Daurismo (Glasdegib)
Hedgehog pathway inhibitor for acute myeloid leukemia (AML)
Daurismo (glasdegib) is a targeted cancer therapy that blocks the Hedgehog signaling pathway, used in combination with low-dose cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adults who are not candidates for intensive chemotherapy. This guide covers dosage, side effects, drug interactions, contraindications, and important safety information based on EMA and FDA approved prescribing information.
Quick Facts
Key Takeaways
- Daurismo (glasdegib) is a Hedgehog pathway inhibitor used with low-dose cytarabine for newly diagnosed AML in adults ineligible for intensive chemotherapy.
- The recommended dose is 100 mg orally once daily, taken at approximately the same time each day with or without food.
- Daurismo must not be used during pregnancy due to the risk of severe birth defects or fetal death — effective contraception is mandatory for both women and men.
- Common side effects include anemia, nausea, fatigue, muscle pain, bleeding, and low blood cell counts — regular blood monitoring is required.
- Significant drug interactions exist with strong CYP3A4 inhibitors, CYP3A4 inducers, and QTc-prolonging medications — inform your doctor about all medications you take.
What Is Daurismo and What Is It Used For?
Quick Answer: Daurismo (glasdegib) is a prescription cancer medicine used in combination with low-dose cytarabine to treat adults newly diagnosed with acute myeloid leukemia (AML) who cannot receive intensive chemotherapy. It works by blocking the Hedgehog signaling pathway in leukemic stem cells.
Daurismo contains the active substance glasdegib, which belongs to a class of targeted cancer therapies known as Hedgehog (Hh) pathway inhibitors. It was developed by Pfizer and has been approved by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults.
Acute myeloid leukemia is an aggressive blood cancer that originates in the bone marrow, where abnormal white blood cells (myeloblasts) multiply uncontrollably and interfere with the production of normal blood cells. AML is the most common type of acute leukemia in adults, with the median age at diagnosis being approximately 68 years. Many older patients or those with significant comorbidities are not able to tolerate standard intensive induction chemotherapy regimens, creating a need for less intensive treatment options.
Daurismo is specifically indicated for use in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed AML in adult patients who are not candidates for standard induction chemotherapy due to age (typically 75 years or older) or significant comorbidities. The BRIGHT AML 1003 clinical trial demonstrated that the combination of glasdegib plus LDAC significantly improved overall survival compared to LDAC alone in this patient population, with a median overall survival of 8.8 months versus 4.9 months.
How Does Daurismo Work?
In AML, a subpopulation of cancer cells known as leukemic stem cells (LSCs) plays a crucial role in disease maintenance, relapse, and treatment resistance. These LSCs can continuously generate new leukemic cells and are often resistant to conventional chemotherapy. The Hedgehog (Hh) signaling pathway is abnormally activated in many AML cases and contributes to the self-renewal and survival of these leukemic stem cells.
Glasdegib works by binding to and inhibiting Smoothened (SMO), a key transmembrane protein in the Hedgehog signaling cascade. When SMO is activated, it triggers a series of intracellular events that promote cell growth, survival, and stem cell maintenance. By blocking SMO, glasdegib disrupts Hedgehog signaling, which weakens the capacity of leukemic stem cells to self-renew and generate new cancer cells.
Furthermore, blocking the Hedgehog pathway can sensitize AML cells to the effects of cytarabine, a standard chemotherapy agent used in leukemia treatment. This synergistic mechanism is why Daurismo is used in combination with cytarabine rather than as a standalone therapy. By combining these two approaches — targeting cancer stem cells with glasdegib while directly killing leukemic cells with cytarabine — the treatment aims to improve patient outcomes by reducing cancer growth and potentially eliminating more cancer cells.
What Should You Know Before Taking Daurismo?
Quick Answer: Before starting Daurismo, your doctor will check for pregnancy, heart conditions (particularly QTc prolongation), kidney problems, and electrolyte imbalances. Daurismo must never be taken during pregnancy due to the risk of severe birth defects. Regular blood tests and ECGs are required throughout treatment.
Contraindications
Daurismo must not be taken if you are allergic to glasdegib or any of the other ingredients in the tablets. The inactive ingredients include sodium starch glycolate, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), magnesium stearate, and the film-coating components lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, yellow iron oxide, and red iron oxide (100 mg tablets only).
Daurismo is strictly contraindicated in pregnancy. Glasdegib can cause severe birth defects (embryo-fetal toxicity) or fetal death. Pregnancy must be excluded before starting treatment, and effective contraception must be used by both female and male patients during treatment and for at least 30 days after the last dose.
