ab-oh-BOT-yoo-LYE-num TOX-in ay

Therapeutic Classification: antispasticity agents, cosmetic agents

Pharmacologic Classification: neurotoxins

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

• 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.

Absorption: Minimal but may be significant in selected populations.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

(improvement in spasticity/appearance of lines)

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.

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.

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

• Assess heart rate in patients with history of heart disease. May cause a slight (3 beats per minute) reduction in heart rate 30 min following injection.
• Cervical Dystonia: Assess amount of spasticity prior to and following therapy.
• Glabellar Lines: Assess level of glabellar lines prior to and following therapy.
• Upper and Lower limb spasticity: Assess amount of spasticity prior to and following therapy.

• May cause slight ↑ of blood glucose.

• The potency units of abobotulinumtoxinA are not interchangeable with other botulinum toxin products.

Cervical Dystonia

• IM: Reconstitute each single-use 500 unit vial with 1 mL or 300 unit vial with 0.6 mL of 0.9% NaCl without preservatives. Concentration: 50 units/0.1 mL Swirl gently to dissolve. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Refrigerate solution and protect from light; do not freeze. Administer into affected muscles within 4 hrs using a 23 or 25 gauge needle. Discard remaining solution.

Glabellar Lines

• IM: Reconstitute each 300 unit vial with 2.5 mL or 1.5 mL of 0.9% NaCl without preservatives. Concentration: 12 units/0.1 mL or 20 units/0.1 mL, respectively. Using a 21 gauge needle, insert at a 45° angle into abobotulinumtoxinA vial and allow the vacuum to pull 0.9% NaCl into vial. Discard vial if vacuum has been lost. Gently rotate until white substance is fully dissolved; do not shake. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Solution is stable for 4 hrs if refrigerated and protected from light; do not freeze. Draw up single dose and expel any air bubbles in syringe barrel. Exchange needle for a 30 gauge needle for administration. Administer 5 equally divided aliquots of 10 Units each into 5 sites (2 in each corrugator muscle, 1 in procerus muscle).

Upper and Lower Limb Spasticity

• IM: Reconstitute each single-use 300 unit vial with 1.5 mL and each 500 unit vial with 2.5 mL of 0.9% NaCl without preservatives. Concentration: 20 units/0.1 mL. Swirl gently to dissolve. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Refrigerate solution and protect from light; do not freeze. Base dose of 500–1000 units on muscles affected, severity of muscle spasticity, prior response and adverse reaction history following treatment. Do not administer >1 mL for adults and >0.5 mL for children in any single injection site. Maximum total dose of 1500 units for adults and 1000 units for children per treatment session.

• 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.

• Localized reduction of muscle activity, with decreased spasticity in cervical dystonia.
• Decreased appearance of glabellar lines.
• Decrease in upper and lower limb spasticity.

Dysport