SPEVIGO® Product Monograph, Boehringer Ingelheim (Canada) Ltd. July 31, 2024.
Choon SE, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomized, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open 2021;11:e043666 doi:10.1136/bmjopen-2020-043666.
Morita A, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalized pustular psoriasis flares (Effisayil 2): an international, multicentre, randomized, placebo-controlled trial. Lancet 2023;402(10412):1541–51.
Supplement to: Morita A, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalized pustular psoriasis flares (Effisayil 2): an international, multicentre, randomized, placebo-controlled trial. Lancet 2023; published online Sept 19. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01378-8/abstract.
Data on file. Boehringer Ingelheim, September 11, 2024.
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.
