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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, and

  • Who have already received a previous treatment, and
  • Whose tumor has a certain type of abnormal “FGFR2” gene

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

Your healthcare provider will test your cancer cells for certain types of genetic abnormalities (like FGFR2 fusion) and make sure that TRUSELTIQ is right for you.

TRUSELTIQ is FDA approved based on how well tumors have responded to treatment and how long that response has lasted. Additional studies are ongoing to further evaluate the benefit of TRUSELTIQ for this use.

FDA=Food and Drug Administration; FGFR2=fibroblast growth factor receptor 2.

How does TRUSELTIQ work?

In patients who have FGFR2 fusion-driven bile duct cancer, bile duct cells create an abnormal version of the FGFR2 gene. This abnormal gene can cause cells to grow and divide out of control, leading to cancerous tumors. TRUSELTIQ blocks these abnormal FGFR2 genes and reduces their activity.

How was TRUSELTIQ studied?

TRUSELTIQ was studied in a clinical trial
involving 108 adult patients with bile duct
cancer who:


  • Had their cancer get worse after receiving at least 1 previous treatment
  • Had disease that was metastatic (spread to other parts of the body) or could not be removed surgically
  • Had an FGFR2 fusion or other abnormal FGFR2 gene expression in their tumor

The purpose of the trial was to determine how
patients' tumors responded to TRUSELTIQ in 2 ways:


How many patients taking TRUSELTIQ saw their
tumors shrink or disappear (known as the overall response rate)

How long tumor response lasted from the time of the initial response (known as the duration of response)

Patients with metastatic bile duct cancer experienced antitumor results in the clinical trial with TRUSELTIQ


  • 23% of patients responded to treatment with TRUSELTIQ
  • This response continued for a median of 5 months, with a range of 0.92 to 19.1 months

Patients have different results from treatment with TRUSELTIQ. Talk to your healthcare provider about what you may expect during treatment.

Side effects may occur while taking TRUSELTIQ

  • 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
    • 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 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, 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

  • 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 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 blood tests

  • Changes in kidney function tests
  • Decreased levels of phosphate, sodium, and potassium
  • Changes in liver function tests
  • Decreased red blood cell, white blood cell, and platelet counts
  • Increased lipase levels (done to check your pancreas)
  • Increased calcium levels
  • Increased fat levels (triglycerides)
  • Increased levels of uric acid
  • Decreased protein levels (albumin)

Changes to the nails, skin, or hair

  • Nails separate from the bed or poor formation of the nail
  • Hair loss
  • Redness, swelling, peeling, or tenderness, mainly on the hands or feet (“hand-foot syndrome”)
  • Dry skin

Mouth symptoms

  • Mouth sores
  • Changes in sense of taste
  • Dry mouth

Eye symptoms

  • Dry eyes
  • Changes in eyelashes
  • Blurred vision

Stomach, digestion, and gastrointestinal symptoms

  • Constipation
  • Stomach-area (abdominal) pain or discomfort
  • Diarrhea
  • Decreased appetite
  • Vomiting

Other

  • Feeling tired or weak
  • Joint pain

These are not all the possible side effects of TRUSELTIQ. For more information, talk to your healthcare provider or pharmacist. 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.

  • Staying connected with your healthcare team

    Your healthcare provider will closely monitor your side effects throughout treatment using lab tests and other exams. If you experience any of the side effects above, or if you encounter other changes to your body that are different from how you normally feel, be sure to tell your healthcare provider. Your healthcare provider will evaluate your treatment plan and make any changes if needed.

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.