Dosing & Uses
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
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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 <65 years
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
- Ipsen Biopharm Limited; 1 Bath Road Maidenhead, Berkshire, SL6 4UH; UK
Dosage Forms & Strengths
injection, powder for reconstitution
- 300 units/vial
- 500 units/vial
Spasticity
Indicated for spasticity in children aged ≥2 yr
Upper limb
- 8-16 units/kg per limb
- Maximum total dose per treatment session: 16 units/kg or 650 units, whichever is lower
-
Dosage range per muscle
- Brachialis: 3-6 units/kg divided in 1-2 injection sites
- Brachioradialis: 1.5-3 units/kg in 1 injection site
- Biceps brachii: 3-6 units/kg divided in 1-2 injection sites
- Pronator teres: 1-2 units/kg in 1 injection site
- Pronator quadratus: 0.5-1 units/kg in 1 injection site
- Flexor carpi radialis (FCR): 2-4 units/kg divided in 1-2 injection sites
- Flexor carpi ulnaris (FCU): 1.5-3 units/kg in 1 injection site
- Flexor digitorum profundus (FDP): 1-2 units/kg in 1 injection site
- Flexor digitorum superficialis (FDS): 1.5-3 units/kg divided in up to 4 injection sites
Lower limb
- 10-15 units/kg per limb
-
Maximum doses
- Unilateral limb injection: 15 units/kg or 1000 units, whichever is lower
- Bilateral limb injections: 30 units/kg or 1000 units, whichever is lower
- Maximum total dose per treatment session: 30 units/kg or 1000 units, whichever is lower
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Dosage range per muscle per leg
- Gastrocnemius (unilateral injection): 6-9 units/kg divided in up to 4 injection sites
- Soleus (unilateral injection): 4-6 units/kg divided in 1-2 injection sites
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Dysphagia (15%)
Dry mouth (13%)
Headache (11%)
Inj site discomfort (13%)
Muscle weakness (16%)
Fatigue (12%)
1-10%
Dyspnea (3%)
Facial paresis (5%)
Dysphonia (6%)
Injection site pain (5%)
Musculoskeletal pain (7%)
Eye disorders (7%)
Postmarketing Reports
Hypoesthesia
Warnings
Black Box Warnings
Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects
These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
These symptoms have been reported hours to weeks after injection
Swallowing and breathing difficulties can be life threatening, and death have been reported
The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms
In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses
Contraindications
Hypersensitivity
Allergy to cow milk protein
Injection site infection
Cautions
Exercise caution when administering to patients with surgical alterations to facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart
Not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxin cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method
Toxin may spread - watch for dyspnea, dysphagia or speech impairment
Product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes; carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD); there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote; no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products
Neutralizing antibody formation and loss of efficacy associated with higher doses or more frequent administration of the drug
Arrhythmia and myocardial infarction reported with use
Dysphagia reported with use for cervical dystonia; may persist for several weeks following administration and could cause the patient to require alternative feeding methods, including a feeding tube; smaller neck muscle mass, injections into the elevator scapulae or injections into the sternocleidomastoid muscle may increase risk of dysphagia; risk of aspiration may result from severe dysphagia when swallowing is already compromised; occurrence may be reduced by limiting the dose injected into sternocleidomastoid muscle
Use caution in patients with neuromuscular disease, including myasthenia gravis and Eaton-Lambert syndrome, and neuropathic disorders, such as, amyotrophic lateral sclerosis
Injection of the orbicularis muscle may reduce blinking and lead to corneal exposure and ulceration, when treating blepharospasm
Use caution when treating patients with preexisting respiratory disease; treatment of cervical dystonia, may weaken accessory muscles necessary to patients to maintain adequate ventilation; serious breathing difficulties, including respiratory failure reported
Dry eye has been reported in the treatment of glabellar lines; reduce tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins; if symptoms of dry eye (eg, eye irritation, photophobia, visual changes) persist, consider referring patient to an ophthalmologist
Possibility of an immune reaction when injected intradermally is unknown; safety for the treatment of hyperhidrosis has not been established; approved only for IM injection
Drug interaction overview
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Aminoglycosides and other agents interfering with neuromuscular transmission
- Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like agents) should only be used with caution because the effect of the botulinum toxin may be potentiated
- If coadministered, closely monitor patients
-
Anticholinergic drugs
- Use of anticholinergic drugs after administration may potentiate systemic anticholinergic effects such as blurred vision
-
Other botulinum neurotoxin products
- Effect of administering botulinum neurotoxin products, at the same time or within several months of each other is unknown
- Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
-
Muscle relaxants
- Excessive weakness may be exaggerated by administration of a muscle relaxant before or after botulinum toxin administration
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled clinical studies in pregnant women
Use only during pregnancy if the potential benefit justifies the potential risk to the fetus
In rats, abobotulinumtoxinA produced adverse effects on mating behavior and fertility
Animal data
- AbobotulinumtoxinA produced embryofetal toxicity in relation to maternal toxicity when given to pregnant rats and rabbits at doses lower than or similar to the maximum recommended human dose (MRHD) of 1000 units on a body weight (units/kg) basis
Lactation
There are no data on the presence in human or animal milk, the effects on the breastfed infant, or the effects on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane
Pharmacokinetics
Onset of action: Cervical Dystonia: 2-4 weeks
Duration cervical dystonia: Up to 4 months
Administration
Instructions for safe use
Potency units of abobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method
IM Preparation
Only use sterile preservative-free 0.9% NaCl injection for reconstituting vials
Swirl gently to dissolve
Visually inspect for particulate matter and discoloration prior to administration
Reconstituted solution should be a clear, colorless, and free of particulate matter, otherwise it should not be injected
Dilution
- Dilute with preservative-free 0.9% NaCl
-
500 units/vial
- Reconstitute with 1 mL 0.9% NaCl (yields 50 units/0.1 mL)
- Reconstitute with 2 mL 0.9% NaCl (yields 25 units/0.1 mL)
- Reconstitute with 2.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
- Reconstitute with 5 mL 0.9% NaCl (yields 10 units/0.1 mL)
-
300 units/vial
- Reconstitute with 0.6 mL 0.9% NaCl (yields 50 units/0.1 mL)
- Reconstitute with 1.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
- Reconstitute with 2.5 mL 0.9% NaCl (yields 12 units/0.1 mL)
- Reconstitute with 3 mL 0.9% NaCl (yields 10 units/0.1 mL)
Recommended concentration for adults
- Cervical dystonia: 50 units/0.1 mL or 25 units/0.1 mL
- Glabellar lines: 12 units/0.1 mL or 20 units/0.1 mL
- Spasticity: 10 units/0.1 mL or 20 units/0.1 mL
Recommended concentration for children and adolescents
- Spasticity: 20 units/0.1 mL or 50 units/0.1 mL
IM Administration
IM administration only
Reconstituted solution should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected
Expel any air bubbles in the syringe barrel
After reconstitution, use for only 1 injection session and for only 1 patient
Storage
Store unreconstituted vials in refrigerator at 2-8°C (36-46°F)
Use each vial for only 1 injection session and for only 1 patient
Once reconstituted, store in the original container, refrigerated at 2-8°C (36-46°F) for up to 24 hr (must discard if not used within 24 hr)
Protected from light
Do not freeze reconstituted solution
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Patient Handout
Formulary
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