Dysport 500 unit Botulinum toxin A

What’s in Dysport

Dysport 500 unit

Dysport has been approved by US FDA in 2009 for carrying out the treatment of cervical dystonia or blepharospasm in the adults, apart from cosmetic treatment. These have been running successfully over the years. Each sterile vial contains 500 units of lyophilized abobotulinumtoxinA. Nonmedicinal ingredients: human serum albumin and lactose.
Botulinum toxin belongs to the class of medications called neuromuscular paralytic agents. It blocks the nerves that are responsible for muscle activity. For cosmetic purposes, it can be used to smooth out facial lines and wrinkles, such as those that form between the eyebrows, on the forehead, and around the eyes (crow’s feet). It gives skin a smoother appearance by relaxing the muscles in the area where it was injected. It may also be used to treat cervical dystonia, also known as spasmodic torticollis, a condition in which the muscles of the neck stay in a state of contraction, and to treat focal spasticity such as arm spasms after a stroke. Dysport 500 unit

Possible side effects

Dysport 500 unit

• drooping of the upper eyelid
• face pain
• general feeling of being unwell
• headache
• muscle weakness at the injection site
• nausea
• pain, tenderness or bruising, burning, swelling, or stinging at the injection site
• redness of the skin
• stuffy nose
• tightness of the skin

How to use Dysport 500 unit

Dosage Forms & Strengths

injection, powder for reconstitution

• 300 units/vial
• 500 units/vial

Cervical Dystonia

Indicated for cervical dystonia

Initial: 500 unit IM divided among affected muscles

Retreat every 12 – 16 weeks or longer: 250 – 1000 unit IM

Titrate in 250 – unit steps

Spasticity

Indicated for treatment of spasticity in adults

Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history (EMG guidance recommended)

Do not inject >1 mL at any single injection site; the maximum total dose (upper and lower limb combined) is 1500 units

Repeat treatment when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection

A majority of patients are retreated between 12 – 16 weeks, although some may have a longer response (eg, 20 wk)

Upper limb spasticity

• Dose per muscle

  • In the clinical trial, doses of 500 – 1000 units were divided among selected upper limb muscles at a given treatment session
  • Flexor carpi radialis: 100 – 200 units in 1 – 2 sites
  • Flexor carpi ulnaris: 100 – 200 units in 1 – 2 sites
  • Flexor digitorum profundus: 100 – 200 units in 1 – 2 sites
  • Flexor digitorum sublimis: 100 – 200 units in 1 – 2 sites
  • Brachialis: 200 – 400 units in 1 – 2 sites
  • Brachioradialis: 100 – 200 units in 1 – 2 sites
  • Biceps brachii: 200 – 400 units divided in 1 – 2 sites
  • Pronator Teres: 100 – 200 units in 1 site

Lower limb spasticity

• Dose per muscle

  • In the clinical trial, doses of 1000 – 1500 units were divided among selected lower limb muscles at a given treatment session
  • Gastrocnemius medial head: 100 – 150 units in 1 site
  • Gastrocnemius lateral head: 100 – 150 units in 1 site
  • Soleus: 330 – 500 units in 3 sites
  • Tibialis posterior: 200 – 300 units in 2 sites
  • Flexor digitorum longus: 130 – 200 units in 1 – 2 sites
  • Flexor hallucis longus: 70 – 200 units in 1 site

Glabellar Lines

Indicated for temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults aged

50 units total divided in 5 equal doses IM to affected muscles

Retreat no sooner than 3 months

Dosage Modifications

Renal or hepatic impairment: No dose adjustment necessary

Essential Blepharospasm (Orphan)

Orphan indication sponsor

• Porton International, Inc; 1155 15th Street, N. W. , #315; Washington, DC 20005

Spasmodic Torticollis (Orphan)

Treatment of spasmodic torticollis (cervical dystonia)

Orphan indication sponsor