UK-BNO-230019. DOP: January 2023.
Administering BOTOX® for your post-stroke spasticity (PSS) patients
BOTOX® has proven long-term evidence and experience in PSS in the upper and lower limb5,6
- Localisation of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended7
- Multiple injection sites may allow BOTOX® to have more uniform contact with the innervation areas of the muscle and are especially useful in larger muscles7
- The maximum recommended dose for upper limb PSS is between 200 and 240 Units divided among selected muscles†7
UNITS
Adductor pollicis
20 Units
1–2 sites
Flexor carpi ulnaris
10–50 Units
1–2 sites
Flexor pollicis longus
20 Units
1–2 sites
Flexor digitorum sublimis
15–50 Units
1–2 sites
Flexor carpi radialis
15–60 Units
1–2 sites
Flexor digitorum profundus
15–50 Units
1–2 sites
Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.7
†The exact dosage and number of injection sites may be tailored to the individual based on the size, number and location of muscles involved, the severity of spasticity, the presence of local muscle weakness and the patient response to previous treatment.7
BOTOX® has proven efficacy in upper limb PSS5
Patients with PSS treated with a single cycle of BOTOX® show significantly reduced finger flexor tone at Weeks 6 and 12 vs placebo5
Adapted from Brashear A, et al 2002.5
§p<0.001 versus placebo.
Study context: A randomised, double-blind, placebo-controlled, multi-centre trial assessed the efficacy and safety of BOTOX® in 126 subjects with increased flexor tone in the wrist and fingers after a stroke. At Week 6, 62% of the BOTOX® group, vs 27% of the placebo group reported improvement of at least one point on the Disability Assessment Scale in the principal target of treatment (p<0.001) (primary endpoint).5
- The recommended dose for lower limb PSS is 300 Units to 400 Units divided among up to six muscles7
Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.7
The effect of BOTOX® on lower limb PSS was sustained over 12 weeks8
Significantly more patients improved their ankle Modified Ashworth Scale (MAS) score by ≥1 grade following treatment with BOTOX® vs placebo over 12 weeks‡8
The benefits of BOTOX® were sustained in a subsequent 1-year open-label study8
Adapted from Wein T, et al. 2018.8
‡p≤0.04 vs placebo
Study context: a multi-centre, randomised, double-blind, placebo-controlled trial evaluating the efficacy, safety and sustained benefit of BOTOX® in adults with lower limb PSS. Primary endpoint was ankle MAS change from baseline (average of Weeks 4 and 6).8
Upper limb spasticity in paediatric patients
- The recommended dose for treating paediatric upper limb spasticity is 3 Units/kg to 6 Units/kg body weight divided among the affected muscles7
- Prior to injection, local anaesthesia or local anaesthesia in combination with minimal or moderate sedation may be used, per local site practice7
UNITS
Bicep
50-100 Units
4 sites
Brachialis
30-60 Units
2 sites
Brachioradialis
20-40 Units
2 sites
Flexor carpi radialis
25-50 Units
2 sites
Flexor carpi ulnaris
25-50 Units
2 sites
Flexor digitorum profundus
25-50 Units
2 sites
Flexor digitorum sublimis
25-50 Units
2 sites
Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.7
Lower limb spasticity in paediatric patients
- The recommended dose for paediatric lower limb spasticity is 4 Units/kg to 8 Units/kg body weight divided among the affected muscles7
- Prior to injection, local anaesthesia or local anaesthesia in combination with minimal or moderate sedation may be used, per local site practice7
Please refer to the dilution table in the SmPC. For the patient preparation and post-injection monitoring, please see Section 4.4 of the SmPC.7
MAS: Modified Ashworth Scale; PSS: post-stroke spasticity; SmPC: summary of product characteristics.
BOTOX® (botulinum toxin type A) is indicated for the treatment of focal spasticity including:7
- elbow, wrist and hand in paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy
- ankle and foot in ambulant paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy
- 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
- 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
- Brashear A, Gordon M, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002;347(6):395–400
- Kaji R, Osako Y, et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol. 2010;257:1330–1337
- BOTOX® Summary of Product Characteristics. Available at: www.medicines.org.uk. Accessed October 2022
- Wein T, Esquenazi A, et al. Onabotulinumtoxina for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. PM R. 2018;10(7):693–703
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-220219.
