risankizumab 150 mg solution for injection in
What Skyrizi is and what it is used for
Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat the following inflammatory diseases:
- Plaque psoriasis
- Psoriatic arthritis
How Skyrizi works
This drug works by inhibiting a protein in the body called IL-23, which causes inflammation.
Plaque psoriasis
Skyrizi is used to treat adult patients with moderate to severe plaque psoriasis. Skyrizi suppresses inflammation and can thus reduce the symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.
Psoriatic arthritis
Skyrizi is used to treat adult patients with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflammation of the joints and psoriasis. If you have active psoriatic arthritis, you may have been given other medicines first. If these medicines have not worked well enough, you can be given Skyrizi, either as a single medicine or together with other medicines to treat your psoriatic arthritis.
Skyrizi suppresses inflammation and can therefore help reduce pain, stiffness, and swelling in and around your joints, pain, and stiffness in your spine, psoriasis on the skin, and damage caused by psoriasis on the nails, and slow down damage to bones and cartilage in your joints. These effects can facilitate your daily activities, reduce your fatigue and improve your quality of life.
What you need to know before using 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 considers significant, such as active tuberculosis.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and while using Skyrizi:
- if you have an ongoing infection or if you have an infection that recurs.
- if you have tuberculosis (TB).
- if you have recently received or are about to receive vaccination (immunization). You should not receive certain types of vaccines while using Skyrizi.
It is important to document the Skyrizi manufacturing batch number.
Each time you receive a new package of Skyrizi, you must record the date and batch number (which is on the package after “Lot”) and keep this information in a safe place.
Allergic reactions
Tell your doctor or seek medical attention immediately if you notice signs of an allergic reaction while taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- severe skin itching, with red rashes or raised nodules
Children and young people
Skyrizi is not recommended for children and adolescents under 18 years of age as Skyrizi has not been studied in this age group.
Other medicines and Skyrizi
Tell the doctor, pharmacist, or nurse:
- if you are taking, have recently taken, or may be taking other medicines.
- if you have recently received or are about to receive a vaccination. You should not receive certain types of vaccines while using Skyrizi.
If you are not sure, talk to your doctor, pharmacist, or nurse before and while using Skyrizi.
Pregnancy, contraception, and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. This is because it is not known how this medicine affects the baby.
If you are a woman who could become pregnant, you should use birth control while you are using 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 ability and use of machinery
Skyrizi is unlikely to affect your ability to drive or use machines.
Skyrizi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled pen, i.e. it is almost ‘sodium-free’.
How to use Skyrizi
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
This medicine is given as an injection under the skin (so-called “subcutaneous injection”).
How much Skyrizi to use
Each dose is 150 mg and is given as a single injection. After the first dose, you will receive the next dose 4 weeks later, and then every 12 weeks.
Together with your doctor, pharmacist, or nurse, you will be able to decide when you are ready to start injecting the medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist, or nurse. A healthcare provider can also give you your injection after receiving training.
Read section 7 “Instructions for use” at the end of this information before injecting Skyrizi yourself.
If you have used too much Skyrizi
Talk to your doctor if you have used more Skyrizi than you should or if a dose has been given earlier than prescribed.
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 first talking to your doctor. If you stop treatment, your symptoms may return.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Talk to a doctor or seek medical attention immediately if you have symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough that does not go away
- hot, red, and painful skin, or a painful rash with blisters
The doctor will then decide whether you can continue to use Skyrizi.
Other side effects ar
Tell your doctor, pharmacist, or nurse if you get any of the following side effects
Very common: may affect more than 1 in 10 users
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose
Common: may affect up to 1 in 10 users
- feeling of fatigue
- fungal infection of the skin
- injection site reactions (such as redness or pain)
- itching
- headache
Uncommon: may affect up to 1 in 100 users
- small raised bumps on the skin
Reporting of side effects ar
If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can contribute to increasing information about drug safety.
How to store Skyrizi
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the pen label and the outer packaging after “EXP”.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Store the pre-filled pen in the original packaging. Light sensitive.
If necessary, you can also store the pre-filled injection pen outside the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original packaging to protect it from light.
Do not use this medicine if the solution is cloudy, and contains flakes or large particles.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is risankizumab. Each pre-filled pen contains 150 mg of risankizumab in 1 ml of solution.
- Other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.
Appearance and package sizes of the medicine
Skyrizi is a clear and colorless to yellow liquid in a pre-filled pen. The solution may contain small white or transparent particles.
Each pack contains 1 pre-filled pen.
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany