Fedratinib (Oral route)

Pronunciation:

fed-RA-ti-nib

Brand Names:

Inrebic

Dosage Forms:

Capsule

Warnings:

Oral route(Capsule)

Warning: Encephalopathy including Wernicke'sSerious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with fedratinib. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. Do not start fedratinib in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue fedratinib and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Fedratinib is used to treat intermediate-2 or high-risk myelofibrosis, including primary or secondary (post-polycythemia vera and post-essential thrombocythemia) myelofibrosis. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fedratinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fedratinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept
Abemaciclib
Abiraterone Acetate
Acalabrutinib
Alfentanil
Alfuzosin
Alprazolam
Amiodarone
Amitriptyline
Amlodipine
Amprenavir
Apalutamide
Apixaban
Aprepitant
Aripiprazole
Atazanavir
Atomoxetine
Atorvastatin
Avacopan
Avanafil
Avapritinib
Avatrombopag
Axitinib
Baricitinib
Bedaquiline
Belumosudil
Benzhydrocodone
Bictegravir
Boceprevir
Bosentan
Bosutinib
Brigatinib
Bromocriptine
Brotizolam
Budesonide
Buspirone
Cabozantinib
Cannabidiol
Capmatinib
Carbamazepine
Carvedilol
Cenobamate
Ceritinib
Cilostazol
Cisapride
Citalopram
Clarithromycin
Clindamycin
Clobazam
Clomipramine
Cobicistat
Cobimetinib
Codeine
Colchicine
Conivaptan
Copanlisib
Crizotinib
Cyclosporine
Dabrafenib
Daclatasvir
Dalfampridine
Daridorexant
Darifenacin
Darolutamide
Darunavir
Dasatinib
Desipramine
Deutetrabenazine
Dexamethasone
Dexlansoprazole
Dextromethorphan
Diazepam
Dihydroergotamine
Diltiazem
Dipyrone
Docetaxel
Dofetilide
Dolutegravir
Domperidone
Dronedarone
Duloxetine
Duvelisib
Ebastine
Efavirenz
Elagolix
Elbasvir
Eletriptan
Elexacaftor
Eliglustat
Elvitegravir
Encorafenib
Entrectinib
Enzalutamide
Eplerenone
Eravacycline
Ergotamine
Erythromycin
Estradiol
Eszopiclone
Etravirine
Everolimus
Felodipine
Fenfluramine
Fentanyl
Finerenone
Flecainide
Flibanserin
Fluconazole
Fluoxetine
Fluticasone
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fostamatinib
Fostemsavir
Ganaxolone
Gilteritinib
Glasdegib
Gliclazide
Grazoprevir
Guanfacine
Haloperidol
Hexobarbital
Hydrocodone
Hydrocortisone
Ibrexafungerp
Ibrutinib
Idelalisib
Ifosfamide
Imatinib
Imipramine
Indinavir
Irinotecan
Irinotecan Liposome
Isavuconazole
Istradefylline
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Ixazomib
Josamycin
Ketoconazole
Lansoprazole
Lapatinib
Larotrectinib
Lemborexant
Lercanidipine
Lesinurad
Levamlodipine
Levomethadyl
Lofexidine
Lomitapide
Lonafarnib
Lopinavir
Lorlatinib
Lovastatin
Lumacaftor
Lumateperone
Lurasidone
Lurbinectedin
Macimorelin
Maraviroc
Mephobarbital
Metformin
Methadone
Metoprolol
Mexiletine
Mibefradil
Midazolam
Midostaurin
Mifepristone
Mitotane
Mobocertinib
Modafinil
Nafcillin
Naldemedine
Naloxegol
Nateglinide
Nebivolol
Nefazodone
Nelfinavir
Neratinib
Netupitant
Nifedipine
Nilotinib
Nintedanib
Nisoldipine
Nortriptyline
Omeprazole
Ondansetron
Osilodrostat
Oxycodone
Paclitaxel
Pacritinib
Palbociclib
Pantoprazole
Paritaprevir
Pemigatinib
Perampanel
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pimozide
Pitolisant
Posaconazole
Primidone
Progesterone
Proguanil
Propafenone
Propranolol
Quetiapine
Quinidine
Rabeprazole
Ranolazine
Reboxetine
Repaglinide
Ribociclib
Rifabutin
Rifampin
Rifapentine
Rilpivirine
Rimegepant
Ripretinib
Risperidone
Ritonavir
Rivaroxaban
Rolapitant
Ruxolitinib
Salmeterol
Samidorphan
Saquinavir
Saxagliptin
Selpercatinib
Selumetinib
Sildenafil
Simeprevir
Simvastatin
Sirolimus
Sonidegib
St John's Wort
Sunitinib
Suvorexant
Tacrolimus
Tamoxifen
Tamsulosin
Tazemetostat
Telaprevir
Telithromycin
Telotristat Ethyl
Temsirolimus
Tepotinib
Terfenadine
Tezacaftor
Thioridazine
Thiotepa
Ticagrelor
Tilidine
Timolol
Tipranavir
Tivozanib
Tolterodine
Tolvaptan
Trabectedin
Tramadol
Trazodone
Triazolam
Trimipramine
Troleandomycin
Tucatinib
Ubrogepant
Ulipristal
Upadacitinib
Vardenafil
Velpatasvir
Venetoclax
Venlafaxine
Verapamil
Vinblastine
Vincristine
Vincristine Sulfate Liposome
Vinorelbine
Voclosporin
Vorapaxar
Voriconazole
Voxelotor
Voxilaprevir
Zaleplon
Ziprasidone
Zolpidem
Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia (low number of red blood cells) or
Cancer, history of or
Heart or blood vessel disease or
Liver disease or
Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Severe liver disease or
Thiamine (Vitamin B1) deficiency—Should not be started in patients with this conditions.

