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AbobotulinumtoxinA

Pronunciation

(aye bo BOT yoo lin num TOKS in aye)

Index Terms

  • Botulinum Toxin Type A

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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Solution Reconstituted, Intramuscular:

Dysport: 300 units (1 ea); 500 units (1 ea) [contains milk protein]

Dysport (Glabellar Lines): 300 units (1 ea) [contains albumin human, milk protein]

Brand Names: U.S.

  • Dysport
  • Dysport (Glabellar Lines)

Pharmacologic Category

  • Neuromuscular Blocker Agent, Toxin

Pharmacology

AbobotulinumtoxinA (previously known as botulinum toxin type A) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus, which appears to affect only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls.

Absorption

Not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection

Onset of Action

Peak effect: Cervical dystonia: 2 to 4 weeks; Upper limb spasticity: 1 week

Duration of Action

Cervical dystonia, glabellar lines: Up to 4 months; Upper limb spasticity: Up to 5 months

Use: Labeled Indications

Cervical dystonia: Treatment of adult patients with cervical dystonia.

Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adults <65 years.

Upper limb spasticity: Treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors

Contraindications

Hypersensitivity to botulinum toxin or any component of the formulation, including milk protein; infection at the proposed injection site(s)

Dosage

Adults:

Cervical dystonia: IM: Initial: 500 units divided among affected muscles in toxin-naïve or toxin-experienced patients. May re-treat at intervals of ≥12 weeks

Dosage adjustments: Adjust dosage in 250-unit increments; do not administer at intervals <12 weeks; dosage range used in studies: 250 to 1000 units

Glabellar lines: Adults <65 years: IM: Inject 10 units into each of 5 sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle) for a total dose of 50 units; do not administer at intervals <3 months; efficacy has been demonstrated with up to 4 repeated administrations

Upper limb spasticity: IM: Individualize dose based on patient size, number and location of muscle involvement, severity of spasticity, local muscle weakness, response to prior treatment, and/or adverse reaction history. May repeat therapy at intervals ≥12 weeks; in clinical studies, the majority of patients were re-treated between 12 to 16 weeks; however, some patients had a longer duration of response (eg, 20 weeks). Total doses of 500 and 1,000 units divided among selected muscles were used in clinical trials

Brachialis: 200 to 400 units (1 to 2 injections per muscle)

Brachioradialis: 100 to 200 units (1 to 2 injections per muscle)

Biceps brachii: 200 to 400 units (1 to 2 injections per muscle)

Flexor carpi radialis: 100 to 200 units (1 to 2 injections per muscle)

Flexor carpi ulnaris: 100 to 200 units (1 to 2 injections per muscle)

Flexor digitorum profundus: 100 to 200 units (1 to 2 injections per muscle)

Flexor digitorum superficialis: 100 to 200 units (1 to 2 injections per muscle)

Pronator teres: 100 to 200 units (1 injection per muscle)

Elderly:

Cervical dystonia: Refer to adult dosing.

Glabellar lines: Not recommended in patients ≥65 years of age

Upper limb spasticity: Refer to adult dosing.

Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as abobotulinumtoxin A is not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as abobotulinumtoxin A is not expected to be present in peripheral blood at recommended doses following IM injection.

Reconstitution

Reconstitute with sterile, preservative free 0.9% sodium chloride. Swirl gently to dissolve; do not shake. Preparation instructions vary by indication and strength; use appropriate reconstitution methods.

Cervical dystonia: Reconstitute 300-unit vial with 0.6 mL of diluent to obtain a concentration of 50 units per 0.1 mL; reconstitute 500-unit vial with 1 mL of diluent to obtain a concentration of 50 units per 0.1 mL.

Glabellar lines: Reconstitute 300-unit vial with 2.5 mL of diluent to obtain a concentration of 10 units per 0.08 mL (12 units per 0.1 mL); alternatively, may reconstitute 300-unit vial with 1.5 mL of diluent to a obtain concentration of 10 units per 0.05 mL (20 units per 0.1 mL).

