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.

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.

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.

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

13.5 mg orally once daily 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:
-FGFR 2 fusion positivity status must be known prior to initiation of therapy.
-Assessment for FGFR 2 fusion positivity in tumor specimen should be performed with an appropriate diagnostic test.
-This indication is approved under accelerated approval based on overall response rate and duration of response.

Use: 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

Usual Adult Dose for Lymphoma:

13.5 mg orally once daily

Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-FGFR 1 rearrangement positivity status must be known prior to the initiation of therapy.
-Assessment for FGFR 1 rearrangement positivity in tumor specimen should be performed with an appropriate diagnostic test.

Use: For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement

Usual Adult Dose for Multiple Myeloma:

13.5 mg orally once daily

Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-FGFR 1 rearrangement positivity status must be known prior to the initiation of therapy.
-Assessment for FGFR 1 rearrangement positivity in tumor specimen should be performed with an appropriate diagnostic test.

Use: For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement

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.

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat large amounts of grapefruit or drink grapefruit juice while taking this medication.

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

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.

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.

Keep all appointments with your doctor, eye doctor, and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with pemigatinib. Your doctor will also order certain lab and eye tests before and during your treatment to check your body's response to pemigatinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.