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
• a type of blood cancer called myeloid/lymphoid neoplasms (MLNs):
  • when it has come back or did not respond to treatment, and
  • whose tumor has a certain type of abnormal FGFR1 gene

Your healthcare provider will test your cancer for certain types of abnormal FGFR1 or FGFR2 genes 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 kidney problems
• have liver problems
• 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 last 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 last dose of PEMAZYRE.
• are breastfeeding or plan to breastfeed. It is not known if PEMAZYRE passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last 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) and buildup of minerals in different tissues in your body. Hyperphosphatemia is common with PEMAZYRE but can also be serious. High levels of phosphate in your blood may lead to buildup of minerals such as calcium, in different tissues in your body. 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 for cholangiocarcinoma include:

The most common side effects of PEMAZYRE for myeloid/lymphoid neoplasms (MLN) include:

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.

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

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.

Please see the Full Prescribing Information for PEMAZYRE.

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.