glasdegib 25 mg tablet

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Medication name

Generic name:
Glasdegib - oral

Pronunciation
(glas-DEG-ib)

Brand name(s)
Daurismo

Warning

Glasdegib is not recommended for use during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a pregnancy test within 7 days before starting this medication. They should also use reliable forms of birth control while taking glasdegib and for at least 30 days after the last dose.

It is unknown if glasdegib passes into semen. Because of the possible risk of passing the drug to a partner, men (including men who have had a vasectomy) must use condoms during sex with women who are pregnant or of childbearing age, both during treatment with glasdegib and for at least 30 days after the last dose. Men should also not donate sperm during this time.

If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.

Uses

This medication is used to treat a certain type of cancer (acute myeloid leukemia-AML). It works by slowing or stopping the growth of cancer cells.

How to use

Read the Medication Guide provided by your pharmacist before you start taking glasdegib 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, usually once daily. Swallow the tablets whole. Do not break, crush, or chew the tablets. The dosage is based on your medical condition and response to treatment.

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

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

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

Side effects

Nausea, vomiting, diarrhea, constipation, abdominal pain, dizziness, headache, change in how food tastes/loss of ability to taste, loss of appetite, weight loss, joint pain, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

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

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:

  • easy bruising/bleeding
  • chest pain
  • signs of kidney problems (such as change in the amount of urine)
  • swelling hands/ankles/feet
  • muscle pain/spasms

Get medical help right away if you have any very serious side effects, including:

  • fast/irregular heartbeat
  • severe dizziness
  • fainting

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).

Glasdegib can commonly cause a 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 reaction. Tell your doctor 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

Before taking glasdegib, 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:

  • current/recent infection
  • kidney problems
  • liver problems

Glasdegib 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).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Glasdegib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using glasdegib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

  • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
  • family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using glasdegib safely.

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

Do not donate blood while taking this drug and for at least 30 days after stopping treatment. This will prevent your blood from being given to a pregnant woman.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. Consult your doctor for more details. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 30 days after your last dose of this medication is not recommended. 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 glasdegib from your body, which may affect how glasdegib works. Examples include apalutamide, azole antifungals (such as itraconazole, ketoconazole), enzalutamide, nefazodone, HIV protease inhibitors (such as ritonavir, saquinavir), rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telithromycin, 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. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, complete blood count, EKG) 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 more than 12 hours before the next dose. If it is less than 12 hours before 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. 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.

Medical alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised December 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.