COSENTYX

2 DOSAGE AND ADMINISTRATION Prior to COSENTYX initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis (TB). ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration of COSENTYX. ( 2.2 , 2.10 , 2.11 ) Administration of Intravenous Formulation: COSENTYX for intravenous use must be diluted prior to administration. Administer as an intravenous infusion after dilution over a period of 30 minutes. ( 2.11 ) Plaque Psoriasis: Subcutaneous Dosage in Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For some patients, a dose of 150 mg may be acceptable. ( 2.3 ) Subcutaneous Dosage in Pediatric Patients 6 Years and Older: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients < 50 kg, the dose is 75 mg. For patients ≥ 50 kg, the dose is 150 mg. ( 2.3 ) Psoriatic Arthritis: Adult Patients Subcutaneous Dosage: For PsA patients with coexistent moderate to severe PsO, use the dosage and administration for PsO. ( 2.3 ) For other PsA patients, administer with or without a loading dosage. With a loading dosage : 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter Without a loading dosage : 150 mg every 4 weeks If a patient continues to have active PsA, consider a dosage of 300 mg every 4 weeks. ( 2.4 ) Intravenous Dosage: The recommended intravenous dosages are: With a loading dosage : 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion). Without a loading dosage : 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion). ( 2.4 ) Pediatric Patients 2 Years and Older Subcutaneous Dosages : Administer by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter: For patients ≥ 15 kg and < 50 kg the dose is 75 mg. For patients ≥ 50 kg the dose is 150 mg. ( 2.5 ) Ankylosing Spondylitis: Subcutaneous Dosage: Administer with or without a loading dosage. The recommended dosages are: With a loading dosage : 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dosage : 150 mg every 4 weeks. If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks. ( 2.6 ) Intravenous Dosage: The recommended intravenous dosages are: With a loading dosage : 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion). Without a loading dosage : 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion). ( 2.6 ) Non-Radiographic Axial Spondyloarthritis: Subcutaneous Dosage: Administer with or without a loading dosage. The recommended dosage is: With a loading dosage : 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dosage : 150 mg every 4 weeks. ( 2.7 ) Intravenous Dosage: The recommended intravenous dosages are: With a loading dosage : 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion). Without a loading dosage : 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion). ( 2.7 ) Enthesitis-Related Arthritis: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients ≥ 15 kg and < 50 kg the dose is 75 mg. For patients ≥ 50 kg the dose is 150 mg. ( 2.8 ) Hidradenitis Suppurativa: Subcutaneous Dosage in Adults : Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. ( 2.9 ) Subcutaneous Dosage in Pediatric Patients 12 Years and Older : Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients ≥ 30 kg and < 90 kg, the dose is 150 mg. For patients ≥ 90 kg, the dose is 300 mg. ( 2.9 ) 2.1 Testing and Procedures Prior to Treatment Initiation Perform the following evaluations prior to COSENTYX initiation: Evaluate for active or latent tuberculosis (TB). 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 (5.3)] . Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with COSENTYX [see Warnings and Precautions (5.7)] . 2.2 Important Administration Instructions COSENTYX is for use under the guidance and supervision of a healthcare provider. UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous use only. Solution in vials is for intravenous use in adult patients only. Important Subcutaneous Administration Instructions 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. Administer each subcutaneous 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 subcutaneous COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider. The COSENTYX “Instructions for Use” for each presentation and strength contains more detailed instructions on the preparation and administration of COSENTYX for patients and caregivers [see Instructions for Use] . Important Intravenous Infusion Instructions Intravenous infusion is only for use by a healthcare professional in a healthcare setting. Prepare COSENTYX intravenous infusion by diluting COSENTYX injection in vial(s) and administering based on patient body weight [see Dosage and Administration (2.11)] . Intravenous infusion may be administered only in adults with PsA, AS, and nr-axSPA. 2.3 Recommended Dosage in Plaque Psoriasis Recommended Subcutaneous Dosage in Adults The recommended dosage in adults with PsO is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. 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 dosage of 150 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter may be acceptable. Recommended Subcutaneous Dosage in Pediatric Patients 6 Years of Age and Older The recommended weight-based dosage in pediatric patients 6 years of age and older with PsO is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients < 50 kg, the recommended dose is 75 mg. For patients ≥ 50 kg, the recommended dose is 150 mg. 2.4 Recommended Dosage in Adults with Psoriatic Arthritis COSENTYX may be administered with or without methotrexate. Recommended Subcutaneous Dosage For adult patients with PsA and with coexistent moderate to severe PsO, use the dosage and administration recommendations for adults with PsO [see Dosage and Administration (2.3)] . For other adult patients with PsA, administer COSENTYX with or without a loading dosage by subcutaneous injection. The recommended dosage in adults with PsA: 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 increasing the dosage to 300 mg by subcutaneous injection every 4 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Recommended Intravenous Dosage COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adults with PsA: With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage). Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] . Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with PsA [see Dosage and Administration (2.11)] . 