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.
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.
- 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.