Inrebic 100 Mg Capsule Antineoplastic - Janus Kinase (JAK) Inhibitors

GENERIC NAME(S): Fedratinib

OTHER NAME(S): Inrebic Capsule

WARNINGS:

Rarely, a serious (sometimes fatal) brain condition (encephalopathy) has occurred in people receiving this medication. Low levels of vitamin B1 (thiamine) can increase your risk. Your doctor will check your thiamine blood levels before starting this medication and regularly during treatment. Get medical help right away if you develop symptoms of encephalopathy such as mental/mood changes (including confusion, trouble thinking clearly, memory loss), balance/walking problems, or eye problems (such as double/blurred vision or unusual eye movements).

Who should not take Inrebic 100 Mg Capsule Antineoplastic - Janus Kinase (JAK) Inhibitors?

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Uses

Uses

This medication is used to treat a certain type of cancer (myelofibrosis). Fedratinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How to use Inrebic 100 Mg Capsule Antineoplastic - Janus Kinase (JAK) Inhibitors

Read the Medication Guide provided by your pharmacist before you start taking fedratinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. If you have nausea or vomiting, it may help to take this medication with a high-fat meal.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side Effects

Side Effects

Diarrhea, nausea, and vomiting commonly occur and can be severe. Your doctor may prescribe medication(s) to prevent or help relieve diarrhea, nausea, and vomiting. Muscle spasms, headache, dizziness, or unusual tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual/sudden weight gain), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before taking fedratinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, kidney problems, liver problems, pancreatitis.

Fedratinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using fedratinib. Fedratinib may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 1 month after the last dose is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of fedratinib from your body, which may affect how fedratinib works. Examples include azole antifungals (such as fluconazole, voriconazole), rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples include flibanserin, lomitapide, among others.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as thiamine blood levels, complete blood count, kidney/liver function, amylase/lipase) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised November 2019. Copyright(c) 2019 First Databank, Inc.

Images
Inrebic 100 mg capsule
Inrebic 100 mg capsuleiconicon
Inrebic 100 mg capsule

color
reddish-brown
shape
oblong
imprint
FEDR, 100 mg
Inrebic 100 mg capsule
Inrebic 100 mg capsule

color
reddish-brown
shape
oblong
imprint
FEDR, 100 mg
This medicine is a reddish-brown, oblong, capsule imprinted with "FEDR" and "100 mg".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.