Glasdegib
Glasdegib is a targeted cancer medicine used to treat newly diagnosed acute myeloid leukemia (AML) in adults who cannot tolerate intensive chemotherapy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Glasdegib (Daurismo) is a specialist leukemia drug that blocks the Hedgehog growth signal, taken with low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in older adults or those unable to have intensive chemotherapy, on the market since about 2018 and brand-only. It is gentler than intensive chemotherapy, but tiredness, nausea, muscle aches and swelling are common. Its boxed warning is for severe birth defects or pregnancy loss, so women need a pregnancy test first and both sexes need contraception (condoms for men, even after vasectomy) until at least 30 days after the last dose. Expect ECGs to check for QTc prolongation (a risky heart rhythm change), and report muscle pain early.
Clinical pearls
- Swallow the tablets whole without splitting or crushing, with or without food, at about the same time each day.
- If you vomit after a dose, do not repeat it; just take the next one at the usual time.
- Rifampin, some antifungals and HIV medicines, and other heart-rhythm-affecting drugs interact badly, so every prescriber needs your full medicine list.
- Do not donate blood or semen, or breastfeed, during treatment and for at least 30 days after the last dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Daurismo can cause the death of an unborn baby or severe, life-altering birth defects if taken during pregnancy. This risk has been confirmed in animal studies. Before starting this medicine, women who can become pregnant must have a negative pregnancy test. Women must use effective birth control during treatment and for at least 30 days after the final dose. Men must use a condom — even after a vasectomy — with a pregnant partner or any partner who could become pregnant, during treatment and for at least 30 days after stopping, because the drug may be present in semen. Do not donate blood or semen while taking Daurismo or for at least 30 days afterward.
Patient information guide A plain-language walkthrough of Glasdegib, written from its FDA label.
What Glasdegib is used for
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Glasdegib is a prescription cancer medicine approved for use in adults with acute myeloid leukemia (AML).
- Daurismo (glasdegib) tablets are approved, in combination with low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older, or who have other medical conditions (comorbidities) that make intensive induction chemotherapy too risky or unsuitable.
How Glasdegib works
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Glasdegib works by blocking a cellular communication system called the Hedgehog pathway. It attaches to a protein called Smoothened — a kind of molecular switch — and shuts it off. This pathway can be abnormally active in AML, helping leukemia cells survive and multiply. By blocking Smoothened, glasdegib disrupts these signals. In laboratory models of human AML, glasdegib combined with low-dose cytarabine slowed tumor growth and reduced leukemia blast cells in the bone marrow more effectively than either medicine alone.
Glasdegib dosage
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Daurismo tablets are taken by mouth once daily, at roughly the same time each day, with or without food. Treatment is given in 28-day cycles alongside low-dose cytarabine injections on specific days of each cycle, as directed by your care team. Treatment typically continues for a minimum of 6 cycles to give the medicine time to work, as long as it is tolerated.
- Swallow tablets whole — do not split or crush them
- If you vomit a dose, skip it and take the next one on schedule; never double up
- If you miss a dose, take it as soon as possible — but only if your next dose is at least 12 hours away
- Your doctor may adjust or pause your dose if side effects occur
Dosing details from the FDA-approved label
From the Glasdegib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage and schedule (in combination with cytarabine)
- 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle, in the absence of unacceptable toxicity or loss of disease control
- For patients without unacceptable toxicity, treat for a minimum of 6 cycles
- Administer with or without food; do not split or crush tablets; take about the same time each day
- QTc interval greater than 500 ms (on at least 2 separate ECGs)
- Interrupt DAURISMO
- Resume at a reduced dosage of 50 mg once daily when QTc interval returns to within 30 ms of baseline or less than or equal to 480 ms
- Consider re-escalating to 100 mg daily if an alternative etiology for the QTc prolongation can be identified
- Monitor ECGs at least weekly for 2 weeks following resolution
- Grade 3 musculoskeletal adverse reactions or serum CPK elevation between 2.5 and 10 times ULN
- Interrupt DAURISMO until symptoms reduce to mild or return to baseline
