Glasdegib
Pronunciation: pronunciation varies by local usage.
- Generic name
- glasdegib
- Brand names
- DAURISMO
- Drug class
- Hedgehog-pathway inhibitor
- Form
- Film-coated tablet
- Route
- Oral
- Legal status
- Prescription-only oral anticancer medicine
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What glasdegib is and how it works
Glasdegib is an oral medicine that blocks the Hedgehog signalling pathway. The only indication currently covered by the reviewed United States label is first-line treatment of acute myeloid leukaemia (AML) in adults who are 75 years or older or who have comorbidities that rule out intensive induction chemotherapy; it must be used in combination with low-dose cytarabine. (1)
Glasdegib is not a stand‑alone treatment and requires specialist initiation and monitoring. Eligibility, blood counts, cardiac and electrolyte status, drug interactions, and the need for contraception or pregnancy avoidance must be reviewed before and during treatment.
Mechanism of action: how glasdegib works
Glasdegib is an oral inhibitor of the Hedgehog signalling pathway. (1)
What glasdegib is used for
Newly diagnosed acute myeloid leukaemia (AML) in selected adults
Daurismo (glasdegib), together with low-dose cytarabine, is indicated for treating newly diagnosed AML in adults who are ≥75 years old or who have comorbidities that make standard intensive induction chemotherapy unsuitable. The medicine is started and supervised by an oncology team. (1)
Before taking glasdegib
Do not take / not appropriate for
- Glasdegib carries a boxed warning: it can cause embryo‑fetal death or severe birth defects when administered to a pregnant woman. Tell your oncology team immediately if you are, or think you might be, pregnant, or if a partner becomes pregnant during your treatment — they will advise on next steps; this is not a decision to make on your own. Effective contraception is required during treatment and for at least 30 days after the last dose. Whether pregnancy is a formal contraindication was not established from the sources reviewed for this draft — no contraindications section was found in the extracted label excerpt, so this remains unresolved rather than confirmed either way. (all patients) (1)
Tell your clinician about
- Whether you are pregnant, planning pregnancy, breastfeeding, or your partner could become pregnant (pregnancy testing is required shortly before starting).
- All current medicines, including over‑the‑counter products, supplements, and any strong or moderate CYP3A4 inhibitors or inducers (e.g. ketoconazole, rifampin, efavirenz).
- Any history of heart rhythm disorders, QT prolongation, fainting, electrolyte problems, liver or kidney disease, or other medical conditions.
- Any unexplained muscle pain, weakness, or fatigue that could relate to musculoskeletal side effects or CPK elevation.
How to take glasdegib
- Glasdegib is a tablet taken by mouth once daily. It is used together with low‑dose cytarabine, a separate medicine given by subcutaneous injection on Days 1–10 of each 28‑day cycle — cytarabine is a distinct component from the glasdegib tablet; who administers each injection was not established from the sources reviewed for this draft.
- The typical adult dose is 100 mg on days 1–28 of each cycle, but the oncology team will determine and adjust the dose based on side effects, blood counts, heart tracing (ECG/QTc), and liver/muscle enzyme checks.
- Never change the dose or schedule yourself; dose adjustments (interruptions, reductions to 50 mg, or discontinuation) must be decided by the treating oncologist.
- Specific instructions on timing relative to food or time of day were not established from the sources reviewed for this draft — take glasdegib exactly as prescribed by your oncology team. If you have any concern about continuing cytarabine or glasdegib, contact your treating oncology team — they will advise on whether treatment should continue, be interrupted, or be changed.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
No specific missed‑dose instructions were found in the reviewed sources. Contact the treating oncology service immediately for guidance; do not take an extra dose or alter the next scheduled dose without specialist advice.
Overdose
No overdose‑management protocol was identified in the reviewed label excerpt. If an overdose is suspected, contact a poison information centre or seek emergency medical care promptly. Be ready to provide details of the medicine, dose, and time of last intake. (1)
Side effects
Glasdegib combined with low‑dose cytarabine commonly causes laboratory abnormalities and symptoms. Adverse reactions may be managed by dose modification or supportive care; decisions should be made by the oncology team.
