fedratinib dihydrochloride monohydrate at a glance
Medicine class
JAK2-selective protein kinase inhibitor
Usual role
Treats disease-related spleen enlargement or symptoms in adults with primary or secondary myelofibrosis
Administration
Swallow capsules whole, preferably with water. Food may reduce nausea and vomiting.
Important precaution
Vitamin B1 status must be checked and managed because deficiency can cause serious encephalopathy.
What is fedratinib dihydrochloride monohydrate used for?
Licensed uses in adults include disease-related spleen enlargement or symptoms caused by:
Primary myelofibrosis
Myelofibrosis following polycythaemia vera
Myelofibrosis following essential thrombocythaemia
These uses include people who have not received a JAK inhibitor and those previously treated with ruxolitinib.
How does fedratinib dihydrochloride monohydrate work?
Fedratinib preferentially inhibits JAK2, including abnormally activated JAK2, and also acts against FLT3. This reduces STAT3 and STAT5 signalling involved in abnormal blood-cell proliferation.
fedratinib dihydrochloride monohydrate preparations and strengths
Capsule
Route: Oral
Strengths: 100 mg
How to take fedratinib dihydrochloride monohydrate
Follow the specialist team’s instructions and do not stop treatment without discussing it with them.
Swallow capsules whole, preferably with water; do not open, break or chew them.
Capsules may be taken with or without food. Food may reduce nausea and vomiting.
Avoid grapefruit and grapefruit juice because they can increase fedratinib exposure.
Take prescribed oral thiamine as directed by the treatment team.
fedratinib dihydrochloride monohydrate side effects
Common or expected effects
- Diarrhoea, nausea, vomiting or constipation
- Anaemia
- Low platelets, bruising or bleeding
- Low neutrophils and increased susceptibility to infection
- Headache, muscle spasms, fatigue or weakness
- Urinary tract infection
- Changes in liver, kidney, amylase or lipase blood tests
Get urgent medical advice
- Confusion, memory loss, balance or walking problems, or visual disturbance suggesting encephalopathy
- Fever or recurrent infection associated with low neutrophils
- Unusual or persistent bleeding
- Sudden breathlessness, chest pain or a swollen, painful limb suggesting a blood clot
- Eye pain, redness, light sensitivity, floaters or reduced vision suggesting uveitis
fedratinib dihydrochloride monohydrate in pregnancy
Fedratinib is contraindicated during pregnancy because it may harm the fetus. People who could become pregnant should use effective contraception during treatment and for at least one month afterwards. Seek prompt specialist advice if pregnancy is suspected.
fedratinib dihydrochloride monohydrate while breastfeeding
Breastfeeding is not recommended during treatment or for at least one month afterwards. It is unknown whether fedratinib or its metabolites enter human milk, and risk to the child cannot be excluded.
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.
Common questions about fedratinib dihydrochloride monohydrate
Answers are fully visible for fast scanning and source review.
What is it used for?
It treats disease-related spleen enlargement or symptoms in adults with primary myelofibrosis or myelofibrosis following polycythaemia vera or essential thrombocythaemia.
Why is vitamin B1 checked?
Low thiamine can cause Wernicke’s encephalopathy, a neurological emergency. Deficiency must be corrected before treatment and monitored during therapy.
Can the capsules be opened or chewed?
No. They should be swallowed whole, preferably with water.
Can I have grapefruit?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.