
Inrebic
Inrebic (fedratinib) is a medication used to treat a rare type of blood cancer called myelofibrosis (MF) in adults. It’s a JAK inhibitor that helps stop abnormal blood cells from growing too much. This medication is a tablet that you take by mouth once a day. But common side effects include diarrhea, nausea, and anemia (low red blood cells). There’s also a risk of a serious brain problem called Wernicke encephalopathy.
What is Inrebic (fedratinib)?
What is Inrebic (fedratinib) used for?
- Intermediate or high-risk myelofibrosis (MF) in adults
How Inrebic (fedratinib) works
Inrebic (fedratinib) is a JAK inhibitor. It blocks proteins in the body called Janus kinase, or JAK. In people with myelofibrosis, these proteins don’t work properly and cause abnormal blood cells to grow.
By blocking JAK, Inrebic (fedratinib) helps stop abnormal blood cells from growing out of control.
Drug facts
| Common Brands | Inrebic |
|---|---|
| Drug Class | JAK inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Inrebic (fedratinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Anemia (low red blood cells, 74%)
- Diarrhea (66%)
- Nausea (62%)
- Higher creatinine levels (59%)
- Low platelets (47%)
- Higher liver enzyme levels (up to 43%)
- Vomiting (39%)
- Higher lipase levels (35%)
- Low sodium (26%)
- Higher amylase levels (24%)
- Low white blood cells (23%)
Less Common Side Effects
- Tiredness or weakness
- Dizziness
- Headache
- Muscle spasms
- Pain in the arm or leg
- Bone pain
- Weight gain
- Urinary tract infection (UTI)
- Pain while urinating
Inrebic (fedratinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious brain problems: confusion, memory loss, trouble speaking or walking, double vision, fast back-and-forth eye movements
- Low platelets: frequent nosebleeds, unexplained bruising, bleeding that won’t stop, blood in urine, blood in stool
- Liver problems: yellow skin, yellow eyes, swollen belly
- Eye inflammation: eye pain, redness, sensitivity to light, floaters, blurry vision
- Heart attack: chest pain, chest tightness, sweating, nausea
- Stroke: sudden and severe chest pain, sudden and severe headache, weakness on one side of the body, trouble speaking or walking
- Blood clot: swelling or tenderness in one arm or leg, sudden chest pain, trouble breathing
The following Inrebic (fedratinib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Eye pain, redness, irritation, or discharge with blurry or decreased vision
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Severe or prolonged vomiting or diarrhea
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Uncontrollable eye movements
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Muscle spasms
- Vomiting
- Weight gain
Pros and cons of Inrebic (fedratinib)
Pros
- Taken by mouth once a day
- Can help shrink an enlarged spleen, which can improve comfort
- Can help control MF symptoms, like tiredness and night sweats
Cons
- Often causes diarrhea and anemia
- Must also take vitamin B1 every day to lower the risk of a rare brain problem (Wernicke encephalopathy)
- Can interact with other medications, like fluconazole (Diflucan) and certain antibiotics
Pharmacist tips for Inrebic (fedratinib)
- You can take Inrebic (fedratinib) with or without food. Taking it with a high-fat meal might help lower your risk of nausea and vomiting.
- If you miss a dose of Inrebic (fedratinib), don’t take an extra dose. Wait and take your next scheduled dose as usual the next day.
- If you have trouble swallowing Inrebic (fedratinib) capsules whole or use a feeding tube, talk to your care team. They can show you how to take the medication safely. You can open the capsule and mix the contents with a certain amount of Ensure Plus liquid at room temperature. Use the mixture within 2 hours. If it’s been longer, discard it safely.
- You’ll need to take a vitamin B1 (thiamine) supplement every day while taking Inrebic (fedratinib). It helps keep your vitamin B1 levels from getting too low. Low vitamin B1 can lead to a serious brain problem called Wernicke encephalopathy. This is rare with Inrebic but still possible.
- Nausea and vomiting can often happen as side effects of Inrebic (fedratinib). If you end up vomiting, be sure to drink enough fluids to prevent dehydration. Also try eating plain foods to calm your stomach. If you still feel very nauseous or vomit a lot, talk to your care team. Your prescriber might recommend managing this side effect with medications like ondansetron (Zofran).
