SKYRIZI 180 mg INJECTABLE SOLUTION IN CARTRIDGE
How to use SKYRIZI 180 mg INJECTABLE SOLUTION IN CARTRIDGE
Introduction
Package Leaflet: Information for the Patient
Skyrizi 180mg solution for injection in a cartridge
Skyrizi 360mg solution for injection in a cartridge
risankizumab
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Skyrizi and what is it used for
- What you need to know before you use Skyrizi
- How to use Skyrizi
- Possible side effects
- Storage of Skyrizi
- Contents of the pack and other information
- Instructions for use
1. What is Skyrizi and what is it used for
Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat adult patients with:
- moderate to severe Crohn's disease
- moderate to severe ulcerative colitis
How Skyrizi works
This medicine works by blocking a protein in the body called "IL-23" that causes inflammation.
Crohn's disease
Crohn's disease is an inflammatory disease of the digestive system. If you have active Crohn's disease, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn's disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine. If you have active ulcerative colitis, you may first be given other medicines. If these medicines do not work well enough or if you cannot take them, you will be given Skyrizi to treat your ulcerative colitis.
Skyrizi reduces inflammation and can help reduce the signs and symptoms of your disease.
2. What you need to know before you use Skyrizi
Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection that your doctor thinks is important, for example, active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you start using Skyrizi and during your treatment:
- if you have a current infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or are scheduled to receive a vaccine. Certain vaccines should not be given during treatment with Skyrizi.
It is important to keep a copy of the batch number of Skyrizi.
Each time you receive a new pack of Skyrizi, write down the date and batch number (which appears on the pack after "Lot") and keep this information in a safe place.
Allergic reactions
Talk to your doctor or seek medical attention immediately if you notice any signs of an allergic reaction while receiving Skyrizi, such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- intense itching of the skin, with a red rash or bumps
Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Skyrizi
Tell your doctor, pharmacist, or nurse:
- if you are using, have recently used, or might use any other medicines.
- if you have recently been vaccinated or are scheduled to be vaccinated. Certain vaccines should not be given during treatment with Skyrizi.
If in doubt, talk to your doctor, pharmacist, or nurse before using Skyrizi and during your treatment.
Pregnancy, contraception, and breastfeeding
If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine. You must do this because it is not known how this medicine will affect your baby.
If you are a woman who can become pregnant, you must use contraception while being treated with this medicine and for at least 21 weeks after your last dose of Skyrizi.
If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine.
Driving and using machines
Skyrizi is unlikely to affect your ability to drive or use machines.
Skyrizi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per cartridge; this is essentially "sodium-free".
3. How to use Skyrizi
Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If in doubt, talk to your doctor or pharmacist again.
This medicine is given by injection under the skin (called "subcutaneous injection").
How much Skyrizi to use
You will start treatment with Skyrizi at an initial dose that will be given to you by your doctor or nurse through a drip in your arm (intravenous infusion).
Initial doses
How much? | When? | |
Crohn's disease | 600 mg | When your doctor tells you |
600 mg | 4 weeks after the 1st dose | |
600 mg | 4 weeks after the 2nd dose |
Ulcerative colitis | How much? | When? |
1,200 mg | When your doctor tells you | |
1,200 mg | 4 weeks after the 1st dose | |
1,200 mg | 4 weeks after the 2nd dose |
After that, you will receive Skyrizi by injection under the skin.
Maintenance doses
Crohn's disease | How much? | When? |
1st maintenance dose | 360 mg | 4 weeks after the last initial dose (in week 12) |
Following doses | 360 mg | Every 8 weeks, starting after the 1st maintenance dose |
Ulcerative colitis | How much? | When? |
1st maintenance dose | 180 mg or 360 mg | 4 weeks after the last initial dose (in week 12) |
Following doses | 180 mg or 360 mg | Every 8 weeks, starting after the 1st maintenance dose |
You and your doctor, pharmacist, or nurse will decide if you could inject this medicine yourself. You must not inject this medicine yourself unless your doctor, pharmacist, or nurse has taught you how to do it. It is also possible that a caregiver who has learned how to do it will give you the injection.