- Resume at the same dose level, or at a reduced dose of 50 mg
- If toxicity recurs, discontinue
- Obtain CPK and serum creatinine levels at least weekly until resolution
- Grade 3 nonhematologic toxicity
- Interrupt DAURISMO and/or low-dose cytarabine until symptoms reduce to mild or return to baseline
- Resume DAURISMO at the same dose level, or at a reduced dose of 50 mg
- Resume low-dose cytarabine at the same dose level, or at a reduced dose of 15 mg or 10 mg
- If toxicity recurs, discontinue DAURISMO and low-dose cytarabine
- If toxicity is attributable to DAURISMO only, low-dose cytarabine may be continued
- Concomitant use with moderate CYP3A4 inducers (current dosage 100 mg orally once daily)
- 200 mg orally once daily
- After the inducer has been discontinued for 7 days, resume the prior dose
- Concomitant use with moderate CYP3A4 inducers (current dosage 50 mg orally once daily)
- 100 mg orally once daily
- After the inducer has been discontinued for 7 days, resume the prior dose
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended dosage: 100 mg orally once daily. ( 2.1 ) 2.1 Recommended Dosage and Schedule The recommended dosage of DAURISMO is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response. Administer DAURISMO with or without food. Do not split or crush DAURISMO tablets. Administer DAURISMO about the same time each day. If a dose of DAURISMO is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of DAURISMO is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses of DAURISMO within 12 hours. 2.2 Monitoring and Dosage Modifications Assess complete blood counts, electrolytes, renal, and hepatic function prior to the initiation of DAURISMO and at least once weekly for the first month. Monitor electrolytes and renal function once monthly for the duration of therapy. Obtain creatine phosphokinase (CPK) levels prior to initiating DAURISMO and as indicated clinically thereafter (e.g., if muscle symptoms are reported). Monitor electrocardiograms (ECGs) prior to the initiation of DAURISMO, approximately one week after initiation, and then once monthly for the next two months to assess for QTc prolongation. Repeat ECG if abnormal. Certain patients may require more frequent and ongoing ECG monitoring [see Warnings and Precautions (5.2) ]. Manage any abnormalities promptly [see Adverse Reactions (6.1) ]. See Table 1 for dosage modification guidelines for patients who develop an adverse reaction. Table 1. Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Recommended Action Abbreviations: CPK = creatine phosphokinase, ULN = upper limit of normal. QTc interval prolongation on at least 2 separate electrocardiograms (ECGs) [see Warnings and Precautions (5.2) ] QTc interval greater than 480 ms to 500 ms Assess electrolyte levels and supplement as clinically indicated.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Glasdegib side effects
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The most common side effects reported with Daurismo plus low-dose cytarabine include:
Common side effects
- Anemia (low red blood cell count)
- Fatigue or weakness
- Nausea
- Muscle or bone pain
- Swelling (edema)
- Decreased appetite
- Mouth sores (mucositis)
- Rash or skin changes
- Low platelet count (thrombocytopenia)
- Altered taste (dysgeusia)
- Constipation
When to get medical help
- Call your doctor right away if you feel heart palpitations, dizziness, fainting, or an irregular heartbeat — these can be signs of a dangerous heart rhythm problem (QTc prolongation)
- Tell your doctor immediately about severe muscle pain, weakness, or dark-colored urine — these may signal a serious muscle problem
- Seek help for signs of serious infection such as fever, chills, or feeling very unwell (febrile neutropenia is common and serious)
- Report any unusual bleeding or bruising right away
- Tell your care team if you have trouble breathing or shortness of breath that is getting worse
- If you are pregnant or become pregnant during treatment, contact your doctor immediately — this medicine can cause severe harm or death to an unborn baby
Serious reactions to act on immediately include signs of a dangerous heart rhythm (palpitations, fainting, dizziness), severe muscle pain with weakness or dark urine, signs of severe infection (high fever, chills), and any unusual or heavy bleeding. Contact your care team right away if these occur.
Glasdegib warnings and precautions
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- Embryo-fetal toxicity (harm to an unborn baby): This is the most critical warning. Daurismo can cause severe birth defects or fetal death. Pregnancy must be ruled out before starting treatment. Women must use effective contraception during treatment and for at least 30 days after the last dose. Men must use condoms — even after vasectomy — during treatment and for at least 30 days after stopping. Do not donate blood or semen during this period.
