Upadacitinib

This information sheet has been produced by the Australian Rheumatology Association to help you understand the medication that has been prescribed for you. It includes important information about:

• how you should take your medication
• what are the possible side effects 
• what tests you will have to monitor your condition 
• other precautions you should take while you are taking upadacitinib.

Please read it carefully and discuss it with your doctor. This information sheet is not intended to replace the product information or discussion with your rheumatologist.

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.

• You may notice some relief of joint swelling, pain and stiffness within the first 2 to 4 weeks of treatment, though it can take up to 3 months to improve.
• The benefits of continuing upadacitinib will be reviewed at each clinic appointment and it is important you advise your treating rheumatologist of any new medical conditions at each visit. 
   

If you stop or delay your upadacitinib treatment, your disease may get worse. Keep taking your treatment, 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. Failure to do so may mean that your treatment may no longer be funded.
 

• Upadacitinib will only be given if your disease is active and if standard treatments have not worked.
• Upadacitinib will only be continued if it helps your condition. This will be checked around 12 weeks after the start of your treatment.
• Blood tests are needed during your treatment to monitor for side effects and to assess if the treatment is working.
• How often you have blood tests will depend on what other medications you are taking and what other illnesses you have. Your rheumatologist will advise on this.

Upadacitinib is taken by mouth in tablet form. It is a modified release tablet and must be swallowed whole. Do not crush, break or chew the tablet.

Take this medication with a full glass of water at the same time each day. 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 medication to make up for a missed dose.
 

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

This medication may be used alone or with other arthritis medications including: 

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

There may be some instances where these medications may not be right for you, always check with your doctor prior to taking any of these medications.

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

You might experience side effects with your treatment. Tell your doctor if you notice side effects that you think are caused by this medication. Many side effects disappear when upadacitinib treatment is stopped. 

Most common possible side effects:

The most common side effects reported are mild upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. Infections may need treatment and upadacitinib may need to be stopped for a while if you develop infection, so it is important to contact 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. This can happen more often in patients with an inflammatory condition. Other risk factors including heart disease will be assessed by your doctor.  
• Serious infections such as tuberculosis (TB) are seen rarely, and screening for TB is needed before treatment begins.
• Increases in cholesterol levels occur in some patients when taking upadacitinib. This will be monitored using blood tests.
• Changes in liver function can occur, it is recommended to have regular liver function tests to monitor this. 
• 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.
• Upadacitinib may increase the chance of bowel perforation, although this is rare. 
• People with rheumatoid arthritis and other inflammatory conditions are at increased risk of lymphoma and some other cancers. Medications 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.

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 cardiovascular disorders. Recent reports have associated some JAK inhibitors with an increased risk of heart related events. Ensure your doctor is aware of any pre-existing risk factors (e.g. high blood pressure, high cholesterol, smoking status) so they can be appropriately managed.

Use with other medications  
Some medications may not be used with upadacitinib as it may change their effectiveness and how well upadacitinib may work for you. Medications that may change how upadacitinib works include: 

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

This list is not exhaustive. You should inform your doctor and pharmacist of all of the medications you are taking or plan to take. This includes over the counter or herbal/naturopathic medications 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 be immunised with ‘live’ vaccines such as:

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

Talk with your rheumatologist before receiving any vaccines.

Pneumococcal vaccines and the yearly seasonal flu vaccinations are encouraged.

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

Surgery
If you require surgery for any reason, treatment with upadacitinib should be stopped 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 of childbearing potential 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 medication might be excreted in breastmilk.

More detailed information is available here.

• 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.