Turalio 200 Mg Capsule Antineoplastic - Protein-Tyrosine Kinase Inhibitors

GENERIC NAME(S): Pexidartinib

OTHER NAME(S): Turalio Capsule

WARNINGS:

Pexidartinib may rarely cause serious (possibly fatal) liver disease. Careful monitoring by your doctor may decrease your risk. Your doctor will check liver tests before you start taking this medication and regularly during treatment (usually every week for the first 8 weeks, then every 2 weeks for one month, then every 3 months). Based on your results, your doctor may check lab tests more often. Tell your doctor right away if you develop symptoms such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Turalio REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Turalio 200 Mg Capsule Antineoplastic - Protein-Tyrosine Kinase Inhibitors?

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Uses

Uses

This medication is used to treat a certain type of tumor (tenosynovial giant cell tumor) that is not likely to improve with surgery. Pexidartinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of certain tumor cells.

How to use Turalio 200 Mg Capsule Antineoplastic - Protein-Tyrosine Kinase Inhibitors

Read the Medication Guide provided by your pharmacist before you start taking pexidartinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily on an empty stomach, at least 1 hour before or 2 hours after food. Swallow the capsules whole. Do not open, break, or chew the capsules.

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).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

If you vomit after taking a dose, do not take another dose. Take your next dose at the regular time.

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.

Avoid certain drugs that reduce stomach acid/heartburn (proton pump inhibitors-PPIs such as lansoprazole, omeprazole) during treatment with pexidartinib. If you are taking an antacid, take it 2 hours before or after taking this medication. If you are taking certain other drugs that reduce stomach acid/heartburn (H2 blockers such as famotidine, ranitidine), take it at least 10 hours before or 2 hours after pexidartinib.

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.

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 capsules.

Side Effects

Side Effects

See also Warning section.

Nausea, vomiting, constipation, itching, tiredness, changes in hair color, loss of taste, or changes in how food tastes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she 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: swelling around your eyes/eyelids, vision changes (such as blurred vision, decreased vision), numbness/tingling, swelling arms/legs/feet.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication may affect fertility in men and women. Consult your doctor for more details.

Pexidartinib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

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

Precautions

Before taking pexidartinib, 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: kidney problems, liver problems.

Pexidartinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This drug may blur your vision. Do not drive, use machinery, or do anything that needs clear vision until you can do it safely.

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 capsules.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Your doctor may direct you to get a pregnancy test before starting this medication. Women of childbearing age should use reliable forms of birth control during treatment and for 1 month after the last dose. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 1 week after the last dose. If you or your partner becomes pregnant, or if you think you may be pregnant, tell your doctor right away.

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

Interactions

Interactions

See also How to Use section.

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 pexidartinib from your body, which may affect how pexidartinib works. Examples include rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Overdose

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. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function, cholesterol, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Keep the container tightly closed with the desiccant to protect from 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.Information last revised August 2019. Copyright(c) 2019 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.