Truseltiq is a prescription medicine 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 certain FGFR2 gene abnormalities to make sure that Truseltiq is right for you.
It is not known if this medicine is safe and effective in children.

• Take Truseltiq exactly as your healthcare provider tells you.
• Take your prescribed dose of Truseltiq 1 time each day for 21 days, followed by 7 days off treatment. This is 1 cycle of treatment (28 days). You will repeat this cycle for as long as your healthcare provider tells you to.
• Take Truseltiq at about the same time each day.
• Take Truseltiq capsules on an empty stomach, at least 1 hour before or 2 hours after food.
• Swallow the capsules whole with a glass of water.
• Do not crush, chew, or dissolve the capsules. Tell your healthcare provider if you have problems swallowing capsules whole.
• If you need to take an acid reducer called H2 blocker, take Truseltiq 2 hours before or 10 hours after taking the acid reducer.
• If you need to take an antacid, take Truseltiq 2 hours before or 2 hours after taking the antacid.
• You should not eat or drink grapefruit products during treatment.
• Your healthcare provider may change your dose, temporarily stop, or completely stop treatment if you get certain side effects.
• If you miss a dose, you can take the missed dose within 4 hours on the same day. If more than 4 hours have passed, do not take the dose. Take your regular dose the next day at the usual time. Do not take more Truseltiq than prescribed to make up for the missed dose.
• If you vomit after taking Truseltiq, do not take an extra dose. Take your regular dose the next day at the usual time.

Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:

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

Females who can become pregnant:

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

Males with female partners who can become pregnant:

• • You should use effective birth control when sexually active during treatment, and for 1 month after your final dose.
  • are breastfeeding or plan to breastfeed. It is not known if Truseltiq passes into your breast milk. Do not breastfeed during treatment and for 1 month after your final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Truseltiq with certain other medicines may affect how Truseltiq works.

Especially tell your healthcare provider if you take medicines used to decrease stomach acid and treat heartburn, called proton pump inhibitors (PPIs), H2 blockers, or antacids. You should avoid taking these medicines during treatment with Truseltiq. If you cannot avoid taking H2 blockers or antacids, see How should I take Truseltiq? for more information on how to take Truseltiq with these medicines.

Truseltiq may cause serious side effects, including:

• Eye problems. Certain eye problems are common with Truseltiq but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and disorders 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, at 1 month, at 3 months, and then every 3 months during treatment. Your healthcare provider should closely monitor you for eye problems.
  • You should use artificial tear 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 including blurred vision, during treatment. You may need to see an eye specialist right away.
• High phosphate levels in the blood (hyperphosphatemia) and buildup of minerals in different tissues in your body. Hyperphosphatemia is common with Truseltiq 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.
  • Your healthcare provider may prescribe phosphate lowering therapy or change, interrupt, or stop Truseltiq if needed.
  • Tell your healthcare provider right away if you develop any muscle cramps, numbness, or tingling around your mouth.

The most common side effects include:

• changes in kidney function blood tests
• decreased levels of phosphate, sodium, and potassium in the blood
• nails separate from the bed or poor formation of the nail
• mouth sores
• changes in liver function blood tests
• decreased red blood cell, white blood cell, and platelet counts
• increased lipase levels (a blood test done to check your pancreas)
• dry eyes
• feeling tired or weak
• increased calcium levels in the blood
• hair loss
• increased fat levels (triglyceride) in the blood
• increased levels of uric acid in the blood
• redness, swelling, peeling or tenderness, mainly on the hands or feet (‘hand-foot syndrome’)
• joint pain
• changes in sense of taste
• constipation
• stomach-area (abdominal) pain or discomfort
• dry mouth
• changes in eyelash
• diarrhea
• decreased protein levels (albumin) in the blood
• dry skin
• decreased appetite
• blurred vision
• vomiting

These are not all possible side effects. 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Take your infigratinib dose 2 hours before or 10 hours after taking an "H2 blocker" stomach acid medicine. This includes cimetidine, famotidine, nizatidine, ranitidine, Pepcid, Tagamet, and Zantac.

Tell your doctor about any medicines you take to reduce stomach acid. This includes esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Nexium, and Prilosec.

Other drugs may interact with infigratinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.