USES
Fedratinib should be taken once a day with food. Taking it with food helps reduce nausea and vomiting. Swallow the capsule whole—do not crush or chew it.
Try to take it at the same time every day to keep a steady level in your body. If you miss a dose, take it as soon as you remember, unless it’s close to the next dose. Do not double up on doses.
Your doctor will check your blood often to make sure the medicine is working and is safe for you.
WORKING
Fedratinib works by blocking certain proteins in the body called Janus-associated kinases (JAK2). In people with myelofibrosis, the JAK2 protein is too active, which causes the body to make abnormal blood cells and scar tissue in the bone marrow.
By blocking JAK2, Fedratinib helps to:
- Slow down the growth of abnormal blood cells
- Reduce swelling of the spleen
- Improve blood counts
- Help with symptoms like tiredness, fever, and bone pain
It does not cure the disease, but it helps people feel better and may improve their quality of life.
SIDE EFFECTS
Fedratinib can cause side effects. Some are common and mild, while others can be serious.
Common side effects include:
- Nausea
- Vomiting
- Diarrhea
- Tiredness (fatigue)
- Headache
- Low red blood cells (anemia)
- Low platelets (thrombocytopenia)
Serious side effects include:
- Wernicke’s encephalopathy, a brain disorder caused by low vitamin B1 (thiamine)
- Severe liver problems
- Severe diarrhea or vomiting, which can lead to dehydration
- Infections due to low white blood cells
Your doctor will do regular blood tests and check vitamin B1 levels before and during treatment to help prevent serious side effects.
WARNINGS
There are important warnings to know before taking Fedratinib:
- Wernicke’s encephalopathy warning: This is a rare but serious brain condition caused by low vitamin B1. Symptoms include confusion, memory problems, trouble with balance, or eye movement issues. Your doctor may give you vitamin B1 if needed.
- Liver warning: Fedratinib can harm the liver. Regular blood tests are needed.
- Blood tests: You will need regular checks for red cells, white cells, and platelets.
- Pregnancy: Do not use if you are pregnant or planning to become pregnant. It may harm an unborn baby.
- Breastfeeding: Do not breastfeed while using this medicine.
- Alcohol: Limit alcohol as it can increase liver stress or lower vitamin B1 levels.
Tell your doctor if you have any stomach problems, liver disease, or vitamin deficiencies before starting Fedratinib.
INTERACTIONS
The usual dose of Fedratinib is 400 mg once a day, taken with food. It comes in capsule form and should be swallowed whole with water.
Fedratinib may interact with other medicines. These interactions can change how it works or increase side effects. Some important drug interactions include:
- Antifungal medicines (like ketoconazole)
- Antibiotics (like clarithromycin)
- HIV medicines
- Seizure drugs
- St. John’s Wort (a herbal supplement)
These drugs can change how your body processes Fedratinib. Always tell your doctor about all the medicines, supplements, or vitamins you are taking.
DOSAGE
The recommended dose is:
- 400 mg once a day, taken with food
Your doctor may adjust the dose if:
- You have kidney or liver problems
- You have severe side effects
- Your blood counts drop too low
If you miss a dose for less than 6 hours, take it as soon as you remember. If more than 6 hours have passed, skip it and take the next dose at the usual time. Do not take extra medicine to make up for a missed dose.
Do not stop taking Fedratinib without talking to your doctor, as stopping suddenly may make your symptoms worse.
PRESCRIPTION
Fedratinib is a prescription-only medicine. You cannot buy it without a doctor’s approval. It is only prescribed by specialists, usually hematologists or oncologists, who treat blood cancers.
Before giving you this medicine, your doctor will:
- Check your medical history
- Do blood tests
- Test your vitamin B1 level
- Review your current medications
Regular monitoring is needed during treatment to keep you safe and ensure the medicine is working.
FAQ's
What is Fedratinib used for?
It is prescribed to treat intermediate-2 or high-risk myelofibrosis, including:
What is the brand name?
Inrebic®.
What type of drug is Fedratinib?
It is a Janus kinase (JAK) inhibitor, specifically targeting JAK2.
How does Fedratinib work?
It blocks abnormal JAK2 enzyme activity, which drives excessive blood cell production and spleen enlargement in myelofibrosis.
How is Fedratinib taken?
As an oral capsule, usually once daily, with or without food. Taking it with a high-fat meal may reduce nausea.
What are the available strengths?
100 mg capsules.
What are the common side effects?
Nausea, vomiting, diarrhea, fatigue, headache, dizziness, and low blood counts (anemia or thrombocytopenia).
Are there serious side effects?
Yes, serious but rare risks include:
Why does Fedratinib have a boxed warning?
For the risk of serious and potentially fatal encephalopathy, including Wernicke’s encephalopathy, caused by thiamine (vitamin B1) deficiency.
Do I need blood tests before starting Fedratinib?
Yes — your doctor will check thiamine levels, complete blood count (CBC), and liver and kidney function before and during treatment.
Can I take vitamin B1 with Fedratinib?
Yes — thiamine supplementation is often recommended during therapy to prevent deficiency.
Can Fedratinib shrink an enlarged spleen?
Yes, many patients experience significant spleen size reduction and symptom improvement.
What should I do if I experience confusion or vision changes?
Contact your doctor immediately — these may be early signs of Wernicke’s encephalopathy.
Is Fedratinib used for other conditions?
It is primarily used for myelofibrosis, though research continues for other JAK2-related disorders.
Is it safe during pregnancy?
No — it may harm an unborn baby. Effective contraception is required during treatment and for at least 1 month after stopping.
Can I take Fedratinib while breastfeeding?
No — it is not recommended, as it may pass into breast milk.
Does Fedratinib interact with other medications?
Yes — avoid strong CYP3A inhibitors/inducers (e.g., ketoconazole, rifampin) and certain antivirals and antifungals.
Can Fedratinib cause weight loss?
Some patients experience appetite loss and weight reduction during treatment.
How long does it take to work?
Clinical improvements in spleen size and symptoms often appear after 8–12 weeks.
What if I miss a dose?
Take it as soon as you remember unless it’s almost time for your next dose. Do not double up.
Is there a generic version available?
No — Fedratinib (Inrebic) is currently available as brand only.
Where can I get Fedratinib?
Available through specialty pharmacies with a prescription from a hematologist or oncologist.