Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
Secukinumab
Novartis Europharm Limited
L04AC10
secukinumab
Immunosuppressants
Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Plaque psoriasisCosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy.Hidradenitis suppurativa (HS)Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.Psoriatic arthritisCosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.Axial spondyloarthritis (axSpA)Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non-radiographic axial spondyloarthritis (nr-axSpA)Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs).Juvenile idiopathic arthritis (JIA)Enthesitis-related arthritis (ERA)Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.Juvenile psoriatic arthritis (JPsA)Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Revision: 34
Authorised
2015-01-14
140 B. PACKAGE LEAFLET 141 PACKAGE LEAFLET: INFORMATION FOR THE USER COSENTYX 75 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE secukinumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU (OR YOUR CHILD) START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION. - 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 (or your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours (or your child’s). - If you (or your child) 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 Cosentyx is and what it is used for 2. What you need to know before you (or your child) use Cosentyx 3. How to use Cosentyx 4. Possible side effects 5. How to store Cosentyx 6. Contents of the pack and other information 1. WHAT COSENTYX IS AND WHAT IT IS USED FOR Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and axial spondyloarthritis. Cosentyx is used for the treatment of the following inflammatory diseases: • Paediatric plaque psoriasis • Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis PAEDIATRIC PLAQUE PSORIASIS Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is used in adolescents and children (6 years of age and older) with moderate to severe plaque psoriasis. Using Cosentyx in plaque psoriasis will benefit you (or your child) by leading to improvemen Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cosentyx 75 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 75 mg secukinumab in 0.5 ml. Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is clear and colourless to slightly yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paediatric plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Juvenile idiopathic arthritis (JIA) _Enthesitis-related arthritis (ERA) _ Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy (see section 5.1). _ _ _Juvenile psoriatic arthritis (JPsA) _ Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Posology _Paediatric plaque psoriasis (adolescents and children from the age of 6 years) _ The recommended dose is based on body weight (Table 1) and administered by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg. Each Lees het volledige document