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IncyteCARES is a program for residents of the United States and US territories.

Patient Terms and Conditions. Amount of savings on PEMAZYRE will not exceed $9,000 per claim and $25,000 per year. You must have minimum out-of-pocket costs of $.01 to redeem this. Patients will be responsible for any out-of-pocket costs above the maximum annual and monthly program benefit. Card must be activated before use. Card is valid through December 31 of the year of activation. On January 1 of the following year, the card automatically resets and is subject to annual limits if the prescription benefit remains the same. Offer is not valid if you are uninsured or paying cash for your prescription. Offer is not valid if you are enrolled in a federal or state prescription program (including Medicare Part D, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program). If you move or switch from commercial prescription benefit coverage to any government prescription benefit coverage, you will no longer be eligible. If you have any questions, please call 1-855-452-5234. This card is not insurance. Offer valid only for an FDA-approved use. You are responsible for reporting receipt of program benefits to any commercial or private insurer that pays for or reimburses any part of the prescriptions filled with this program, to the extent required by law or by the insurer. You agree not to seek reimbursement from your insurer or any other third party for all or any part of the benefit received through this offer. This card may not be sold, purchased, traded, or transferred and is void if reproduced. You agree that you will not in any way report or count the value of the PEMAZYRE provided under this program as true out-of-pocket spending (TrOOP) under a Medicare Part D prescription drug benefit. One card per patient. No substitutions are permitted. Use of this card does not obligate you to use or continue to use PEMAZYRE. No other purchase and no refills are necessary. This offer is limited to one (1) per person during this offering period and is not transferable. You are responsible for all taxes. Program cards are the property of Incyte Corporation and must be turned in on request. No membership fees. Offer is good only in the United States and US territories, and void where prohibited or otherwise restricted by law. For Massachusetts residents, this offer expires on January 1, 2021 absent a change in Massachusetts law. Incyte Corporation reserves the right to rescind, revoke, or amend this program without notice.

INDICATIONS AND USAGE

PEMAZYRE is a prescription medicine that is used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery:

  • who have already received a previous treatment, and
  • whose tumor has a certain type of abnormal "FGFR2” gene

Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that PEMAZYRE is right for you.

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

PEMAZYRE is approved based on tumor response and duration of response. There are ongoing studies to show whether PEMAZYRE can improve survival or symptoms.

IMPORTANT SAFETY INFORMATION

Before you take PEMAZYRE, tell your healthcare provider about all of your medical conditions, including if you:

  • have vision or eye problems
  • have problems swallowing tablets
  • are pregnant or plan to become pregnant. PEMAZYRE can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment with PEMAZYRE.

    Females who can become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with PEMAZYRE.
    • You should use an effective method of birth control during treatment and for 1 week after your final dose of PEMAZYRE. Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

    Males with female partners who can become pregnant:

    • You should use effective birth control when sexually active during treatment with PEMAZYRE and for 1 week after your final dose of PEMAZYRE.
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 1 week after your final dose of PEMAZYRE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of PEMAZYRE?

PEMAZYRE may cause serious side effects, including:

  • Eye problems. Certain eye problems are common with PEMAZYRE but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with PEMAZYRE, every 2 months for the first 6 months, and then every 3 months during treatment with PEMAZYRE.
    • You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes.
    • Tell your healthcare provider right away if you develop any changes in your vision during treatment with PEMAZYRE, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
  • High phosphate levels in your blood (hyperphosphatemia). Hyperphosphatemia is common with PEMAZYRE but can also be serious. Your healthcare provider will check your blood phosphate levels during treatment with PEMAZYRE.
    • Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt, or stop PEMAZYRE if needed.
    • Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.

The most common side effects of PEMAZYRE include:

  • hair loss
  • diarrhea
  • nails separate from the bed or poor formation of the nail
  • feeling tired
  • change in sense of taste
  • nausea
  • constipation
  • mouth sores
  • dry eyes
  • dry mouth
  • decrease in appetite
  • vomiting
  • joint pain
  • stomach-area (abdominal) pain
  • low phosphate in blood
  • back pain
  • dry skin

These are not all the possible side effects of PEMAZYRE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

General information about the safe and effective use of PEMAZYRE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PEMAZYRE for a condition for which it is not prescribed. Do not give PEMAZYRE to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals. Keep PEMAZYRE and all medicines out of the reach of children.

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.