Warnings and Precautions
Before starting treatment with Daurismo, discuss the following with your doctor, pharmacist, or nurse:
- QTc prolongation: Glasdegib can prolong the QTc interval, a measurement of the heart's electrical activity. This can lead to serious irregular heart rhythms (arrhythmias). Tell your doctor if you have a history of QTc prolongation, heart disease, or are taking other medications known to prolong the QTc interval.
- Electrolyte abnormalities: Abnormal levels of electrolytes such as calcium, magnesium, or potassium in the blood can increase the risk of QTc prolongation. Your doctor will monitor these levels before and during treatment.
- Kidney problems: If you have kidney disease or impaired kidney function, your doctor may need to adjust your treatment plan as kidney function can affect drug levels in the body.
- Muscle problems: Daurismo can cause muscle pain, cramps, or weakness. If you experience unexplained muscle symptoms during treatment, tell your doctor immediately as the dose may need to be adjusted or treatment temporarily interrupted.
During treatment with Daurismo, you will need regular blood tests to check blood cell counts, creatine kinase levels, electrolyte levels, kidney function, and liver function. Electrocardiograms (ECGs) will also be performed to monitor your heart rhythm. These tests are typically done before starting treatment and at regular intervals throughout therapy.
Children and Adolescents
Daurismo is not approved for use in patients under 18 years of age. The safety and effectiveness of glasdegib in the pediatric population have not been established. Hedgehog pathway inhibitors can affect bone growth and development in growing individuals, which is why use in children and adolescents is not recommended.
Pregnancy, Breastfeeding, and Fertility
Pregnancy: Daurismo must not be taken during pregnancy. The Hedgehog signaling pathway plays a critical role in embryonic development, and glasdegib has been shown to cause severe birth defects and embryo-fetal death in animal studies. A pregnancy test is required before initiating treatment. If you or your partner become pregnant or suspect pregnancy during treatment or within 30 days after the last dose, contact your doctor immediately.
Contraception for women: Women of childbearing potential must use effective contraception during treatment and for at least 30 days after the last dose of Daurismo. Discuss suitable contraceptive methods with your doctor.
Contraception for men: Male patients must use effective contraception, including condoms (with spermicide, if available), even after vasectomy, during treatment and for at least 30 days after the last dose. Men must not donate sperm during treatment or for 30 days after the final dose.
Breastfeeding: Do not breastfeed during treatment with Daurismo or for one week after the final dose. It is unknown whether glasdegib passes into breast milk and could harm the nursing infant.
Fertility: Daurismo may affect fertility in both men and women. Discuss fertility preservation options with your doctor before starting treatment if future fertility is important to you.
Driving and Operating Machinery
Daurismo may cause fatigue, muscle cramps, pain, or nausea, which could impair your ability to drive or operate machinery safely. If you experience these symptoms, exercise caution and avoid driving or using machines until you know how the medication affects you.
Important Information About Excipients
Daurismo tablets contain lactose (found in milk and dairy products). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets also contain less than 1 mmol (23 mg) of sodium per tablet, meaning they are essentially sodium-free.
How Does Daurismo Interact with Other Drugs?
Quick Answer: Daurismo has significant interactions with strong CYP3A4 inhibitors (which increase glasdegib levels), strong CYP3A4 inducers (which decrease its effectiveness), and QTc-prolonging medications (which increase cardiac risk). Grapefruit and grapefruit juice must be avoided during treatment.
Glasdegib is primarily metabolized by the cytochrome P450 enzyme CYP3A4 in the liver. Drugs that inhibit or induce this enzyme can significantly alter glasdegib blood levels, potentially increasing the risk of side effects or reducing therapeutic effectiveness. Additionally, because glasdegib can prolong the QTc interval, combining it with other QTc-prolonging drugs increases the risk of dangerous heart rhythm disturbances.
It is essential to inform your doctor, pharmacist, or nurse about all medications you are currently taking, have recently taken, or might take, including over-the-counter drugs and herbal supplements.
