Skyrizi 180 mg solution for injection in cartridge
SpainTable of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Skyrizi is and what it is used for
- 2. What you need to know before using Skyrizi
- 3. How to use Skyrizi
- 4. Possible adverse effects
- 5. Storage of Skyrizi
- 6. Contents of the container and additional information
- Each package contains 1 cartridge and 1 body injector.
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Skyrizi 180mg solution for injection in cartridge
Skyrizi 360mg solution for injection in cartridge
risankizumab
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Skyrizi is and what it is used for
- What you need to know before using Skyrizi
- How to use Skyrizi
- Possible side effects
- How to store Skyrizi
- Contents of the pack and other information
- Instructions for use
1. What Skyrizi is and what it is 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 condition of the digestive tract. If you have active Crohn’s disease, you may first be given other medications. If these medications do not work well enough, Skyrizi will be given 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 medications. If these medications do not work well enough or if you cannot take them, Skyrizi will be given to treat your ulcerative colitis.
Skyrizi reduces inflammation and, therefore, may help reduce the signs and symptoms of your disease.
2. What you need to know before using Skyrizi
Do not use Skyrizi
- if you are allergic to risankizumab or to any of the other ingredients of this medicine (listed in section 6).
- if you have an infection that your doctor considers serious, for example, active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting Skyrizi and during your treatment:
- if you currently have an infection or if you have a recurring infection.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive any vaccine. Certain vaccines should not be given during treatment with Skyrizi.
It is important to keep a record of the Skyrizi batch number.
Each time you receive a new Skyrizi package, note the date and the batch number (shown on the package after “Lot”) and keep this information in a safe place.
Severe allergic reactions
Skyrizi may cause serious side effects, including severe allergic reactions (“anaphylaxis”).
Contact your doctor or seek immediate medical attention 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
- low blood pressure, which may cause dizziness or lightheadedness
- intense itching of the skin, with a red rash or lumps
Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age, as the use of Skyrizi has not been studied in this age group.
Other medicines and Skyrizi
Inform your doctor, pharmacist, or nurse:
- if you are taking, have recently taken, or might need to take any other medicines.
- if you have recently been vaccinated or plan to be vaccinated. Certain vaccines should not be given during treatment with Skyrizi.
If in doubt, consult your doctor, pharmacist, or nurse before using Skyrizi and during your treatment.
Pregnancy, contraception, and breastfeeding
If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This is necessary because it is unknown how this medicine will affect the baby.
If you are a woman of childbearing potential, you must use contraception during treatment with this medicine and for at least 21 weeks after your last dose of Skyrizi.
If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Skyrizi will affect your ability to drive or operate machinery.
Skyrizi contains polysorbate and sodium
This medicine contains 0.24 mg of polysorbate 20 in each 180 mg dose and 0.48 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
This medicine contains less than 1 mmol of sodium (23 mg) per cartridge; this is essentially “sodium-free”.
3. How to use Skyrizi
Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered by injection under the skin (called a “subcutaneous injection”).
How much Skyrizi to use
You will start treatment with Skyrizi at an initial dose administered by your doctor or nurse through an intravenous infusion (IV infusion) into your arm.
Initial doses
How much? | When? | |
Crohn's disease | 600 mg | As directed by your physician |
600 mg | 4 weeks after the 1st dose | |
600 mg | 4 weeks after the 2nd dose |
Ulcerative colitis | How much? | When? |
1200 mg | As directed by your physician | |
1200 mg | 4 weeks after the 1st dose | |
1200 mg | 4 weeks after the 2nd dose |
Later, you will receive Skyrizi via a subcutaneous injection.
Maintenance dose
Crohn's Disease | How much? | When? |
1st maintenance dose | 360 mg | 4 weeks after the last induction dose (at week 12) |
Subsequent doses | 360 mg | Every 8 weeks, starting after the 1st maintenance dose |
Ulcerative colitis | How much? | When? |
First maintenance dose | 180 mg or 360 mg | 4 weeks after the last induction dose (at week 12) |
Subsequent doses | 180 mg or 360 mg | Every 8 weeks, starting after the first maintenance dose |
You and your doctor, pharmacist, or nurse will decide whether you can self-inject this medicine. You must not self-inject this medicine unless your doctor, pharmacist, or nurse has shown you how to do so. It is also possible that a caregiver who has been trained may administer the injection to you.
Read section 7 “Instructions for use” at the end of this leaflet before injecting Skyrizi.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should, or if you administered the dose earlier than prescribed, consult your doctor.
If you forget to use Skyrizi
If you forget to inject Skyrizi, administer a dose as soon as you remember. If in doubt, consult your doctor.
