Pemazyre 13.5mg is a prescription medicine that is 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 a certain type of abnormal FGFR2 gene and make sure that Pemazyre is right for you.
It is not known if Pemazyre 13.5mg is safe and effective in children.
What are the important side effects of Pemazyre?
Pemazyre 13.5mg may cause serious side effects, including:
Eye problems. Certain eye problems are common with Pemazyre 13.5mg but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder 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 Pemazyre, every 2 months for the first 6 months, and then every 3 months during treatment with Pemazyre.
You should use artificial tears or 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 during treatment with Pemazyre 13.5mg, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
High phosphate levels in your blood (hyperphosphatemia).Hyperphosphatemia is common with Pemazyre but can also be serious. Your healthcare provider will check your blood phosphate levels during treatment with Pemazyre.
Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt or stop Pemazyre 13.5mg if needed.
Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.
The most common side effects of Pemazyre include:
hair loss
diarrhea
nails separate from the bed or poor formation of the nail
These are not all the possible side effects of Pemazyre. For more information, ask your healthcare provider or pharmacist.
INDICATIONS
PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see DOSAGE AND ADMINISTRATION].
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
DOSAGE AND ADMINISTRATION
Patient Selection
Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with PEMAZYRE based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved testz
FAQ’s
What is Pemazyre used for?
PEMAZYRE is a prescription medicine that is 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.
Is pemazyre a chemotherapy drug?
PEMAZYRE is not chemotherapy; it is a targeted-treatment for cholangiocarcinoma, meaning it may help block the spread of cancer by interfering with a specific molecular target on cancer cells.
How is pemigatinib administered?
You take pemigatinib as tablets. You swallow them whole with a glass of water. You may take them with or without food. You should not open, crush or chew the tablets.
