Secukinumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of secukinumab.
Drugs List
Therapeutic Indications
Uses
Active psoriatic arthritis
Ankylosing spondylitis when other therapy is unsuitable
Juvenile idiopathic arthritis
Moderate to severe plaque psoriasis
Non-radiographic axial spondyloarthritis
Psoriatic arthritis when inadequate response or intolerant to prior DMARDs
Adult plaque psoriasis
Secukinumab is indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy.
Paediatric plaque psoriasis
Secukinumab 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.
Psoriatic arthritis
Secukinumab, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Axial spondyloarthritis (asSpA)
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
Secukinumab is indicated for the treatment of active ankylosing spondylitis in patients who have responded inadequately to conventional therapy.
Non-radiographic axial spondyloarthritis (nr-axSpA)
Secukinumab is indicated for the treatment of active non-radiographic axial spondyloarthritis with signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs).
Juvenile idiopathic arthritis (JIA)
Enthesitis-related arthritis (ERA)
Secukinumab, 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)
Secukinumab, 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.
Dosage
Adults
Plaque psoriasis
The recommended dose is 300mg of secukinumab by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Based on clinical response, a maintenance dose of 300mg every 2 weeks may provide additional benefit for patients with a body weight of 90kg or higher.
Each 300mg dose is given as two subcutaneous injections of 150mg or as one subcutaneous injection of 300mg.
Psoriatic arthritis
For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNF alpha inadequate responders (IR), the recommended dose is 300mg of secukinumab by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Each 300mg dose is given as two subcutaneous injections of 150mg or as one subcutaneous injection of 300mg.
For other patients, the recommended dose is 150mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4 followed by monthly maintenance dosing. Based on the clinical response of the patient, the dose can be increased to 300mg.
Axial spondyloarthritis
Ankylosing Spondylitis (AS, radiographic axial spondyloarthritis)
The recommended dose is 150mg of secukinumab by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on the clinical response of the patient, the dose can be increased to 300mg.
Each 300mg dose is given as two subcutaneous injections of 150mg or as one subcutaneous injection of 300mg.
Non-radiographic axial spondyloarthritis
The recommended dose is 150mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Children
The 150mg solution for injection in pre-filled syringe/pen and the 300mg solution for injection pre-filled pen are not indicated for administration to paediatric patients with a weight of less than 50kg. The 75mg solution for injection pre-filled syringe is appropriate for this population.
Paediatric plaque psoriasis
Children aged 6 years or over
The recommended dose is based on body weight and administered with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Children weighing 50kg and over: 150mg (may be increased to 300mg)
Children weighing between 25 and 50kg: 75mg
Children weighing under 25kg: 75mg
Each 75mg dose is given as one subcutaneous injection of 75mg.
Juvenile idiopathic arthritis (JIA) including ERA and JPsA
Children aged 6 years and over
The recommended dose is based on body weight and administered with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Children weighing 50kg and over: 150mg
Children weighing under 50kg: 75mg
Each 75mg dose is given as one subcutaneous injection of 75mg. Each 150mg dose is given as one subcutaneous injection of 150mg.
Administration
For subcutaneous injection administration.
Contraindications
Children under 6 years
Severe infection
Breastfeeding
Pregnancy
Tuberculosis
Precautions and Warnings
Children under 18 years
Chronic infection
Females of childbearing potential
History of recurrent infection
Crohn's disease
Inflammatory bowel disease
Latent or healed tuberculosis
Ulcerative colitis
Administration of live vaccines is not recommended
Crohn's disease: Monitor patients closely as may cause exacerbation
Ulcerative colitis: Monitor patients closely as may cause exacerbation
Before starting therapy ensure immunisations are up to date in children
Consider prophylactic anti-tuberculosis therapy if appropriate
Not all available strengths are licensed for all indications
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Presentation (e.g. syringe, needle cap) may contain a derivative of latex
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Warm to room temperature prior to use
Discontinue if signs and symptoms of inflammatory bowel disease occur
Monitor patient for signs of serious infection
Advise patient to report symptoms of infection immediately
Discontinue if allergic reaction occurs
Discontinue if no improvement after 4 months of therapy
Interrupt treatment if severe infection develops
Not licensed for all indications in all age groups
Female: Contraception required during & for at least 5 months after therapy
Breastfeeding: Do not breastfeed during & for 5 months after treatment
Areas of the skin that show psoriasis should be avoided as injection sites.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 16 weeks of treatment. However some patients with initially partial response may subsequently improve with continued treatment beyond 16 weeks.
After proper training in subcutaneous injection technique, patients may self-inject secukinumab if a physician determines that this is appropriate. However, the physician should ensure appropriate follow-up of patients.
Pregnancy and Lactation
Pregnancy
Secukinumab is contraindicated during pregnancy.
The manufacturer does not recommend using secukinumab during pregnancy.
There is little data from the use of secukinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Lactation
Secukinumab is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues breastfeeding during treatment and up to 20 weeks after treatment or to discontinue therapy with secukinumab must be made.
It is not known whether secukinumab is excreted in human milk. Immunoglobulins are excreted in human milk and it is not known if secukinumab is absorbed systemically after ingestion.
Side Effects
Anaphylactic reaction
Candida mucocutaneous
Conjunctivitis
Diarrhoea
Dyshidrotic eczema
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Fatigue
Headache
Infections
Inflammatory bowel disease
Lower respiratory tract infection
Nasopharyngitis
Nausea
Neutropenia
Oesophageal candidiasis
Oral herpes
Oropharyngeal candidiasis
Otitis externa
Rhinorrhoea
Tinea pedis
Upper respiratory tract infection
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2021
Reference Sources
Summary of Product Characteristics: Cosentyx 75mg solution for injection in pre-filled syringe. Novartis Pharmaceuticals UK Ltd. Revised November 2022.
Summary of Product Characteristics: Cosentyx 150mg solution for injection in pre-filled pen. Novartis Pharmaceuticals UK Ltd. Revised November 2022.
Summary of Product Characteristics: Cosentyx 150mg solution for injection in pre-filled syringe. Novartis Pharmaceuticals UK Ltd. Revised November 2022.
Summary of Product Characteristics: Cosentyx 300mg solution for injection in pre-filled pen. Novartis Pharmaceuticals UK Ltd. Revised November 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 April 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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