- QTc interval prolongation (heart rhythm changes): Daurismo can affect the electrical activity of the heart in a way that may lead to dangerous irregular heartbeats, including ventricular fibrillation and ventricular tachycardia. ECGs and electrolyte levels are monitored before and regularly during treatment. Tell your doctor if you have a history of heart rhythm problems, long QT syndrome, or heart failure. Some medicines taken alongside Daurismo can increase this risk further.
- Musculoskeletal adverse reactions: Muscle pain and muscle spasms are common. In some cases, an enzyme called CPK rises in the blood, which can signal muscle stress or damage. Your doctor will check CPK levels and may pause or reduce your dose if these problems are severe.
Glasdegib interactions
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Daurismo can interact with several types of medicines that affect how it is processed in the body or that affect heart rhythm.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, certain antifungals, some HIV medicines): These raise glasdegib blood levels, increasing the risk of side effects including dangerous heart rhythm changes. Your doctor may switch you to a different medication.
- Strong CYP3A4 inducers (e.g., rifampin): These lower glasdegib levels significantly, which may make it less effective. Avoid this combination.
- Moderate CYP3A4 inducers (e.g., efavirenz): Also reduce glasdegib levels. Avoid if possible; if unavoidable, the Daurismo dose may need to be increased under medical supervision.
- QTc-prolonging drugs (any medicine that affects heart electrical activity): Using these alongside Daurismo increases the risk of a serious heart rhythm problem. Avoid combining them when possible; if unavoidable, your heart will be monitored more closely.
Interactions listed in the FDA-approved label
From the Glasdegib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inhibitors: Increased glasdegib plasma concentrations, which may increase the risk of adverse reactions including QTc interval prolongation. Consider alternative therapies that are not strong CYP3A4 inhibitors; monitor patients for increased risk of adverse reactions including QTc interval prolongation.
- Strong CYP3A inducers: Decreased glasdegib plasma concentrations, which may reduce efficacy. Avoid co-administration with DAURISMO.
- Moderate CYP3A inducers: Decreased glasdegib plasma concentrations, which may reduce efficacy. Avoid co-administration; if it cannot be avoided, increase the dose of DAURISMO.
- QTc prolonging drugs: May increase the risk of QTc interval prolongation. Avoid co-administration or replace with alternative therapies; if unavoidable, monitor patients for increased risk of QTc interval prolongation.
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 5. Drug Interactions with DAURISMO Strong CYP3A Inhibitors Clinical Impact • Co-administration of DAURISMO with strong CYP3A inhibitors increased glasdegib plasma concentrations [see Clinical Pharmacology (12.3) ]. • Increased glasdegib concentrations may increase the risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2) ] . Prevention or Management • Consider alternative therapies that are not strong CYP3A4 inhibitors during treatment with DAURISMO. • Monitor patients for increased risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2) ]. Strong and Moderate CYP3A Inducers Clinical Impact Co-administration of DAURISMO with strong and moderate CYP3A inducers decreased glasdegib plasma concentrations [see Clinical Pharmacology (12.3) ] . • Decreased glasdegib concentrations may reduce efficacy. Prevention or Management • Avoid co-administration of DAURISMO with strong and moderate CYP3A4 inducers. • If co-administration of DAURISMO with moderate CYP3A4 inducers cannot be avoided, increase the dose of DAURISMO [see Dosage and Administration (2.3) ] . QTc Prolonging Drugs Clinical Impact Co-administration of DAURISMO with QTc prolonging drugs may increase the risk of QTc interval prolongation [see Warnings and Precautions (5.2) ]. Prevention or Management • Avoid co-administration of QTc prolonging drugs with DAURISMO or replace with alternative therapies. • If co-administration of a QTc prolonging drug is unavoidable, monitor patients for increased risk of QTc interval prolongation [see Warnings and Precautions (5.2) ]. • 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 ) • Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. ( 7 ) • Moderate CYP3A4 Inducers: Avoid concomitant use with DAURISMO.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Glasdegib
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- Pregnancy: Do not take Daurismo if you are pregnant. A pregnancy test is required within 7 days before starting treatment.
- Breastfeeding: Do not breastfeed during treatment or for at least 30 days after the last dose — potential risk to the infant cannot be ruled out.
