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Cholangiocarcinoma is also known as bile duct cancer

Cholangiocarcinoma (ko-LAN’-jee-o-car-sin-O’-ma) is a rare, serious, and fast-moving cancer that forms in the bile ducts. Your bile ducts are a network of small tubes that move bile through the liver, gallbladder, and small intestine in order to help with digestion. Cancer can start in any part of the bile duct system.

How bile duct cancer occurs

Like all cancers, bile duct cancer develops in the body when changes in the cells cause them to act unusually, grow out of control, and form tumors.

Bile duct cancer can be divided into 2 main categories:

Intrahepatic
is when a tumor grows in
the bile ducts located
inside the liver

Extrahepatic
is when a tumor grows in the
part of the bile duct system
that is outside the liver

Metastatic bile duct cancer occurs when some of the cancerous cells from the original tumor in the bile ducts have spread to different places in the liver and/or other parts of the body over time.

Certain genes in your cancer cells can help identify a treatment plan that may be right for you

To understand more about your bile duct cancer, your healthcare provider will look for certain unusual changes to the genes within your bile duct tumor cells.

Unusual gene changes include:

Fusion

Parts of 2 different
genes join together

Amplification

An increase in the number
of copies of a gene

Mutation

A change in the DNA
of a gene

  • FGFR2 fusion:

    One gene change that can lead to bile duct cancer is found in a protein called the fibroblast growth factor receptor (FGFR).

    Typically, the FGFR protein expressed in healthy cells helps them grow and divide normally. But when one type of protein (called FGFR2) is changed because of a gene fusion, it can cause cells to grow out of control and turn into FGFR2 fusion-driven bile duct cancer. Not all bile duct cancers have this specific genetic change.

Molecular testing

To find out if your cancer has one of these genetic changes, your healthcare provider will do a biopsy (removal of cells or tissue) of your tumor to send to a lab for testing. This process is often called molecular testing.

Having your tumor tested for gene changes (like FGFR2 fusion) can help you and your healthcare team determine which treatment options might be right for you.

Targeted treatment options

Targeted therapies, also known as precision medicines, are available for people whose cancer includes certain types of gene changes.

Molecular testing has revealed that up to 16% of cases of bile duct cancer are caused by FGFR2 fusion. Treatment with TRUSELTIQ, a type of personalized, targeted therapy called an FGFR inhibitor, may be an option for those people whose test shows an FGFR2 fusion.

Your healthcare provider will tell you if TRUSELTIQ is right for you.

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.