Drugs That May Increase Daurismo Side Effects
Strong CYP3A4 inhibitors can increase glasdegib blood levels, potentially leading to more frequent or severe side effects. Additionally, QTc-prolonging medications should be used with extreme caution or avoided:
| Drug | Category | Interaction Type | Clinical Significance |
|---|---|---|---|
| Itraconazole, Ketoconazole, Voriconazole, Posaconazole | Antifungals | Strong CYP3A4 inhibitors | Increased glasdegib exposure — dose adjustment may be needed |
| Ritonavir, Cobicistat, Telaprevir | Antivirals (HIV/HCV) | Strong CYP3A4 inhibitors | Significantly increased glasdegib levels |
| Boceprevir, Troleandomycin | Anti-infectives | Strong CYP3A4 inhibitors | Increased glasdegib exposure |
| Conivaptan | Vasopressin antagonist | Strong CYP3A4 inhibitor | Increased glasdegib exposure |
| Amiodarone, Sotalol, Quinidine, Disopyramide, Dofetilide, Ibutilide | Antiarrhythmics | QTc prolongation | Additive QTc prolongation — increased risk of arrhythmia |
| Haloperidol, Droperidol, Pimozide | Antipsychotics | QTc prolongation | Additive QTc prolongation risk |
| Moxifloxacin | Antibiotic | QTc prolongation | Additive QTc prolongation risk |
| Methadone | Opioid | QTc prolongation | Additive QTc prolongation risk |
Drugs That May Reduce Daurismo Effectiveness
Strong CYP3A4 inducers accelerate the metabolism of glasdegib, reducing its blood levels and potentially compromising its anticancer activity. These drugs should be avoided during treatment:
| Drug | Category | Interaction Effect |
|---|---|---|
| Rifampicin | Anti-tuberculosis | Strong CYP3A4 inducer — significantly reduces glasdegib levels |
| Carbamazepine, Phenytoin | Antiepileptics | Strong CYP3A4 inducers — reduce glasdegib effectiveness |
| Enzalutamide | Prostate cancer treatment | Strong CYP3A4 inducer — reduces glasdegib levels |
| St. John's Wort (Hypericum perforatum) | Herbal supplement | CYP3A4 inducer — reduces glasdegib effectiveness |
| Efavirenz, Etravirine | Antivirals (HIV) | CYP3A4 inducers — reduce glasdegib levels |
| Mitotan | Adrenal cancer treatment | Strong CYP3A4 inducer — reduces glasdegib levels |
| Bosentan, Modafinil, Nafcillin | Various | Moderate CYP3A4 inducers — may reduce glasdegib levels |
Other Notable Interactions
Digoxin: Glasdegib may affect the levels of digoxin, a medication used for heart conditions. If you are taking digoxin, your doctor may need to monitor your digoxin levels more closely and adjust the dose if necessary.
Grapefruit: Do not drink grapefruit juice or eat grapefruit during treatment with Daurismo. Grapefruit contains compounds that inhibit CYP3A4, which can increase glasdegib levels in your blood and raise the risk of side effects.
What Is the Correct Dosage of Daurismo?
Quick Answer: The recommended dose of Daurismo is 100 mg (one tablet) taken orally once daily, at approximately the same time each day, with or without food. It is used in combination with low-dose cytarabine. Your doctor may adjust the dose based on side effects or interactions.
Always take Daurismo exactly as your doctor or pharmacist has told you. Do not change your dose or stop taking it without consulting your doctor first. It is important to take Daurismo consistently at the same time each day to maintain stable drug levels in your body.
Adults
Standard Dosing
Dose: 100 mg (one tablet) orally once daily
Timing: At approximately the same time each day
Food: Can be taken with or without food
Combination: Used together with low-dose cytarabine (LDAC)
Duration: Continue for as long as your doctor prescribes
Your doctor may reduce your dose or temporarily interrupt treatment if you experience certain side effects, have abnormal blood test results, or are taking medications that interact with Daurismo. The 25 mg tablets are available for dose adjustments.
| Patient Group | Dose | Frequency | Notes |
|---|---|---|---|
| Adults (standard) | 100 mg | Once daily | With low-dose cytarabine; with or without food |
| Adults (dose reduction) | 25 mg | Once daily | For certain side effects or drug interactions |
| Children (<18 years) | Not recommended | N/A | Safety and efficacy not established |
| Elderly (≥75 years) | 100 mg | Once daily | No dose adjustment based on age alone |
Children
Daurismo is not approved for use in patients under 18 years of age. The Hedgehog pathway plays an important role in normal growth and development, and inhibition of this pathway in pediatric patients could potentially affect bone and cartilage growth. No clinical studies have been conducted in the pediatric population.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, since Daurismo is specifically indicated for patients who are not candidates for intensive chemotherapy — which frequently includes older adults — careful monitoring of side effects and organ function is especially important. Older patients may be more susceptible to QTc prolongation and other cardiac effects.
Missed Dose
If you forget to take a dose of Daurismo, take it as soon as you remember, provided that no more than 10 hours have passed since the scheduled dosing time. If more than 10 hours have elapsed, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed one.
