Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Skyrizi 150 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Risankizumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Skyrizi contains the active substance risankizumab. Skyrizi is used to treat the following inflammatory diseases: • •
Plaque psoriasis Psoriatic arthritis
How Skyrizi works This medicine works by stopping a protein in the body called 'IL-23', which causes inflammation. Plaque psoriasis Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling. Psoriatic arthritis Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis. Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.
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What you need to know before you take it
e 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, including active tuberculosis, which your doctor thinks is important. Warnings and precautions Talk to your doctor, pharmacist, or nurse before and during the use of Skyrizi: • if you currently have an infection or if you have an infection that keeps coming back. • if you have tuberculosis (TB). • if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi. It is important to keep a record of the batch number of your Skyrizi. Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after "Lot") and keep this information in a safe place. Serious allergic reactions Skyrizi can cause serious side effects, including serious allergic reactions ('anaphylaxis'). Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as: • difficulty breathing or swallowing • swelling of the face, lips, tongue or throat • low blood pressure, which can cause dizziness or light-headedness • severe itching of the skin, with a red rash or raised bumps Children and adolescents Skyrizi is not recommended for children and adolescents under 18 years of age. This is because Skyrizi 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 had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi. If you are not sure, talk to your doctor, pharmacist, or nurse before and during the use of Skyrizi. Pregnancy, contraception and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby. If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. Driving and using machines Skyrizi is not likely to affect your driving and use of machines. Skyrizi contains polysorbate and sodium This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
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This medicine contains less than 1 mmol sodium (23 mg) per pre-filled pen, that is to say essentially 'sodium-free'. 3.
How to take it
Skyrizi
Always use this medicine exactly as your doctor or pharmacist, has told you. Check with your doctor or pharmacist if you are not sure. This medicine is given as an injection under your skin (called a 'subcutaneous injection'). How much Skyrizi to use Each dose is 150 mg given as a single injection. After the first dose, you will have the next dose 4 weeks later, and then every 12 weeks. You and your doctor, pharmacist, or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist, or nurse. A caregiver may also give your injection after they have been trained. Read section 7 'Instructions for use' at the end of this leaflet before injecting Skyrizi yourself. If you use more Skyrizi than you should If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor. If you forget to use Skyrizi If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do. 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 Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs: Serious allergic reactions ('anaphylaxis') are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include: • • •
difficulty breathing or swallowing swelling of the face, lips, tongue or throat low blood pressure, which can cause dizziness or light-headedness
Talk to your doctor or get medical help immediately if you have the following symptoms. Symptoms of a serious infection such as: • fever, flu-like symptoms, night sweats • feeling tired or short of breath, cough which will not go away 3
•
warm, red and painful skin, or a painful skin rash with blisters
Your doctor will decide if you can keep using Skyrizi. Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects Very common: may affect more than 1 in 10 people • upper respiratory infections with symptoms such as sore throat and stuffy nose Common: may affect up to 1 in 10 people • feeling tired • fungal skin infection • injection site reactions (such as redness or pain) • itching • headache • rash • eczema Uncommon: may affect up to 1 in 100 people • small raised red bumps on the skin • hives (urticaria) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
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 pen label and outer carton after 'EXP'. Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled pen in the original carton in order to protect from light. If needed, you may also store the pre-filled pen out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light. Do not use this medicine if the liquid is cloudy or contains flakes or large particles. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Skyrizi contains
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The active substance is risankizumab. Each pre-filled pen contains 150 mg of risankizumab in 1 mL solution. The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".
What Skyrizi looks like and contents of the pack Skyrizi is a clear and colourless to yellow liquid in a pre-filled pen. The liquid may contain tiny white or clear particles. Each pack contains 1 pre-filled pen. Marketing Authorisation Holder AbbVie Ltd Maidenhead SL6 4UB UK Tel: +44 (0)1628 561090 Manufacturer AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany This leaflet was last revised in 08/2025
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the Marketing Authorisation Holder. 7.