2.5 Recommended Dosage in Pediatric Patients 2 Years of Age and Older with Juvenile Psoriatic Arthritis COSENTYX may be administered with or without methotrexate. The recommended weight-based subcutaneous dosage in pediatric patients 2 years of age and older with PsA at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter is as follows: For patients ≥ 15 kg and < 50 kg, the recommended dose is 75 mg. For patients ≥ 50 kg, the recommended dose is 150 mg. 2.6 Recommended Dosage in Adults with Ankylosing Spondylitis Recommended Subcutaneous Dosage Administer COSENTYX with or without a loading dosage by subcutaneous injection in adult patients with active AS. 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 increasing the dosage to 300 mg every 4 weeks by subcutaneous injection. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Recommended Intravenous Dosage COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active AS: With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage). Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] . Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with AS [see Dosage and Administration (2.11)] . 2.7 Recommended Dosage in Adults with Non-Radiographic Axial Spondyloarthritis Recommended Subcutaneous Dosage Administer COSENTYX with or without a loading dosage by subcutaneous injection in adult patients with active nr-axSpA. 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. Recommended Intravenous Dosage COSENTYX injection for intravenous use (solution in vials) requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active nr-axSpA: With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage). Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes [see Dosage and Administration (2.11)] . Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with nr-axSpA [see Dosage and Administration (2.11)] . 2.8 Recommended Dosage in Enthesitis-Related Arthritis COSENTYX may only be administered as a subcutaneous injection in pediatric patients aged 4 years and older with active ERA. The recommended weight-based dosage in pediatric patients 4 years of age and older with ERA is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter: For patients ≥ 15 kg and < 50 kg, the recommended dose is 75 mg. For patients ≥ 50 kg, the recommended dose is 150 mg. 2.9 Recommended Dosage in Hidradenitis Suppurativa Recommended Subcutaneous Dosage in Adults The recommended dosage in adult patients with moderate to severe HS is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. If an adult patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Recommended Subcutaneous Dosage in Pediatric Patients 12 Years of Age and Older The recommended weight-based dosage in pediatric patients 12 years of age and older with moderate to severe HS is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter [see Clinical Pharmacology (12.3)] . For patients ≥ 30 kg and < 90 kg, the recommended dose is 150 mg. For patients ≥ 90 kg, the recommended dose is 300 mg. 2.10 Preparation for Use of COSENTYX UnoReady Pen, Sensoready Pen, and Prefilled Syringes COSENTYX UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous injection only. Before subcutaneous injection, remove COSENTYX from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes for the Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL)); 30 to 45 minutes for the UnoReady pen and prefilled syringe (300 mg/2 mL)) without removing the needle cap. The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex and should not be handled by latex-sensitive individuals [see Warnings and Precautions (5.6)] . 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. 2.11 Preparation and Administration of COSENTYX for Intravenous Use COSENTYX (for intravenous use) must be diluted prior to infusion. Using aseptic technique, prepare COSENTYX (for intravenous use) as follows: Step 1. Volume Calculation Calculate the total volume of COSENTYX for intravenous use solution (in mL) required based on the patient’s actual body weight as follows: Loading dose (6 mg/kg) is 0.24 mL/kg Maintenance dose (1.75 mg/kg) is 0.07 mL/kg Use the number of vials based on total volume needed (one vial contains 5 mL of COSENTYX solution). Step 2. Dilution Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulates or discolorations are noted. Follow Table 1 for recommended infusion bag size based on patient's body weight. Table 1: Recommended Infusion Bags for Dilution and Preparation of COSENTYX for Intravenous Use Based on Body Weight and Dose * If a 50 mL infusion bag is unavailable, then use a 100 mL infusion bag and withdraw and discard 50 mL of saline using aseptic technique and continue to follow the preparation and administration steps. Body weight at time of dosing For the loading dose (6 mg/kg) recommended infusion bag For maintenance dose (1.75 mg/kg) recommended infusion bag Greater than 52 kg 100 mL 100 mL Less than or equal to 52 kg 100 mL 50 mL * From the infusion bag, withdraw and discard a volume of 0.9% Sodium Chloride Injection, USP, equal to the calculated volume of the COSENTYX solution required for the patient’s dose [see Dosage and Administration (2.4, 2.6, 2.7)] . From the vial(s), withdraw the calculated volume (mL) of COSENTYX solution and add slowly into the 0.9% Sodium Chloride Injection, USP infusion bag. To mix the solution, gently invert the bag to avoid foaming. Do not shake. Discard unused COSENTYX product in vials because it does not contain preservatives. Allow the diluted COSENTYX solution for infusion to warm to room temperature prior to the start of the intravenous infusion. Administer the diluted COSENTYX solution for infusion as soon as possible. If not administered immediately, store the diluted solution either: At room temperature 20ºC to 25ºC (68ºF to 77ºF) for no more than 4.5 hours from the start of the preparation (piercing the first vial) to the completion of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, from the start of the time of the preparation (piercing the first vial) to the completion of infusion. This time includes the refrigeration of the diluted solution and the time to allow the diluted solution to warm to room temperature. Protect the diluted solution from light during storage under refrigeration. Step 3. Administration Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). Administer the infusion at a flow rate of about 3.3 mL/minute for a 100 mL bag or 1.7 mL/min for a 50 mL bag (total administration time: 30 minutes). When administration is complete, flush the line with 0.9% Sodium Chloride Injection, USP to guarantee that all the COSENTYX solution for infusion in the line has been administered. Do not infuse COSENTYX concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the IV coadministration of COSENTYX with other drugs.

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1 INDICATIONS AND USAGE COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.