Indication

What is INREBIC^® (fedratinib)?

INREBIC is a prescription medicine used to treat adults with certain types of myelofibrosis (MF). It is not known if INREBIC is safe and effective in children.

Important Safety Information

What is the most important information I should know about INREBIC?

INREBIC may cause serious side effects, including:

• Encephalopathy (including Wernicke’s encephalopathy). A serious and sometimes fatal neurological problem called encephalopathy (including Wernicke’s encephalopathy) has happened in some people who take INREBIC. Wernicke’s encephalopathy is a neurologic emergency that can happen if you do not have enough Vitamin B1 (thiamine) in your body. Your healthcare provider will do a blood test to check your Vitamin B1 level and treat you with Vitamin B1 if your level is too low before starting treatment with INREBIC. Your healthcare provider may also check your Vitamin B1 level during treatment with INREBIC. You should take a Vitamin B1 supplement (100 mg of thiamine) daily during treatment with INREBIC. Your healthcare provider may tell you to stop taking INREBIC if you develop side effects during treatment with INREBIC.

   

   

  Get emergency medical help right away if you develop the following:

  • confusion, memory problems, or drowsiness
  • problems with balance and movement, such as difficulty walking
  • eye problems, such as double or blurred vision or abnormal eye movements

   

  Call your healthcare provider if you experience diarrhea, nausea, vomiting, and weight loss that does not get better with treatment.

 

Before taking INREBIC, tell your healthcare provider about all your medical conditions, including if you:

• have low Vitamin B1 (thiamine) levels
• have low red blood cell or platelet counts
• have or have had liver problems
• have or have had kidney problems
• are a current or past smoker
• have had a blood clot, heart attack, other heart problems, or stroke
• have or have had any other cancer
• are pregnant or plan to become pregnant. It is not known if INREBIC may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if INREBIC passes into your breast milk. You should not breastfeed during treatment with INREBIC and for at least 1 month after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with INREBIC.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

Taking INREBIC with certain other medicines may cause side effects from INREBIC or from the other medicine and may affect the way that INREBIC works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

 

How should I take INREBIC?

• Take INREBIC exactly as your healthcare provider tells you to. Do not change your dose or stop taking INREBIC unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with INREBIC if you develop side effects.
• Take INREBIC 1 time each day.
• Take INREBIC with or without food. Taking INREBIC with a high fat meal may help to reduce nausea and vomiting symptoms.
• Take Vitamin B1 (thiamine 100 mg) by mouth daily to prevent low Vitamin B1 levels during treatment with INREBIC.
• If you miss a dose of INREBIC, skip the missed dose and take your usual dose the next day at your regularly scheduled time. Do not take 2 doses to make up for the missed dose.
• If you cannot swallow INREBIC capsules whole or have a nasogastric tube, the capsules can be opened, and the contents can be mixed with Ensure^® Plus liquid nutritional supplement:
• Carefully open your prescribed dose of INREBIC capsules into a glass container and mix it with about 180 mL (6 oz) of liquid nutritional supplement at room temperature, between 68°F to 77°F (20°C to 25°C).
• Swallow the mixture right away or give it through a nasogastric (NG) tube (French size 14 or 16) within 2 hours of preparation. If using a NG tube, flush the NG tube with 60 mL (2 oz) of water after giving the INREBIC mixture.
• Throw away prepared dose if not given within 2 hours and mix a new dose. If you take too much INREBIC, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

 

What are the possible side effects of INREBIC?
INREBIC can cause serious side effects, including:

• Low blood cell counts. INREBIC may cause new or worsening low red blood cell counts (anemia) and low platelet counts (thrombocytopenia) in some people. You may need a blood transfusion if your blood counts drop too low. Your healthcare provider will do blood tests to check your blood counts before you start and during treatment with INREBIC. Tell your healthcare provider if you develop any bleeding or bruising during treatment with INREBIC.
• Diarrhea, nausea, and vomiting. Your healthcare provider may give you certain medicines to help treat your diarrhea, nausea, and vomiting. Call your healthcare provider or get emergency medical help right away if you have diarrhea, nausea, or vomiting that does not get better with treatment.
• Liver problems.INREBIC may cause increased liver enzymes Your healthcare provider will do blood tests to check your liver function before starting and during treatment with INREBIC.
• Amylase and lipase increases. You may have increases in your blood amylase or lipase levels that may indicate a problem with your pancreas. Your healthcare provider will do blood tests to check your amylase or lipase levels before starting and during treatment with INREBIC.
• Eye problem called uveitis. INREBIC may cause inflammation of the middle layer of the eyeball (uvea) called uveitis. Tell your healthcare provider if you develop any symptoms, including eye pain, redness, sensitivity to light, new or increased floaters (specks or threads that float in your vision), or decrease in your vision. You may need to see an eye specialist to check your eyes if you develop any signs and symptoms of eye problems.
• Major cardiac events such as heart attack, stroke, or death. An increased risk of major cardiac events has happened in people, especially those who have cardiovascular risk factors and who are current or past smokers, while taking another Janus Kinase (JAK)-inhibitor to treat rheumatoid arthritis. Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with INREBIC, including:
• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech
• Blood clots.Increased risk of blood clots in the veins of the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK-inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with INREBIC, including:
• swelling, pain, or tenderness in one or both legs
• sudden unexplained chest or upper back pain
• shortness of breath or difficulty breathing
• New (secondary) cancers People who take another JAK-inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers, except nonmelanoma skin cancer. People who smoke or who smoked in the past have an added increased risk of new cancers.

 

The most common side effects of INREBIC include:

• diarrhea
• nausea
• low red blood cell counts (anemia)
• vomiting

 

These are not all of the possible side effects of INREBIC.

 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088.

Please see full Prescribing Information for INREBIC including Boxed WARNING and Medication Guide.