If you stop using Skyrizi
Do not stop using Skyrizi without first talking to your doctor. If you discontinue treatment, your symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
Allergic reactions – may require urgent treatment. Inform your doctor or seek immediate medical help if you experience any of the following signs:
Severe allergic reactions (“anaphylaxis”) are rare in patients using Skyrizi (may affect up to 1 in 1,000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- low blood pressure, which may cause dizziness or lightheadedness
Consult your doctor or seek immediate medical attention if you have any of the following symptoms.
Symptoms of a serious infection, for example:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, persistent cough
- warmth, redness, and pain in the skin or a painful skin rash with blisters
Your doctor will decide whether you can continue using Skyrizi.
Other adverse effects
Tell your doctor, pharmacist, or nurse if you notice any of the following adverse 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 infection
- 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 spots on the skin
- hives (urticaria)
Reporting of adverse effects
If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the label of the pen and on the outer carton after EXP.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep the pre-filled pen in the original packaging to protect it from light.
If necessary, the pre-filled pen may also be stored outside the refrigerator (at a maximum temperature of 25 °C) for up to 24 hours, while remaining 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.
6. Contents of the container and additional information
Composition of Skyrizi
The active substance is risankizumab.
Skyrizi 180 mg injectable solution in cartridge
- Each cartridge contains 180 mg of risankizumab in 1.2 ml of solution.
- The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections. See section 2, “Skyrizi contains polysorbate and sodium”.
Skyrizi 360 mg injectable solution in cartridge
- Each cartridge contains 360 mg of risankizumab in 2.4 ml of solution.
- The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections. See section 2, “Skyrizi contains polysorbate and sodium”.
Appearance of the product and contents of the container
Skyrizi is a clear, colorless to yellow liquid contained in a cartridge. The liquid may contain small transparent or white particles.
Each package contains 1 cartridge and 1 body injector.
Marketing Authorization Holder and Manufacturing Responsible
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium AbbVie SA Tel/Tel: +32 10 477811 | Lithuania AbbVie UAB Tel: +370 5 205 3023 |
| Luxembourg/Luxembourg AbbVie SA Belgium/Belgium Tél/Tel: +32 10 477811 |
Czech Republic AbbVie s.r.o. Tel: +420 233 098 111 | Hungary AbbVie Kft. Tel: +36 1 455 8600 |
Denmark AbbVie A/S Tlf: +45 72 30-20-28 | Malta V.J.Salomone Pharma Limited Tel: +356 21220174 |
Germany AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (toll-free) Tel: +49 (0) 611 / 1720-0 | Netherlands AbbVie B.V. Tel: +31 (0)88 322 2843 |
Estonia AbbVie OÜ Tel: +372 623 1011 | Norway AbbVie AS Tlf: +47 67 81 80 00 |
Greece AbbVie PHARMACEUTICAL S.A. Tel: +30 214 4165 555 | Austria AbbVie GmbH Tel: +43 1 20589-0 |
Spain AbbVie Spain, S.L.U. Tel: +34 91 384 09 10 | Poland 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 |
Croatia AbbVie d.o.o. Tel: +385 (0)1 5625 501 | Romania AbbVie S.R.L. Tel: +40 21 529 30 35 |
Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenia AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060 |
Iceland Vistor Tel: +354 535 7000 | Slovakia AbbVie s.r.o. Tel: +421 2 5050 0777 |
Italy AbbVie S.r.l. Tel: +39 06 928921 | Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel: +357 22 34 74 40 | Sweden AbbVie AB Tel: +46 (0)8 684 44 600 |
Latvia AbbVie SIA Tel: +371 67605000 |
Date of the latest review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Detailed and up-to-date information on this product is available below or on the outer packaging by scanning the QR code with a smartphone. The same information is also available at the following website: www.skyrizi.eu
QR code to be included
To request a copy of this leaflet in
7. Instructions for use
Read all of section 7 before using Skyrizi
Skyrizi body injector
Front view Material adhesive | Status light | Start button Do not touch until ready to inject |
Grey door Do not close the grey door without the cartridge inside | Medication window | Flaps |
Posterior view
Transparent plastic strip | Needle shield | Adhesive coating |
| Be careful. Needle inside (under the needle shield) Do not touch the needle shield area or the needle | |
Green tab of the small section | Green tab of the large section |
Side view
Door closing The opening side has slots The gray door must be slightly open Do not close the gray door without the cartridge inside Needle shield Needle inside (under the needle shield) Do not touch the needle shield area or the needle |
|
Cartridge
White plunger moves through the chamber toward the bottom of the cartridge as medication is injected. Medication Smaller lower end |
| Larger upper end of the cartridge Do not rotate or remove Expiration 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 keep track of when you need 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 it is time to use it.
