Skip to main content

Information on TRUSELTIQ Dosing

Before you and your healthcare team decide TRUSELTIQ may be right for you:

  • 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 with TRUSELTIQ
      Females who can become pregnant:
      • Your healthcare provider should do a pregnancy test before you start treatment with TRUSELTIQ
      • You should use effective birth control during treatment and for 1 month after your final dose of TRUSELTIQ
      • 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 a female partner who can become pregnant:
      • You should use effective birth control when sexually active during treatment with TRUSELTIQ and for 1 month after your final dose of TRUSELTIQ
    • 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 of TRUSELTIQ
  • Tell your healthcare provider about all the medicines you’re currently taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TRUSELTIQ with certain other medicines may affect how TRUSELTIQ works
  • Important things to consider
    • 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 with TRUSELTIQ
    • If you need to take an acid reducer called an H2 blocker, take TRUSELTIQ 2 hours before or 10 hours after taking the acid reducer
    • Avoid use with strong or moderate CYP3A inhibitors or inducers
Calendar showing the TRUSELTIQ™ (infigratinib) treatment cycle. 21 days on, 7 days off.

How to take TRUSELTIQ:

TRUSELTIQ is taken on a 28-day cycle

When you start, you will take TRUSELTIQ oral capsules daily for 21 days, followed by 7 days when you don’t take any capsules. You will then repeat this process again each month.

Each week and day of the treatment cycle is labeled on the TRUSELTIQ blister cards to help you stay on track

On the days you take TRUSELTIQ:

When you’re starting out with the usual prescribed dose of 125 mg, you will take one 100 mg capsule and one 25 mg capsule (for a total of 125 mg) together by mouth, once a day. Your healthcare provider may provide you with a different dose schedule, depending on what works best for you.

TRUSELTIQ capsules should be:


Taken once a day
by mouth

Taken on an empty stomach at least 1 hour before or 2 hours after a meal

Taken about the same time every day

Swallowed whole with a glass of water—do not crush, chew, or dissolve the capsules

Remember: There will be 7 days at the end of each treatment cycle when you don’t take TRUSELTIQ; the days are listed on the blister cards to help you stay on track

Once you complete a treatment cycle:

You will repeat the 28-day cycle for as long as your healthcare provider instructs you to do so. Your healthcare provider will watch your progress on TRUSELTIQ and decide how long you should take it. You might take TRUSELTIQ until your cancer no longer responds.

What to do if you miss a dose:

  • If you miss a dose of TRUSELTIQ, you can take the missed dose within 4 hours on the same day
  • If you miss a dose by more than 4 hours, do not take your dose for that day. 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

Talk to your healthcare provider if you have any side effects from TRUSELTIQ. Your healthcare provider may change your dose, temporarily stop, or completely stop treatment if you get certain side effects.

And remember: your healthcare team is always there to support you. Be sure to call them with any questions you have about your treatment with TRUSELTIQ

If you want to learn more about TRUSELTIQ, Your Guide to TRUSELTIQ brochure is available for download

INDICATION AND IMPORTANT
SAFETY INFORMATION

What is TRUSELTIQ?

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 and make sure that TRUSELTIQ is right for you.

TRUSELTIQ is approved based on tumor response and duration of response. Data are not yet available to show if TRUSELTIQ improves symptoms or survival.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of TRUSELTIQ?

Serious side effects of TRUSELTIQ include:
  • 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 start treatment with TRUSELTIQ, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Your healthcare provider should closely monitor you for eye problems
    • You should use artificial tear substitutes, or 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 with TRUSELTIQ. 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 and may lead to a buildup of minerals such as calcium in different tissues in your body. Your healthcare provider will check your blood phosphate levels during treatment with TRUSELTIQ
    • 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 of TRUSELTIQ include changes in kidney function blood tests; decreased phosphate, sodium, potassium, and protein (albumin) in the blood; separation of nails 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, calcium, fat (triglycerides), and uric acid in the blood; dry eyes; feeling tired or weak; hair loss; redness, swelling, peeling or tenderness on the hands or feet (“hand-foot” syndrome); joint pain; changes in sense of taste; constipation; stomach-area (abdominal) pain or discomfort; dry mouth; eyelash changes; diarrhea; dry skin; decreased appetite; blurred vision; and vomiting.

These are not all possible side effects of TRUSELTIQ. For more information, talk to your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking TRUSELTIQ?

  • All your medical conditions, including vision or eye, kidney, or liver problems
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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, take TRUSELTIQ 2 hours before or 10 hours after taking the H2 blocker. If you cannot avoid taking antacids, take TRUSELTIQ 2 hours before or 2 hours after taking the antacid
  • If you are pregnant or plan to become pregnant. TRUSELTIQ can harm your unborn baby. Females who can become pregnant should have a pregnancy test before starting treatment with TRUSELTIQ and use effective birth control during treatment with TRUSELTIQ and for 1 month after the final dose. Talk to your healthcare provider about birth control methods. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with TRUSELTIQ. Males with female partners who can become pregnant should use effective birth control during treatment with TRUSELTIQ and for 1 month after the final dose
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed while taking TRUSELTIQ and for 1 month after the final dose

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.

Please click for full Prescribing Information, including Patient Information.