(glasdegib)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DAURISMO safely and effectively. See full prescribing information for DAURISMO.

DAURISMO™ (glasdegib) tablets, for oral use
Initial U.S. Approval: 2018

WARNING: EMBRYO-FETAL TOXICITY

See full prescribing information for complete boxed warning.

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DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals. (5.1, 8.1)
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Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose. (5.1, 8.1, 8.3)
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Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure. (5.1, 8.3)

INDICATIONS AND USAGE

DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. (1)

DOSAGE AND ADMINISTRATION

Recommended dosage: 100 mg orally once daily. (2.1)

DOSAGE FORMS AND STRENGTHS

Tablets: 100 mg, 25 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

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Blood Donation: Advise patients not to donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose. (5.1)
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QTc Interval Prolongation: Monitor electrocardiograms and electrolytes. If QTc prolongation occurs, interrupt treatment with DAURISMO. (2.2, 5.2)
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Musculoskeletal Adverse Reactions: Obtain creatine phosphokinase (CPK) and serum creatinine levels prior to initiating DAURISMO and as indicated clinically thereafter. Temporary dose interruption, dose reduction, or discontinuation of DAURISMO may be required for musculoskeletal adverse reactions or serum CPK elevation. (2.2, 5.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) are anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. (6.1)



To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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Strong CYP3A4 Inhibitors: Consider alternative therapies that are not strong CYP3A4 inhibitors or monitor for increased risk of adverse reactions, including QTc interval prolongation. (7)
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Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. (7)
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Moderate CYP3A4 Inducers: Avoid concomitant use with DAURISMO. If, concomitant use cannot be avoided, increase the dose of DAURISMO. (2.3, 7)
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QTc Prolonging Drugs: Avoid co-administration with DAURISMO. If co-administration is unavoidable, monitor for increased risk of QTc interval prolongation. (7)

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2024

Medication Guide

MEDICATION GUIDE

MEDICATION GUIDE
DAURISMO™ (DOOR-is-moe)
(glasdegib) tablets

What is the most important information I should know about DAURISMO?
DAURISMO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
For females who can become pregnant:

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You should talk to your healthcare provider about the risks of DAURISMO to your unborn child.
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Your healthcare provider will do a pregnancy test within 7 days before you start taking DAURISMO.
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You should not use DAURISMO during pregnancy.
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You should use effective birth control during treatment and for at least 30 days after your last dose of DAURISMO. Talk with your healthcare provider about what birth control method is right for you during this time.
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Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.
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Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

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It is not known if DAURISMO is present in semen. Do not donate semen during treatment with DAURISMO and for at least 30 days after your last dose.
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You should always use effective birth control, including a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with DAURISMO and for at least 30 days after your last dose to protect your female partner from being exposed to DAURISMO.
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Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking DAURISMO.

Exposure to DAURISMO during pregnancy:
If you think that you or your female partner may have been exposed to DAURISMO during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with DAURISMO, you or your healthcare provider should report your pregnancy to Pfizer at 1-800-438-1985.

What is DAURISMO?
DAURISMO is a prescription medicine that is used with the medicine cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults who:

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are 75 years of age or older, or
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have other medical conditions that prevent the use of standard chemotherapy.

It is not known if DAURISMO is safe and effective in children.

Before you take DAURISMO, tell your healthcare provider about all of your medical conditions, including if you:

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have heart problems, including a condition called long QT syndrome.
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abnormal blood salt (electrolytes) levels.
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have muscle pain or spasms.
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have kidney problems.
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are pregnant or plan to become pregnant. See "What is the most important information I should know about DAURISMO?"
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are breastfeeding or plan to breastfeed. It is not known if DAURISMO passes into your breast milk. Do not breastfeed or provide breast milk to infants or children during treatment with DAURISMO and for at least 30 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take DAURISMO?

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Take DAURISMO with the medicine cytarabine exactly as your healthcare provider tells you.
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Take DAURISMO 1 time each day, at about the same time each day.
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Take DAURISMO with or without food.
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Do not chew, split or crush DAURISMO tablets.
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If you miss a dose of DAURISMO, take it as soon as you remember. If it is less than 12 hours before your next dose, just skip the missed dose and take your next dose at your regular time. Do not take 2 doses of DAURISMO within 12 hours.
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If you vomit after taking a dose of DAURISMO, do not take an extra dose, just take your next dose at your regular time.
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Your healthcare provider will perform certain tests to check you for side effects before and during treatment with DAURISMO.
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Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with DAURISMO if you have certain side effects. Do not change your dose or stop taking DAURISMO unless your healthcare provider tells you.
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If you take too much DAURISMO, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking DAURISMO?

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Do not donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose.
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Do not donate semen during treatment with DAURISMO and for at least 30 days after the last dose.

What are the possible side effects of DAURISMO?
DAURISMO can cause serious side effects, including:

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See "What is the most important information I should know about DAURISMO?"
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Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with DAURISMO.
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Muscle Problems. Muscle problems are common with DAURISMO, but can also sometimes be serious. DAURISMO can increase your risk of muscle pain or muscle spasms. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain, tenderness or weakness during and after treatment with DAURISMO. Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking DAURISMO, during treatment, and if you develop muscle problems.

The most common side effects of DAURISMO with cytarabine include:

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low red blood cell count (anemia)
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tiredness
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bleeding
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fever with low white blood cell count
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muscle pain
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swelling of arms or legs
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low platelet count
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nausea
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shortness of breath
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decreased appetite
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changes in taste
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pain or sores in your mouth or throat
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constipation
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rash

DAURISMO may affect fertility in males. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of DAURISMO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store DAURISMO?

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Store DAURISMO at room temperature between 68°F to 77°F (20°C to 25°C).

Keep DAURISMO and all medicines out of the reach of children.

General information about the safe and effective use of DAURISMO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAURISMO for a condition for which it was not prescribed. Do not give DAURISMO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about DAURISMO that is written for health professionals.

What are the ingredients in DAURISMO?
Active ingredient: glasdegib
Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
Film-coating:
25 mg tablets: Opadry II Yellow (33G120011) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, and iron oxide yellow.
100 mg tablets: Opadry II Beige (33G170003) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, iron oxide yellow, and iron oxide red.

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LAB-1285-4.0
For more information, go to www.DAURISMO.com or call 1-800-438-1985.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 12/2024

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If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.