- Women of childbearing age: Must use effective contraception throughout treatment and for 30 days after stopping.
- Men: Must use a condom with any pregnant partner or partner who could become pregnant, during treatment and for 30 days after stopping; should not donate semen during this time. Daurismo may also affect male fertility — discuss fertility preservation with your doctor before starting.
- Heart conditions: Tell your doctor if you have long QT syndrome, congestive heart failure, or electrolyte imbalances — you will need closer heart monitoring.
- Kidney problems: Patients with moderate to severe kidney impairment may have higher glasdegib levels in their blood and need closer monitoring for side effects.
- Liver problems: Mild liver impairment does not require a dose change, but liver function will be monitored.
- Children: Daurismo has not been studied in children and is not approved for pediatric use.
- Older adults: Most patients in clinical trials were over 65 — Daurismo is specifically approved for use in this population.
Glasdegib overdose
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There is no specific antidote for a Daurismo overdose. If too much is taken, treatment focuses on managing symptoms and monitoring the heart with an ECG. In clinical studies, the highest doses were associated with nausea, vomiting, dehydration, low blood pressure, fatigue, and dizziness.
What Glasdegib does in the body
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Glasdegib affects the heart's electrical system in a dose-related way — higher blood levels cause greater lengthening of the QT interval (the time it takes the heart to reset between beats). This effect is measurable even at the recommended therapeutic dose and becomes more pronounced at higher concentrations. This is why heart monitoring with ECGs is an important part of treatment with Daurismo.
How your body processes Glasdegib
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After taking Daurismo by mouth, about 77% of the dose is absorbed into the bloodstream, with peak levels reached within about 1 to 2 hours. The medicine reaches steady, stable levels in the blood within about 8 days of daily dosing. Glasdegib is primarily broken down by liver enzymes (mainly CYP3A4) and is cleared from the body through both urine and stool, with a half-life of roughly 17 hours — meaning it takes about 17 hours for the body to eliminate half of the drug. Eating a high-fat meal reduces how much of the drug is absorbed, though Daurismo can be taken with or without food.
How to store Glasdegib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Glasdegib
146 supplements and herbal products have documented interactions with Glasdegib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 98
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Glasdegib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Glasdegib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Daurismo and why has my doctor prescribed it for me?
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How should I take my Daurismo tablets each day?
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What side effects should I expect, and which ones mean I need to call my doctor right away?
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I heard this medicine can affect my heart — what does that mean and how will I be watched?
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Is it safe to get pregnant or father a child while taking Daurismo?
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Are there any medicines or supplements I should avoid while taking Daurismo?
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Is Glasdegib available over the counter?
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When was Glasdegib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Glasdegib on HelloPharmacist
Glasdegib forms and strengths (how it comes)
Glasdegib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Glasdegib inactive ingredients by manufacturer.
Tablet
How this form is used
- Daurismo tablets are used in combination with low-dose cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older, or in adults who cannot tolerate intensive induction chemotherapy
- Daurismo tablets are taken by mouth once daily, with or without food, at about the same time each day
- Do not split or crush Daurismo tablets — swallow them whole
- If you vomit after taking a Daurismo dose, do not take a replacement dose; wait until your next scheduled dose
- If you miss a Daurismo dose, take it as soon as you remember, as long as it is at least 12 hours before the next scheduled dose
Glasdegib on the U.S. market: products, makers and brands
How Glasdegib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Glasdegib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Daurismo; the rest are generics.
Compare Glasdegib products
A representative set of FDA-listed product records for Glasdegib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 25 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 100 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Glasdegib NDCs →
Glasdegib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Glasdegib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Glasdegib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Glasdegib FDA approval history
How Glasdegib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Glasdegib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Glasdegib recalls since July 2021.
✅No Glasdegib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2105845 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2105849In current FDA listings
Look up RxCUI 2105845 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Glasdegib supply and shortage status
Whether Glasdegib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Glasdegib brand names
Glasdegib is sold under one brand name in the FDA directory — Daurismo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Glasdegib: manufacturers and labelers
One company lists Glasdegib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Glasdegib drug class (RxNorm)
Glasdegib belongs to the Hedgehog Pathway Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Glasdegib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →