SPEVIGO®

Indication and clinical use

SPEVIGO® (spesolimab injection/spesolimab for injection) is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.

The safety and efficacy of SPEVIGO® in children below the age of 12 years have not been established. No data are available in this population. In people 65 years of age and older, no dose adjustment is required. There is limited information in this population.

Relevant warnings and precautions

• Limited safety data are available for re-treatment with SPEVIGO® for a subsequent new flare
• To improve traceability, clearly record the trade name and batch number of the administered product in the patient file
• May increase risk of infections, such as urinary tract infections and upper respiratory tract infections. Treatment with SPEVIGO® should not be initiated during clinically important active infection. Stop treatment with SPEVIGO® SC if patient develops a clinically important active infection
• Evaluate for tuberculosis (TB) prior to initiating treatment. SPEVIGO® should not be administered to patients with active TB infection. Consider anti-TB therapy in patients with latent TB or a history of TB. Monitor patients for signs and symptoms of active TB during and after SPEVIGO® treatment
• Hypersensitivity and infusion-related reactions may occur
• Consider completion of all appropriate immunizations before initiating SPEVIGO® SC
• Live vaccines should not be given concurrently with SPEVIGO®. Leave at least 4 weeks between live vaccinations and initiation of SPEVIGO®; do not administer live vaccines during and for at least 16 weeks after treatment with SPEVIGO®
• SPEVIGO® has no, or negligible, influence on the ability to drive and use machines
• Peripheral neuropathy potential is unknown and cases have been reported
• There are no data available on the effect of SPEVIGO® on human fertility
• There are limited data from the use of SPEVIGO® in pregnant women. As a precautionary measure, it is recommended to avoid the use of SPEVIGO® in pregnancy
• There are no data on the effects on the breastfed infant, or the effects on milk production. A risk to newborns/infants cannot be excluded
• Use in pediatric patients ≥12 years of age

For more information

Please refer to the Product Monograph at https://www.boehringer-ingelheim.com/ca/bipdf/spevigopmen for important information relating to adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling 1-800-263-5103 ext. 84633.