Ustekinumab-ttwedosage

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight Range (kilograms) 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) 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 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) 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 and 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 (2 vials) greater than 55 kg to 85 kg 390 mg (3 vials) greater than 85 kg 520 mg (4 vials) Crohn's Disease and 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 PYZCHIVA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of PYZCHIVA 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 PYZCHIVA 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 PYZCHIVA 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* 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 0.30 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 0.40 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 * Refer to

2.2 Psoriatic

Arthritis; Subcutaneous Pediatric Dosage Regimen.

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 PYZCHIVA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of PYZCHIVA 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 PYZCHIVA 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* 0.75 mg/kg 60 kg or more 45 mg greater than 100 kg with co-existent moderate-to-severe plaque psoriasis 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.

2.3 Recommended

Dosage in Crohn's Disease and Ulcerative Colitis Intravenous Induction Adult Dosage Regimen A single intravenous infusion dose of PYZCHIVA using the weight-based dosage regimen specified in Table 4.

Table 4: Initial Intravenous Dosage of PYZCHIVA Body Weight of Patient at the time of dosing Dose Number of 130 mg/26 mL (5 mg/mL) PYZCHIVA vials 55 kg or less 260 mg 2 more than 55 kg to 85 kg 390 mg 3 more than 85 kg 520 mg 4 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 General

Considerations for Administration PYZCHIVA is intended for use under the guidance and supervision of a healthcare provider. PYZCHIVA 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 PYZCHIVA 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 PYZCHIVA after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use. 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 PYZCHIVA for particulate matter and discoloration. PYZCHIVA is a clear, colorless to light yellow, sterile and preservative-free solution. Do not use PYZCHIVA if it is discolored or cloudy, or if other particulate matter is present. PYZCHIVA does not contain preservatives; therefore, discard any unused product remaining in the vial, syringe and/or PYZCHIVA AUTOINJECTOR.

2.5 Preparation and

Administration of PYZCHIVA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn's Disease and Ulcerative Colitis) PYZCHIVA solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique. Calculate the dose and the number of PYZCHIVA vials needed based on patient weight (Table 4). Each 26 mL vial of PYZCHIVA contains 130 mg of ustekinumab-ttwe. Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of PYZCHIVA to be added (discard 26 mL sodium chloride for each vial of PYZCHIVA needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used. Withdraw 26 mL of PYZCHIVA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix. Protect from light. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed. Infuse the diluted solution over a period of at least one hour. Once diluted in the infusion bag, the infusion should be completely administered within 36 hours at room temperature up to 30°C (86°F). Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). Do not infuse PYZCHIVA concomitantly in the same intravenous line with other agents. PYZCHIVA does not contain preservatives. Each vial is for one-time use in only one patient. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements. Storage The diluted infusion solution may be kept at room temperature up to 30°C (86°F) for up to 36 hours including infusion period. If necessary, the diluted infusion solution may be stored refrigerated at 2ºC to 8ºC (36ºF to 46ºF) for up to 15 days. After removal from refrigeration, the diluted solution may be stored at room temperature at up to 30°C (86°F) for an additional 24 hours including infusion period. Storage time at refrigerated or room temperature begins once the diluted solution has been prepared. Do not freeze. Protect from light. Discard any unused portion of the infusion solution.