Overdose
If you accidentally take more Daurismo tablets than prescribed, contact your doctor, pharmacist, or nurse immediately. You may require urgent medical attention. There is no specific antidote for glasdegib overdose, and treatment would be supportive, focusing on managing symptoms and monitoring cardiac function.
Vomiting After a Dose
If you vomit after taking a dose of Daurismo, do not take an additional dose. Simply take your next scheduled dose at the usual time.
Do not stop taking Daurismo unless your doctor tells you to do so. It is important to take Daurismo every day for as long as your doctor prescribes. If you feel you no longer need the medication or cannot take it as directed, speak with your doctor before making any changes.
What Are the Side Effects of Daurismo?
Quick Answer: The most common side effects of Daurismo (when used with cytarabine) include anemia, bleeding, fever, nausea, decreased appetite, muscle pain, fatigue, low platelet counts, diarrhea, and pneumonia. Serious side effects include QTc prolongation and severe birth defects if used during pregnancy.
Like all medicines, Daurismo can cause side effects, although not everybody gets them. The side effects listed below have been observed when Daurismo is used in combination with cytarabine. Some side effects may be related to the underlying leukemia or to cytarabine rather than glasdegib itself.
Daurismo can cause severe birth defects or fetal death. You must not become pregnant while taking this medication. Both female and male patients must use effective contraception during treatment and for at least 30 days after the last dose. See the pregnancy section above for full details.
Very Common
May affect more than 1 in 10 patients
- Anemia (low hemoglobin — reduced oxygen-carrying capacity of blood)
- Bleeding (hemorrhage)
- Fever (pyrexia)
- Nausea (feeling sick)
- Decreased appetite (anorexia)
- Muscle pain (myalgia)
- Fatigue (tiredness)
- Low platelet counts (thrombocytopenia)
- Diarrhea
- Pneumonia (lung infection)
- Taste changes (dysgeusia)
- Peripheral edema (swelling of arms and legs)
- Constipation
- Abdominal pain (stomach pain)
- Skin rash
- Shortness of breath (dyspnea)
- Vomiting
- Weight loss
- Low white blood cell counts (leukopenia)
- Low neutrophil counts (neutropenia)
- Joint pain (arthralgia)
- Hair loss (alopecia)
Common
May affect up to 1 in 10 patients
- Changes in heart electrical activity (ECG changes, QTc prolongation)
- Heart palpitations (rapid, strong, or irregular heartbeat)
- Bloodstream infection (sepsis, bacteremia)
- Urinary tract infection (burning sensation during urination, frequent and urgent need to urinate)
- Mouth irritation (stomatitis, mucositis)
When to Seek Immediate Medical Attention
Contact your doctor or seek emergency medical care immediately if you experience any of the following during treatment with Daurismo:
- Severe muscle pain, cramps, or unexplained muscle weakness
- Signs of infection such as high fever, chills, or cough
- Unusual bleeding or bruising
- Rapid or irregular heartbeat, dizziness, or fainting
- Severe shortness of breath
- Signs of pregnancy in yourself or your partner
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed above. You can also report side effects directly to your national pharmacovigilance agency (such as the FDA MedWatch program in the US, or the Yellow Card Scheme in the UK). By reporting side effects, you can help provide more information about the safety of this medicine.
How Should You Store Daurismo?
Quick Answer: Store Daurismo at room temperature with no special storage conditions required. Keep out of sight and reach of children. Do not use after the expiration date or if the packaging appears damaged or tampered with.
Keep Daurismo out of the sight and reach of children at all times. This medication is a cytotoxic agent that can be harmful if ingested by anyone other than the intended patient.
Do not use Daurismo after the expiry date printed on the carton, blister pack, or bottle after “EXP.” The expiry date refers to the last day of the stated month. There are no special storage conditions required for this medicine — it can be stored at room temperature.
Do not use this medicine if the packaging is damaged or appears to have been tampered with. Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines that are no longer needed. These measures help protect the environment.
What Does Daurismo Contain?
Quick Answer: Daurismo tablets contain glasdegib maleate as the active substance (equivalent to 25 mg or 100 mg glasdegib). Inactive ingredients include microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate, and film-coating agents including lactose monohydrate.
Active Substance
The active substance in Daurismo is glasdegib, present as glasdegib maleate:
- Daurismo 25 mg tablets: Each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib.
- Daurismo 100 mg tablets: Each film-coated tablet contains glasdegib maleate equivalent to 100 mg of glasdegib.
Inactive Ingredients (Excipients)
Tablet core: Sodium starch glycolate, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), and magnesium stearate.
Film coating: Lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, yellow iron oxide, and red iron oxide (100 mg tablets only).
