2.1 Testing and Procedures Prior to Treatment Initiation

Perform the following evaluations prior to COSENTYX initiation:

• Evaluate patients for tuberculosis (TB) infection. COSENTYX initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of COSENTYX [see Warnings and Precautions (5.2)].
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with COSENTYX [see Warnings and Precautions (5.6)].

2.2 Plaque Psoriasis

Adults

​The recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.

For some patients, a dose of 150 mg may be acceptable.

Pediatric Patients

The recommended dosage for pediatric patients 6 years of age and older is based on body weight (Table 1) and administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.

2.3 Psoriatic Arthritis

Adults

For PsA patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis [see Dosage and Administration (2.1)].

For other PsA patients, administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage:

• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks
• ​If a patient continues to have active PsA, consider a dosage of 300 mg every 4 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.

Pediatric Patients

The recommended dose based on body weight is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

• For patients weighing ≥ 15 kg and < 50 kg, the recommended dose is 75 mg
• For patients weighing ≥ 50 kg, the recommended dose is 150 mg

COSENTYX may be administered with or without methotrexate.

2.4 Ankylosing Spondylitis

Administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage:

• ​With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• ​Without a loading dosage is 150 mg every 4 weeks
• ​If a patient continues to have active AS, consider a dosage of 300 mg every 4 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.

2.5 Non-Radiographic Axial Spondyloarthritis

Administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage:

• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

2.6 Enthesitis-Related Arthritis

The recommended dose based on body weight is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

• For patients weighing ≥ 15 kg and < 50 kg, the recommended dose is 75 mg
• For patients weighing ≥ 50 kg, the recommended dose is 150 mg

2.7 Important Administration Instructions

​The lyophilized powder in vial for reconstitution is for healthcare provider use only [see Instructions for Use for Health Care Professionals]. COSENTYX is intended for use under the guidance and supervision of a physician.

​The COSENTYX “Instructions for Use” for each dosage form contains more detailed instructions on the preparation and administration of COSENTYX [see Instructions for Use].

UnoReady Pen/Sensoready Pen/Prefilled Syringes

​Adult patients may self-administer COSENTYX or be injected by a caregiver after proper training in subcutaneous injection technique.

​Pediatric patients should not self-administer COSENTYX. An adult caregiver should prepare and inject COSENTYX after proper training in subcutaneous injection technique.

Administration Instructions

Administer each injection at a different anatomic location (such as upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Administration of COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider.

​2.8 Preparation for Use of COSENTYX 300 mg/2 mL UnoReady Pen, 150 mg/mL Sensoready Pen and Prefilled Syringes (300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL)

​Before injection, remove COSENTYX from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes for the Sensoready pen, the 150 mg/mL and 75 mg/0.5 mL prefilled syringes; 30 to 45 minutes for the UnoReady pen and the 300 mg/2 mL prefilled syringe) without removing the needle cap.

The removable cap of the COSENTYX 150 mg/mL Sensoready pen and the COSENTYX prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contain natural rubber latex and should not be handled by latex-sensitive individuals [see Warnings and Precautions (5.5)].

Inspect COSENTYX visually for particulate matter and discoloration prior to administration. COSENTYX injection is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy. Discard any unused product.

2.9 Reconstitution and Preparation of COSENTYX Lyophilized Powder

COSENTYX lyophilized powder should be prepared and reconstituted with Sterile Water for Injection by a trained healthcare provider using aseptic technique and without interruption. The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes.

a) Remove the vial of COSENTYX lyophilized powder from the refrigerator and allow to stand for 15 to 30 minutes to reach room temperature. Ensure the Sterile Water for Injection is at room temperature.

b) Slowly inject 1 mL of Sterile Water for Injection into the vial containing COSENTYX lyophilized powder and direct the stream of Sterile Water for Injection onto the lyophilized powder.

c) Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.

d) Allow the vial to stand for about 10 minutes at room temperature to allow for dissolution. Note that foaming may occur.

e) Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.

f) Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The reconstituted COSENTYX solution should be essentially free of visible particles, clear to opalescent, and colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains visible particles, is cloudy or discolored.

g) Prepare the required number of vials (1 vial for the 150 mg dose or 2 vials for the 300 mg dose).

h) The COSENTYX reconstituted solution contains 150 mg of secukinumab in 1 mL of solution. After reconstitution, use the solution immediately or store in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) for up to 24 hours. Do not freeze.

i) If stored at 2ºC to 8ºC (36ºF to 46ºF), allow the reconstituted COSENTYX solution to reach room temperature (15 to 30 minutes) before administration. COSENTYX does not contain preservatives; therefore, administer within 1 hour after removal from 2ºC to 8ºC (36ºF to 46ºF) storage.