Futibatinib
Cholangiocarcinoma
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Futibatinib
Summary
Futibatinib is used to treat adults with a type of bile duct cancer known as unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma, which has been previously treated. This cancer cannot be removed by surgery and has spread to nearby tissues or other parts of the body.
Futibatinib is a kinase inhibitor that targets specific proteins involved in cancer cell growth. It blocks the action of abnormal proteins that signal cancer cells to multiply, thereby slowing or stopping the spread of cancer cells.
The usual daily dose of Futibatinib for adults is 20 mg taken orally once daily. It should be taken with or without food at approximately the same time each day. The tablets should be swallowed whole and not crushed, chewed, split, or dissolved.
Common side effects of Futibatinib include constipation, diarrhea, dry mouth, abdominal pain, nausea, vomiting, decreased appetite, and weight loss. It can also cause fatigue, visual disturbances, and gastrointestinal side effects. Serious adverse effects include ocular toxicity and hyperphosphatemia.
Futibatinib can harm a fetus, so effective contraception is necessary during treatment. It should not be used during breastfeeding. Regular eye exams and monitoring of phosphate levels are necessary during treatment. Patients should avoid concomitant use with certain drugs as they may affect the medication's metabolism.
Indications and Purpose
How does Futibatinib work?
Futibatinib is a kinase inhibitor that targets and blocks the action of fibroblast growth factor receptors (FGFRs) 1, 2, 3, and 4. By inhibiting these receptors, Futibatinib disrupts the signaling pathways that promote cancer cell growth and survival, thereby slowing or stopping the spread of cancer cells.
Is Futibatinib effective?
Futibatinib has been shown to be effective in treating adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements. In clinical trials, the overall response rate was 42%, with a median duration of response of 9.7 months.
What is Futibatinib?
Futibatinib is used to treat adults with a specific type of bile duct cancer (cholangiocarcinoma) that has spread and cannot be removed by surgery. It works by blocking the action of abnormal proteins that signal cancer cells to multiply, helping to slow or stop the spread of cancer cells. It is taken orally, usually once a day.
Directions for Use
For how long do I take Futibatinib?
Futibatinib is typically used until disease progression or unacceptable toxicity occurs. The exact duration can vary based on individual response and tolerance to the medication.
How do I take Futibatinib?
Futibatinib should be taken once daily, with or without food, at approximately the same time each day. Swallow the tablets whole without crushing, chewing, or splitting them. Avoid eating or drinking grapefruit products while taking this medication.
How long does it take for Futibatinib to start working?
The median time to response for Futibatinib is approximately 2.5 months, although this can vary depending on individual patient factors and the specific condition being treated.
How should I store Futibatinib?
Futibatinib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It should be kept in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.
What is the usual dose of Futibatinib?
The usual daily dose of Futibatinib for adults is 20 mg, taken orally once daily. There is no established dose for children as the safety and effectiveness of Futibatinib in pediatric patients have not been established.
Warnings and Precautions
Can Futibatinib be taken safely while breastfeeding?
Women are advised not to breastfeed during treatment with Futibatinib and for 1 week after the last dose due to the potential for serious adverse reactions in breastfed children. It is unknown if Futibatinib is present in human milk.
Can Futibatinib be taken safely while pregnant?
Futibatinib can cause fetal harm when administered to a pregnant woman. Women of reproductive potential should use effective contraception during treatment and for 1 week after the last dose. If pregnancy occurs, the patient should inform their healthcare provider immediately. There is strong evidence from animal studies indicating potential fetal harm.
Can I take Futibatinib with other prescription drugs?
Futibatinib is affected by drugs that are dual P-gp and strong CYP3A inhibitors or inducers. Inhibitors can increase futibatinib exposure, while inducers can decrease its efficacy. Patients should inform their healthcare provider of all medications they are taking to avoid interactions.
Is Futibatinib safe for the elderly?
In clinical studies, 22% of patients treated with Futibatinib were 65 years or older. No overall differences in safety or effectiveness were observed between older and younger patients. However, elderly patients should be monitored closely for side effects, and any concerns should be discussed with a healthcare provider.
Is it safe to exercise while taking Futibatinib?
Futibatinib may cause fatigue and muscle pain, which could potentially limit the ability to exercise. If you experience these side effects, it is advisable to discuss them with your healthcare provider to determine the best course of action.
Who should avoid taking Futibatinib?
Important warnings for Futibatinib include the risk of ocular toxicity, hyperphosphatemia, and embryo-fetal toxicity. Patients should have regular eye exams and monitor phosphate levels. Futibatinib can harm an unborn baby, so effective contraception is necessary during treatment. There are no specific contraindications, but patients should inform their doctor of any allergies or medical conditions.