- It’s common to have diarrhea while taking Inrebic (fedratinib). If this happens, it’s important to rehydrate with fluids, like water or Pedialyte. Try to stay away from sugary sports drinks since they can actually make diarrhea worse. Also avoid greasy, spicy, or fried foods. If diarrhea doesn’t get any better, tell your care team. They can help you find other options, such as with over-the-counter medication like loperamide (Imodium A-D).
- Be sure to get your lab tests done when your prescriber tells you to while taking Inrebic (fedratinib). This helps check your blood counts since the medication can lower your red blood cells and platelets. They’ll also check your vitamin B1 levels to watch for a rare brain problem called Wernicke encephalopathy. Talk to your prescriber about your lab results.
- Give your care team a list of all the medications and supplements you take. Also tell them if you start or stop any medications. Inrebic (fedratinib) can interact with other medications. Some, like fluconazole (Diflucan), can raise your risk of side effects. Others, like carbamazepine (Tegretol), can make Inrebic (fedratinib) work less well. Updating your care team helps them keep you safe and make changes if needed.
Risks and warnings for Inrebic (fedratinib)
Inrebic (fedratinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious brain problems, including Wernicke encephalopathy
- Risk factors: Low thiamine (vitamin B1)
It’s rare, but some people taking Inrebic (fedratinib) developed a serious brain problem called encephalopathy. One type, called Wernicke encephalopathy, can happen when vitamin B1 (thiamine) levels are too low.
Before starting Inrebic (fedratinib), your oncologist or hematologist will check your vitamin B1 levels. If they’re low, you’ll need to take vitamin B1 supplements first to get them back up before you can start treatment.
While you’re taking Inrebic (fedratinib), you’ll need to take vitamin B1 supplements. This will help prevent your levels from getting too low. Your care team will check your vitamin B1 levels as needed.
Watch for symptoms of Wernicke encephalopathy while taking Inrebic (fedratinib) . This can include trouble speaking or walking, confusion, or memory loss. It can also cause fast back-and-forth eye movements or double vision. If you notice any of these symptoms, get medical help right away.
Anemia and low platelets
Inrebic (fedratinib) can cause anemia, or low red blood cell count. It can sometimes drop dangerously low. On average, red blood cell counts go down during the first few months of treatment. Then, they can go back up a little and stay steady months later.
Inrebic (fedratinib) can also cause low platelet levels. This can sometimes be serious.
To help keep you safe, your hematologist or oncologist will check your blood counts with a blood test. This is done before you start Inrebic (fedratinib) and as needed during treatment. If your blood counts are too low, you might need to take a break from the medication or take a lower dose. If it’s serious, you also might need blood transfusions to keep your blood counts in a safe range.
Anemia can make you feel more tired than usual. And low platelets can make you bleed and bruise more easily. If this happens while you’re taking Inrebic (fedratinib), let your care team know. Get medical help right away if you have bleeding that’s hard to stop or blood in your urine or stool. These can be signs of serious bleeding.
Nausea, vomiting, and diarrhea
Common side effects of Inrebic (fedratinib) include nausea, vomiting, and diarrhea. These are usually mild or moderate but can still be uncomfortable. They often start in the first 2 weeks of treatment, sometimes even on the first day.
Talk to your care team about ways to help prevent stomach problems while taking Inrebic (fedratinib). Taking the medication with a high-fat meal might help with nausea and vomiting. Your oncologist or hematologist might also give you an antiemetic medication, like ondansetron (Zofran). For diarrhea, they might suggest taking over-the-counter medication like loperamide (Imodium A-D).
If these side effects don’t get better within 2 days of trying to manage them yourself, call your care team. You might need to take a break from Inrebic (fedratinib) and then restart at a lower dose later.
Serious liver problems
Inrebic (fedratinib) can sometimes cause higher liver enzyme levels. These lab results can be a sign of liver damage or irritation. It’s usually mild or moderate and rarely severe. Most times, these lab changes can happen about 1 month or so after starting the medication.
