upadacitinib

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

You should not start taking upadacitinib if you have any kind of infection. Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

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?

Tell your doctor if you have ever had:

• a chronic infection;
• liver or kidney disease;
• hepatitis B or C;
• a stomach or intestinal problem such as diverticulitis or an ulcer;
• a perforation (a hole or tear) in your esophagus, stomach, or intestines;
• a blood clot;
• cancer;
• low red or white blood cell counts;
• a weak immune system (caused by disease or by using certain medicine);
• herpes zoster (also called shingles);
• high cholesterol;
• lung disease;
• diabetes; or
• if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

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?

Before you start treatment with 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.

Upadacitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

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?

Do not receive a "live" vaccine while using upadacitinib. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of upadacitinib?

• fever, chills, sweating;
• skin sores;
• tiredness, muscle pain;
• increased urination, pain or burning when you urinate;
• stomach pain, diarrhea, weight loss; or
• cough, shortness of breath, coughing up pink or red mucus.

Further doses may be delayed until your infection clears up.

• shingles --burning pain, numbness, tingling, itching, skin rash or blisters;
• signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg --swelling, warmth, or redness in the leg;
• signs of perforation (a hole or tear) in your stomach or intestines --fever, ongoing stomach pain, change in bowel habits; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

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 other medicines, 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. Other drugs may affect upadacitinib, including 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 pharmacist can provide more information about upadacitinib.