quizartinib dihydrochloride: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
quizartinib dihydrochloride: clinical details
Prescribing considerations
- Initiation and supervision should be by a clinician experienced in anticancer treatment.
- Confirm FLT3-ITD-positive AML with an appropriate validated test before treatment.
- Assess cardiovascular history, QT-prolonging medicines, CYP3A interactions and electrolyte abnormalities.
- Patients older than 65 years require particular vigilance for severe infection, especially early in treatment.
- Discuss the cardiac risk and ensure the patient receives the supplied alert card.
Contraindications and cautions
- Hypersensitivity to quizartinib or an excipient
- Congenital long QT syndrome
- Breastfeeding
- Not recommended in severe hepatic or severe renal impairment because safety and efficacy have not been established
- Use cautiously with significant cardiovascular disease, previous torsade de pointes risk, electrolyte disturbance or other QT-prolonging medicines
Monitoring
- ECG and potassium, magnesium and other relevant electrolytes before treatment and serially during treatment
- Full blood count for neutropenia, anaemia, thrombocytopenia and pancytopenia
- Liver function tests, including alanine aminotransferase
- Clinical assessment for infection, bleeding and gastrointestinal losses that may worsen electrolyte disturbances
- Pregnancy testing before treatment where relevant
Clinical pharmacology
Quizartinib and AC886 competitively bind the ATP-binding site of FLT3 and inhibit downstream signalling. Quizartinib is principally metabolised through CYP3A4 and CYP3A5; elimination is mainly hepatobiliary and faecal, with little renal excretion.
Formulation and product differences
- The selected product is a white, round film-coated tablet containing 17.7 mg quizartinib as the dihydrochloride and marked “DSC 511”.
- The product does not require special storage conditions.
quizartinib dihydrochloride preparations and strengths
Tablet
Route: Oral
Strengths: 17.7 mg, 26.5 mg
quizartinib dihydrochloride interactions
The oncology team should review all medicines and supplements because interactions may affect exposure, effectiveness or heart rhythm.
Strong CYP3A/P-glycoprotein inhibitors, including itraconazole, posaconazole, voriconazole and clarithromycin
These can raise quizartinib exposure and increase toxicity, requiring specialist management.
Strong or moderate CYP3A inducers, including rifampicin, carbamazepine, phenytoin, phenobarbital, primidone and St John's wort
These can substantially lower quizartinib exposure and reduce effectiveness, so combined use should be avoided.
QT-prolonging medicines, including ondansetron, azithromycin, moxifloxacin, prochlorperazine and tacrolimus
Combined use can further increase the risk of QT prolongation and abnormal heart rhythms.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.