glasdegib maleate at a glance
Class
Smoothened inhibitor targeting the Hedgehog signalling pathway
Licensed role
Used with low-dose cytarabine for selected adults with newly diagnosed AML
Administration
An oral film-coated tablet that may be taken with or without food
Important checks
Blood tests and ECG monitoring are required because of blood-count, electrolyte, muscle and heart-rhythm risks
What is glasdegib maleate used for?
The selected UK product has one licensed use.
In combination with low-dose cytarabine for newly diagnosed de novo or secondary acute myeloid leukaemia in adults who are not candidates for standard induction chemotherapy.
How does glasdegib maleate work?
Glasdegib binds to Smoothened, a signalling protein in the Hedgehog pathway. This reduces downstream GLI activity and the ability of leukaemic stem cells to maintain and initiate AML. The full basis of its combined effect with cytarabine is not completely understood.
glasdegib maleate preparations and strengths
Tablet
Route: Oral
Strengths: 25 mg, 100 mg
How to take glasdegib maleate
The film-coated tablet is taken by mouth, with or without food. Avoid grapefruit and grapefruit juice, and do not stop or alter treatment without speaking to the specialist team.
Tell the treatment team about prescription, non-prescription and herbal products before starting anything new.
glasdegib maleate side effects
Common or expected effects
- Anaemia and other reduced blood-cell counts
- Bleeding or bruising
- Fever and infections, including pneumonia
- Nausea, vomiting or reduced appetite
- Tiredness
- Muscle pain or spasms
- Diarrhoea, constipation or abdominal pain
- Taste changes
- Swelling of the arms or legs
- Rash, breathlessness or weight loss
Get urgent medical advice
- Fever or infection with reduced white blood cells
- Serious bleeding
- QT prolongation or an abnormal heart rhythm
- Severe or unexplained muscle pain, tenderness or weakness
- Severe breathlessness or serious lung infection
glasdegib maleate in pregnancy
Glasdegib can cause foetal death or severe birth defects and should not be used during pregnancy. Pregnancy status should be checked before treatment where relevant. Effective contraception is required for patients who could become pregnant and for male patients with partners who could become pregnant during treatment and for at least 30 days afterwards. Contact the specialist team immediately if pregnancy is suspected.
glasdegib maleate while breastfeeding
It is unknown whether glasdegib passes into human milk. Because serious adverse effects in a breastfed child are possible, breastfeeding is not recommended during treatment or for at least one week after the last dose.
glasdegib maleate interactions
A full interaction review is needed, including herbal and non-prescription products.
Strong CYP3A4 inhibitors, including itraconazole, posaconazole, voriconazole, ritonavir and cobicistat
These can increase glasdegib exposure and adverse effects; an alternative with little CYP3A4 inhibition is preferred where possible.
Grapefruit or grapefruit juice
These can increase glasdegib exposure and should be avoided.
CYP3A4 inducers, including rifampicin, carbamazepine, phenytoin, efavirenz and St John’s wort
Common questions about glasdegib maleate
Answers are fully visible for fast scanning and source review.
Is glasdegib maleate chemotherapy?
It is a targeted anticancer treatment rather than conventional cytotoxic chemotherapy. It blocks Smoothened in the Hedgehog signalling pathway and is licensed for use with cytarabine.
Can glasdegib maleate be taken with food?
Yes. The tablet may be taken with or without food.
Why are ECGs needed?
Glasdegib can prolong the QT interval, which may lead to an abnormal heart rhythm. ECGs help detect this risk before and during treatment.
Why are blood tests needed?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.