warnings

What is the most important information I should know about Upadacitinib (Rinvoq)?

Taking upadacitinib can increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:

a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);
any type of cancer;
kidney disease, a kidney transplant, or if you are on dialysis;
diverticulitis, an ulcer in your stomach or intestines;
heart problems;
a heart attack, stroke, or blood clot;
high cholesterol; or
if you've ever smoked.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Also tell your doctor if you have ever had:

liver disease (especially hepatitis B or C);
chronic lung disease;
diabetes;
low red or white blood cells; or
if you are scheduled to receive any vaccine.

Using upadacitinib may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Use effective birth control while using upadacitinib and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 6 days after your last dose.

Not approved for use by anyone younger than 18 years old.

Side Effects

What are the side effects of Upadacitinib (Rinvoq)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking upadacitinib have developed heart attacks, strokes, or serious blood clots. Stop taking upadacitinib and seek emergency medical attention if you have:

sudden shortness of breath;
chest pain or pressure that may spread to your jaw, shoulder, arms, or back;
nausea, vomiting, cold sweat;
a light-headed feeling, like you might pass out;
weakness on one side of your body;
slurred speech, drooping on one side of your mouth; or
pain, swelling, or redness in an arm or a leg.

Call your doctor at once if you have:

fever, chills, night sweats, constant tiredness;
wheezing, trouble breathing, severe or worsening cough;
increased urination, pain or burning when you urinate;
unexplained weight loss;
lumps in your neck, armpits, or groin;
signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body;
a hole (perforation) in your digestive tract--fever, severe stomach pain, diarrhea or changes in bowel habits; or
signs of hepatitis--loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

fever;
cough;
nausea; or
cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Guidelines & Tips

How to take Upadacitinib (Rinvoq)?

Use Upadacitinib (Rinvoq) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine with a full glass of water.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster) or hepatitis B or C, using upadacitinib can cause these viruses to become active or get worse.

Store upadacitinib in the original container at room temperature, away from moisture and heat.

What should I do if I missed a dose of Upadacitinib (Rinvoq)?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.