COSENTYX SOLUTION FOR INJECTION IN PRE-FILLED UNOREADY PEN 300MG/2ML

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage regimen** **Plaque psoriasis** **Adult patients** 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. 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 300mg or as two subcutaneous injections of 150 mg. For some patients, a dosage of 150 mg may be acceptable. **Pediatric patients** 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 (every 4 weeks). 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.  **Psoriatic arthritis** 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. For patients with concomitant moderate to severe plaque psoriasis, the dosage and administration for adult plaque psoriasis is recommended. For patients who are anti-TNF-alpha 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 300mg or as two subcutaneous injections of 150 mg. **Ankylosing spondylitis (AS)** 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 300mg or as two subcutaneous injections of 150 mg. For all 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. **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. For patients weighing < 50 kg the dose is 75 mg. For patients weighing ≥ 50 kg the dose is 150 mg. Cosentyx is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks). 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. COSENTYX may be administered with or without methotrexate. **Hidradenitis Suppurativa** 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. **Special populations** **Renal impairment / hepatic impairment** Cosentyx has not been studied specifically in these patient populations. **Pediatric patients** Limited data in pediatric patients with the JIA categories of ERA and JPsA below the age of 6 years. Safety and effectiveness of pediatric patients with plaque psoriasis below the age of 6 years have not been established. Safety and effectiveness in pediatric patients below the age of 18 years in other indications have not yet been established. **Geriatric patients (65 years or above)** No dose adjustment is required. **Method of administration** **Pre-filled syringe & pre-filled pen** Cosentyx is administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. After proper training in subcutaneous injection technique, patients may self-inject Cosentyx or be injected by a caregiver if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients and/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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. For patients receiving the 75 mg dose, the 75 mg/0.5 mL pre-filled syringe should be used. Full instructions for use are provided in section PHARMACEUTICAL INFORMATION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.