IMPORTANT SAFETY INFORMATION about RINVOQ® (upadacitinib)
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. You may be at higher risk of developing shingles (herpes zoster).
- Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
- Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer.
- Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
- Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
- Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection, such as:
- - Fever, sweating, or chills
- - Shortness of breath
- - Warm, red, or painful skin or sores on your body
- - Muscle aches
- - Feeling tired
- - Blood in phlegm
- - Diarrhea or stomach pain
- - Cough
- - Weight loss
- - Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
- Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
- Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I do or tell my HCP AFTER starting RINVOQ?
- Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
- Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, 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
- Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
- - Swelling
- - Pain or tenderness in the leg
- - Sudden unexplained chest pain
- - Shortness of breath
- Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
What are the common side effects of RINVOQ?
These include upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg extended-release tablets.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.