• Cervical dystonia.
• Moderate to severe glabellar (frown) lines.
• Upper limb spasticity.
• Lower limb spasticity.

Contraindicated in:

• Hypersensitivity to botulinum toxin products or additives
• Allergy to cow's-milk protein
• Infection at injection site.

Use Cautiously in:

• Previous surgical facial alterations, marked facial asymmetry, known weakness/atrophy of muscle in question, inflammation or skin abnormality at injection site, ptosis
• Peripheral motor neuropathic disorders (may exacerbate clinical effects and ↑ the risk of severe dysphagia and respiratory compromise)
• Hyperhydrosis (safety not established)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <2 yr (safety and effectiveness not established)
• Geri: Use cautiously; consider concurrent diseases and drug therapy.

Cervical Dystonia

EENT: dysphonia, eye disorder .

GI: dry mouth, dysphagia.

Local: injection site pain.

MS: muscle weakness, neck pain.

Neuro: fatigue, headache, depression, dizziness, SEIZURES, syncope.

Resp: dyspnea.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, SERUM SICKNESS, SOFT TISSUE EDEMA, DYSPNEA), SPREAD OF TOXIN EFFECT.

Glabellar Lines

EENT: nasopharyngitis, dry eye, eyelid edema, eyelid ptosis, sinusitis.

GI: nausea.

Local: injection site pain/reaction.

Resp: cough.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, SERUM SICKNESS, SOFT TISSUE EDEMA, DYSPNEA), SPREAD OF TOXIN EFFECT.

Upper Limb Spasticity

CV: hypertension.

EENT: nasopharyngitis.

GI: constipation, diarrhea, nausea.

GU: urinary tract infection.

Local: injection site pain/reaction.

Metab: hypertriglyceridemia.

MS: back pain, muscle pain, muscle weakness.

Resp: cough.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, SERUM SICKNESS, SOFT TISSUE EDEMA, DYSPNEA), SPREAD OF TOXIN EFFECT.

Drug-Drug:

• Concurrent use of aminoglycosides or other agents interfering with neuromuscular transmission including curare-like agents or muscle relaxants may ↑ effect.
• Concurrent use of anticholinergics ↑ systemic anticholinergic effects.

• Lyophilized powder for injection: 300 units/vial; 500 units/vial;

Cervical Dystonia

• IM (Adults): 500 units as a divided dose among affected muscles; may be repeated every 12–16 wk, based on return of symptoms (range 250 and 1000 units). Increments may be made in 250–unit steps according to response.

Glabellar Lines

• IM (Adults <65 yr): 50 units, divided in five equal aliquots of 10 units; may be repeated every 3 mo.

Upper Limb Spasticity

• IM (Adults): 500–1000 units as a divided dose among affected muscles, with the following doses being used for each muscle: Flexor carpi radialis: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms; Flexor carpi ulnaris: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms; Flexor digitorum profundus: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms; Flexor digitorum superficialis: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms; Brachialis: 200–400 units; may be repeated every 12–16 wk, based on return of symptoms; Brachioradialis: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms; Biceps brachii: 200–400 units; may be repeated every 12–16 wk, based on return of symptoms; Pronator teres: 100–200 units; may be repeated every 12–16 wk, based on return of symptoms.
• IM (Children ≥2 yr and ≥10 kg): 8–16 units/kg as a divided dose among affected muscles, with the following doses being used for each muscle (total dose should not exceed 640 units): Flexor carpi radialis: 2–4 units/kg/upper limb in up to 2 sites; may be repeated every 16–28 wk, based on return of symptoms; Flexor carpi ulnaris: 1.5–3 units/kg/upper limb in 1 site; may be repeated every 16–28 wk, based on return of symptoms; Flexor digitorum profundus: 1–2 units/kg/upper limb in 1 site; may be repeated every 16–28 wk, based on return of symptoms; Flexor digitorum superficialis: 1.5–3 units/kg/upper limb in up to 4 sites; may be repeated every 16–28 wk, based on return of symptoms; Brachialis: 3–6 units/kg/upper limb divided in up to 2 sites; may be repeated every 16–28 wk, based on return of symptoms; Brachioradialis: 1.5–3 units/kg/upper limb in 1 site; may be repeated every 16–28 wk, based on return of symptoms; Biceps brachii: 3–6 units/kg/upper limb divided in up to 2 sites; may be repeated every 16–28 wk, based on return of symptoms; Pronator teres: 1–2 units/kg/upper limb in 1 site; may be repeated every 16–28 wk, based on return of symptoms; Pronator quadratus: 0.5–1 units/kg/upper limb in 1 site; may be repeated every 16–28 wk, based on return of symptoms.

Lower Limb Spasticity

• IM (Adults): 1000–1500 units as a divided dose among affected muscles, with the following doses being used for each muscle: Gastrocnemius (medial head): 100–150 units; Gastrocnemius muscle (lateral head): 100–150 units;Soleus: 330–500 units; Tibialis posterior: 200–300 units; Flexor digitorum longus: 130–200 units; Flexus hallucis longus: 70–200 units; may be repeated every 12–16 wk, based on return of symptoms.
• IM (Children ≥2 yr): 10–15 units/kg as a divided dose among affected muscles, with the following doses being used for each muscle: Gastrocnemius: 6–9 units/kg/leg divided in 4 sites; may be repeated after 3 mo, based on return of symptoms; Soleus: 4–6 units/kg/leg divided in 2 sites; may be repeated after 3 mo, based on return of symptoms.

Dysport

• Inhibits release of acetylcholine from peripheral cholinergic nerve endings, resulting chemical denervation of treated muscle.

• Localized reduction of muscle activity, with decreased spasticity in cervical dystonia, upper limbs, and lower limbs.
• Temporary improvement of glabellar lines.

Therapeutic Classification: antispasticity agents, cosmetic agents

Pharmacologic Classification: neurotoxins

Absorption: Minimal but may be significant in selected populations.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

(improvement in spasticity/appearance of lines)

• Inform patient of purpose of abotulinumtoxinA. Advise patient to read Patient Medication Guide prior to treatment.
• Inform patient that effects of abotulinumtoxinA may spread beyond the site of local injection. Advise patient to notify health care professional immediately if problems swallowing, speaking, or breathing occur or if signs and symptoms of spread (asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysarthria, urinary incontinence, breathing difficulties) occur. May occur hrs to wks after injection.
• May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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