SPEVIGO 450 mg concentrate for solution for infusion

Manufacturer
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG(GERMANY)

Registraction Number
MAL24106002AZ

Content:
SPEVIGO 450 mg Concentrate for Solution for Infusion contains 450 mg of spesolimab in 7.5 mL of solution (60 mg/mL). It also contains 386 mg of sucrose as an excipient.
Indication:
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults and pediatric patients aged 12 years and older who weigh at least 40 kg.
Instructions:

1. Preparation: Must be diluted before intravenous use. Follow the preparation and administration instructions provided in the prescribing information.
2. Administration: Administer as a single 900 mg dose by intravenous infusion over 90 minutes. If flare symptoms persist, a second 900 mg dose may be administered one week after the initial dose.
3. Monitoring: Regularly monitor for signs of infection, hypersensitivity, and infusion-related reactions.
4. Storage: Store at room temperature, away from moisture and heat.
5. Precautions: Do not use during any clinically important active infection. Evaluate patients for tuberculosis prior to initiating treatment.