upadacitinib

What is the most important information I should know about upadacitinib?

Taking upadacitinib may 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 have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis, shingles, or HIV. Also tell your doctor if you've ever had diverticulitis, an ulcer in your stomach or intestines, cancer, heart problems, or a history of smoking, heart attack, stroke, or blood clots.

What is upadacitinib?

Upadacitinib is used to treat moderate to severe rheumatoid arthritis in adults after other treatments have failed.

Upadacitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking upadacitinib?

• 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.

How should I take upadacitinib?

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

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking upadacitinib?

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of upadacitinib?

• 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.

• 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.

What other drugs will affect upadacitinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect upadacitinib, especially:

• phenytoin;
• an antibiotic --clarithromycin, rifampin;
• antifungal medicine --fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
• drugs that weaken the immune system --azathioprine, cyclosporine, and others;
• NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• steroid medicine --dexamethasone, prednisone, and others.

This list is not complete and many other drugs may affect upadacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about upadacitinib.