Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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.
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).
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).
Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
No dose adjustment is required (see section 5.2).
Cosentyx has not been studied in these patient populations. No dose recommendations can be made.
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.
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.
Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
2 years.
If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
Cosentyx 150 mg solution for injection in pre-filled syringe:
Cosentyx 150 mg solution for injection in pre-filled syringe is supplied in a pre-filled 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber assembled in an automatic needle guard of polycarbonate.
Cosentyx 150 mg solution for injection in pre-filled syringe is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Cosentyx 300 mg solution for injection in pre-filled syringe:
Cosentyx 300 mg solution for injection in pre-filled syringe is supplied in a pre-filled 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of synthetic polyisoprene rubber assembled in an automatic needle guard of polycarbonate.
Cosentyx 300 mg solution for injection in pre-filled syringe is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Cosentyx 150 mg solution for injection in pre-filled pen:
Cosentyx 150 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber.
Cosentyx 150 mg solution for injection in pre-filled pen is available in unit packs containing 1 or 2 pre-filled pens and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Cosentyx 300 mg solution for injection in pre-filled pen:
Cosentyx 300 mg solution for injection in pre-filled pen is supplied in a single-use pre-filled syringe assembled into a squared-shaped pen with transparent window and label. The pre-filled syringe inside the pen is a 2.25 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of synthetic polyisoprene rubber.
Cosentyx 300 mg solution for injection in pre-filled pen is available in unit packs containing 1 pre-filled pen and in multipacks containing 3 (3 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
Cosentyx 150 mg solution for injection in pre-filled syringe:
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Cosentyx 300 mg solution for injection in pre-filled syringe:
Cosentyx 300 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. The syringe should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach room temperature.
Cosentyx 150 mg solution for injection in pre-filled pen:
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Cosentyx 300 mg solution for injection in pre-filled pen:
Cosentyx 300 mg solution for injection is supplied in a single-use pre-filled pen for individual use. The pen should be taken out of the refrigerator 30-45 minutes before injecting to allow it to reach room temperature.
Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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