Rinvoq (upadacitinib)

Reviewed by: HU Medical Review Board | Last reviewed: August 2023

Rinvoq® (upadacitinib) is approved to treat some adults with moderate or severe Crohn's disease or ulcerative colitis (UC). Before starting Rinvoq, users must have tried at least 1 tumor necrosis factor (TNF) blocker. If it did not work or the user could not tolerate it, they can start using Rinvoq. TNF blockers are a different type of drug that may be used to treat UC.1,2

Rinvoq is approved to treat other conditions, such as arthritis and eczema (atopic dermatitis). It is also approved to treat children with some of these conditions. However, Rinvoq is only approved to treat adults with UC.1

What are the ingredients in Rinvoq?

The active ingredient in Rinvoq is upadacitinib.1

How does Rinvoq work?

Rinvoq is a type of drug called a Janus kinase (JAK) inhibitor. JAK inhibitors treat many different conditions. They work by targeting certain kinases, which are a type of protein that cells use for many different functions.1

Rinvoq inhibitors work by targeting JAK. These kinases have a role in signaling the body’s inflammation response. By targeting this kinase, Rinvoq interrupts the signal. This can reduce the inflammation caused by conditions like Crohn's disease and UC.1

What are the possible side effects?

The most common side effects of Rinvoq include:1

  • Upper respiratory tract infections, such as colds or sinus infections
  • Acne
  • Cold sores
  • Rash
  • Inflammation or infection of the hair follicules (folliculitis)
  • Flu
  • Shingles
  • Increased blood cholesterol levels
  • Increased creatine phosphokinase (CPK), which measures injury or stress to muscles, your heart, or brain
  • Low number of some types of white blood cells

Rinvoq has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because taking Rinvoq can increase your risk of severe and life-threatening side effects, including:1

  • Serious infections such as tuberculosis (TB)
  • Heart failure, heart attack, or stroke
  • Certain cancers, including lymphomas and lung cancers
  • Blood clots

Other serious side effects of Rinvoq may include:1

  • Allergic reactions
  • Tears in the stomach or intestines
  • Changes in certain lab test results, including low white and red blood cell counts, high cholesterol levels, and high liver enzymes

These are not all the possible side effects of Rinvoq. Talk to your doctor about what to expect when taking Rinvoq. You also should call your doctor if you have any changes that concern you when taking Rinvoq.

Other things to know

Rinvoq lowers the immune system. This can make you more likely to get infections. Call your doctor right away if you have any signs of infection while taking Rinvoq, such as:1

  • Fever or chills
  • Shortness of breath
  • Unusual tiredness
  • Cough
  • Muscle aches

Your doctor should test you for TB before starting treatment with Rinvoq. You should also be monitored for signs and symptoms of TB during treatment.1

You should not take Rinvoq if you have any kind of infection unless your doctor says it is okay. You may be at higher risk of developing shingles (herpes zoster).1

Before starting Rinvoq, tell your doctor if you:1

  • Are being treated for an infection or have had an infection that does not go away or keeps coming back
  • Are a current or past smoker
  • Have diabetes, chronic lung disease, HIV, or a weak immune system
  • Have had a heart attack, other heart problems, or stroke
  • Have liver or kidney problems
  • Have TB or have been in close contact with someone with TB
  • Have had shingles
  • Have or have had hepatitis B or C
  • Have unexplained stomach pain, have a history or diverticulitis or ulcers in your stomach or intestine, or are taking non-steroidal anti-inflammatories (NSAIDs)
  • Have low red or white blood cell counts
  • Have recently received or are scheduled to receive any vaccines
  • Live, have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valley and the Southwest) where there is an increased risk of getting certain kinds of fungal infections
  • Think you have an infection or have symptoms of an infection

Rinvoq can harm an unborn baby. If you can become pregnant, you should use birth control during treatment and for some time after the last dose of Rinvoq. You should also not breastfeed during treatment with Rinvoq and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Rinvoq.1

Before beginning treatment for IBD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. You may have side effects if you take Rinvoq along with other drugs, including medicines:1

  • For fungal or bacterial infections
  • For neurological disorders
  • That affect your immune system

For more information, read the full prescribing information of Rinvoq.

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