What is Daurismo (glasdegib) used for?
Daurismo (glasdegib) is a hedgehog pathway inhibitor used alongside low-dose cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adults aged 75 and above, or those with health conditions that make them unsuitable for intensive chemotherapy.
It is available in tablet form with 25 mg or 100 mg of glasdegib.
How does Daurismo (glasdegib) work?
Glasdegib targets and blocks a protein called SMO, which plays a role in uncontrolled cancer cell growth. When SMO is overactive, cancer cells grow and resist treatment. By inhibiting SMO, Daurismo helps prevent cancer progression and makes chemotherapy more effective.
When used with chemotherapy, such as cytarabine, Daurismo helps eliminate cancer cells that may otherwise survive and grow after treatment.
Regulatory Approvals
Daurismo (glasdegib) has been approved for AML treatment by:
- FDA (USA) – November 21, 2018
- EMA (Europe) – June 26, 2020
- Health Canada – June 12, 2020
(Availability may vary by country; please contact us for regional details.)
How is Daurismo taken?
The typical regimen includes:
- 100 mg of Daurismo taken orally once daily.
- Cytarabine 20 mg injected subcutaneously twice daily on days 1–10 of each 28-day cycle.
Tablets should be swallowed whole, with or without food, at the same time each day. Do not crush or split tablets.
Missed dose instructions:
If a dose is missed, take it as soon as possible (at least 12 hours before the next dose). Do not take two doses within 12 hours.
Important safety tip:
Avoid donating blood or blood products during treatment and for 30 days after the last dose.
Possible Side Effects
Common side effects (≥20% patients):
- Anemia
- Fatigue
- Nausea
- Bleeding
- Fever with low white blood cell count
- Muscle pain
- Appetite loss
- Swelling in limbs
- Taste changes
- Rash
- Mouth sores
- Constipation
Serious side effects:
- Heart rhythm changes (QTc prolongation)
Use in Special Populations
Pregnancy Warning:
Daurismo may cause serious harm to unborn babies. Effective contraception is required during treatment and for:
- Women: At least 30 days after the final dose
- Men: At least 4 months after the final dose
Breastfeeding is not recommended during and for 30 days after treatment.
Before starting Daurismo, inform your doctor if you:
- Are pregnant or planning pregnancy
- Have heart issues, especially long QT syndrome
- Have abnormal electrolyte levels
- Are taking other medications
Always consult your doctor for personalized medical advice and dosage adjustments.
References
1. Full prescribing information [FDA]: Daurismo (glasdegib) [PDF]
Pfizer, Nov 2018
2. Daurismo Patient Brochure
Pfizer, cited Sep 2021
3. FDA approves new treatment for patients with acute myeloid leukemia
FDA, Nov 2018
4. Daurismo
EMA Jun 2020
5. Health Canada Approval of Daurismo (glasdegib)
Pfizer, Jun 2020