COSENTYX® Oman
COSENTYX® Oman
Regulatory Affairs
COSENTYX® (secukinumab)
150 mg/1 mL Solution for injection in a pre-filled syringe or pre-filled pen
National Succinct Statement (NSS)
Version 3.6
Effective date: 29-Feb-2024
Safety Label Change (SLC) 2024-PSB/GLC-1406-s + 2023-PSB/GLC-1388-s + 2024-PSB/GLC-
Tracking number: 1451-l
Document status: Final
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COSENTYX®
Important note:
Before prescribing, consult full prescribing information: EU:
Disclaimer: This link will contain the most updated product information approved by the reference country.
Presentation:
Secukinumab. Solution for subcutaneous injection in pre-filled syringe or pre-filled pen containing 150 mg of secukinumab.
Indications:
Adult plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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.
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 (see section 5.1).
Psoriatic arthritis
Cosentyx, 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 (see section 5.1).
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 (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).
Dosage and 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
Adult plaque psoriasis
The recommended dose is 300 mg 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 300 mg every 2 weeks may provide additional benefit for patients with a body weight of 90 kg or higher. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
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 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Table 1 Recommended dose for paediatric plaque psoriasis
Body weight at time of dosing | Recommended dose |
<25 kg | 75 mg |
25 to <50 kg | 75 mg |
≥50 kg | 150 mg (*may be increased to 300 mg) |
*Some patients may derive additional benefit from the higher dose.
The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to paediatric patients with a weight <50 kg. Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.
Hidradenitis suppurativa (HS)
The recommended dose is 300 mg 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, the maintenance dose can be increased to 300 mg every 2 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Psoriatic arthritis
For patients with concomitant moderate to severe plaque psoriasis, please refer to adult plaque psoriasis recommendation.
For patients who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg.
Axial spondyloarthritis (axSpA)
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Non-radiographic axial spondyloarthritis (nr-axSpA)
The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Juvenile idiopathic arthritis (JIA)
Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA)
The recommended dose is based on body weight (Table 2) and administered by subcutaneous injection 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.
Table 2 Recommended dose for juvenile idiopathic arthritis
Body weight at time of dosing | Recommended dose |
<50 kg | 75 mg |
≥50 kg | 150 mg |
The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to paediatric patients with a weight <50 kg. Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.
For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Special populations
Elderly patients (aged 65 years and over)
No dose adjustment is required (see section 5.2).
Renal impairment / hepatic impairment
Cosentyx has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of Cosentyx in children with plaque psoriasis and in the juvenile idiopathic arthritis (JIA) categories of ERA and JPsA below the age of 6 years have not been established.
The safety and efficacy of Cosentyx in children below the age of 18 years in other indications have not yet been established. No data are available.
Method of administration
Cosentyx is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The syringe or the pen must not be shaken.
After proper training in subcutaneous injection technique, patients may self-inject Cosentyx or be injected by a caregiver if a physician determines that this is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or caregivers should be instructed to inject the full amount of Cosentyx according to the instructions provided in the package leaflet.
Comprehensive instructions for administration are given in the package leaflet.
Contraindications: ♦Cosentyx is contraindicated in patients who have/had severe hypersensitivity reactions reaction to the active substance or to any of the excipients. ♦ Clinically important, active infection, e.g. active tuberculosis.
Warnings and precautions:
♦ Infections: Caution in patients with chronic or history of recurrent infection. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves. Anti-tuberculosis therapy should be considered prior to initiation of Cosentyx in patients with latent tuberculosis. Cosentyx should not be given to patients with active tuberculosis.
♦ Inflammatory bowel disease:
Cases of new or exacerbations of inflammatory bowel disease have been reported with secukinumab (see section 4.8). Secukinumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, secukinumab should be discontinued and appropriate medical management should be initiated.
Cases of new onset IBD have been reported with post-marketing use.
♦ Hypersensitivity reactions: Rare cases of anaphylactic reactions and angioedema have been observed during clinical trials and in the post-marketing setting in patients receiving Cosentyx. Administration of
Cosentyx should be discontinued immediately and appropriate therapy initiated if an anaphylactic or other serious allergic reaction occurs.
♦ Latex-sensitive individuals: The removable caps of the 1 mL Cosentyx pre-filled syringe/pen, and 0.5 mL pre-filled syringe contain a derivative of natural rubber latex.
♦ Vaccinations: Cosentyx should not be given concurrently with live vaccines. Prior to initiating therapy with Cosentyx, it is recommended that pediatric patients receive all age-appropriate immunizations as per current immunization guidelines.
Hepatitis B reactivation
Hepatitis B virus reactivation can occur in patients treated with secukinumab. In accordance with clinical guidelines for immunosuppresants, testing patients for HBV infection is to be considered before initiating treatment with secukinumab. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation during secukinumab treatment. If reactivation of HBV occurs while on secukinumab, discontinuation of the treatment should be considered, and patients should be treated according to clinical guidelines.
Pregnancy, lactation, females and males of reproductive potential Pregnancy:
There are no adequate data from the use of secukinumab in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy.
Lactation: Caution should be exercised when Cosentyx is administered to a woman who is breast- feeding.
Fertility: The effect of secukinumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Adverse drug reactions:
Very common (≥10%):
Upper respiratory tract infections.
Common (≥1 to <10%):
Oral herpes, diarrhoea, eczema, rhinorrhoea, headache, diarrhoea, nausea, fatigue.
Uncommon (≥0.1 to <1%):
Oral candidiasis, neutropenia, tinea pedis, conjunctivitis, inflammatory bowel disease, dyshidrotic eczema, otitis externa, lower respiratory tract infections, urticaria.
Rare (≥1/10 000 to <1/1 000):
Anaphylactic reactions, angioedema, exfoliative dermatitis, hypersensitivity vasculitis.
Frequency not known:
Mucosal and cutaneous candidiasis (including oesophageal candidiasis), pyoderma gangrenosum.
Interactions:
Live vaccines should not be given concurrently with Cosentyx.
In a study in adult subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP 3A4 substrate).