Read section 7 "Instructions for use" at the end of this leaflet before giving yourself the Skyrizi injection.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or have given yourself the dose too early, talk to your doctor.
If you forget to use Skyrizi
If you forget to give yourself Skyrizi, you should give yourself a dose as soon as you remember. If in doubt, talk to your doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Talk to your doctor or seek medical attention immediately if you have any symptoms of a serious infection, such as:
- fever, flu-like symptoms, night sweats
- feeling tired or having trouble breathing, persistent cough
- heat, redness, and pain in the skin or a painful skin rash with blisters
Your doctor will decide if you can continue using Skyrizi.
Other side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects
Very common:may affect more than 1 in 10 people
- upper respiratory tract infections with symptoms such as sore throat and nasal congestion.
Common:may affect up to 1 in 10 people
- feeling tired
- fungal skin infections
- reactions at the injection site (such as redness or pain)
- itching
- headache
- rash
- eczema
Uncommon:may affect up to 1 in 100 people
- small red bumps on the skin
- hives (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Skyrizi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge label and on the outer carton after EXP.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
If necessary, the cartridge can also be stored at room temperature (up to 25°C) for a maximum of 24 hours.
Keep the cartridge in the original packaging to protect it from light.
Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Each body injector with cartridge is for single use only.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
Composition of Skyrizi
The active substance is risankizumab.
Skyrizi 180 mg solution for injection in a cartridge
- Each cartridge contains 180 mg of risankizumab in 1.2 ml of solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.
Skyrizi 360 mg solution for injection in a cartridge
- Each cartridge contains 360 mg of risankizumab in 2.4 ml of solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.
Appearance and packaging
Skyrizi is a clear, colorless to yellow liquid contained in a cartridge. The liquid may contain tiny transparent or white particles.
Each container contains 1 cartridge and 1 body injector.
Marketing authorization holder and manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien AbbVie SA Tel: +32 10 477811 | Lietuva AbbVie UAB Tel: +370 5 205 3023 |
| Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tel: +32 10 477811 |
Ceská republika AbbVie s.r.o. Tel: +420 233 098 111 | Magyarország AbbVie Kft. Tel: +36 1 455 8600 |
Danmark AbbVie A/S Tlf: +45 72 30-20-28 | Malta V.J.Salomone Pharma Limited Tel: +356 22983201 |
Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (toll-free) Tel: +49 (0) 611 / 1720-0 | Nederland AbbVie B.V. Tel: +31 (0)88 322 2843 |
Eesti AbbVie OÜ Tel: +372 623 1011 | Norge AbbVie AS Tlf: +47 67 81 80 00 |
Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. Τηλ: +30 214 4165 555 | Österreich AbbVie GmbH Tel: +43 1 20589-0 |
España AbbVie Spain, S.L.U. Tel: +34 91 384 09 10 | Polska AbbVie Sp. z o.o. Tel: +48 22 372 78 00 |
France AbbVie Tél: +33 (0) 1 45 60 13 00 | Portugal AbbVie, Lda. Tel: +351 (0)21 1908400 |
Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 501 | România AbbVie S.R.L. Tel: +40 21 529 30 35 |
Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenija AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060 |
Ísland Vistor hf. Tel: +354 535 7000 | Slovenská republika AbbVie s.r.o. Tel: +421 2 5050 0777 |
Italia AbbVie S.r.l. Tel: +39 06 928921 | Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 |
Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40 | Sverige AbbVie AB Tel: +46 (0)8 684 44 600 |
Latvija AbbVie SIA Tel: +371 67605000 |
Date of last revision of this prospectus:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Detailed and updated information on this product is available below or on the outer packaging by scanning the QR code through a smartphone. The same information is also available on the following website: www.skyrizi.eu
QR code to be included
To request a copy of this prospectus in
- Instructions for use
Read the entire section7 before using Skyrizi
Skyrizi body injector
Front view Material adhesive | Status light | Start button Do not touch until ready to inject |
Gray door Do not close the gray door without the cartridge inside | Medicine window | Tab |
Rear view
Transparent plastic strip | Needle protector | Adhesive coating |
| Be careful. Needle inside (under the needle protector) Do not touch the needle protector area or the needle | |
Small green tab | Large green tab |
Lateral view
Door closure The opening side has grooves The gray door should be slightly open Do not close the gray door without the cartridge inside Needle protector Needle inside (under the needle protector) Do not touch the needle protector area or the needle |
