fedratinib dihydrochloride monohydrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
fedratinib dihydrochloride monohydrate: clinical details
Prescribing considerations
- Initiation and monitoring should be supervised by a clinician experienced with anticancer treatments.
- Assess nutritional and thiamine status and correct deficiency before initiation; provide prophylactic oral thiamine during treatment.
- Gastrointestinal toxicity may contribute to thiamine deficiency and requires prompt supportive management.
- Review renal function, interacting medicines, thromboembolic and cardiovascular risk, smoking history and malignancy risk.
- Clinical experience in people aged 75 years and over is limited, with more serious reactions and discontinuations reported.
Contraindications and cautions
- Hypersensitivity to fedratinib or any excipient
- Pregnancy
Monitoring
- Thiamine level and nutritional status
- Full blood count, including haemoglobin, platelets and neutrophils
- Liver function, amylase, lipase, blood urea nitrogen and creatinine
- Neurological symptoms suggesting encephalopathy
- Persistent gastrointestinal toxicity and hydration or nutritional compromise
- New eye pain, redness, photophobia, floaters or reduced vision
Clinical pharmacology
An oral JAK2-selective kinase inhibitor active against wild-type and mutation-activated JAK2 and FLT3. It suppresses JAK2-mediated STAT3/5 phosphorylation and is metabolised predominantly through CYP3A4, with lesser contributions from CYP2C19 and flavin-containing monooxygenases.
Formulation and product differences
- Supplied as a hard gelatin capsule for oral use.
- Capsules must be swallowed whole and not opened, broken or chewed.
- The product is essentially sodium-free and should be kept tightly closed to protect it from moisture.
fedratinib dihydrochloride monohydrate preparations and strengths
Capsule
Route: Oral
Strengths: 100 mg
fedratinib dihydrochloride monohydrate interactions
The treatment team should review prescription, non-prescription and herbal products before and during treatment.
Grapefruit or grapefruit juice
May increase fedratinib exposure and should be avoided.
Strong CYP3A4 inhibitors, including ketoconazole and ritonavir
Can substantially increase fedratinib exposure and toxicity risk.
Dual CYP3A4 and CYP2C19 inhibitors, including fluconazole and fluvoxamine
May increase fedratinib exposure and require closer safety monitoring.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.