Inrebic is a prescription medication used to treat adults with certain types of myelofibrosis (MF), an uncommon bone marrow cancer.

Inrebic belongs to a group of drugs called kinase inhibitors. Kinases are enzymes that promote cell growth. Kinase inhibitors can slow the growth of cancer cells by blocking these enzymes from working.

This medication comes as a capsule to take by mouth. It is usually taken once a day, with or without food. Taking Inrebic with a high fat meal may help to reduce nausea and vomiting.

Common side effects include diarrhea, nausea and vomiting, and low red blood cell counts.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects may occur. See "Inrebic Precautions" section.

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-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• clarithromycin (Biaxin, in PrevPac)
• diltiazem (Cardizem, Dilacor, Tiazac, others)
• erythromycin (E.E.S., E-mycin, Erythrocin) 
• idelalisib (Zydelig)
• indinavir (Crixivan)
• itraconazole (Sporanox) 
• ketoconazole (Nizoral) 
• metoprolol (Lopressor, Toprol XL, in Dutoprol, others)
• midazolam (Versed)
• nefazodone 
• nelfinavir (Viracept)
• omeprazole (Prilosec, in Zegerid) 
• ribociclib (Kisqali, Kisqali, in Femera) 
• ritonavir (Norvir)
• ruxolitinib (Jakafi) 
• saquinavir (Invirase)

This is not a complete list of Inrebic drug interactions. Ask your doctor or pharmacist for more information.

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 before starting and during treatment with Inrebic. Your healthcare provider may tell you to stop taking Inrebic and take a vitamin B1 supplement if you develop side effects during treatment with Inrebic.

Call your healthcare provider right away if you develop diarrhea, nausea, or vomiting that does not respond to treatment.

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 rapid weight loss or weight loss that does not get better with treatment.

• Low blood cell counts. Inrebic may cause 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.

• Nausea, vomiting, and diarrhea. Your healthcare provider may give you certain medicines to help treat your nausea, vomiting, and diarrhea. Call your healthcare provider or get emergency medical help right away if you have nausea, vomiting, or diarrhea that does not get better with treatment.

• Liver problems. 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 changes 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.

Grapefruit and grapefruit juice may interact with Inrebic and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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

• have low red blood cell or platelet counts
• have or have had liver problems
• have or have had kidney problems
• 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.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

Do not breastfeed during treatment with Inrebic and for at least 1 month after your final dose. 

• 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.
• 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.
• If you miss a dose of Inrebic, skip the missed dose and take your next dose at your regular time. Do not take 2 doses to make up for the missed dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage of Inrebic is 400 mg taken orally once daily for patients with a baseline platelet count of greater than or equal to 50 × 109/L.

If you take too much Inrebic call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Inrebic below 86°F (30°C).

Keep Inrebic and all medicines out of the reach of children.

WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S

Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.