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Uses

What is Inrebic used for?

Inrebic (fedratinib) is commonly used to treat certain types of a blood cancer called myelofibrosis (MF).

Inrebic may also be used for other conditions as determined by your healthcare provider.

How does Inrebic work (mechanism of action)?

Inrebic is a type of medicine known as a JAK2 inhibitor. It inhibits a specific kinase called Janus associated kinase 2 (JAK2). Janus associated kinases (JAKs) are proteins that become overactive in myelofibrosis. The JAKs can cause your body to make blood cells that are not healthy, leading to myelofibrosis. Inrebic blocks the action of JAK2 to slow down the creation of blood cells that are not normal. 

How is Inrebic supplied (dosage forms)?

Brands and other names

  • Inrebic

Dosage forms and strengths

  • 100 mg oral capsules

How should I store Inrebic?

Inrebic should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Inrebic?

The most common side effects of Inrebic are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Diarrhea
  • Nausea and vomiting
  • Low red blood cell levels, also called anemia (see below)

There may be other side effects of Inrebic that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Inrebic?

While less common, the most serious side effects of Inrebic are described below, along with what to do if they happen.

Severe Allergic Reactions. Inrebic may cause allergic reactions, which can be serious. Stop taking Inrebic and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Brain Problems. Inrebic can cause brain problems, including a condition called Wernicke encephalopathy that can happen when you do not have enough vitamin B1. Your healthcare provider will likely tell you to take vitamin B1, also called thiamine, while taking Inrebic. Get emergency help if you get any of the following symptoms of brain problems.

  • Confusion
  • Memory problems
  • Tiredness
  • Problems with your balance or difficulty walking
  • Eye problems, such as blurred vision or abnormal eye movements
  • Severe diarrhea
  • Severe nausea and vomiting
  • Weight loss

Anemia. Inrebic may cause anemia, which is when you have low levels of red blood cells. Tell your healthcare provider if you have any of the following symptoms of anemia.

  • Unusual weakness or tiredness
  • Cold hands and feet
  • Fast or abnormal heartbeat
  • Pale or yellowish skin
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Shortness of breath

Severely Low Platelet Levels. Inrebic can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Tell your healthcare provider if you have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds

Stomach Issues. Inrebic can cause stomach issues, including diarrhea, nausea, and vomiting. If you are given medicine to prevent or treat diarrhea, nausea, or other stomach issues, take it exactly as your healthcare provider tells you. Call your healthcare provider right away if you have any of the following.

  • Severe diarrhea
  • Diarrhea that does not go away
  • Diarrhea with weakness, dizziness, or fever
  • Severe nausea or vomiting
  • Severe constipation

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Inrebic. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

High Digestive Enzyme Levels. Inrebic may cause high levels of certain digestive enzymes called lipase and amylase. In rare cases, people taking Inrebic who had high levels of these enzymes developed pancreatitis, which is inflammation of the pancreas. Attend all appointments for blood work so that your healthcare provider can monitor these enzyme levels. Stop taking Inrebic and call your healthcare provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Warnings & Precautions

Who should not use Inrebic?

Allergies to Ingredients. People who are allergic to any of the following should not take Inrebic.

  • Inrebic
  • Fedratinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Inrebic.

What should I know about Inrebic before using it?

Do not take Inrebic unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Inrebic with other people, even if they have the same condition as you. It may harm them.

Keep Inrebic out of the reach of children.

If you have nausea or vomiting, eating a high-fat meal when you take your Inrebic dose may help to prevent or lessen these symptoms. 

What should I tell my healthcare provider before using Inrebic?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Inrebic is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Low vitamin B1 (thiamine) levels
  • Low red blood cell levels
  • Low platelet levels
  • Liver problems
  • Kidney problems
  • Smoke or have previously smoked
  • Heart problems, including blood clots, heart attacks, or a stroke
  • Previously had any other cancer

Rheumatoid Arthritis. Some people with rheumatoid arthritis who took another medicine that is very similar to Inrebic had an increased risk of new cancers and of heart problems, including a heart attack, blood clots, and stroke. Tell your healthcare provider if you have rheumatoid arthritis or take any medicines for rheumatoid arthritis. 

Other Medicines and Supplements. Inrebic may interact with other medicines and supplements. Before taking Inrebic, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is unknown if Inrebic may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. 

Breastfeeding. Do not take Inrebic while you are breastfeeding and for at least one month after your last dose. It is not known if Inrebic passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Inrebic?

For more information about Inrebic, you can visit the manufacturer’s website at www.inrebic.com or call them at 800-861-0048.

Interactions

Does Inrebic interact with foods or drinks?

There are no known interactions between Inrebic and foods or drinks.

It is unknown if drinking alcohol will affect Inrebic. 

Does Inrebic interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Many medicines may alter the blood levels of Inrebic, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Inrebic. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Inrebic?

If you or someone else has used too much Inrebic, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Inrebic?

If you miss a dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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