SKYRIZI ®
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Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
 
This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

Why am I using Skyrizi?

Skyrizi contains the active ingredient risankizumab. Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
For more information, see Section 1. Why am I using Skyrizi? in the full CMI.

What should I know before I use Skyrizi?

Check the list of ingredients at the end of the CMI. Do not use Skyrizi if you have ever had an allergic reaction to any of them.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Skyrizi? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Skyrizi and affect how it works or Skyrizi may interfere with other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I use Skyrizi?

Skyrizi is injected under the skin. More instructions can be found in Section 4. How do I use Skyrizi? in the full CMI.

What should I know while using Skyrizi?

Things you should do
Ensure you are up to date with your immunisations before you start therapy with Skyrizi.
Speak to your doctor if you think you have an infection.
Remind any doctor or dentist you visit that you are using Skyrizi.
Things you should not do
Do not stop using this medicine or change the dose without checking with your doctor.
Driving or using machines
Skyrizi is not expected to have any effect on your ability to drive or use machines.
Drinking alcohol
There is no information on the effects of using Skyrizi with alcohol.
Looking after your medicine
Store Skyrizi in the refrigerator at 2°C to 8°C. Do not freeze.
Keep it in the original carton until it's time to inject it to protect it from light.
For more information, see Section 5. What should I know while using Skyrizi? in the full CMI.

Are there any side effects?

The more serious side effects include: Symptoms of a serious infection, including fever, flu-like symptoms, night sweats, feeling tired or short of breath, a cough that won't go away, warm, red, painful skin or painful rash with blisters.
The more common side effects include: upper respiratory infections with symptoms such as sore throat and stuffy nose, tiredness, headache, injection site reactions, itching, fungal skin infection.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
SKYRIZI ® (sky-ri-zee)
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Active ingredient: risankizumab (ri-zan-ki-zyu-mab)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Skyrizi. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Skyrizi.
Where to find information in this leaflet:

Why am I using Skyrizi?

Skyrizi contains the active ingredient risankizumab which is a type of protein called a monoclonal antibody. It works by stopping a protein in the body called IL-23 which causes inflammation.
Skyrizi is used to treat adults with moderate to severe plaque psoriasis by reducing the inflammation. Skyrizi improves skin clearance and the appearance of the nails. It also reduces the symptoms of psoriasis such as burning, itching, pain, redness and scaling.

What should I know before I use Skyrizi?

Warnings

Do not use Skyrizi if:

1. you are allergic to risankizumab, or any of the ingredients listed at the end of this leaflet.

2. you have an infection considered by your doctor to need special attention.

Check with your doctor if you:

have an infection now
have had an infection that keeps coming back
have or have had tuberculosis
have had a recent vaccination or are scheduled for any immunisations
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Make sure your doctor is aware that you are pregnant or plan to become pregnant or are breastfeeding or plan to do so.

Children

Skyrizi is not recommended for children younger than 18 years.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do this even though Skyrizi is not expected to be affected by other medicines, nor is it expected to interfere with other medicines.

How do I use Skyrizi?

How much to use

The dose is 150 mg given as two 75 mg injections.

1. Inject two 75 mg injections on the first day;

2. Inject two 75 mg injections on the same day 4 weeks later (Week 4);

3. Inject two 75 mg injections on the same day 12 weeks later (Week 16);

4. Continue injecting two 75 mg injections on the same day every 12 weeks.

Follow all the instructions given to you and continue to use Skyrizi until your doctor tells you to stop.

How to inject Skyrizi

Skyrizi is injected under the skin (subcutaneous injection).
It can be injected by the patient or by someone else, such as a family member, friend or carer.
An injection should not be attempted until proper training has been received on the correct injection technique.
Read the instructions for preparing and giving a Skyrizi injection that are supplied with the product.

If you forget to inject Skyrizi

It is important that you use your medicine as instructed.
If you miss your dose at the usual time, inject Skyrizi as soon as you remember, and continue injecting the next dose at the usual time on your next scheduled day.
Do not inject a double dose to make up for the dose you missed.

If you inject too much Skyrizi

You should immediately:
phone the Poisons Information Centre
( by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.

What should I know while using Skyrizi?

Things you should do

Ensure you are up to date with your immunisations before you start therapy with Skyrizi
Keep all your doctor’s appointments so your progress can be tracked.

Call your doctor straight away if you:

Have symptoms of an infection, such as fever, flu-like symptoms, night sweats.
Feeling tired or short of breath and have a cough that will not go away.
Become pregnant while using Skyrizi.
Remind any doctor or dentist you visit that you are using Skyrizi.

Things you should not do

Do not inject Skyrizi if the liquid looks cloudy or contains flakes or large particles.
Do not stop using this medicine or change the dose without checking with your doctor.

Driving or using machines

Skyrizi is not expected to have any effect on your ability to drive or use machines.

Drinking alcohol

There is no information on the effects of using Skyrizi with alcohol.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.
Keep Skyrizi in the refrigerator (at 2°C to 8°C). Do not freeze.
Keep the syringe in the carton to protect it from light.
The syringe can be taken out of the fridge 15 to 30 minutes before injected, provided it is kept in the carton. This may make the injection more comfortable.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.

When to discard your medicine

Throw away the used syringe immediately after injecting, as instructed by your doctor or nurse.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects
What to do
Upper respiratory tract infection:
sore throat
stuffy nose
Skin:
fungal skin infection, such as athlete's foot (tinea)
pain, or redness at the injection site
small raised red bumps on the skin
General:
headache
feeling especially tired
Speak to your doctor if you have any of these less serious side effects and they worry you.

More serious side effects

More serious side effects
What to do
Signs of a serious infection:
fever
flu-like symptoms
night sweats
feeling tired or short of breath
cough that won't go away
warm, red painful skin
painful skin rash with small red blisters
Call your doctor straight away, if you notice any of these serious side effects.
Very serious side effects
Very serious side effects
What to do
Signs of an allergic reaction:
difficulty breathing or swallowing
swelling of face, lips, tongue or throat
severe itching of skin, with a red rash or raised bumps
Go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

Product details

This medicine is only available with a doctor's prescription.

What Skyrizi contains

Active ingredient
(main ingredient)
risankizumab
Other ingredients
(inactive ingredients)
sodium succinate hexahydrate
succinic acid
sorbitol
polysorbate 20
water for injections
Do not take this medicine if you are allergic to any of these ingredients.
Skyrizi contains 34 mg sorbitol in each 75 mg/0.83mL injection.

What Skyrizi looks like

Skyrizi is a colourless to slightly yellow liquid and is supplied in a prefilled syringe with needle guard. The liquid may contain tiny white or clear particles. Do not use if liquid is cloudy or contains flakes or large particles. Two syringes are supplied per carton. The carton also contains two alcohol pads (AUST R 304226).

Who distributes Skyrizi?

SKYRIZI is distributed in Australia by:
AbbVie Pty Ltd
241 O'Riordan Street
Mascot NSW 2020
Australia
SKYRIZI is distributed in New Zealand by:
AbbVie Limited
6th Floor, 156-158 Victoria Street
Wellington 6011
New Zealand
This leaflet was prepared in October 2020.
Version 3

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