Instructions for use
Please read all of section 7 before using Skyrizi Skyrizi pre-filled pen
Green activator button
Grey hand grips
Inspection window
Needle
White needle sleeve
Important information to know before you inject Skyrizi 5
Dark grey cap (Do not remove until ready to inject)
• • • • • • •
You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist, or nurse if you need help Mark the dates on your calendar so you know when to inject Skyrizi Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles Do not shake the pen Wait to remove the dark grey cap until just before the injection
Return this medicine to the pharmacy • if the expiry date (EXP) has passed • if the liquid has ever been frozen (even if thawed) • if the pen has been dropped or damaged • if the carton perforations are broken Follow the steps below each time you use Skyrizi STEP 1
Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting.
- Do not remove the pen from the carton while allowing Skyrizi to reach room temperature
- Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water
- Do not use the pen if liquid has been frozen, even if it has been thawed
STEP 2
Place the following items on a clean, flat surface:
- 1 pre-filled pen
- 1 alcohol pad (not included in the carton)
- 1 cotton ball or gauze pad (not included in the carton)
- special disposal container (not included in the carton) Wash and dry your hands.
STEP 3
Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)
Areas to inject
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Before the injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
- Do not inject into areas affected by psoriasis
Areas to inject
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STEP 4
Hold the pen with the dark grey cap pointing up, as shown.
- Pull the dark grey cap straight off
- Throw the dark grey cap away
Check liquid
Check the liquid through the inspection window.
- It is normal to see bubbles in the liquid
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles
STEP 5
Hold the pen with your fingers on the grey hand grips.
Abdomen or Thigh
Turn the pen so that the white needle sleeve points toward the injection site and you can see the green activator button. Gently squeeze the skin at your injection site to make a raised area and hold it firmly. Place the white needle sleeve straight (90o angle) against the raised injection site.
STEP 6 First "click"
Hold the pen so that you can see the green activator button and inspection window.
15 seconds
Push and keep pressing the pen down against the raised injection site.
- The pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button Press the green activator button and hold the pen for 15 seconds.
- A loud "click" means the start of the injection
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STEP 7
Keep pressing the pen down against the injection site.
Second "click"
The injection is complete when:
- the pen has made a second "click" or
- the yellow indicator has filled the inspection window This takes up to 15 seconds.
Yellow indicator STEP 8
When the injection is complete, slowly pull the pen out from the skin. The white needle sleeve will cover the needle tip and make another "click." After completing the injection, place a cotton ball or gauze pad on the skin at the injection site.
- Do not rub the injection site
- Slight bleeding at the injection site is normal
STEP 9
Throw away the used pen in a special disposal container straight after use.
- Do not throw away the used pen in the household waste
- Your doctor, pharmacist, or nurse will tell you how to return the full special disposal container
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Frequently asked questions about Skyrizi 150 mg solution for injection in pre-filled pen
How do I take Skyrizi 150 mg solution for injection in pre-filled pen?
Skyrizi 150 mg solution for injection in pre-filled pen comes as injection containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Skyrizi 150 mg solution for injection in pre-filled pen?
The active substance in Skyrizi 150 mg solution for injection in pre-filled pen is risankizumab.
Are there equivalent medicines to Skyrizi 150 mg solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Skyrizi 150 mg solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Skyrizi 150 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Skyrizi 150 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: risankizumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Plaque Psoriasis
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic Arthritis
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
4.2. Posology and method of administration
Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Skyrizi is indicated.
Posology
The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Missed dose
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Special populations
Elderly (aged 65 years and over)
No dose adjustment is required (see section 5.2).
There is limited information in subjects aged ≥65 years.
Renal or hepatic impairment
No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of risankizumab. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
Paediatric population
The safety and efficacy of risankizumab in children and adolescents aged 5 to less than 18 years have not been established. No data are available.