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Cartridge
The white plunger moves through the chamber toward the bottom of the cartridge as the medicine is injected. Medicine Smaller bottom tip |
| Larger top part of the cartridge Do not turn or remove Expiry date (EXP) Located on the cartridge label |
Important information you should know before injecting Skyrizi
- You must have received training on how to inject Skyrizi before administering an injection. If you need help, consult your doctor, pharmacist, or nurse
- Mark the dates on a calendar to know when it's time to inject Skyrizi
- The single-use body injector is designed for use only with the Skyrizi cartridge
- Keep Skyrizi in its original packaging to protect the medicine from light until the time of use
- Remove the box from the refrigerator and let it sit at room temperature, away from direct sunlight, for at least 45 and up to 90minutesbefore injection
- Do notget the body injector wet with water or any other liquid
- Do nottouch the start button until you place the loaded body injector on the skin and are ready to inject
- You can only press the start button once
- During the injection process, limit physical activity. You can perform moderate physical activities, such as walking, stretching, or bending
- Do notdelay the injection of the medicine once the clean cartridge is loaded into the body injector. If you wait, the medicine will dry out and the body injector will stop working
- Do notinject the medicine if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should be clear to yellow in color and may contain tiny transparent or white particles
- Do notshake the box, cartridge, or body injector
- Do notreuse the cartridge or body injector
Return this medicine to the pharmacy
- after the expiry date (EXP) indicated
- if the liquid has been frozen at any time (even if it has been thawed)
- if the cartridge or body injector has been dropped or damaged
- if the perforations on the box are broken
- if the white paper cover of the tray is missing or broken
Follow these steps each time you use Skyrizi
STEP1: Prepare | ||||||||||||||||||||
| Remove the box from the refrigerator and let it sit at room temperature, away from direct sunlight, for at least 45 and up to 90minutesbefore injection.
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Special waste container
| Gather all materials and wash your hands On a smooth and clean surface, place the following:
Wash and dry your hands. | |||||||||||||||||||
| Remove the white paper seal from the tray
Lift the plastic cover
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Gray door Start button Needle inside(under the needle protector) | Inspect the body injector
If the gray start button is pressed before placing the injector on the body, the body injector can no longer be used. If this happens, inform your doctor, pharmacist, or nurse. | |||||||||||||||||||
STEP2: Prepare the body injector | ||||||||||||||||||||
Gray door
Rear view Needle inside(under the needle protector) Needle protector | Open the gray door all the way
Set the body injector aside. | |||||||||||||||||||
Larger top part of the cartridge
Smaller bottom tip | Inspect the cartridge Carefully remove the cartridge from the plastic tray.
Check the cartridge
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Smaller bottom tip Clean the center of the smaller bottom tip | Clean the smaller bottom tip of the cartridge Locate the smaller bottom tip of the cartridge
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Insert straight "click"
| Load the clean cartridge into the body injector
Make sure to proceed with the next step immediately. If you wait, the medicine will dry out. | |||||||||||||||||||
"snap" | Close the gray door Turn the gray door to the left, then press firmly and you will hear a "snap" when the gray door closes
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STEP3: Prepare the injection | ||||||||||||||||||||
Injection sites
Injection sites | Choose and clean the injection site Choose one of these 3 areas for the injection:
Do notinject into skin areas with folds or natural protrusions, as the body injector may fall during use. Before injection, clean the injection site with an alcohol wipe using circular motions.
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Small section Large section
Needle inside (under the needle protector) Activated injector The status light flashes blue | Peel off both tabs to expose the skin adhesive Flip the body injector over to locate the two green tabs
Remove the large section using the green tab to expose the skin adhesive Remove the small section using the green tab to expose the skin adhesive. This will also remove the transparent plastic strip and activate the body injector.
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