Upadacitinib

Updated June 2025

What is Upadacitinib?

Download button - information sheetUpadacitinib (brand name: Rinvoq®) is a medicine that belongs to a group of medicines called Janus Kinase (JAK) inhibitors. JAK inhibitors work by blocking signals involved in inflammation. Blocking these signals in rheumatoid arthritis and other conditions caused by inflammation results in less joint pain, stiffness, swelling and damage.

Important things to remember

  • You must see your rheumatologist regularly to make sure the treatment is working and check for possible side effects.
  • You should have regular blood tests as suggested by your rheumatologist.
  • It is important to tell your doctor if you have serious infections, including shingles while taking upadacitinib 
  • It is important to tell your doctor if you get a new illness such as cancer, heart failure or stroke.
  • If you are worried about any side effects, you should contact your rheumatologist as soon as possible.
  • If you stop upadacitinib for any reason, you must contact your rheumatologist. 
  • You need to see your local doctor regularly to make sure you are being checked for high blood pressure and cholesterol.
  • If you are taking upadacitinib and plan to become pregnant, you must discuss the timing with your rheumatologist.

TGA boxed warning

Upadacitinib should only be used if no suitable treatment alternatives are available in patients:

  • With a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers).
  • With malignancy risk factors (e.g. current malignancy or history of malignancy).
  • Who are 65 years of age and older.

What benefit can you expect from your treatment?

  • You may notice some relief of joint swelling, pain and stiffness in the first 2 to 4 weeks after starting treatment. It can take 3 months for it to have full effect.

Stopping upadacitinib

If you stop your upadacitinib treatment, your condition may get worse. Keep taking upadacitinib, unless advised by your rheumatologist to stop or unless serious side effects occur (see Side effects).

If you stop upadacitinib for any reason, you must contact your rheumatologist. 

 

How will you be checked while on upadacitinib?

You will need to have regular check-ups with your rheumatologist as well as blood tests to monitor your condition and how well your treatment is working. The blood tests will also check for any possible side (harmful) effects.

How is upadacitinib taken?

Upadacitinib is taken as a tablet. It is a modified release tablet which means it slowly is released into your body. This also means it must be swallowed whole and should not be crushed, broken or chewed.

When should it be taken?

Take upadacitinib with a full glass of water, preferably at the same time each day, but it is better to take it a bit late than not at all. It can be taken with or without food.

If you miss a dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
 

What is the dosage?

The usual dose for adults with rheumatoid arthritis and other inflammatory conditions is 15mg taken once a day.

Can other medications be taken with upadacitinib?

Upadacitnib may be used on its own or with other arthritis medicines including: 

  • Other disease modifying anti rheumatic drugs (DMARDs) such as methotrexate. 
  • Steroid medicines such as prednisolone or cortisone injections into the joint.  
  • Anti-inflammatory medicines (NSAIDs) such as naproxen (Naprosyn®) or ibuprofen (Brufen®, Nurofen®). 
  • Simple pain medicines such as paracetamol.

There may be times where these medicines may not be right for you, always check with your doctor before taking these medicines.

Upadacitinib cannot be used with other biologic DMARDs or other JAK inhibitors (such as baricitinib, tofacitinib, etanercept and adalimumab).  
 

Are there any side effects?

Tell your doctor if you notice side effects that you think are caused by this medicine. Many side effects disappear when upadacitinib treatment is stopped.

Most common possible side effects:

The most common side effects in people who take upadacitinib are mild upper respiratory tract infections (runny nose, sore throat, sinus infections), nausea, cough, and fever. upadacitinib may need to be stopped for a while if you have an infection, so it is important to talk to your doctor for advice. 

Less common or rare possible side effects:

  • Blood clots in the veins of the legs, lungs and arteries are possible in some people taking upadacitinib. 
  • Upadacitinib increases the risk of getting shingles. If you get a painful skin rash with blisters inform your doctor immediately. Vaccination for shingles should be discussed with your rheumatologist before starting treatment. 
  • Serious infections such as tuberculosis (TB) are seen rarely, and screening for TB is needed before treatment begins.
  • You will need to have blood tests to check your cholesterol levels and liver function because these can sometimes be affected by upadacitinib.
  • Upadacitinib may increase the chance of bowel perforation, although this is rare. 
  • People with rheumatoid arthritis and similar conditions are at increased risk of lymphoma and some other cancers. Medicines that change your immune system like upadacitinib may increase this risk. 
  • Skin cancers have also been reported in people taking upadacitinib and yearly skin checks are recommended.
  • It is recommended that patients remain up to date with their age recommended cancer screens such as mammogram and bowel cancer screening.
  • If you experience any side effects, please inform your doctor or pharmacist promptly.

 

What precautions are necessary?

Infections

If you have an active infection of any kind, treatment with upadacitinib will not be started until the infection is treated successfully. 

Cardiovascular risk
People with rheumatoid arthritis and other inflammatory conditions have an increased risk of heart attacks and strokes. Recent reports have associated some other JAK inhibitors with an increased risk of heart attacks and similar heart problems. Ensure your doctor is aware of any problems that might increase your risk of heart problems (e.g. high blood pressure, high cholesterol, smoking) so they can be treated.

Use with other medications  

Some medicines can affect how well upadacitinib works and upadacitinib might also affect how well other medicines work. 
Medicines that may change how upadacitinib works include: 

  • Antifungals & antibiotics including ketoconazole, itraconazole, posaconazole or voriconazole, clarithromycin, rifampicin and phenytoin.
  • Some medicines may increase your risk of infection including those used to suppress your immune system including phenytoin, azathioprine, ciclosporin and tacrolimus. 
  • Other medicines may require extra monitoring as they may increase the risk of side effects when taking upadacitinib including: NSAIDs, opioids and corticosteroids.

This list does not include all the medicines that might interfere with upadacitinib. You should tell your doctor and pharmacist all of the medicines you are taking or plan to take. This includes over the counter or herbal/naturopathic medicines to see if these affect upadacitinib.
 

Use with alcohol

You may drink alcohol while taking upadacitinib. However, if you are also taking methotrexate you should be cautious about how much alcohol you drink. 

Vaccines

If you are taking upadacitinib you should not have ‘live’ vaccines such as:

  • MMR (measles, mumps and rubella)
  • Varicella (chicken pox)
  • OPV (oral polio virus)
  • BCG (bacillus calmette guerin) 
  • Japanese Encephalitis or Yellow Fever.

Talk with your rheumatologist before receiving any vaccines.

Pneumococcal and the yearly seasonal flu vaccinations are encouraged.

For more information on vaccination including the COVID-19 vaccination go to click here

Surgery

Depending on the surgery, you will probably need to stop upadacitinib before surgery, usually one week before surgery. It will be restarted again after the operation at a time agreed by your surgeon and rheumatologist.

Use in pregnancy and when breastfeeding

  • It is important to inform your doctor if you are planning a pregnancy while on upadacitinib.
  • Upadacitinib should not be used during pregnancy. Women who can become pregnant should use effective birth control both during treatment and for 4 weeks after the final dose of upadacitinib.
  • Do not breastfeed if you are taking upadacitinib as it is uncertain how much of the medicine passes into breastmilk. 
  • More detailed information is available at here.

How to store upadacitinib

  • Store upadacitinib in a cool, dry place, away from direct heat and light (e.g. not in the bathroom).
  • Keep all medicines out of reach of children.