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How it is administered
Glasdegib is taken by mouth as a film-coated tablet. It is available in 100 mg and 25 mg strengths. The recommended dose for adults with acute myeloid leukemia (AML) is 100 mg orally once daily, taken at about the same time each day, with or without food. Tablets should not be split or crushed.
Glasdegib is used in combination with low-dose cytarabine, which is given as a subcutaneous injection.
How it works
Glasdegib works by blocking a specific signaling pathway in the body known as the Hedgehog pathway. This pathway is involved in the growth and survival of certain cancer cells, including those found in acute myeloid leukemia (AML). Glasdegib binds to and inhibits a protein called Smoothened, which is a key part of the Hedgehog pathway. By blocking this protein, glasdegib helps to slow down or stop the growth of leukemia cells.
In clinical studies, glasdegib in combination with low-dose cytarabine was shown to reduce the number of leukemia cells in the bone marrow and improve survival in certain patients with AML. This combination is particularly useful for patients who are older or have other health problems that make them unable to tolerate more intensive chemotherapy.
Common side effects
- Anemia (low red blood cell count)
- Fatigue
- Hemorrhage (bleeding)
- Febrile neutropenia (fever with low white blood cell count)
- Musculoskeletal pain (muscle or bone pain)
- Nausea
- Edema (swelling)
- Thrombocytopenia (low platelet count)
- Dyspnea (shortness of breath)
- Decreased appetite
- Dysgeusia (altered taste)
- Mucositis (mouth sores)
- Constipation
- Rash
Other possible side effects include muscle spasms, dizziness, headache, vomiting, diarrhea, and infections such as pneumonia.
Who Should take it
Glasdegib is indicated for adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have other health conditions (comorbidities) that prevent them from receiving intensive induction chemotherapy. It is always used in combination with low-dose cytarabine.
This medication is especially considered for patients who may not be able to tolerate the side effects or risks of standard, more aggressive chemotherapy regimens due to age or underlying health issues, such as heart disease or poor kidney function.
Who should not take it
There are no absolute contraindications listed for glasdegib, but it should not be used during pregnancy due to the risk of serious harm to the unborn baby, including birth defects or fetal death. Women of childbearing potential should use effective contraception during treatment and for at least 30 days after the last dose. Men with female partners should also use contraception during and after treatment for at least 30 days.
Patients with a history of long QT syndrome, uncontrolled cardiovascular disease, or those taking certain medications that can prolong the QT interval should use glasdegib with caution and under close monitoring. It is not recommended for children, as its safety and effectiveness have not been established in pediatric patients.
Commonly used with
Glasdegib is always used in combination with low-dose cytarabine for the treatment of AML in adults who are not candidates for intensive chemotherapy.
It is not typically combined with other chemotherapy agents outside of this specific combination for AML.
Commonly tested with
In clinical studies, glasdegib was tested in combination with low-dose cytarabine. The combination was compared to low-dose cytarabine alone in patients with newly-diagnosed AML who were not eligible for intensive chemotherapy.
There is no mention of glasdegib being routinely tested with other medications for AML in the FDA label.