abobotulinumtoxinA (Rx)

>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

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

• 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

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.

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

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