Smoker, current or past—May increase risk for serious side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Your dose depends on your blood tests and needs to be changed several times in order to find out what works best for you. Do not use more medicine, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food. However, taking this medicine with a high fat meal may prevent nausea and vomiting.

Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):
- For myelofibrosis:
  - Adults—400 milligrams (mg) once a day, depending on your blood test results. Your doctor may adjust your dose as needed and tolerated.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Tell your doctor if you are using ruxolitinib (Jakafi®) before starting this medicine. Using these medicines together may cause serious side effects.

This medicine may cause encephalopathy (brain disease), including Wernicke’s encephalopathy, which may be serious and life-threatening. Wernicke’s encephalopathy is caused by acute thiamine (Vitamin B1) deficiency. Check with your doctor right away if you have confusion, drowsiness, double vision, diarrhea, nausea, vomiting, problems with muscle control or coordination, shakiness and unsteady walk, trembling, trouble remembering, and weight loss (leading to malnutrition and lower thiamine levels).

Fedratinib will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Fedratinib may cause diarrhea, nausea, or vomiting, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea, nausea, or vomiting continues, or gets worse, check with your doctor.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis).

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common: Black, tarry stools; bleeding gums; blood in the urine or stools; chills; cough; fever; lower back or side pain; painful or difficult urination; pale skin; pinpoint red spots on the skin; sore throat; trouble breathing with exertion; ulcers, sores, or white spots in the mouth; unusual bleeding or bruising; unusual tiredness or weakness

Less common: Bladder pain; cloudy urine; confusion; difficult, burning, or painful urination; drowsiness; frequent urge to urinate; lower back or side pain; shakiness and unsteady walk; trouble remembering; uncontrolled eye movements; unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known: Anxiety; chest pain; dizziness or lightheadedness; fainting; fast heartbeat; general feeling of illness; pain, redness, or swelling in arm or leg; pains in the chest, groin, or legs, especially calves of legs; persistent non-healing sore; pink growth; reddish patch or irritated area; shiny bump; sudden loss of coordination; sudden onset of slurred speech; sudden vision changes; swollen glands; weight loss; white, yellow or waxy scar-like area; yellow skin and eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Bone pain; diarrhea; headache; lack or loss of strength; muscle spasms; nausea; pain in the arms or legs; vomiting; weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 4/24/2024

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