Rinvoq (upadacitinib)

Generic name: upadacitinib (ue PAD a SYE ti nib)
Brand name: Rinvoq
Drug class: Antirheumatics

Rinvoq (upadacitinib) is a prescription medicine that is a Janus kinase (JAK) inhibitor.

Rinvoq is used to treat adults with moderate to severe rheumatoid arthritis in patients that could not tolerate methotrexate or if treatment with methotrexate did not work well.

It is not known if Rinvoq is safe and effective in children under 18 years of age.


Rinvoq affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

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

Before taking this medicine

You should not use Rinvoq if you have any kind of infection.

To make sure Rinvoq is safe for you, 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 Rinvoq 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.

Upadacitinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 weeks after your last dose.

You should not breastfeed while using Rinvoq and for at least 6 days after your last dose.

Rinvoq is not approved for use by anyone younger than 18 years old.

How should I take Rinvoq?

Take Rinvoq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Before you start treatment with Rinvoq, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

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.

Rinvoq 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.

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

Dosing information

Usual Adult Dose for Rheumatoid Arthritis:

15 mg orally once a day

-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

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

Rinvoq side effects

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

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • 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.

Also call your doctor at once if you have:

  • 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 Rinvoq 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 Rinvoq?

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 interact with Rinvoq, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.