Pemigatinib

Generic name: pemigatinib [ PEM-i-GA-ti-nib ]
Brand name: Pemazyre
Dosage form: oral tablet (13.5 mg; 4.5 mg; 9 mg)
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com on Aug 1, 2023. Written by Cerner Multum.

What is pemigatinib?

Pemigatinib is used in adults to treat bile duct cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery. Pemigatinib is usually given after your cancer has been treated with another medicine.

Pemigatinib is used only if your cancer has a specific genetic marker (an abnormal "FGFR2" gene). Your doctor will test you for this gene.

Pemigatinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to pemigatinib, but further studies are needed.

Pemigatinib may also be used for purposes not listed in this medication guide.

Pemigatinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pemigatinib may cause serious side effects. Call your doctor at once if you have:

• eye problems--eye pain or redness, dry or puffy eyes, watery eyes, your eyes may be more sensitive to light;

• vision changes--blurred vision, seeing black spots or "floaters," or seeing flashes of light; or

• high phosphate levels in your blood--muscle cramps, numbness, tingly feeling around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of pemigatinib may include:

• high or low phosphate levels in your blood;

• dry eyes;

• stomach pain, nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• mouth sores, dry mouth;

• joint pain, back pain;

• feeling tired;

• problems with your fingernails or toenails;

• dry skin, hair loss; or

• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Tell your doctor if you have ever had:

• problems with your eyes;

• vision problems; or

• trouble swallowing pills.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using pemigatinib should use effective birth control to prevent pregnancy. Pemigatinib can harm an unborn baby or cause a miscarriage if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using pemigatinib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I take pemigatinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Pemigatinib is given in a 21-day treatment cycle. You will take the medicine only during the first 2 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, break, or dissolve it.

If you vomit shortly after taking pemigatinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Pemigatinib can cause you to have eye problems. An eye doctor will need to examine your eyes before you start taking this medicine, and every 2 to 3 months while you are taking it. Follow any instructions about using artificial tears or lubricating eye gel to treat or prevent dry eyes.

Pemigatinib can cause you to have high levels of phosphate in your blood. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

You may be given other medication to help lower your phosphate. Keep using this medicine for as long as your doctor has prescribed.

You may also need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your phosphate levels.

Store at room temperature away from moisture and heat.

Pemigatinib dosing information

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

13.5 mg orally once a day for 14 consecutive days followed by 7 days off therapy, in 21-day cycles

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Comments:
-Patients should be selected for the treatment of locally advanced or metastatic cholangiocarcinoma with this drug based on the presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an approved test.
-FGFR2 fusion positivity status must be known prior to initiation of therapy.
-This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by a US FDA-approved test

Usual Adult Dose for Malignant Myeloid/Lymphoid Neoplasm:

13.5 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Comments:
-Patients should be selected for treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) based on the presence of an FGFR1 rearrangement.
---A US FDA-approved test for detection of FGFR1 rearrangement in these patients is not available.

Use: For the treatment of adults with relapsed or refractory MLNs with FGFR1 rearrangement

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pemigatinib?

Grapefruit may interact with pemigatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

What other drugs will affect pemigatinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect pemigatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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