Upper limb spasticity: Reconstitute 300-unit vial with 1.5 mL of diluent to obtain a concentration of 200 units/mL; or reconstitute 300-unit vial with 3 mL diluent to obtain a concentration of 100 units/mL. Reconstitute the 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL. Alternatively, the 500-unit vial can be further diluted to obtain a concentration of 100 units/mL. Using a 5 mL syringe, draw up 2.5 mL of the diluent; then draw up 2.5 mL of the reconstituted solution. Do not invert; mix gently.

Administration

Cervical dystonia: Use an appropriately sized gauge needle to administer intramuscularly. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Simultaneous EMG-guided application may be helpful in locating active muscle not identified by physical examination alone.

Glabellar lines: Use a 30-gauge needle to administer intramuscularly. Apply pressure on the superior medial orbital rim, and inject into each of 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be at least 1 cm above the bony supraorbital ridge. Do not inject toxin closer than 1 cm above the central eyebrow.

Upper limb spasticity: Use an appropriately sized sterile needle to administer intramuscularly. Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique (eg, electromyography), electrical stimulation) is recommended to target the injection sites. No more than 1 mL should generally be administered at any single injection site.

Dietary Considerations

Contains lactose; patients allergic to cow’s milk protein should not receive product.

Storage

Store undiluted vials under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. After reconstitution, store vials in original container under refrigeration, protect from light, and use within 24 hours (does not contain preservative); 500 unit vials diluted to a concentration of 100 units/mL must be used immediately. Do not freeze after reconstitution.

Drug Interactions

Aminoglycosides: May enhance the neuromuscular-blocking effect of AbobotulinumtoxinA. Monitor therapy

Anticholinergic Agents: May enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Neuromuscular-Blocking Agents: AbobotulinumtoxinA may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

OnabotulinumtoxinA: May enhance the adverse neuromuscular effect of AbobotulinumtoxinA. Monitor therapy

RimabotulinumtoxinB: AbobotulinumtoxinA may enhance the adverse neuromuscular effect of RimabotulinumtoxinB. Monitor therapy

Adverse Reactions

Cervical dystonia: Frequency not always defined.

Cardiovascular: Decreased heart rate

Central nervous system: Voice disorder (≤28%), fatigue (12%), headache (11%), facial paresis (≤11%), dizziness (4%)

Endocrine & metabolic: Increased serum glucose

Gastrointestinal: Dysphagia (15% to 39%), xerostomia (13% to 39%)

Immunologic: Antibody development (binding or neutralizing; 3%)

Infection: Infection (13%)

Local: Discomfort at injection site (13% to 22%), pain at injection site (5%)

Neuromuscular & skeletal: Myasthenia (11% to 56%), musculoskeletal pain (7%), amyotrophy (1%)

Ophthalmic: Eye disease (≤17%; includes accommodation disorder, blurred vision, diplopia, dryness, pain, pruritus, visual acuity decreased)

Respiratory: Dyspnea (3%; onset: ~1 week; duration: ~3 weeks)

Glabellar lines:

1% to 10%:

Central nervous system: Headache (9%)

Dermatologic: Contact dermatitis (2% to 3%)

Gastrointestinal: Nausea (2%)

Genitourinary: Hematuria (2%)

Immunologic: Antibody development (<1%)

Infection: Influenza (2% to 3%)

Local: Pain at injection site (3%), discomfort at injection site (2% to 3%), injection site reaction (2% to 3%), swelling at injection site (2% to 3%)

Ophthalmic: Blepharoptosis (2%), eyelid edema (2%)

Respiratory: Nasopharyngitis (10%), upper respiratory tract infection (3%), bronchitis (2% to 3%), cough (2% to 3%), pharyngolaryngeal pain (2% to 3%), sinusitis (2%)

Upper limb spasticity: Frequency not always defined; as reported with doses of 500 units to 1,000 units.

