glasdegib maleate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
glasdegib maleate: clinical details
Prescribing considerations
- Prescribing should be restricted to clinicians experienced in anticancer treatment.
- Confirm newly diagnosed de novo or secondary AML in an adult who is not a candidate for standard induction chemotherapy.
- Review QT risk, electrolytes, renal function, muscle symptoms, interacting medicines and reproductive risks before treatment.
- Discuss fertility preservation before treatment where relevant.
Contraindications and cautions
- Hypersensitivity to glasdegib or any excipient.
- Do not use during pregnancy or when effective contraception is not being used by a patient who could become pregnant.
- Avoid in rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption because the tablet contains lactose.
- Safety and efficacy are not established in people under 18 years; the product should not be used in this population.
- No clinical data are available for patients requiring haemodialysis.
Monitoring
- Check full blood count, electrolytes, renal function and hepatic function before treatment and frequently during the initial treatment period, then at least monthly or as clinically indicated.
- Obtain a baseline creatine kinase measurement and repeat when muscle symptoms occur.
- Obtain a baseline ECG, repeat early after starting and continue scheduled monitoring; monitor more frequently with long-QT syndrome, heart failure, electrolyte abnormalities or QT-prolonging medicines.
- Correct electrolyte abnormalities promptly and reassess medicines that prolong QT or strongly inhibit CYP3A4.
- Assess unexplained muscle pain, tenderness or weakness promptly.
Clinical pharmacology
Glasdegib inhibits Smoothened and reduces downstream GLI signalling. It is orally bioavailable, highly protein-bound, primarily affected by CYP3A4 inhibitors and inducers, and has a mean plasma half-life of approximately 17 hours.
Formulation and product differences
- The selected product is a film-coated oral tablet containing lactose and less than 1 mmol sodium per tablet.
- The selected tablet requires no special storage conditions.
glasdegib maleate preparations and strengths
Tablet
Route: Oral
Strengths: 25 mg, 100 mg
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
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.