Anaemia
What to notice: Fatigue, weakness, pale skin, shortness of breath on exertion.
What to do: Report worsening fatigue or breathlessness to your treating team promptly; they will assess and advise on any changes to treatment. (1)
Fatigue
What to notice: Ongoing tiredness, lack of energy, difficulty carrying out daily activities.
What to do: Discuss persistent fatigue with your treating team; they can advise on management and monitor for other contributing factors. (1)
Haemorrhage (bleeding)
What to notice: Bruising easily, nosebleeds, bleeding gums, blood in urine or stool, or prolonged bleeding from minor cuts.
What to do: Report any unusual bleeding or bruising promptly; your treating team will assess and advise on any adjustments needed. (1)
Febrile neutropenia
What to notice: Fever (temperature ≥38°C), chills, sore throat, or other signs of infection when white blood cell counts are low.
What to do: Seek immediate medical evaluation if fever or infection symptoms develop; do not wait for your next appointment. (1)
Musculoskeletal pain
What to notice: Bone, joint, or muscle pain; may be associated with elevated creatine phosphokinase (CPK) levels.
What to do: Report severe or worsening musculoskeletal pain; the oncologist will monitor CPK and may adjust the dose accordingly. (1)
Oedema (swelling)
What to notice: Swelling of hands, ankles, feet, or around the eyes.
What to do: Inform your doctor; while often managed supportively, oedema may need assessment for other causes. (1)
Thrombocytopenia
What to notice: Bruising, petechiae (tiny red spots on skin), bleeding, or fatigue.
What to do: Platelet counts are monitored regularly; if counts remain severely low for an extended period, treatment may need to be stopped under specialist supervision. (1)
Nausea, altered taste, mucositis, constipation, decreased appetite
What to notice: Nausea, metallic or other taste changes, mouth sores, difficulty passing stools, loss of hunger.
What to do: Talk with your healthcare team about these symptoms; contact them before making any change to your medicines. (1)
Rash
What to notice: Redness, itching, or raised patches on the skin.
What to do: Report any rash to your treating team; they will advise on management. Report severe, blistering, or widespread rash urgently. (1)
Dyspnoea (shortness of breath)
What to notice: Difficulty catching breath, feeling winded with less activity than usual.
What to do: Report new or worsening shortness of breath; your team will assess for anaemia, infection, or other causes. (1)
QTc prolongation and heart rhythm disturbance
What to notice: Palpitations, lightheadedness, fainting, or feeling that the heart is racing or beating irregularly. This can occur with or without ECG changes.
What to do: Contact the oncology team immediately; an ECG and electrolytes will be checked. Glasdegib may be interrupted or the dose reduced if the QT interval is prolonged. (1)
Severe musculoskeletal symptoms or elevated CPK
What to notice: Severe muscle pain, weakness, dark urine (which can signal muscle breakdown), or laboratory results showing high CPK.
What to do: Contact the treating team promptly. Glasdegib may be held and later reduced or, in very severe cases, permanently discontinued. (1)
Serious warnings
Embryo‑fetal toxicity — severe
Symptoms: Pregnancy while taking glasdegib can lead to embryo‑fetal death or severe birth defects.
Action: Pregnancy testing is required before starting. Women must use effective contraception during treatment and for 30 days after the last dose. Men must use condoms and not donate semen during treatment and for 30 days after. If pregnancy occurs, inform the oncology team immediately; do not stop the medicine on your own—let the clinician you see advise on whether to continue or stop. (1)
QTc interval prolongation and ventricular arrhythmia — emergency
Symptoms: Fainting, lightheadedness, rapid or irregular heartbeat, palpitations, or seizure.
