Risankizumab-rzaadosage

For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. Complete all age-appropriate vaccinations as recommended by current immunization guidelines Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Pediatric P atients 6 Years of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

Active Psoriatic Arthritis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Pediatric Patients 6 Y ears of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). Moderately to Severely Active Crohn’s Disease: The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response. Moderately to Severely Active Ulcerative Colitis: The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.

2.1 Procedures

Prior to Treatment Initiation For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Complete all age-appropriate vaccinations as recommended by current immunization guidelines.

2.2 General

Considerations for Administration

Visually inspect SKYRIZI for particulate matter and discoloration prior to administration. The solution may contain a few translucent to white particles. ○ SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe, 180 mg/1.2 mL prefilled syringe or prefilled cartridge, and 360 mg/2.4 mL prefilled cartridge: a colorless to yellow, and clear to slightly opalescent solution. ○ SKYRIZI 90 mg/mL prefilled syringe and 600 mg/10 mL vial: a colorless to slightly yellow, and clear to slightly opalescent solution. ○ Do not use if the solution contains large particles or is cloudy or discolored.

Discard after use. Do not reuse. 2. 3 Recommended Dosage for Moderate-to-Severe Plaque Psoriasis Adults The recommended dosage for adults is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Pediatric Patients 6 Years of Age and Older The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see Table 1 ) and administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Table 1. Recommended Dose of SKYRIZI for Pediatric Patients 6 Years of Age and Older with Moderate-to-Severe Plaque Psoriasis Body Weight Recommended Dose less than 40 kg 55 mg 40 kg or greater 150 mg 2. 4 Recommended Dosage for Active Psoriatic Arthritis Adults The recommended dosage for adult patients is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). Pediatric Patients 6 Years of Age and Older The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see Table 2 ) and administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Table 2. Recommended Dose of SKYRIZI for Pediatric Patients 6 Years of Age and Older with Active Psoriatic Arthritis Body Weight Recommended Dose less than 40 kg 55 mg 40 kg or greater 150 mg SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). 2. 5 Preparation and Administration Instruction s ( Moderate-to-Severe Plaque Psoriasis and Active Psoriatic Arthritis)

Administer SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe subcutaneously.

Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI. After proper training: Adults ○ Adults may self-inject SKYRIZI. Pediatric Patients 6 Years of Age and Older ○ For pediatric patients 10 years of age and older, it is recommended that SKYRIZI be administered by or under the supervision of an adult. ○ For pediatric patients 6 to less than 10 years of age, SKYRIZI should be administered by an adult. Before injecting, remove the carton with SKYRIZI from the refrigerator and without removing the prefilled pen or prefilled syringe from the carton, allow SKYRIZI to reach room temperature out of direct sunlight (30 to 90 minutes for the prefilled pen and 15 to 30 minutes for the prefilled syringe). Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of SKYRIZI in the upper, outer arm may only be performed by a healthcare professional or caregiver. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI. Instruct the patient to read the Instructions for Use before administration.

2.6 Recommended

Dosage for Moderately to Severely Active Crohn’s Disease Adult Patients: Induction The recommended induction dosage of SKYRIZI is 600 mg administered by intravenous infusion over a period of at least one hour at Week 0, Week 4, and Week 8.

Adult Patients: Maintenance The recommended maintenance dosage of SKYRIZI is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response.

2.7 Recommended

Dosage for Moderately to Severely Active Ulcerative Colitis Adult Patients: Induction The recommended induction dosage of SKYRIZI is 1,200 mg administered by intravenous infusion over a period of at least two hours at Week 0, Week 4, and Week 8.

Adult Patients: Maintenance The recommended maintenance dosage of SKYRIZI is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response.

2.8 Preparation and

Administration Instructions ( Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis) Intravenous Induction Dosing Regimen: 1. SKYRIZI vial for intravenous administration is intended for administration by a healthcare provider using aseptic technique. 2. Prior to intravenous administration, determine the dose and number of SKYRIZI vials needed based on the patient’s indication (see table below). Withdraw 10 mL of SKYRIZI solution from a vial (600 mg/10 mL) and inject into an intravenous infusion bag or glass bottle containing 5% Dextrose Injection or 0.9% Sodium Chloride Injection (see Table 3 below) for a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Discard any remaining solution in the vial. Table 3. Total Volume of Diluent Required for Intravenous Induction Dose Indication I ntravenous Induction Dose Number of SKYRIZI 600 mg/10 mL Vials Total Volume of 5% Dextrose or 0.9% Sodium Chloride Injection Crohn’s disease 600 mg 1 100 mL, or 250 mL, or 500 mL Ulcerative colitis 1,200 mg 2 250 mL, or 500 mL 3. Infuse the diluted solution intravenously over a period of at least one hour for the SKYRIZI 600 mg dose; at least two hours for the SKYRIZI 1,200 mg dose. If stored refrigerated, allow the diluted SKYRIZI solution in the infusion bag or glass bottle to warm to room temperature prior to the start of the intravenous infusion. 4. Do not administer SKYRIZI diluted solution concomitantly in the same intravenous line with other medicinal products. Handling and Storage of the Vial and the Diluted Solution: Do not shake the vial or diluted solution in the infusion bag or glass bottle. Use the prepared infusion immediately. If not used immediately, store the diluted SKYRIZI solution refrigerated and protected from light for up to 20 hours between 36°F to 46°F (2°C to 8°C). Immediately after preparation or removal from refrigeration, the diluted SKYRIZI solution can be stored at room temperature at up to 77°F (25°C) (protected from sunlight) for up to 8 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after dilution in the infusion bag. Exposure to indoor light is acceptable during room temperature storage and administration. Do not freeze. Subcutaneous Maintenance Dosing Regimen: Using the single-dose 180 mg or 360 mg prefilled cartridge with On-Body Injector: SKYRIZI is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SKYRIZI using the on-body injector with prefilled cartridge after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI. Before using the on-body injector with prefilled cartridge, remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (45 to 90 minutes) without removing the prefilled cartridge or on-body injector from the carton. Use the on-body injector to administer SKYRIZI 180 mg/1.2 mL or SKYRIZI 360 mg/2.4 mL prefilled cartridge subcutaneously on thigh or abdomen. Start the injection within 5 minutes after inserting the prefilled cartridge into the On-Body Injector. Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI. Instruct the patient to read the Instructions for Use before administration. Using the 90 mg/mL or 180 mg/1.2 mL prefilled syringe:

Administer each SKYRIZI 90 mg/mL or 180 mg/1.2 mL prefilled syringe subcutaneously.

Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI.

Before injecting, remove the carton from the refrigerator and without removing the prefilled syringes from the carton, allow SKYRIZI to reach room temperature out of direct sunlight (15 to 30 minutes).

Use the 90 mg/mL or 180 mg/1.2 mL prefilled syringe(s) to administer SKYRIZI 180 mg or SKYRIZI 360 mg subcutaneously as follows: ○ 180 mg maintenance dose: ▪ SKYRIZI 90 mg/mL prefilled syringes: Two 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen). ▪ SKYRIZI 180 mg/1.2 mL prefilled syringe: One 180 mg prefilled syringe is required. ○ 360 mg maintenance dose: ▪ SKYRIZI 90 mg/mL prefilled syringes: Four 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen). ▪ SKYRIZI 180 mg/1.2 mL prefilled syringes: Two 180 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).

Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions. Administration of SKYRIZI in the upper, outer arm may only be performed by a healthcare professional or caregiver.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI. Instruct the patient to read the Instructions for Use before administration.