Ustekinumabdosage

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight Range (kilograms) Recommended Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage: The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks. Psoriatic Arthritis Pediatric Patients 6 years of Age and Older Subcutaneous Recommended Dosage: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Recommended Dose less than 60 kg 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co-existent moderate-to-severe plaque psoriasis 90 mg Crohn's Disease Initial Adult Intravenous Recommended Dose: A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose 55 kg or less 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Crohn's Disease Maintenance Adult Subcutaneous Recommended Dosage: A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. Crohn's Disease Initial Pediatric Intravenous Recommended Dose: For patients weighing 10 kg or more: A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose 10 kg to 25 kg 10 mg/kg greater than 25 kg to 55 kg 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Crohn's Disease Maintenance Pediatric Subcutaneous Recommended Dosage: The recommended maintenance dosage in pediatric patients using weight-based dosing is: 10 kg to 35 kg: a subcutaneous 2.5 mg/kg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Greater than 35 kg: a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. Ulcerative Colitis Initial Adult Intravenous Recommended Dose: A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose up to 55 kg 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage: A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

2.1 Recommended

Dosage in Plaque Psoriasis Subcutaneous Adult Dosage Regimen For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects. Subcutaneous Pediatric Dosage Regimen Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis Body Weight of Patient at the Time of Dosing Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg more than 100 kg 90 mg For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection Volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis Refer to

2.2 Psoriatic

Arthritis; Subcutaneous Pediatric Dosage Regimen. Weighing Less Than 60 kg Body Weight (kg) at the Time of Dosing Dose (mg) Volume of Injection (mL) 15 11.3 0.12 16 12 0.13 17 12.8 0.14 18 13.5 0.15 19 14.3 0.16 20 15 0.17 21 15.8 0.17 22 16.5 0.18 23 17.3 0.19 24 18 0.20 25 18.8 0.21 26 19.5 0.22 27 20.3 0.22 28 21 0.23 29 21.8 0.24 30 22.5 0.25 31 23.3 0.26 32 24 0.27 33 24.8 0.27 34 25.5 0.28 35 26.3 0.29 36 27 0.3 37 27.8 0.31 38 28.5 0.32 39 29.3 0.32 40 30 0.33 41 30.8 0.34 42 31.5 0.35 43 32.3 0.36 44 33 0.37 45 33.8 0.37 46 34.5 0.38 47 35.3 0.39 48 36 0.4 49 36.8 0.41 50 37.5 0.42 51 38.3 0.42 52 39 0.43 53 39.8 0.44 54 40.5 0.45 55 41.3 0.46 56 42 0.46 57 42.8 0.47 58 43.5 0.48 59 44.3 0.49

2.2 Recommended

Dosage in Psoriatic Arthritis Subcutaneous Adult Dosage Regimen The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. Subcutaneous Pediatric Dosage Regimen Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis Body Weight of Patient at the Time of Dosing Recommended Dose less than 60 kg For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial. 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co-existent moderate-to-severe plaque psoriasis 90 mg

2.3 Recommended

Adult Dosage in Crohn's Disease Intravenous Induction Adult Dosage Regimen The recommended induction dosage is a single intravenous infusion using the weight-based dosage regimen specified in Table 4.

Table 4: Initial Intravenous Dose of STELARA in Adult Patients with Crohn's Disease Body Weight of Patient at the Time of Dosing Dose 55 kg or less 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Subcutaneous Maintenance Adult Dosage Regimen The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

2.4 Recommended

Pediatric Dosage in Crohn's Disease Intravenous Induction Pediatric Dosage Regimen The recommended induction dosage in pediatric patients weighing 10 kg and above is a single intravenous infusion using the weight-based dosage regimen specified in Table 5.

Table 5: Initial Intravenous Dose of STELARA in Pediatric Patients (Weighing 10 kg or More) with Crohn's Disease Body Weight of Patient at the Time of Dosing Dose 10 kg to 25 kg 10 mg/kg greater than 25 kg to 55 kg 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Subcutaneous Maintenance Pediatric Dosage Regimen The recommended maintenance dosage in pediatric patients using weight-based dosing is: 10 kg to 35 kg: a subcutaneous 2.5 mg/kg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. greater than 35 kg: a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

2.5 Recommended

Dosage in Ulcerative Colitis Intravenous Induction Adult Dosage Regimen The recommended induction dosage is a single intravenous infusion using the weight-based dosage regimen specified in Table 6.

Table 6: Initial Intravenous Dosage of STELARA in Adult Patients with Ulcerative Colitis Body Weight of Patient at the Time of Dosing Dose 55 kg or less 260 mg greater than 55 kg to 85 kg 390 mg greater than 85 kg 520 mg Subcutaneous Maintenance Adult Dosage Regimen The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

2.6 General

Considerations for Administration STELARA is intended for use under the guidance and supervision of a healthcare provider. STELARA should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider. The appropriate dose should be determined by a healthcare provider using the patient's current weight at the time of dosing. In pediatric patients, it is recommended that STELARA be administered by a healthcare provider. If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use. The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex. It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated. When using the vial, a 1 mL syringe with a 27 gauge, ½ inch needle is recommended. Prior to administration, visually inspect STELARA for particulate matter and discoloration. STELARA is a colorless to light yellow solution and may contain a few small translucent or white particles. Do not use STELARA if it is discolored or cloudy, or if other particulate matter is present. STELARA does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.

2.7 Preparation and

Administration of STELARA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis) STELARA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique. 1. Calculate the dose and the number of STELARA vials needed based on patient weight (see Table 4, Table 5, and Table 6 above). 2. Obtain the appropriate infusion solution (Table 7). Withdraw and discard a volume of the infusion solution equal to the volume of STELARA solution to be added: Table 7: Appropriate Infusion Solution and Final Infusion Volumes for Intravenous Infusion of STELARA Solution Patient Population Body Weight of Patient at the Time of Dosing Infusion Solution Final Volume in the Infusion Bag Pediatric 10 kg to 25 kg 0.9% Sodium Chloride Injection 100 mL Remove a volume of infusion solution equal to the volume of STELARA solution to be added to obtain the final volume. Greater than 25 kg 0.9% Sodium Chloride Injection 250 mL Adult All weights 0.45% or 0.9% Sodium Chloride Injection 250 mL 3. Add the volume of STELARA solution equal to the calculated dose of STELARA to the infusion solution and gently mix. 4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed. 5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completely administered within the storage time (see Storage below). 6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). 7. Do not infuse STELARA concomitantly in the same intravenous line with other agents. 8. STELARA does not contain preservatives. Each vial is for a one-time use in only one patient. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements. 9. Discard any unused portion of the infusion solution. Storage Do not freeze. Storage time at room temperature begins once the diluted solution has been prepared. 100 mL infusion bag: If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 3 hours. The infusion should be completed within 4 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period). 250 mL infusion bag: If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 7 hours. The infusion should be completed within 8 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period).