Action: Seek emergency medical attention if these occur. Regular ECG and electrolyte monitoring is mandatory. Tell your oncology team about any other medicine you take — they will determine whether other QT‑prolonging medicines should be avoided or closely supervised. (1)
Severe myelosuppression — important
Symptoms: Profoundly low blood cell counts causing severe infection, bleeding that does not stop, or severe anaemia symptoms.
Action: Blood counts, electrolytes, and renal/hepatic function are checked weekly during the first month, then electrolytes and renal function monthly thereafter. If thrombocytopenia persists below 10 Gi/L for more than 42 days, both glasdegib and cytarabine will be stopped by the treating team. Contact your doctor for any fever or uncontrolled bleeding. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g. ketoconazole) | Can increase glasdegib exposure by approximately 2.4‑fold, raising the risk of adverse reactions. | Monitor closely for side effects if co‑administration cannot be avoided; the oncology team may need to adjust the dose. (1) |
| Strong CYP3A4 inducers (e.g. rifampin) | Can decrease glasdegib exposure by approximately 70%, potentially reducing efficacy. | Tell your oncology team about this medicine before starting or continuing it — they will review it and decide whether an alternative is needed. (1) |
| Moderate CYP3A4 inducers (e.g. efavirenz) | Predicted to decrease glasdegib exposure by approximately 55%. | Tell your oncology team about this medicine — they will decide whether it can be avoided, and if co‑administration is unavoidable, whether to increase the glasdegib dose to 200 mg once daily under close monitoring. (1) |
| Other QT‑prolonging medicines (e.g. certain antiarrhythmics, antipsychotics, antiemetics, antibiotics) | Additive effect on QT interval, increasing the risk of arrhythmia. | Contact your oncology team before starting any other medicine — they will determine whether the combination should be avoided, and if it is unavoidable, will arrange baseline and periodic ECG monitoring. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Women of childbearing potential and pregnancy
Glasdegib carries a boxed warning for embryo‑fetal toxicity — it can cause embryo‑fetal death or severe birth defects. Whether pregnancy is a formal contraindication was not established from the sources reviewed for this draft (no contraindications section was found in the extracted label excerpt); treat this as unresolved rather than confirmed. A pregnancy test must be performed within 7 days before starting treatment. Effective contraception is required during treatment and for at least 30 days after the last dose — the specific number of contraceptive methods required was not established from the sources reviewed. Breastfeeding must be avoided during treatment and for 30 days after the last dose. (1)
Males with partners of childbearing potential
Men must use condoms during sexual contact with pregnant women or women who can become pregnant throughout treatment and for 30 days after the last dose. Semen donation is forbidden during this period. Nonclinical findings suggest possible impairment of male reproductive function. (1)
Renal impairment
No routine dose adjustment is recommended for mild‑to‑severe renal impairment (eGFR 15–89 mL/min/1.73m²). Patients with severe impairment (eGFR 15–29) should be monitored more closely for adverse reactions, including QTc prolongation. (1)
Hepatic impairment
In the reviewed label excerpt, no specific dose adjustment was provided for hepatic impairment. Pharmacokinetic changes were noted (approximately 11% increase in AUC with moderate impairment and 24% decrease with severe impairment). The treating specialist must assess and decide management based on current full prescribing information. (1)
Paediatric use
No paediatric dosing or safety data were found in the reviewed sources. Use in children and adolescents has not been established. (1)
Breastfeeding
There are no data on the presence of glasdegib or its active metabolites in human milk, on the effects on a breastfed child, or on milk production. Because of the potential for serious adverse reactions in a breastfed child, the US label advises women taking glasdegib not to breastfeed or provide breast milk to infants or children during treatment and for at least 30 days after the last dose. Whether and when breastfeeding can resume after treatment ends is a decision for the treating specialist. (1)
Monitoring
Before starting
- Confirm AML diagnosis, fitness for intensive chemotherapy, and eligibility for the combination.
- Pregnancy test in women of childbearing potential within 7 days before treatment.
