The safety profile of the approved doses of Dysport® in adult patients treated for spasticity affecting the upper and lower limbs is well established.1
Dysport® (Clostridium botulinum type A toxin-haemagglutinin complex)
Tolerability information
Upper limb adverse drug reactions reported in RCTs in adult patients with spasticity receiving Dysport®1
| Type of adverse event | Adverse event | Frequency* |
|---|---|---|
| Gastrointestinal disorders | Dysphagia† | Uncommon |
| Musculoskeletal and connective tissue disorders | Muscular weakness, musculoskeletal pain, pain in extremity | Common |
| General disorders and administration site conditions | Asthenia, fatigue, influenza-like illness, injection-site reactions (e.g. pain, erythema, swelling etc.) | Common |
| Injury, poisoning and procedural complications | Accidental lesions/fall‡ | Common |
Lower limb adverse drug reactions reported in RCTs in adult patients with spasticity receiving Dysport®1
| Type of adverse event | Adverse event | Frequency* |
|---|---|---|
| Gastrointestinal disorders | Dysphagia† | Common |
| Musculoskeletal and connective tissue disorders | Muscular weakness, myalgia | Common |
| General disorders and administration site conditions | Asthenia, fatigue, influenza-like illness, injection-site reactions (pain, bruising, rash, pruritus) | Common |
| Injury, poisoning and procedural complications | Fall | Common |
When treating both upper and lower limbs concomitantly with Dysport® at a total dose of up to 1500 U, there are no safety findings in addition to those expected from treating either upper limb or lower limb muscles alone.1
*Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).1
†The frequency for dysphagia was derived from pooled data from open-label studies. Dysphagia was not observed in the double-blind studies in the adult upper limb spasticity indication.1
‡Incidence of fall: 2.0% in Dysport® treated subjects, 2.2% in placebo treated subjects.1
Reference:
- Dysport® Summary of Product Characteristics.
Abbreviations:
RCT, randomised controlled trial; U, Units.
For further information, please refer to the Prescribing Information or the Summary of Product Characteristics.