Uses

This medication is used to treat certain types of cancer (such as bile duct cancer, myeloid/lymphoid neoplasms). Pemigatinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using pemigatinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. For the treatment of myeloid/lymphoid neoplasms, this medication is usually taken once daily. For the treatment of bile duct cancer, this medication is usually taken in cycles of 21 days (once daily for 14 days, then stopping the medication for 7 days). Continue taking the medication this way as directed by your doctor.

Swallow the tablets whole. Do not crush, chew, split, or dissolve the tablets.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you have certain side effects, your doctor may adjust your dose or stop treatment for some time.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If you vomit your dose of pemigatinib, do not take another dose. Take your next dose at your regular scheduled time. Do not take two doses at the same time.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day on the days that you are scheduled to take the medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

Dry eyes, loss of appetite, weight loss, mouth sores, dry mouth, changes in taste, nausea, vomiting, diarrhea, constipation, tiredness/weakness, headache, or dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve or prevent dry eyes, use lubricating eye drops or gel (such as artificial tears).

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• vision changes (such as blurred vision, seeing floaters/flashes of light)
• signs of high phosphate levels (such as muscle cramps, mental/mood changes, numbness/tingling around the mouth)
• nail problems (such as loosening of nail)
• stomach/abdominal pain
• yellowing eyes/skin
• signs of kidney problems (such as change in the amount of urine)
• signs of infection (such as fever, chills)
• chest pain
• shortness of breath
• joint pain
• tingling/burning/swelling of the hands/feet
• signs of dehydration (such as extreme thirst, dizziness, fainting)
• unusual tiredness
• easy bruising/bleeding

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking pemigatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• eye disorders
• high level of phosphate in the blood
• liver disease
• kidney disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pemigatinib. Pemigatinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women and men using this medication should ask about reliable forms of birth control during treatment and for 1 week after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 1 week after stopping treatment. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of pemigatinib from your body, which may affect how pemigatinib works. Examples include rifamycins (such as rifampin, rifabutin), drugs to treat seizures (such as phenytoin, carbamazepine, phenobarbital), St. John's wort, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as eye exam, blood mineral levels, liver/kidney function, complete blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember if it is within 4 hours of your usual dosing time. If it is more than 4 hours after your usual dosing time, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.