Side Effects
What’s the most important information to know about side effects?
It’s important to understand the possible side effects of treatment. Talk to your doctor about any side effects that you may experience.
INREBIC may cause serious side effects, such as 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 B1 vitamin 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.
INREBIC can cause serious side effects, including:
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.
Increased risk of major cardiac events such as heart attack, stroke, or death in people
who have cardiovascular risk factors and who are current or past smokers while using
another JAK inhibitor to treat rheumatoid arthritis
Get emergency help right away if you have any symptoms of a heart attack or stroke
while taking 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
Increased risk of blood clots
Blood clots in the veins of your 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
Possible increased risk of 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. People who smoke or
who smoked in the past have an added 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 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.
Talk to your doctor or pharmacist about side effects, including gastrointestinal
(GI) side effects. If you do have GI side effects such as nausea, vomiting and
diarrhea, your doctor may:
- Adjust or stop your dose
- Tell you to take your dose with a high fat meal
- Give you certain medicines to help treat your nausea, vomiting, and
diarrhea
Call your doctor or get emergency medical help right away if you have nausea,
vomiting, or diarrhea that does not get better with treatment.
