Skyrizi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Risankizumab

Available from:

AbbVie Deutschland GmbH & Co. KG

ATC code:

L04AC18

INN (International Name):

risankizumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Psoriasis; Arthritis, Psoriatic

Therapeutic indications:

Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic ArthritisSkyrizi, 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).Crohn's diseaseSkyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2019-04-26

Patient Information leaflet

81_ _
B. PACKAGE LEAFLET
82_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SKYRIZI 150 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
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.
WHAT IS IN THIS LEAFLET
1.
What Skyrizi is and what it is used for
2.
What you need to know before you use Skyrizi
3.
How to use Skyrizi
4.
Possible side effects
5.
How to store Skyrizi
6.
Contents of the pack and other information
7.
Instructions for use
1.
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 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2_ _
1.
NAME OF THE MEDICINAL PRODUCT
Skyrizi 150 mg solution for injection in pre-filled pen
Skyrizi 150 mg solution for injection in pre-filled syringe
Skyrizi 75 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skyrizi 150 mg solution for injection in pre-filled pen
Each pre-filled pen contains 150 mg risankizumab in 1 mL solution.
Skyrizi 150 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 150 mg risankizumab in 1 mL solution.
Skyrizi 75 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 75 mg risankizumab in 0.83 mL
solution.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal
antibody produced in Chinese
Hamster Ovary cells using recombinant DNA technology.
_Excipients with known effect (75 mg solution for injection only) _
This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Skyrizi 150 mg solution for injection in pre-filled pen and in
pre-filled syringe
The solution is colourless to yellow and clear to slightly opalescent.
Skyrizi 75 mg solution for injection in pre-filled syringe
The solution is colourless to slightly yellow and clear to slightly
opalescent.
4.
CLINICAL PARTICULARS
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
3_ _
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
This medicinal product is intended for use under the guidance and
supervision of a physician
experienced in the diagnosis and treatment of conditions for whic