UK-BNO-230019. DOP: January 2023.
BOTOX® has safety and tolerability experience from +30 years of use in a range of conditions1,5-7
BOTOX® is generally well tolerated in the treatment of post-stroke spasticity (PSS)5
- In a meta-analysis of data from 37 randomised controlled trials across all indications (BOTOX® n=1,447):6
- Adverse events (AEs) associated with BOTOX® were generally mild to moderate in severity
- Results were consistent over long-term clinical use
Adapted from the BOTOX® Summary of Product Characteristics.5
Please refer to the BOTOX® Summary of Product Characteristics for the full list of adverse events.
PSS: post-stroke spasticity.
BOTOX® (botulinum toxin type A) is indicated for the treatment of focal spasticity including:5
- wrist and hand disability due to upper limb spasticity associated with stroke in adults
- ankle and foot disability due to lower limb spasticity associated with stroke in adults
References
- Allergan. Data on file. INT/0423/2016(1). 2018.
- Aurora S K, Winner P et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011;51(9):1358-1373
- Blumenfeld A M, Stark R J et al. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain 2018;19(1):13
- Allergan. Data on file. 014
- BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed October 2022
- Naumann M, Albanese A et al. Safety and efficacy of botulinum toxin type A following long-term use. Eur J Neurol. 2006;13 Suppl 4:35-40
- Allergan. Data on file. INT/0572/2016(2). 2019
Please refer to the BOTOX® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.
Adverse events should also be reported to AbbVie on [email protected]
Date of preparation: October 2022. UK-BTX-220209.