- Baseline complete blood count, electrolytes (including potassium, magnesium, calcium), renal and hepatic function.
- Baseline ECG and assessment of QT interval.
- Baseline creatine phosphokinase (CPK) level.
- Review all concomitant medicines for potential interactions (CYP3A4, QTc)
- Counsel patient and, when applicable, partner on contraception, breastfeeding prohibition, and the need for compliance with monitoring.
During treatment
- Full blood counts, electrolytes, and renal/hepatic function weekly during the first month; electrolytes and renal function monthly thereafter.
- CPK at baseline and as clinically indicated for musculoskeletal symptoms.
- ECG at baseline, approximately 1 week after starting, then monthly for the first 2 months; repeat ECG if any result is abnormal.
- Monitor for signs of QTc prolongation, severe myelosuppression, bleeding, infection, and musculoskeletal toxicity.
- Dose adjustments are based on QTc, CPK/musculoskeletal severity, and platelet counts, as per the specialist’s protocol.
Storage
Storage instructions were not established from the sources reviewed for this draft. Confirm current storage instructions from the product packaging or your prescribing team.
Professional information
Clinician‑facing context only. This summary is based solely on the US FDA DailyMed label (accessed 2026‑08‑05); local and updated prescribing information must be consulted for treatment decisions.
United States
Indication: Newly diagnosed AML (adults unfit for intensive induction)
Dose summary: 100 mg orally once daily on days 1–28 of each 28‑day cycle, with low‑dose cytarabine 20 mg subcutaneously twice daily on days 1–10. Dose modifications: for QTc >500 ms, interrupt and resume at 50 mg once resolved; for severe musculoskeletal toxicity/CPK 2.5–10× ULN, interrupt and resume at 50 mg or same dose after improvement; for CPK >10× ULN or grade 4 musculoskeletal reaction, discontinue permanently; for thrombocytopenia <10 Gi/L persisting >42 days, discontinue both glasdegib and cytarabine.
Renal context: No dose adjustment for eGFR 15–89 mL/min/1.73m²; close monitoring for severe impairment (eGFR 15–29). (1)
Hepatic guidance
In the reviewed excerpt, no specific hepatic dose adjustment was stated; pharmacokinetic changes were observed in moderate and severe impairment. The treating clinician must use the full label and clinical judgement.
Overdose note
No formal overdose-management protocol was established from the sources reviewed for this draft; this remains unresolved. Prompt poison-centre or emergency medical contact is a general safety measure, not a source-established protocol. (1)
Frequently asked questions
Can glasdegib be used without low‑dose cytarabine?
No. The reviewed US indication requires that glasdegib be given together with low‑dose cytarabine for the specified adult AML population. (1)
Why do I need ECG checks while taking glasdegib?
Glasdegib can prolong the QT interval on the electrocardiogram, which may lead to dangerous heart rhythms. Regular ECG monitoring allows the oncology team to detect this early and adjust treatment if needed. (1)
What should I do if I miss a dose of glasdegib?
No standardized missed‑dose instructions were available in the reviewed information. Contact your oncology clinic immediately for specific advice; do not take an extra dose or alter the next scheduled dose without specialist advice. (1)
What is the mechanism of action of glasdegib?
Glasdegib is an oral inhibitor of the Hedgehog signalling pathway. (1)
What is the generic name of Glasdegib?
The generic name is glasdegib. It is sold under brand names including DAURISMO. (1)
What class of drug is glasdegib?
Glasdegib is classed as: Hedgehog-pathway inhibitor. (1)
References
- DAURISMO- glasdegib tablet, film coated — prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-05 · source 1
- Daurismo — FDA approval record (Drugs@FDA NDA210656)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 2
- glasdegib — RxNorm normalized drug concept (RXCUI 2105844)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 3
Brand names by country
Single-ingredient glasdegib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Daurismo100 mg, 25 mg · pfizer laboratories div pfizer inc