DYSPORT

What it is

Dysport is clostridium botulinum type A toxin—haemagglutinin complex powder for injection, available in vials containing 125, 300 or 500 Ipsen Units. Ipsen Units are not equivalent to units of any other botulinum toxin preparation. The active ingredient is a complex of proteins with a molecular weight of approximately 900,000 Daltons.

Approved indications

Dysport is indicated for symptomatic treatment of focal spasticity of upper limbs in adults, lower limbs in adults, upper limbs in children aged 2 years and older, and lower limbs in children aged 2 years and older. — Focal spasticity of upper limbs in adults — Focal spasticity of lower limbs in adults — Focal spasticity of upper limbs in children aged 2 years and older — Focal spasticity of lower limbs in children aged 2 years and older — Spasmodic torticollis in adults — Blepharospasm in adults — Hemifacial spasm in adults — Moderate to severe glabellar lines in adults — Moderate to severe lateral canthal lines (crow's feet) in adults

Dosing overview

Dosing is highly individualised and depends on muscle size, number and location, severity of presentation, muscle weakness, and prior response to treatment. For upper limb spasticity in adults, the maximum recommended dose is 1000 U in a single treatment session. For lower limb spasticity in adults, doses of up to 1500 U may be administered in a single treatment session, but the total dose must not exceed 1500 U. For spasmodic torticollis, the recommended initial dose is 250–500 units per patient as a divided dose into the two or three most active neck muscles. For blepharospasm, a dose of 40 units per eye was significantly effective, while 80 units per eye provided longer duration of effect. For glabellar lines, the recommended dose is 50 units divided equally among 5 injection sites. For lateral canthal lines, the recommended dose is 30 units per side (60 units for both sides) divided into 3 injection sites. Clinical improvement may be expected one week after administration. Repeat treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.

Key safety warnings

Recommended dosages and frequencies must not be exceeded, as extensive or inappropriate doses outside the recommended range may lead to increased risk of adverse effects. Dysport should be administered with caution to patients with pre-existing swallowing or breathing problems as these can worsen following toxin distribution; aspiration has occurred in rare cases and is a risk in patients with chronic respiratory disorders. Very rare cases of death have been reported, occasionally in the context of dysphagia, pneumopathy or significant weakness; patients with disorders affecting neuromuscular transmission or with difficulty swallowing or breathing are more at risk and treatment must be administered under specialist control only if benefit outweighs risk. Principal risk factors for neutralising antibody formation are high doses (>600 units per treatment), short intervals (<3 months) between injections, and booster injections within the first month of treatment. Dry eye has been reported with use of Dysport in treatment of glabellar lines, lateral canthal lines, blepharospasm and hemifacial spasm; reduced tear production, reduced blinking and corneal disorders may occur.

Contraindications

Dysport is contraindicated in individuals with known hypersensitivity to any component. Dysport is contraindicated in patients diagnosed with myasthenia gravis or Eaton-Lambert (myasthenic) syndrome. Dysport is contraindicated in the presence of any signs of infection at the proposed injection site.

PBS listing

In July 2019, Dysport was recommended by PBAC for focal spasticity of the lower limb following stroke or other acute neurological event, listed with Authority Required (Streamlined) restriction on a cost minimisation basis with botulinum toxin type A (Botox). In July 2020, PBAC recommended an extension to listing for focal spasticity of the upper limb in patients with cerebral palsy aged 2 years or older.

Regulatory history

The 500 Ipsen Unit vial was first registered on the ARTG on 16 June 2000. The 300 Ipsen Unit vial was first registered on 10 February 2011. The 125 Ipsen Unit vial was first registered on 28 October 2015. An AusPAR was published on 14 July 2020 following TGA approval of Dysport for symptomatic treatment of focal spasticity of upper limbs in children aged 2 years and older.