Skyrizi 360 mg solucion inyectable en cartucho
Introduction
Prescribing Information for the Patient
Skyrizi 180 mg Injectable Solution in CartridgeSkyrizi 360 mg Injectable Solution in Cartridge
risankizumab
Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.
- Keep this prescribing information, as you may need to refer to it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.
1. What is Skyrizi and what is it used for
Skyrizi contains the active ingredient risankizumab.
Skyrizi is used to treatadult patients with:
- moderate to severe Crohn's disease
- moderate to severe ulcerative colitis
How Skyrizi works
This medication acts 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, it is possible that other medications will be administered first. If these medications do not work well enough, Skyrizi will be administered for the treatment of your Crohn's disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine. If you have active ulcerative colitis, it is possible that other medications will be administered first. If these medications do not work well enough or if you cannot take them, Skyrizi will be administered to treat your ulcerative colitis.
Skyrizi reduces inflammation and, therefore, may help reduce the symptoms and signs of your disease.
2. What you need to know before starting to use Skyrizi
Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients in this medicine (listed in section 6).
- if you have an infection that your doctor considers important, for example, active tuberculosis.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use 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 a vaccine. Certain vaccines should not be administered during treatment with Skyrizi.
It is essential that your doctor or nurse keeps a copy of the batch number of Skyrizi.
Each time you receive a new package of Skyrizi, your doctor or nurse should note the date and batch number (which appears on the package after “Lot”).
Allergic reactions
Consult your doctor or seek medical attention immediately if you notice any signs of an allergic reaction while receiving Skyrizi, for example:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- intense itching on 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
Inform your doctor, pharmacist, or nurse:
- if you are using, have used recently, or may need to use any other medicine.
- if you have recently been vaccinated or plan to be vaccinated. Certain vaccines should not be administered during treatment with Skyrizi.
In case of doubt, consult 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, consult your doctor before using this medicine. It is necessary because it is not known how this medicine may affect the baby.
If you are a woman who may become pregnant, you must use contraception while you are 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 a baby, consult your doctor before using this medicine.
Driving and operating machinery
It is unlikely that Skyrizi will affect your ability to drive and use machines.
Skyrizi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.
3. How to use Skyrizi
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medication is administered through a subcutaneous injection.
How much Skyrizi to use
You will start treatment with Skyrizi at an initial dose that your doctor or nurse will administer to you through an intravenous infusion.
Initial doses
How much? | When? | |
Crohn's disease | 600 mg | When your doctor tells you to |
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 to | |
1 200 mg | 4 weeks after the 1st dose | |
1 200 mg | 4 weeks after the 2nd dose |
Subsequently, you will receive Skyrizi through a subcutaneous injection.
Maintenance doses
Crohn's disease | How much? | When? |
1st maintenance dose | 360 mg | 4 weeks after the last initial dose (in week 12) |
Subsequent 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) |
Subsequent 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 this medication can be injected by you. Do not inject this medication yourself unless your doctor, pharmacist, or nurse has taught you how to do it. It is also possible that a caregiver who has learned to do it will administer the injection to you.
Read section 7 “Instructions for use” at the end of this leaflet before administering the Skyrizi injection.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or have administered the dose before the prescribed time, consult your doctor.
If you forget to use Skyrizi
If you forget to administer Skyrizi, you should inject a dose as soon as you remember. If in doubt, consult your doctor.
If you interrupt treatment with Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you interrupt treatment, your symptoms may reappear.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people will experience them.
Severe Adverse Effects
Consult your doctor or seek immediate medical attention if you experience any symptoms of severe infection, for example:
- fever, flu-like symptoms, night sweats
- feeling tired or difficulty breathing, persistent cough
- heat, redness, and pain in the skin or a painful, blistering skin rash
Your doctor will decide if you can continue using Skyrizi.
Other Adverse Effects
Inform 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
- skin fungal infections
- reactions at the injection site (such as redness or pain)
- pruritus
- headache
- eruption
- eczema
Rare:may affect up to 1 in 100 people
- small red bumps on the skin
- hives (urticaria)
Reporting Adverse Effects
If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Storage of Skyrizi
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the cartridge label and on the outer box after EXP.
Store in refrigerator (between 2 °C and 8 °C). Do not freeze.
If necessary, the cartridge can also be stored outside the refrigerator (at a maximum temperature of 25 °C) for a maximum of 24 hours.
Store the cartridge in the original packaging to protect it from light.
Do not use this medication if the liquid is cloudy or contains scales or large particles.
Each prefilled syringe with cartridge is for single use only.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Skyrizi
The active ingredient is risankizumab.
Skyrizi 180mg injectable solution in cartridge
- Each cartridge contains 180mg of risankizumab in 1.2ml of solution.
- The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polisorbate 20 and water for injection.
