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Important safety information1

Clinical use

The safety and efficacy of SPEVIGO® in children below the age of 18 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 should not be initiated during 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 after SPEVIGO® treatment

  • Hypersensitivity and infusion-related reactions may occur

  • 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 for at least 16 weeks after treatment with SPEVIGO®

  • Peripheral neuropathy potential is unknown and cases have been reported

  • SPEVIGO® has no, or negligible, influence on the ability to drive and use machines

  • 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

For more information

Please refer to the Product Monograph 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.