Usual Adult Dose for Pustular Psoriasis

900 mg by intravenous infusion over 90 minutes once

Comment:

• One week after the initial dose, consider administering an additional 900 mg IV dose (over 90 minutes) if generalized pustular psoriasis (GPP) symptoms persist.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Severe or life-threatening hypersensitivity to this drug or any excipients.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug must be diluted before administration.
• This drug should be given as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes.
• Infusion time should not exceed 180 minutes, if infusion is temporarily slowed or stopped.
• Infusion can be given via a preexisting-existing intravenous line provided it is flushed with sterile 0.9% sodium chloride injection prior to and at the end of infusion.
• No other drug should be administered in parallel to this drug via the same IV access.

• Diluted solution can be refrigerated at 2C to 8C (36F to 46F) for no more than 4 hours.
• Protect from light.
• Do not freeze.
• Before using, the vial may be stored unopened at room temperature, 20C to 25C (68F to 77F), for up to 24 hours in the original carton to protect from light.
• Discard the vial if the solution is cloudy, discolored, or contains large or colored particulates.

• Dilution to be prepared aseptically.
• Draw and discard 15 mL from a 100 mL container of sterile 0.9% sodium chloride Injection.
• Slowly replace with 15 mL of spesolimab-sbzo (complete contents from two vials of 450 mg/7.5 mL).
• Mix gently before use.
• Use the diluted solution immediately.

• This drug is compatible with 0.9% sodium chloride.
• Do not mix this drug with any other medicinal preparation/drug products.

• Advise patients to read the FDA-approved patient labeling.
• Inform patients that this drug can decrease the ability of their immune system to fight infections.
• Communicate history of infection to health-care provider and contact them in case, any signs/symptoms of clinically important infection develops.
• Inform patients about the occurrence of hypersensitivity and infusion-related reactions with this drug.
• Advise patients to seek immediate medical attention if they experience any symptoms of a serious hypersensitivity reaction.
• Avoid receiving live vaccines after treatment with this drug.