Spesolimab

Side effects, and when to stop

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Infections
• Hypersensitivity and Infusion-Related Reactions

Who should not take it

SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis.

Storing it

Storage and Handling

Prefilled syringes

300 mg/2 mL:

• Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not use if frozen even if it has been thawed.
• If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light. Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days.

150 mg/mL:

• Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not use if frozen even if it has been thawed.

Single-dose vials

• Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.
• Prior to use, may store unopened SPEVIGO vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.