Skyrizi 360mg 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, polisorbate 20 and water for injection.
Appearance of the product and contents of the package
Skyrizi is a transparent, colorless to yellowish liquid contained in a cartridge. The liquid may contain small, transparent or white particles.
Each package contains 1 cartridge and 1 body injector.
Holder of the marketing authorization and responsible for manufacturing
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien AbbVie SA Tél/Tel: +32 10 477811 | Lietuva AbbVie UAB Tel: +370 5 205 3023 |
Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tél/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 (free of charge) 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 |
Last review date of this leaflet:
Other sources of information
The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
The detailed and updated information about this product is available below or on the outer packaging by scanning the QR code with a smartphone. The same information is also available on the following website:www.skyrizi.eu
QR code to include
To request a copy of this leaflet in
7. Instructions for use
Read the entire section 7 before using Skyrizi
Body injector for Skyrizi
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 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 medication from light until you use it
- Take the box out of the refrigerator and let it reach room temperature, away from direct sunlight, for at least45 and up to 90 minutesbefore injection
- Do notlet the body injector get wet with water or any other liquid
- Do nottouch the start button until you place the body injector loaded with the cartridge on the skin and are ready to inject
- You can only press the start buttononce
- 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 medication once the cartridge is loaded into the body injector. If you wait, the medication will dry out and the body injector will stop working
- Do notinject the medication if the liquid in the inspection window is cloudy or contains scales or large particles. The liquid should be transparent to yellowish and may contain small, transparent or white particles
- Do notshake the box, cartridge or body injector
- Do notre-use the cartridge or body injector
Return this medication to the pharmacy
- after the expiration date (EXP) indicated
- if the liquid has ever frozen (even if it has thawed)
- if the cartridge or body injector has fallen or been damaged
- if the perforations in 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 | |
Take the box out of the refrigerator and let it reach room temperature, away from direct sunlight, for at least45 and up to 90 minutesbefore injection.
| |
Special waste container | Gather all materials and wash your hands On a clean and flat surface, place the following:
Wash and dry your hands. |
Remove the white paper seal from the tray
| |
Remove the plastic cover
| |
Needle inside (under the needle shield) | Inspect the body injector Locate the grey door
If the start button is pressed before placing the body injector on the skin, the body injector will not work. If this happens, consult your doctor, pharmacist or nurse. |
STEP 2: Prepare the body injector | |
Grey door Needle shield | Open the grey door completely
Set the body injector aside. |
Top larger part of the cartridge | Inspect the cartridge Carefully remove the cartridge from the plastic tray.
Check the cartridge
|
Smaller lower part | |
Smaller lower part | Clean the smaller lower part of the cartridge Locate the smaller lower part of the cartridge
|
Clean the center of the smaller lower part | |
Insert in a straight line “click” | Load the clean cartridge into the body injector
Make sure to proceed with the next step immediately. If you wait, the medication will dry out. |
“click” | Close the grey door Turn the grey door to the left, then press firmly and you will hear a “click” as the grey door closes
|
STEP 3: Prepare for injection | |
Injection sites Injection sites | Choose and clean the injection site Choose one of these 3 sites for the injection:
Do notinject in areas of the skin with folds or natural prominences, as the body injector may fall during use. Before the injection, clean the injection site with an alcohol wipe, making circular motions.
|
Small section Large section | Remove the green tabs Locate the two green tabs on the back of the body injector
Remove the large section using the green tab, exposing the adhesive Remove the small section using the green tab, exposing the adhesive. This will activate the body injector.
The body injector must be placed on the skin and the injection started within 30 minutes of removing the green tabs. Make sure to proceed with the next step immediately. |
If the status light flashes red, the body injector is not working correctly. Do not continue using it. Consult your doctor, pharmacist or nurse for help. If the body injector is stuck to your skin, carefully remove it from the skin. | |
Prepare the body injector for placement
Make sure to place the body injector so you can see the status light. Place the body injector on the skin
Proceed immediately with the next step. | |
STEP 4: Inject Skyrizi | |
“click” | Start the injection Press the start button firmly and release it
Do notcontinue using the body injector if the status light flashes red. Carefully remove it from the skin if the status light flashes red. If this happens, consult your doctor, pharmacist or nurse. |
Wait for the injection to finish
Do notcontinue using the body injector if the status light flashes red. Carefully remove it from the skin if the status light flashes red. If this happens, consult your doctor, pharmacist or nurse. | |
The injection is complete when:
| |
Remove the body injector
Proceed with the next step. | |
STEP 5: Completion | |
Check the body injector Inspect the medication window and the status light. Check that the white plunger fills the entire medication window and the green steady light turns off, indicating that all the medication has been injected.
| |
Special waste container | Disposal Dispose of the used body injector in a special waste container immediately after use.
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