Fedratinib (Inrebic®)

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About This Drug

Fedratinib is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

• Decrease in red blood cells. This may make you feel more tired.
• Nausea and vomiting (throwing up)
• Diarrhea (loose bowel movements)

Note: Each of the side effects above was reported in 20% or greater of patients treated with fedratinib. Not all possible side effects are included above. 

Warnings and Precautions

• Changes in your liver and pancreas function.
• Severe nausea, vomiting and diarrhea.
• Severe decrease in red blood cells, and platelets which may make you tired and weak (fatigue) and raise your risk of bleeding.
• Changes in your central nervous system such as Wernicke’s encephalopathy can happen which can be life-threatening. Wernicke’s encephalopathy is a condition that can be caused by a lack of thiamine (vitamin B1). Your doctor will monitor your thiamine levels. You could feel extreme tiredness, agitation, confusion, have hallucinations (see or hear things that are not there), trouble understanding or speaking, loss of control of your bowels or bladder, eyesight changes, numbness or lack of strength to your arms, legs, face, or body, seizures or coma. If you start to have any of these symptoms let your doctor know right away.

Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team. 

How to Take Your Medication

• Swallow the medicine whole with or without food. If you have nausea, taking fedratinib with a high fat meal may help with nausea and vomiting.
• Missed dose: If you miss a dose, take your next dose at the regular time, and contact your doctor. Do not take 2 doses at the same time and do not double up on the next dose.
• Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
• This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
• Storage: Store this medicine in the original container, below 86°F.
• Disposal of unused medicine: Do not flush any expired and/or unused medicine down the toilet or drain unless you are specifically instructed to do so on the medication label. Some facilities have take-back programs and/or other options. If you do not have a take-back program in your area, then please discuss with your nurse or your doctor how to dispose of unused medicine. 

Treating Side Effects

• Manage tiredness by pacing your activities for the day.
• Be sure to include periods of rest between energy-draining activities.
• To help decrease the risk of bleeding, use a soft toothbrush. Check with your nurse before using dental floss.
• Be very careful when using knives or tools.
• Use an electric shaver instead of a razor.
• Drink plenty of fluids (a minimum of eight glasses per day is recommended).
• To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help stop or lessen these symptoms.
• If you throw up or have diarrhea, you should drink more fluids so that you do not become dehydrated (lack of water in the body from losing too much fluid).
• If you have diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
• Ask your doctor or nurse about medicines that are available to help stop or lessen your diarrhea.

Food and Drug Interactions

• This drug may interact with grapefruit and grapefruit juice. Talk to your doctor as this could make side effects worse.
• Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are known drug interactions with fedratinib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.
• Avoid the use of St. John’s Wort while taking fedratinib as this may lower the levels of the drug in your body, which can make it less effective.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

• Feeling dizzy or lightheaded
• Tiredness that interferes with your daily activities
• Easy bleeding or bruising
• Blurry vision or changes in your eyesight
• Extreme tiredness, agitation or confusion
• Symptoms of a seizure such as confusion, blacking out, passing out, loss of hearing or vision, blurred vision, unusual smells or tastes (such as burning rubber), trouble talking, tremors or shaking in parts or all of the body, repeated body movements, tense muscles that do not relax, and loss of control of urine and bowels. If you or your family member suspects you are having a seizure, call 911 right away.
• Hallucinations
• Trouble understanding or speaking
• Loss of control of bowels or bladder
• Numbness or lack of strength to your arms, legs, face, or body
• Have a seizure or coma
• Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
• Throwing up more than 3 times a day
• Diarrhea, 4 times in one day or diarrhea with lack of strength or a feeling of being dizzy
• Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
• If you think you may be pregnant

Reproduction Warnings

• Pregnancy warning: It is not known if this drug may harm an unborn child. For this reason, be sure to talk with your doctor if you are pregnant or planning to become pregnant while receiving this drug. Let your doctor know right away if you think you may be pregnant.
• Breastfeeding warning: Women should not breastfeed during treatment and for at least 1 month after treatment because this drug could enter the breast milk and cause harm to a breastfeeding baby.
• Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

New August 2019

This patient information was developed by Via Oncology, LLC © 2019. This information is not intended to be used as a substitute for professional medical advice, diagnosis, or treatment. You should not rely entirely on this information for your health care needs. Ask your own doctor or health care provider any specific medical questions that you have.

CLIENT acknowledges that the Via Pathways and Via Portal are information management tools only, and that Via Oncology, LLC has not represented the Via Pathways or Via Portal as having the ability to diagnose disease, prescribe treatment, or perform any other tasks that constitute the practice of medicine. The clinical information contained in the Via Pathways and Via Portal are intended as a supplement to, and not a substitute for, the knowledge, expertise, skill, and judgment of physicians, pharmacists and other healthcare professionals involved with patient care at CLIENT facilities.