used to treat adults with certain types of myelofibrosis (MF).
It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of myelofibrosis.

JAKAFI or JAKAFI XR is a prescription medication used to treat adults with polycythemia vera (PV) who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.
It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of polycythemia vera.

JAKAFI or JAKAFI XR is a prescription medication 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.

JAKAFI or JAKAFI XR is a prescription medication used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (GVHD) who have taken one or two types of treatments and they did not work well enough.

IMPORTANT SAFETY INFORMATION

JAKAFI® or JAKAFI XR™ can cause serious side effects, including:

Low blood counts: JAKAFI or JAKAFI XR (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking JAKAFI or JAKAFI XR and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start and regularly during your treatment. Your healthcare provider may change your dose 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
  • a fever

Infection: You may be at risk for developing a serious infection during treatment with JAKAFI or JAKAFI XR. 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

Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment.

Do not interrupt or stop treatment without talking to your healthcare provider. Tell your healthcare provider right away if you have any of the following after stopping treatment:

  • fever
  • trouble breathing
  • weakness
  • night sweats
  • feeling dizzy or lightheaded
  • pain in left upper stomach area or left shoulder

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly check your skin during your treatment. Tell your healthcare provider if you develop any new or changing skin lesions during treatment.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking JAKAFI or JAKAFI XR and as needed.

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 while using another JAK inhibitor to treat rheumatoid arthritis:

Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with JAKAFI or JAKAFI XR, 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 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 JAKAFI or JAKAFI XR, including:

  • swelling, pain, or tenderness in one or both legs
  • sudden, unexplained chest or upper back 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. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of JAKAFI or JAKAFI XR include:

  • for certain types of polycythemia vera (PV) and myelofibrosis (MF) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea
  • for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling
  • for chronic GVHD – low red blood cell or platelet counts and infections, including viral infections

These are not all the possible side effects. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking JAKAFI or JAKAFI XR, tell your healthcare provider about: 

  • all the medications, vitamins, and herbal supplements you are taking
  • your medical conditions, including if you
    • have or had low white or red blood cell counts
    • have an infection
    • have or had tuberculosis (TB) or have been in close contact with someone who has TB
    • had shingles (herpes zoster)
    • have or had hepatitis B
    • have a high level of fat in your blood (high blood cholesterol or triglycerides)
    • have or have had a blood clot, heart attack, other heart problems, or stroke
    • are a current or past smoker
    • had cancer
    • have or had liver or kidney problems or are on dialysis. If you are on dialysis, JAKAFI or JAKAFI XR should be taken after your dialysis
    • have any other medical condition

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

How should I take JAKAFI or JAKAFI XR?

  • Take exactly as your healthcare provider tells you.
  • Do not change your dose or stop taking JAKAFI or JAKAFI XR without first talking to your healthcare provider. If you stop treatment, symptoms of your condition may return.
  • If you miss a dose, take your next dose at your regular time. Do NOT take 2 doses at the same time.
  • You may have regular blood tests during your treatment. Based on the results, your healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.
  • IF YOU ARE PRESCRIBED JAKAFI:
    • Take JAKAFI 2 times a day or exactly as your healthcare provider tells you, with or without food.
    • JAKAFI may also be given through certain nasogastric tubes.
    • Tell your healthcare provider if you cannot take JAKAFI by mouth. Your healthcare provider will decide if you can take JAKAFI through a nasogastric tube. Ask your healthcare provider to give you specific instructions on how to properly take JAKAFI through a nasogastric tube.
  • IF YOU ARE PRESCRIBED JAKAFI XR:
    • Take JAKAFI XR 1 time a day with or without food.
    • Swallow JAKAFI XR whole. Do not split, crush, or chew.

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.

Expand section Close section

WHAT IS JAKAFI OR JAKAFI XR?

JAKAFI® or JAKAFI XR™ (ruxolitinib) is a prescription medication used to treat adults with certain types of myelofibrosis (MF).
It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of myelofibrosis.

JAKAFI or JAKAFI XR is a prescription medication used to treat adults with polycythemia vera (PV) who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.
It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of polycythemia vera.

JAKAFI or JAKAFI XR (ruxolitinib) is a prescription medication 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.

JAKAFI or JAKAFI XR (ruxolitinib) is a prescription medication used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (GVHD) who have taken one or two types of treatments and they did not work well enough.

IMPORTANT SAFETY INFORMATION

JAKAFI® or JAKAFI XR™ can cause serious side effects, including:

Low blood counts: JAKAFI or JAKAFI XR (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking JAKAFI or JAKAFI XR and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start and regularly during your treatment. Your healthcare provider may change your dose 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
  • a fever

Infection: You may be at risk for developing a serious infection during treatment with JAKAFI or JAKAFI XR. 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

Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment.

Do not interrupt or stop treatment without talking to your healthcare provider. Tell your healthcare provider right away if you have any of the following after stopping treatment:

  • fever
  • trouble breathing
  • weakness
  • night sweats
  • feeling dizzy or lightheaded
  • pain in left upper stomach area or left shoulder

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly check your skin during your treatment. Tell your healthcare provider if you develop any new or changing skin lesions during treatment.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking JAKAFI or JAKAFI XR and as needed.

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 while using another JAK inhibitor to treat rheumatoid arthritis:

Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with JAKAFI or JAKAFI XR, 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 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 JAKAFI or JAKAFI XR, including:

  • swelling, pain, or tenderness in one or both legs
  • sudden, unexplained chest or upper back 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. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of JAKAFI or JAKAFI XR include:

  • for certain types of polycythemia vera (PV) and myelofibrosis (MF) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea
  • for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling
  • for chronic GVHD – low red blood cell or platelet counts and infections, including viral infections

These are not all the possible side effects. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking JAKAFI or JAKAFI XR, tell your healthcare provider about: 

  • all the medications, vitamins, and herbal supplements you are taking
  • your medical conditions, including if you
    • have or had low white or red blood cell counts
    • have an infection
    • have or had tuberculosis (TB) or have been in close contact with someone who has TB
    • had shingles (herpes zoster)
    • have or had hepatitis B
    • have a high level of fat in your blood (high blood cholesterol or triglycerides)
    • have or have had a blood clot, heart attack, other heart problems, or stroke
    • are a current or past smoker
    • had cancer
    • have or had liver or kidney problems or are on dialysis. If you are on dialysis, JAKAFI or JAKAFI XR should be taken after your dialysis
    • have any other medical condition

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

How should I take JAKAFI or JAKAFI XR?

  • Take exactly as your healthcare provider tells you.
  • Do not change your dose or stop taking JAKAFI or JAKAFI XR without first talking to your healthcare provider. If you stop treatment, symptoms of your condition may return.
  • If you miss a dose, take your next dose at your regular time. Do NOT take 2 doses at the same time.
  • You may have regular blood tests during your treatment. Based on the results, your healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.
  • IF YOU ARE PRESCRIBED JAKAFI:
    • Take JAKAFI 2 times a day or exactly as your healthcare provider tells you, with or without food.
    • JAKAFI may also be given through certain nasogastric tubes.
    • Tell your healthcare provider if you cannot take JAKAFI by mouth. Your healthcare provider will decide if you can take JAKAFI through a nasogastric tube. Ask your healthcare provider to give you specific instructions on how to properly take JAKAFI through a nasogastric tube.
  • IF YOU ARE PRESCRIBED JAKAFI XR:
    • Take JAKAFI XR 1 time a day with or without food.
    • Swallow JAKAFI XR whole. Do not split, crush, or chew.

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.