Pemigatinib
Cholangiocarcinoma
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Drug Status
Government Approvals
None
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Pemigatinib
Summary
Pemigatinib is used to treat adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and adults with relapsed or refractory myeloid-lymphoid neoplasms with FGFR1 rearrangement.
Pemigatinib works by blocking proteins called FGFR1, FGFR2, and FGFR3, which are involved in cell growth and division. By inhibiting these proteins, it disrupts the pathways that promote cancer cell proliferation and survival, thereby slowing or stopping the growth of cancer cells.
Pemigatinib is typically prescribed for adults at a dose of 13.5 mg taken orally once daily. For cholangiocarcinoma, it is taken for 14 consecutive days followed by 7 days off in a 21-day cycle. For myeloid-lymphoid neoplasms, it is taken continuously.
Common side effects of Pemigatinib include hyperphosphatemia, decreased appetite, diarrhea, nausea, constipation, stomatitis, dry mouth, vomiting, abdominal pain, fatigue, and dry eye. Serious adverse effects can include retinal pigment epithelial detachment and embryofetal toxicity.
Pemigatinib can cause ocular toxicity and hyperphosphatemia, which can lead to soft tissue mineralization. Regular eye exams and monitoring of phosphate levels are recommended. Pemigatinib can also cause fetal harm, so effective contraception is necessary for both males and females of reproductive potential.
Indications and Purpose
How does Pemigatinib work?
Pemigatinib is a kinase inhibitor that targets FGFR1, FGFR2, and FGFR3 proteins, which are involved in cell growth and division. By blocking these proteins, Pemigatinib helps to slow down or stop the growth of cancer cells that have specific genetic mutations, thereby controlling the spread of the disease.
Is Pemigatinib effective?
Pemigatinib has been shown to be effective in treating certain types of cholangiocarcinoma and myeloid/lymphoid neoplasms with specific genetic mutations. In clinical trials, it demonstrated a significant overall response rate and duration of response in patients with these conditions. The effectiveness of Pemigatinib is contingent upon the presence of FGFR1 or FGFR2 genetic rearrangements, as confirmed by FDA-approved tests.
What is Pemigatinib?
Pemigatinib is used to treat certain types of bile duct cancer (cholangiocarcinoma) and myeloid/lymphoid neoplasms with specific genetic mutations. It works by inhibiting abnormal proteins that signal cancer cells to multiply, thereby slowing or stopping the spread of cancer. Pemigatinib is taken orally and requires regular monitoring to ensure its effectiveness and manage side effects.
Directions for Use
For how long do I take Pemigatinib?
Pemigatinib is typically used until disease progression or unacceptable toxicity occurs. The duration can vary based on individual response and tolerance to the medication. Your doctor will monitor your condition and adjust the treatment duration as needed.
How do I take Pemigatinib?
Pemigatinib should be taken once daily, with or without food, at the same time each day. Swallow the tablets whole without crushing, chewing, or splitting them. Avoid consuming grapefruit or grapefruit juice while taking this medication, as it can interfere with how the drug works in your body.
How long does it take for Pemigatinib to start working?
The median time to response for Pemigatinib is approximately 2.7 months, although this can vary depending on the individual and the specific condition being treated. Regular monitoring by your healthcare provider will help assess how well the medication is working for you.
How should I store Pemigatinib?
Pemigatinib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom or areas with excess heat and moisture. Proper storage ensures the medication remains effective and safe to use.
What is the usual dose of Pemigatinib?
Pemigatinib is typically prescribed for adults with a recommended dosage of 13.5 mg taken orally once daily. For cholangiocarcinoma, it is taken for 14 consecutive days followed by 7 days off in a 21-day cycle. For myeloid/lymphoid neoplasms, it is taken continuously. There is no established dosage for children as its safety and effectiveness in pediatric patients have not been determined.
Warnings and Precautions
Can I take Pemigatinib with other prescription drugs?
Pemigatinib interacts with strong and moderate CYP3A inhibitors and inducers. Strong CYP3A inhibitors can increase Pemigatinib levels, leading to more side effects, while inducers can decrease its effectiveness. Patients should inform their doctor of all medications they are taking to avoid these interactions. Adjustments to Pemigatinib dosage may be necessary if these drugs cannot be avoided.
Can Pemigatinib be taken safely while breastfeeding?
Women are advised not to breastfeed while taking Pemigatinib and for at least one week after the final dose. There is no data on whether Pemigatinib passes into breast milk, but due to the potential for serious adverse reactions in breastfed children, breastfeeding is not recommended during treatment.
Can Pemigatinib be taken safely while pregnant?
Pemigatinib can cause fetal harm and is not recommended during pregnancy. Women of reproductive potential should use effective contraception during treatment and for at least one week after the final dose. Men with partners who can become pregnant should also use contraception during treatment and for one week after the last dose. There is strong evidence from animal studies indicating potential fetal harm, but human studies are limited.
Is it safe to exercise while taking Pemigatinib?
Pemigatinib may cause fatigue, which could potentially limit your ability to exercise. If you experience fatigue or any other side effects that affect your physical activity, it's important to discuss this with your doctor. They can provide guidance on how to manage these effects and adjust your treatment plan if necessary.
Is Pemigatinib safe for the elderly?
In clinical studies, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, as with any medication, elderly patients should be monitored closely for side effects and their response to treatment. It's important for elderly patients to follow their doctor's instructions and report any unusual symptoms or side effects.
Who should avoid taking Pemigatinib?
Key warnings for Pemigatinib include the risk of ocular toxicity, hyperphosphatemia, and potential harm to a fetus. Patients should have regular eye exams and monitor phosphate levels. It's contraindicated in pregnancy due to the risk of fetal harm. Patients should inform their doctor of any other medications they are taking, as there are significant drug interactions. Avoid grapefruit products while on this medication.
