pemigatinib

What is the most important information I should know about pemigatinib?

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.

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 this medicine, but further studies are needed.

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

What should I discuss with my healthcare provider before taking pemigatinib?

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.

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.

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.

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 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.

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?

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 are the possible side effects of pemigatinib?

• 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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about pemigatinib.