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

Asthma, neuromuscular disorder, facial abnormalities, ptosis

Concomitant anticholinergic drugs, neuromuscular blockers or muscle relaxants

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

Pregnancy: There are no adequate and well-controlled clinical studies in pregnant women; only use during pregnancy if potential benefit justifies potential risk to fetus

Lactation: There are no data on the presence of drug in human or animal milk, the effects on the breastfed child, or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from the drug 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

IM Preparation

Only use sterile preservative-free 0.9% NaCl injection for reconstituting vials

Swirl gently to dissolve

Parenteral drug products should be inspected visually 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

Cervical dystonia

• 500 units/vial: Reconstitute with 1 mL 0.9% NaCl (yields 50 units/0.1 mL)
• 300 units/vial: Reconstitute with 0.6 mL 0.9% NaCl (yields 50 units/0.1 mL)

Glabellar lines

• 300 units/vial: Reconstitute with 2.5 mL 0.9% NaCl (yields 10 units/0.08 mL [12 units/0.1 mL]) OR,
• Reconstitute 300 units/vial with 1.5 mL 0.0% NaCl (yields 10 units/0.05 mL [20 units/0.1 mL])

Upper limb spasticity

• Recommended concentration for ULS is 100-200 units/1 mL
• For adult administration only

• Steps for use of 5 mL of diluent for 500 unit vial

  • 1. 500 unit vial: Reconstitute with 2.5 mL 0.9% NaCl, gently mix and set the vial aside
  • 2. Withdraw 2.5 mL 0.9% NaCl into a 5 mL syringe
  • 3. Take the 5 mL syringe with the saline and draw up the reconstituted solution in the vial without inverting and gently mix the syringe (resulting concentration is 10 units/0.1 mL [100 units/1 mL])
  • 4. Use immediately after reconstitution in the syringe

Lower limb spasticity (LLS)

• For pediatric administration only
• Recommended concentration for LLS is 100-200 units/1 mL

• Vial reconstitution

  • 500-unit vial: Reconstitute with 2.5 mL 0.9% NaCl
  • 300-unit vial: Reconstitute with 1.5 mL 0.9% NaCl
  • Resulting concentrations are 20 units/0.1 mL; reconstituted solution should be clear, colorless, and without particulate matter
  • Further dilution with 0.9% NaCl may be required to achieve the final volume for injection

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