- Remove the box from the refrigerator and allow it to reach room temperature, away from direct sunlight, for at least 45 and up to 90 minutes before injection.
- The body injector will not work if Skyrizi is not allowed to warm to room temperature for at least 45 minutes.
- Do not get the body injector wet with water or any other liquid.
- Do not press the start button until you place the body injector, loaded with the cartridge, against your skin and are ready to inject.
- The start button can only be pressed once.
- Physical activity should be limited during the injection process. Moderate activities such as walking, stretching, or bending are acceptable.
- Do not delay injecting the medicine once the cartridge has been loaded into the body injector. If delayed, the medicine may dry out and the body injector will no longer function.
- Do not inject the medicine if the liquid in the viewing window appears 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 not shake the box, cartridge, or body injector.
- Do not reuse the cartridge or body injector.
Return this medicine to the pharmacy
- after the expiration date (EXP) indicated,
- if the liquid has ever been frozen (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 every time you use Skyrizi
STEP 1: Prepare | |
| Remove the box from the refrigerator and allow it to reach room temperature, away from direct sunlight, for at least 45 and up to 90 minutes before injection.
|
Sharps disposal container
| Gather all materials and wash your hands On a clean, flat surface, place the following items:
Wash and dry your hands. |
| Remove the white paper seal from the tray
Lift the plastic cover
|
Grey door Start button Needle inside (under needle shield) | Inspect the body injector
If the grey start button is pressed before placing the injector on the body, the body injector cannot be used. If this occurs, inform your doctor, pharmacist, or nurse. Proceed to the next step. |
STEP 2: Prepare the body injector | |
Grey door
Back view Needle inside (under needle shield) Needle shield | Open the grey door fully
Set the body injector aside. |
Larger top portion of the cartridge
Smaller lower tip | Inspect the cartridge
Carefully remove the cartridge from the plastic tray. Check the cartridge
|
Smaller lower tip Clean the center of the smaller lower tip | Clean the smaller lower tip of the cartridge Locate the smaller lower tip of the cartridge
|
Insert straight ‘click’
| Load the clean cartridge into the body injector
Be sure to proceed immediately to the next step after inserting the cartridge. If you wait, the medicine may dry and the body injector will not function. |
'snap’ No gaps | Confirm the cartridge is inserted and close the grey door
Do not press the grey start button until ready to inject. It can only be pressed once. Proceed immediately to the next step. |
STEP 3: Prepare for injection | |
Injection sites
Injection sites | Choose and clean the injection site Choose one of these 3 areas for your injection:
Do not inject into areas of skin with folds or natural prominences, as the body injector may fall off during use. Before injection, clean the injection site with an alcohol wipe using circular motions.
|
Small section Large section
Needle inside (under needle shield) Activated injector Status light blinks blue ‘pii-pii-pii’ | Peel off both tabs to expose the skin adhesive Turn 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 remove the clear plastic strip and activate the body injector.
The Skyrizi body injector must be placed on the skin and the injection started within 30 minutes after removing the green tabs; otherwise, it will not function. Be sure to proceed immediately to the next step. |
‘pii-pii-pii-pii-pii’ | If the status light blinks red and emits beeping sounds, the body injector is not functioning correctly. Do not continue using it. Consult your doctor, pharmacist, or nurse for assistance. If the body injector is attached to your body, carefully remove it from the skin. |
| Prepare the body injector for placement
Ensure the body injector is positioned so that you can see the blue status light. Place the body injector on the skin
Proceed immediately to the next step. |
STEP 4: Inject Skyrizi | |
'click’ ‘pii-pii-pii’ | Start the injection
Do not continue using the body injector if the status light blinks red. Carefully remove it from the skin if the status light blinks red. If this occurs, inform your doctor, pharmacist, or nurse. |
| Wait for the injection to complete
Do not continue using the body injector if the status light blinks red and emits beeping sounds. Carefully remove it from the skin if the status light blinks red. If this occurs, inform your doctor, pharmacist, or nurse. |
‘pii-pii-pii’ | The injection is complete when:
|
‘pii-pii-pii’ | Remove the body injector
Proceed to the next step. |
STEP 5: Completion | |
| Check the body injector Inspect the medicine window and status light. Verify that the white plunger fills the entire medicine window and that the solid green light turns off, indicating that the full dose has been injected.
|
Sharps disposal container
| Disposal Dispose of the used body injector immediately into a sharps disposal container.
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