Before starting Inrebic (fedratinib), your oncologist or hematologist will check your liver enzyme levels with lab tests. They’ll keep checking periodically during treatment and as needed. If your test results are abnormal, you might need to pause treatment and then restart the medication later at a lower dose.
If you notice yellowing of your skin, yellowing of the whites of your eyes, or new belly pain, let your care team know. These can be signs of liver problems.
Higher digestive protein levels
It’s not common, but some people taking Inrebic (fedratinib) had high levels of certain digestive proteins. This includes high amylase and lipase levels. These lab changes can happen within the first month of treatment. Having high digestive protein levels can mean that your pancreas is irritated. If it gets too irritated, it might lead to pancreatitis or an inflamed pancreas.
Your oncologist or hematologist will check your amylase and lipase levels with lab tests. They’ll check before you start Inrebic (fedratinib), during treatment, and as needed. If your levels are high, you might need to stop the medication for a short time so you can recover. Then, you might restart the medication later at a lower dose.
Eye inflammation
It’s not common, but some people taking Inrebic (fedratinib) have had inflammation inside the eye (uveitis). This has happened several months after starting the medication and can come back. It can be mild or more serious.
Watch for signs of eye inflammation while taking Inrebic (fedratinib). This can include eye pain, redness, sensitivity to light, floaters, or unclear vision. If this happens, tell your care team. They’ll probably send you to an eye specialist. Treatment often includes steroid eye drops or other steroid medications.
Possible serious health outcomes, like heart-related death, heart attack, and stroke
- Risk factors: Risks for cardiovascular disease | Current or past smoker
People with rheumatoid arthritis (RA) who took a similar JAK inhibitor had a higher risk of serious health problems. These included heart-related death, heart attack, and stroke.
It’s important to know about this risk, even though Inrebic (fedratinib) isn’t used for RA. Tell your oncologist or hematologist about all your medical conditions and if you’ve smoked before. They can help decide if Inrebic (fedratinib) is safe for you. Talk to your oncologist or hematologist if you have concerns about this risk.
Call 911 right away if you have any signs of a heart attack or stroke. A heart attack can look like sudden chest pain, nausea, or sweating. And a stroke can cause a droopy face, sudden weakness on one side of the body, a sudden headache, or trouble walking or talking.
Possible blood clots
Some people with rheumatoid arthritis (RA) who took a similar JAK inhibitor had blood clots during treatment. This included deep vein thrombosis (DVT) and pulmonary embolism (PE).
Although Inrebic (fedratinib) isn’t used for RA, it works in a similar way and might have the same risk. Watch for symptoms of a blood clot like swelling or tenderness in one arm or leg, sudden chest pain, or trouble breathing. If this happens, get medical help right away.
New cancers
- Risk factors: Cancer | Current or past smoker
Some people with rheumatoid arthritis (RA) who took a different JAK inhibitor have had a higher risk of developing new cancers, such as lymphoma. The risk of having a new cancer appears to be higher in people who smoke.
Inrebic (fedratinib) isn’t approved for RA. But it’s important to be aware of the risk of possible new cancers during treatment. Tell your care team if you have cancer, are a smoker, or are a past smoker. They can discuss with you about the risks and benefits of taking Inrebic (fedratinib). Talk with your oncology or hematology care team if you’re worried about the risk of a new cancer.
Worsening of symptoms after pausing or stopping treatment
Don’t pause or stop taking Inrebic (fedratinib) without talking to your oncologist or hematologist. Your MF symptoms can get worse if you stop. This can include fever, breathing problems, low blood pressure, or other serious problems.
Your oncologist or hematologist can help decide if pausing or stopping Inrebic (fedratinib) is right for you. If it’s needed for other reasons besides serious side effects, your care team can tell you how to do this in a safe way. They'll lower your dose slowly before you can stop.
Inrebic (fedratinib) dosage
Typical dosage for Inrebic (fedratinib)
The typical dose is 400 mg by mouth once a day.
Your dose might be different if you have kidney problems. It also might be different if you take certain medications that interact with Inrebic (fedratinib).
Your oncologist or hematologist can adjust the dose if you have serious or bothersome side effects.
What are alternatives to Inrebic (fedratinib)?
News about Inrebic (fedratinib)



