(glasdegib)

Prescribing Information
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5 WARNINGS AND PRECAUTIONS

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal embryo-fetal developmental toxicity studies, DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. There are no clinical data on the use of DAURISMO in pregnant women. In animal embryo-fetal developmental toxicity studies, glasdegib caused embryotoxicity, fetotoxicity and teratogenicity at maternal exposures that were less than the human exposure at the recommended human dose of 100 mg [see Use in Specific Populations (8.1, 8.2), Clinical Pharmacology (12.1)]. Advise pregnant women of the potential risk to the fetus.

Females of Reproductive Potential

DAURISMO is not recommended for use during pregnancy. Conduct pregnancy testing in female patients of reproductive potential prior to initiating 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. Advise women not to breastfeed during treatment with DAURISMO and for at least 30 days after the last dose [see Use in Specific Populations (8.2, 8.3)].

Males

Advise male patients with female partners of the potential risk of exposure through semen and to use effective contraception, including a condom, even after vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose [see Use in Specific Populations (8.3)].

Blood Donation

Advise patients not to donate blood or blood products while taking DAURISMO and for at least 30 days after the last dose of DAURISMO because their blood or blood products might be given to a female of reproductive potential.

5.2 QTc Interval Prolongation

Patients treated with DAURISMO can develop QTc prolongation and ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia. Of the 98 evaluable patients treated with DAURISMO 100 mg in combination with low-dose cytarabine in the clinical trial, 5% were found to have a QTc interval greater than 500 ms and 4% of patients had an increase from baseline QTc greater than 60 ms. The clinical trial excluded patients with baseline QTc of greater than 470 ms or with a history of long QT syndrome or uncontrolled cardiovascular disease.

Monitor electrocardiograms (ECGs) and electrolytes [see Dosage and Administration (2.2)]. Concomitant use of DAURISMO with drugs known to prolong the QTc interval and CYP3A4 inhibitors may increase the risk of QTc interval prolongation [see Drug Interactions (7), Clinical Pharmacology (12.2)]. In patients with congenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring is recommended.

Interrupt DAURISMO if QTc increases to greater than 500 ms. Discontinue DAURISMO permanently for patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia [see Dosage and Administration (2.2)].

5.3 Musculoskeletal Adverse Reactions

Musculoskeletal adverse reactions, which may be accompanied by CPK elevations, have occurred with DAURISMO and other drugs which inhibit the hedgehog (Hh) pathway. In BRIGHT AML 1003, musculoskeletal adverse reactions occurred in 45% of patients treated, with 2% (7/79) reported as Grade 3 or higher. The most frequent manifestations of musculoskeletal adverse reactions reported were musculoskeletal pain (30%) and muscle spasms (15%). Increased CPK laboratory values occurred in 16% of patients [see Adverse Reactions (6.1)].

Obtain baseline CPK levels prior to initiating DAURISMO and as clinically indicated (e.g., if muscle symptoms are reported). Obtain CPK and serum creatinine levels at least weekly in patients with musculoskeletal adverse reactions with concurrent CPK elevation greater than 2.5 times ULN until resolution of clinical signs and symptoms. Depending on the severity of symptoms, temporary dose interruption, dose reduction, or discontinuation of DAURISMO may be required for musculoskeletal adverse reactions or serum CPK elevation [see Dosage and Administration (2.2)].

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.
•
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.
•
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.
•
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:

•
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.
•
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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