There is no relevant use of risankizumab in children aged below 6 years for the indication of moderate to severe plaque psoriasis or in children aged below 5 years for the indication of psoriatic arthritis.
Overweight patients
No dose adjustment is required (see section 5.2).
Method of administration
Skyrizi is administered by subcutaneous injection.
The injection should be administered in the thigh or abdomen. Patients should not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
Patients may self-inject Skyrizi after training in subcutaneous injection technique. Patients should be instructed to read the 'Instructions for use' provided in the package leaflet before administration.
Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clinically important active infections (e.g. active tuberculosis, see section 4.4).
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Infections
Risankizumab may increase the risk of infection.
In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Tuberculosis
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Immunisations
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment (see section 5.2).
Hypersensitivity
Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of risankizumab (see section 4.8). If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Excipients with known effect
Polysorbate
This medicinal product contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say, essentially 'sodium free'.
4.5. Interaction with other medicinal products and other forms of interaction
Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Interactions between risankizumab and inhibitors, inducers, or substrates of medicinal product metabolising enzymes are not expected, and no dose adjustment is needed (see section 5.2).
Concomitant immunosuppressive therapy or phototherapy
The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics or phototherapy, have not been evaluated.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.
Pregnancy
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
Breast-feeding
It is unknown whether risankizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Fertility
The effect of risankizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
4.7. Effects on ability to drive and use machines
Risankizumab has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were upper respiratory infections.
Tabulated list of adverse reactions
Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); and very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1: List of adverse reactions
System Organ Class
Frequency
Adverse reactions
Infections and infestations
Very common
Upper respiratory infectionsa
Common
Tinea infectionsb
Uncommon
Folliculitis
Nervous system disorders
Common
Headachec
Skin and subcutaneous tissue disorders
Common
Pruritus
Rash
Eczema
Uncommon
Urticaria
General disorders and administration site conditions
Common
Fatigued
Injection site reactionse
Immune system disorders
Rare
Anaphylactic reactions
a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis, laryngitis, tracheitis
b Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis, fungal skin infection
c Includes: headache, tension headache, sinus headache
d Includes: fatigue, asthenia
e Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling, induration, rash
Description of selected adverse reactions
Infections
The rate of infections was 75.5 events per 100 subject-years from the psoriasis clinical studies and 43.0 events per 100 subject-years from the psoriatic arthritis clinical studies, including long-term exposure to risankizumab. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab. The rate of serious infections was 1.7 events per 100 subject-years from the psoriasis studies and 2.6 events per 100 subject-years from the psoriatic arthritis studies (see section 4.4).
Immunogenicity
As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1 079) and 14% (150/1 079) of evaluated subjects, respectively. For subjects exposed to long term treatment of risankizumab in the extension study, the immunogenicity profile observed up to 204 weeks of treatment was consistent compared to the first 52 weeks of treatment.
For most subjects with psoriasis, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety. Among the few subjects (approximately 1%; 7/1 000 at week 16 and 6/598 at week 52) with high antibody titres (>128), clinical response appeared to be reduced. The incidence of injection site reactions is numerically higher in the anti-drug antibody-positive groups compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) and longer-term treatment (52 weeks: 5.0% vs 3.3%). The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.
For subjects treated with risankizumab at the recommended clinical dose for up to 28 weeks in psoriatic arthritis clinical trials, treatment-emergent anti-drug antibodies and neutralizing antibodies were detected in 12.1% (79/652) and 0% (0/652) of evaluated subjects, respectively. Antibodies to risankizumab were not associated with changes in clinical response or safety for psoriatic arthritis.
Psoriatic arthritis
Overall, the safety profile observed in patients with psoriatic arthritis treated with risankizumab was consistent with the safety profile observed in patients with plaque psoriasis.
Elderly
There is limited safety information in subjects aged ≥65 years.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
💬 Ask about this leaflet
Ask anything about Skyrizi 150 mg solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.