Risankizumab

• While taking risankizumab, you must see your rheumatologist regularly to ensure the treatment is working and to minimise any possible side effects.
• It is important to tell your rheumatologist if you have a new serious illness such as a serious infection or cancer.
• If you are worried about any side effects, you should contact your rheumatologist as soon as possible.
• If you stop risankizumab for any reason, you must contact your rheumatologist. Failure to do so may mean that your treatment may no longer be subsidised.
• If you are taking Risankizumab and plan to become pregnant, you must discuss the timing with your rheumatologist.

• Risankizumab is a medicine used for patients who have severe psoriatic arthritis. It helps reduce inflammation, which can ease pain, stiffness, and swelling in your joints. It can also improve psoriatic skin rash and protect your joints from further damage. By reducing these symptoms, risankizumab can make daily activities easier, lessen tiredness, and improve your quality of life. While it can be effective, it is normal for it to take some time to work. It may take several weeks for you to start noticing relief from joint swelling, pain and stiffness.

If you stop or delay your risankizumab treatment, your disease may get worse again.  Remain on your treatment, unless told by your rheumatologist to stop or unless serious side effects occur (see Side effects).
If you stop risankizumab for any reason, you must contact your rheumatologist. Failure to do so may mean that your treatment may no longer be subsidised.

• Medicines like risankizumab are very expensive and subsidised by Medicare. Certain conditions must be met to receive it.
• Risankizumab will only be given if your disease is active and if standard treatments have not worked.
• Blood tests are needed during your treatment to monitor the medicine and help determine if the treatment is working.
• How often you have blood tests will depend on what other medicines you are taking and what other illnesses you might have. Your rheumatologist can tell you more about this.

Risankizumab is injected under the skin of the abdomen or thigh (subcutaneous). It is best to avoid (if possible) any areas of skin involved with psoriasis. 

It can be injected by your doctor, nurse, carer or by yourself. If injecting yourself, be sure to follow the instructions carefully to ensure the best response. It is particularly important to change where you inject each time.

Before use, remove the carton from the refrigerator and keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes.

• The usual dose for adults with psoriatic arthritis is 150mg given as a pre-filled syringe or pre-filled pen. After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks thereafter.

Risankizumab may be used with other arthritis medicines including:
•    other 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)
•    pain medicines such as paracetamol.

Risankizumab cannot be used with other bDMARDs.

There are separate information sheets for the medicines mentioned above.

Your doctor will tell you how long to continue treatment with risankizumab. Most treatments for psoriatic arthritis are continued for years. If your disease is under control (in remission), some medications may be able to be weaned (reduced in dose).

Most people who take risankizumab do not experience side effects. Contact your doctor if you are worried about any side effects. Many side effects go away when you stop taking risankizumab.

Most common possible side effects

• The most common side effects with risankizumab are upper respiratory tract infections such as sinus infection, sore throat or headache or feeling especially tired. 
• Other less serious side effects include injection site reactions such as redness, pain and itching of the skin.
• These are usually mild. Tell your doctor if you are concerned, or if the side effects continues for a long time. 

Less common or rare possible side effects

• Less common side effects include injection site reactions (redness, pain and itching), nausea or diarrhoea.

There are some rare but potentially serious side effects with risankizumab

• Serious allergic reaction: signs of a serious allergic reaction may include a skin rash, a swollen face, lips, mouth or throat, or wheezing, dizziness, trouble swallowing or breathing.
• Tell your doctor or go to the hospital immediately if you have an allergic reaction as you need urgent medical attention. 
• Serious infections: risankizumab may lower your ability to fight infections. Signs of a serious infection include, fever, flu-like symptoms, feeling tired or short of breath, warm, red or painful skin. Some infections could become serious, and you may need to be admitted to hospital. If you have an infection before you start treatment with risankizumab, you must tell your doctor. If you get an infection while on risankizumab, tell your doctor straight away.
• Cancer: annual skin checks are recommended when using any medication that can suppress the immune system as there is a slight risk in increase in skin cancers. Tell your doctor if you have ever had any previous cancers of any kind.

Other side effects not listed in this leaflet may also occur. Tell your doctor if you notice any other side effects that you think might be caused by risankizumab.

Infections  

• Serious infections such as tuberculosis (TB) are seen rarely, but screening for TB, HIV and hepatitis B and C are needed before treatment begins.

Use with other medicines

• Risankizumab may interact with other medicines. You should tell all your doctors about all medicines you are taking or plan to take. This includes over the counter or herbal/naturopathic medicines.   

Vaccines

• If you are on risankizumab you should not get ‘live’ vaccines such as:  MMR (measles, mumps and rubella), OPV (oral polio virus), BCG (Bacillus Calmette Guerin), or Yellow Fever. Talk with your rheumatologist before getting any vaccines.  
• Pneumococcal, COVID-19 vaccines and the yearly seasonal flu vaccines are safe and recommended. Shingrix is also recommended as a safe and effective vaccine to protect you from shingles. 

For more information on vaccination please see: https://rheumatology.org.au/For-Patients/Vaccinations-in-Rheumatology or https://rheumatology.org.au/For-Patients/COVID-Information/COVID-Vaccination-Information

Surgery

• If you need surgery for any reason, risankizumab may need to be stopped before surgery. You can start taking it again after surgery when your surgeon and rheumatologist say it's okay. This is usually after your wound has healed and there is no infection.

Use with alcohol

• It is not known precisely what level of drinking is safe when on risankizumab, however there is general agreement that 1 to 2 standard drinks taken once or twice a week is unlikely to cause a problem. 
• It is strongly advised not to drink more than four standard drinks at one time, even if it doesn’t happen often.

Use in pregnancy and when breastfeeding  

• Not much is known about the possible effects of risankizumab on the unborn baby. Effective birth control measures are recommended while using risankizumab. If you get pregnant while taking risankizumab or plan to become pregnant, you should discuss this with your rheumatologist.
• Risankizumab use during breastfeeding has not been studied, however it is likely that little, if any, passes on to the unborn baby. Please speak to your rheumatologist for more information.

• Store risankizumab in a refrigerator between 2°C and 8°C. Do not freeze. Keep the product in the original carton to protect from light until the time of use. Do not shake the product. 

• Keep all medicines out of reach of children.  

• After injecting risankizumab, the used syringe or pen should be placed into a sharps container. Dispose of your sharps container according to your state or local regulations. If you are unsure of how to dispose of your sharps container, ask your pharmacist. 
• Do not put the used syringe or pen into your normal household or recycling waste. 
• If your doctor tells you to stop using risankizumab, or the expiry date has passed, ask your pharmacist what to do with the leftover medicine. 
• For more information, see ‘Your guide to Safe Disposal of Sharps’.