Cardiovascular: Hypertension (1% to 2%), syncope (1% to 2%)

Central nervous system: Myasthenia (2% to 4%), dizziness (3%), falling (3%), depression (2% to 3%), convulsions (2%), fatigue (2%), headache (2%), hypoesthesia (2%), seizure (partial; ≤2%), abnormal gait (<1%), feeling of heaviness (<1%), hypertonia (<1%)

Endocrine & metabolic: Increased serum triglycerides (1% to 2%)

Gastrointestinal: Constipation (2%), nausea (2%), diarrhea (1% to 2%), dysphagia (<1%)

Genitourinary: Urinary tract infection (3%)

Hematologic & oncologic: Bruise (1% to 2%)

Immunologic Antibody development (7%; neutralizing: ≤4%)

Infection: Infection (2%), influenza (2%)

Local: Injection site reaction

Neuromuscular & skeletal: Musculoskeletal pain (3%), back pain (2%), limb pain (2%), weakness (1% to 2%)

Respiratory: Nasopharyngitis (4%), cough (2%)

Miscellaneous: Accidental injury (2%)

Any indication: Postmarketing and/or case reports (Limited to important or life-threatening): Burning sensation, erythema, excessive granulation tissue, photophobia, vertigo

ALERT: U.S. Boxed Warning

Spread of toxin effect:

Postmarketing reports indicate that the effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These 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 there have been reports of death. 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 in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur rarely; immediate treatment (including epinephrine 1:1000) should be available.

• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.

• Cardiovascular events: Rarely, arrhythmia and myocardial infarction have been reported with use of onabotulinumtoxinA (another botulinum toxin formulation), sometimes in patients with preexisting cardiovascular disease.

• Dysphagia: Common when used for cervical dystonia and may persist anywhere from 2 weeks up to 5 months after administration. In severe cases, patients may require alternative feeding methods (eg, feeding tube). Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae. Risk of aspiration resulting from severe dysphagia is increased in patients when swallowing is already compromised. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.

• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include asthenia, blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence which may develop within hours or weeks following injection. Risk likely greatest in children treated for the unapproved use of spasticity, but symptoms can also occur in adults treated for spasticity and other conditions. Systemic effects have occurred following use in approved and unapproved uses, including lower than the maximum recommended total dose. Immediate medical attention required if respiratory, speech, or swallowing difficulties appear.

Disease-related concerns:

• Neuromuscular disease: Use with caution in patients with neuromuscular diseases (eg, myasthenia gravis, Eaton-Lambert syndrome) and neuropathic disorders (eg, amyotrophic lateral sclerosis).

• Ocular diseases: Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration when treating blepharospasm. Retrobulbar hemorrhages may occur from needle penetration into orbit when treating strabismus; spatial disorientation, double vision, or past-pointing may occur if one or more extraocular muscles are paralyzed. Covering the affected eye may help. Careful testing of corneal sensation, avoidance of lower lid injections, and treatment of epithelial defects are necessary. Use caution in patients with angle closure glaucoma.

• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment of cervical dystonia using botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.

Dosage form specific issues:

• Albumin: Product contains albumin and may carry a remote risk of virus transmission.

• Lactose: Product may contain lactose; do not administer to patients allergic to cow’s milk protein.

• Product interchangeability: Botulinum products (abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.

Special populations:

• Elderly: Temporary reduction in glabellar lines: Efficacy was not observed in older adults (≥65 years of age) and an increased frequency of ocular adverse events was reported in older adults compared to younger adults.

Other warnings/precautions:

• Chronic therapy: Long-term effects of chronic therapy unknown.

• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present.

• Hyperhidrosis: Safety in the treatment of hyperhidrosis has not been established. The possibility of an immune reaction resulting from an intradermal injection is unknown.

• Temporary reduction in glabellar lines: Appropriate use: Do not use more frequently than every 3 months. Patients with marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart were excluded from clinical trials. Use with caution in patients with surgical alterations to the facial anatomy. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration. Spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation, headache, dyspepsia, cervicalgia, reduced blinking, rhinitis, rhinorrhea, xerophthalmia, or xerostomia. Have patient report immediately to prescriber signs of infection, dyspnea, dysphagia, difficulty speaking, severe myalgia, significant asthenia, sudden vision changes, ophthalmalgia, depression, intolerable eye irritation, blurred vision, dysphonia, urinary incontinence, diplopia, or ptosis (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

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