IMULDOSA

2 DOSAGE AND ADMINISTRATION Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ): Weight Range (kilograms) Dosage Regimen 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 ( 2.1 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Dose 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2 ): 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 ( 2.2 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Dosage Regimen 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 Dosage ( 2.3 ): A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dosage 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 ( 2.3 ): 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 [ see Clinical Studies ( 14 ) ]. Subcutaneous Pediatric Dosage Regimen Administer IMULDOSA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of IMULDOSA 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 IMULDOSA for Subcutaneous Injection in Pediatric Patients 6 years of age and older with Plaque Psoriasis There is no dosage form for IMULDOSA that allows weight-based dosing for pediatric patients below 60 kg. Body Weight of Patient at the Time of Dosing Recommended Dose 60 kg to 100 kg 45 mg more than 100 kg 90 mg 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 IMULDOSA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. The recommended dose of IMULDOSA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 2). Table 2: Recommended Dose of IMULDOSA 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 60 kg or more 45 mg greater than 100 kg with co-existent moderate- to-severe plaque psoriasis 90 mg There is no dosage form for IMULDOSA that allows weight-based dosing for pediatric patients below 60 kg. 2.3 Recommended Dosage in Crohn’s Disease and Ulcerative Colitis Intravenous Induction Adult Dosage Regimen A single intravenous infusion dose of IMULDOSA using the weight-based dosage regimen specified in Table 3 [ see Instructions for dilution of IMULDOSA 130 mg vial for intravenous infusion ( 2.5 ) ]. Table 3: Initial Intravenous Dosage of IMULDOSA Body Weight of Patient at the time of dosing Dose Number of 130 mg/26 mL (5 mg/mL) IMULDOSA 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 IMULDOSA is intended for use under the guidance and supervision of a healthcare provider. IMULDOSA 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 IMULDOSA 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 IMULDOSA after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use [ see 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 single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch needle is recommended. Prior to administration, visually inspect IMULDOSA for particulate matter and discoloration IMULDOSA is a clear to slightly opalescent and colorless to slightly yellow solution. Do not use IMULDOSA if it is discolored or cloudy, or if other particulate matter is present. IMULDOSA does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe. 2.5 Preparation and Administration of IMULDOSA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn’s Disease and Ulcerative Colitis) IMULDOSA solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique. Calculate the dose and the number of IMULDOSA vials needed based on patient weight (Table 3). Each 26 mL vial of IMULDOSA contains 130 mg of ustekinumab-srlf. 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 IMULDOSA to be added (discard 26 mL sodium chloride for each vial of IMULDOSA 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. Infusion bags must be made of either polypropylene (PP) or polyethylene (PE). Withdraw 26 mL of IMULDOSA 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. 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, the infusion should be completely administered within eight hours of the dilution in the infusion bag. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). Do not infuse IMULDOSA concomitantly in the same intravenous line with other agents. 8. IMULDOSA 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 If necessary, the diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 7 hours. Storage time at room temperature begins once the diluted solution has been prepared. 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). Do not freeze. Discard any unused portion of the infusion solution.

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1 INDICATIONS AND USAGE IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.