Tablet Appearance and Pack Sizes
25 mg tablets: Round, yellow film-coated tablets imprinted with “Pfizer” on one side and “GLS 25” on the other. Available in blister packs of 10 tablets, with each pack containing 60 tablets (6 blisters or one plastic bottle).
100 mg tablets: Round, light orange film-coated tablets imprinted with “Pfizer” on one side and “GLS 100” on the other. Available in blister packs of 10 tablets, with each pack containing 30 tablets (3 blisters or one plastic bottle).
Not all pack sizes may be marketed in your country.
Frequently Asked Questions About Daurismo
Daurismo (glasdegib) is used in combination with low-dose cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adult patients who are not eligible for intensive induction chemotherapy. This typically includes older adults (75 years and over) or patients with significant comorbidities that make intensive chemotherapy too risky. Daurismo works by blocking the Hedgehog signaling pathway in leukemic stem cells, helping to slow or stop cancer growth.
Unlike standard intensive induction chemotherapy (which typically uses high-dose cytarabine combined with an anthracycline), Daurismo is a targeted oral therapy that specifically blocks the Hedgehog signaling pathway. It is combined with low-dose cytarabine, making it a less intensive treatment option. This approach is designed for patients who cannot tolerate aggressive chemotherapy, offering a treatment that targets cancer stem cells while being better tolerated overall.
Daurismo can affect fertility in both men and women and poses a serious risk of birth defects. If you are planning to have children in the future, discuss fertility preservation options with your doctor before starting treatment. During treatment, strict contraception is required for both male and female patients, and men must not donate sperm. Contraception must continue for at least 30 days after the last dose.
If you miss a dose, take it as soon as you remember, as long as it has been fewer than 10 hours since your scheduled dosing time. If more than 10 hours have passed, skip the missed dose entirely and take your next dose at the usual time the following day. Never take a double dose to compensate for a missed one. If you vomit after taking a dose, do not take an extra dose.
Regular blood tests are essential to monitor your blood cell counts (since Daurismo and cytarabine affect blood cell production), electrolyte levels (imbalances can increase cardiac risk), creatine kinase levels (to detect muscle damage), and kidney and liver function. ECGs monitor your heart's electrical activity because glasdegib can prolong the QTc interval, which in rare cases could lead to dangerous heart rhythm disturbances. These tests help your doctor adjust your treatment safely.
No. Grapefruit and grapefruit juice should be completely avoided during treatment with Daurismo. Grapefruit contains natural compounds (furanocoumarins) that inhibit the CYP3A4 enzyme in the gut and liver, which is responsible for breaking down glasdegib. Consuming grapefruit can increase glasdegib blood levels, potentially raising the risk of side effects including QTc prolongation and other adverse reactions.
References
All medical information in this article is based on the following peer-reviewed sources and regulatory documents:
- European Medicines Agency (EMA). Daurismo (glasdegib) — Summary of Product Characteristics. Available at: EMA EPAR: Daurismo. Last updated 2025.
- U.S. Food and Drug Administration (FDA). Daurismo (glasdegib) Prescribing Information. Approved November 2018. Available at: FDA Label.
- Cortes JE, Heidel FH, Hellmann A, et al. Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Leukemia. 2019;33(2):379-389. doi:10.1038/s41375-018-0312-9.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. Version 3.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO.
- Savona MR, Pollyea DA, Stock W, et al. Phase Ib Study of Glasdegib, a Hedgehog Pathway Inhibitor, in Combination with Standard Chemotherapy in Patients with AML or High-Risk MDS. Clinical Cancer Research. 2018;24(10):2294-2303. doi:10.1158/1078-0432.CCR-17-2824.
- Wellbrock J, Latuske E, Köhler J, et al. Expression of Hedgehog Pathway Mediators in Acute Myeloid Leukemia Is Associated With Adverse Prognosis. Blood. 2015;126(13):1589. doi:10.1182/blood.V126.23.1589.1589.
Editorial Team
This article has been written and medically reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians with specialist training in oncology and hematology.
Written by the iMedic Medical Editorial Team based on EMA-approved product information, FDA prescribing information, published clinical trial data, and international treatment guidelines.
Reviewed by board-certified physicians specializing in oncology and hematology. All medical claims verified against current evidence-based guidelines and peer-reviewed literature.
iMedic follows strict editorial standards. All content is evidence-based, peer-reviewed, and free from commercial influence. We adhere to the GRADE evidence framework and cite only authoritative sources including WHO, EMA, FDA, and peer-reviewed journals. For more information, visit our Editorial Standards page.