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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB 15105/0177.
Inrebic 100 mg hard capsules
Inrebic 100 mg hard capsules
fedratinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Inrebic is and what it is used for
2. What you need to know before you take Inrebic
3. How to take Inrebic
4. Possible side effects
5. How to store Inrebic
6. Contents of the pack and other information
Inrebic contains the active substance fedratinib. It is a type of medicine known as ‘protein kinase inhibitors’.
Inrebic is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer.
An enlarged spleen is one of the characteristics of myelofibrosis. Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged. By blocking the action of certain enzymes (called Janus Associated Kinases), Inrebic can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss in patients with myelofibrosis.
Talk to your doctor or pharmacist before taking these capsules and during treatment, if you have any of the following signs or symptoms:
Condition affecting the brain called encephalopathy, including Wernicke’s encephalopathy
Talk to your doctor or pharmacist during your treatment
The following has been observed in another similar type of medicine used for the treatment of rheumatoid arthritis: heart problems, blood clots and cancer. Talk to your doctor or pharmacist before or during treatment if you:
Your doctor will discuss with you if Inrebic is appropriate for you.
Blood tests
Before and during treatment, you will have blood tests to check your blood cell levels (red blood cells, white blood cells and platelets), your vitamin B1 levels and your liver and pancreatic function. Your doctor may adjust the dose or stop treatment based on the results of the blood tests.
Inrebic should not be used in children or young people under 18 years of age because this medicine has not been studied in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Inrebic can affect the way some other medicines work. Also some other medicines can affect the way Inrebic works.
The following may increase the risk of side effects with Inrebic:
The following may reduce the effectiveness of Inrebic:
Inrebic may affect other medicines:
Your doctor will decide if the dose needs to be changed.
Also tell your doctor if you recently had an operation or if you are going to have an operation or a procedure as Inrebic may interact with some sedatives.
You should not eat grapefruit or drink grapefruit juice during your treatment with Inrebic, as they may increase the amount of the medicine that passes into your blood. Taking Inrebic with a high fat meal may reduce the likelihood of feeling sick (nausea) or being sick (vomiting). (See section 3 for more information on how to take Inrebic)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Inrebic during pregnancy. If you are able to become pregnant, you must use effective contraception whilst taking these capsules and avoid becoming pregnant for at least one month after the last dose.
Do not breast-feed while taking Inrebic and for at least one month after the last dose as it is not known if this medicine passes into breast milk.
If you feel dizzy, do not drive or operate machines until these side effects have gone away.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 400 mg (four 100 mg capsules) taken by mouth once daily.
You will have blood tests before and while you take this medicine to monitor your progress.
If you get certain side effects while you are taking Inrebic (see section 4) your doctor may lower your dose or pause or stop treatment.
You should continue taking Inrebic for as long as your doctor tells you to. This is a long-term treatment.
If you accidentally take too many Inrebic capsules or a higher dose than you should, contact your doctor or pharmacist straight away.
If you miss a dose or vomit after taking a capsule, skip the missed dose and take your next scheduled dose at your regular time the next day. Do not take a double dose to make up for a forgotten or vomited capsule.
Do not stop taking Inrebic unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor if you get any other side effects. These can include:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
Keep the bottle tightly closed in order to protect from moisture.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
This leaflet was last revised in April 2023