AbobotulinumtoxinA

Name: AbobotulinumtoxinA

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What other drugs will affect Dysport?

Other drugs can increase some of the side effects of Dysport, including cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines. Tell your doctor if you regularly use any of these medicines.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an injected antibiotic-- amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.

This list is not complete. Other drugs may interact with Dysport, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Do not start a new medication without telling your doctor that you have received Dysport in the past.

Cautions for AbobotulinumtoxinA

Contraindications

  • Known hypersensitivity to any botulinum toxin preparation or any ingredient in their formulations.384

  • Allergy to cow milk protein.384

  • Infection at proposed injection site(s).384

Warnings/Precautions

Warnings

Distant Spread of Toxin Effects

In some cases, toxin effects may be observed beyond local sites of injection.381 382 383 384 (See Boxed Warning.)

Serious adverse effects consistent with mechanism of botulinum toxin action (e.g., asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties) reported.371 381 382 383 384 (See Advice to Patients.)

In some cases, severe swallowing and breathing difficulties required hospitalization, mechanical ventilation, or feeding tubes and/or resulted in death.381 384 (See Dysphagia/Breathing Difficulties under Cautions.)

Risk of toxin spread probably highest in children treated for spasticity.381 383 384

Sensitivity Reactions

Hypersensitivity Reactions

Potential risk of hypersensitivity.384 (See Contraindications under Cautions.) Serious hypersensitivity reactions (including anaphylaxis) reported rarely with another preparation of botulinum toxin type A (Botox).1

Intradermal Sensitivity

Possibility of immune reaction following intradermal administration of abobotulinumtoxinA not known.384 Manufacturer states that safety and efficacy of abobotulinumtoxinA for treatment of hyperhidrosis not established.384

Other Warnings/Precautions

Lack of Interchangeability Among Botulinum Toxin Preparations

The method used to determine potency (“units”) of abobotulinumtoxinA is specific to the Dysport preparation;381 384 388 391 396 399 therefore, units of biologic activity for abobotulinumtoxinA cannot be compared with or converted to units of any other botulinum toxin preparation.381 384 385 388 391 393 396 397

Dysphagia/Breathing Difficulties

Risk of dysphagia in patients receiving a botulinum toxin for cervical dystonia.381 383 384 388 Usually a consequence of cervical muscle weakening from local areas of injection, but also may be related to distant spread of toxin effects.381 384 (See Distant Spread of Toxin Effects under Cautions.)

Botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation, resulting in critical loss of breathing capacity in patients with respiratory disorders.403 Aspiration and death reported as a complication of severe dysphagia.381 383 384 Patients with compromised swallowing function are at increased risk of aspiration.384

Immediate medical attention may be required if sudden difficulties in speech or swallowing develop during or following treatment; such effects may occur hours to weeks after injection.381 384 Gastric feeding tubes may be required in severe cases.381 384

Administration Precautions in Patients with Glabellar Facial Lines

Administer with caution in patients with surgically altered facial anatomy, excessive weakness or atrophy in target muscles, marked facial asymmetry, inflammation, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or glabellar lines that cannot be substantially decreased manually.384

Clinicians who administer abobotulinumtoxinA should understand the relevant neuromuscular and/or orbital anatomy of the therapeutic area and effects of any changes from surgical alterations.384

Increased incidence of ptosis observed with use of higher than recommended dosages; do not exceed recommended dose and frequency.384 Minimize risk of ptosis with careful monitoring (e.g., examining upper lid for separation or weakness of the levator palpebrae muscle, evaluating range of eyelid excursion, identifying lash ptosis) and adherence to manufacturer's recommended dosages and injection techniques.384 (See Injection Techniques [Glabellar Facial Lines] under Dosage and Administration.)

Preexisting Neuromuscular Disorders

Risk of adverse effects (e.g., severe dysphagia and/or respiratory compromise) with usual dosages of abobotulinumtoxinA appears to be increased in patients with neuromuscular disorders (e.g., peripheral motor neuropathic diseases [e.g., amyotrophic lateral sclerosis, motor neuropathy] or neuromuscular junction disorders [e.g., myasthenia gravis, Lambert-Eaton syndrome]); closely monitor such patients.384

Risk of Viral Transmission

Preparation contains albumin derived from human blood.384 Remote risk of transmission of Creutzfeldt-Jakob disease (CJD) and other viral diseases via albumin component; however, no cases identified to date.384

Immunogenicity

Potential immunogenicity.384 388 Development of binding or neutralizing antibodies reported in a few patients receiving abobotulinumtoxinA.384 385 Clinical importance not established.384 385

Antibodies may reduce therapeutic effect; however, some patients with neutralizing antibodies continue to respond to the drug.384 385 Certain botulinum toxin preparations may be more likely to elicit an immune response.388

Reporting Adverse Effects or Overdosage

If the patient receives an overdose of abobotulinumtoxinA or the drug is injected into the wrong muscle (i.e., misinjection), contact the local or state health department to process a request for botulism antitoxin through the CDC Drug Service.384 If a response is not received within 30 minutes, contact the CDC Emergency Operations Center directly at 770-488-7100.384 Information about the antitoxin is available at .

Botulism antitoxin will not reverse any botulinum toxin-induced muscle weakness evident at the time of antitoxin administration but may stabilize the deficits.384

Specific Populations

Pregnancy

Category C.384

Lactation

Not known whether distributed into milk.384

Pediatric Use

Manufacturer states that safety and efficacy not established in patients <18 years of age with cervical dystonia.384

Not recommended for cosmetic improvement of glabellar lines in patients <18 years of age.384

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether such patients respond differently than younger adults;384 select dosage with caution due to age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.384

Efficacy for glabellar lines not observed in individuals ≥65 years of age.384 Higher incidence of ocular adverse effects observed in geriatric compared with younger individuals.384

Race/Ethnicity

Response rates in African Americans (with Fitzpatrick skin types IV–VI) and Hispanic patients with glabellar facial lines appear to be similar to those observed in the general population.384

Common Adverse Effects

Cervical dystonia: Muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, eye disorders (blurred vision, diplopia, reduced visual acuity and accommodation).384 385

Glabellar facial lines: Nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, ptosis, sinusitis, nausea.384 393 394 395 398

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

AbobotulinumtoxinA

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

300 units

Dysport

Ipsen

500 units

Dysport

Ipsen

How is this medicine (AbobotulinumtoxinA) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all uses of abobotulinumtoxinA:

  • This medicine will be given to you by a doctor.

For lines and wrinkles of the face:

  • It is given as a shot into the muscles of the face.

For other reasons:

  • It is given as a shot into a muscle.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Brand Names U.S.

  • Dysport
  • Dysport (Glabellar Lines) [DSC]

Duration of Action

Cervical dystonia, glabellar lines: ≥4 months; Lower limb spasticity: ≥5 ½ months; Upper limb spasticity: ≥5 months

Use Labeled Indications

Cervical dystonia: Treatment of adults 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.

Lower limb spasticity: Treatment of lower limb spasticity in pediatric patients ≥2 years.

Spasticity: Treatment of spasticity in adults.

Dosing Pediatric

Lower limb spasticity: Children ≥2 years and Adolescents: IM: Individualize dose based on patient size, number and location of muscles involved, 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 16 to 22 weeks; however, some patients had a longer duration of response.

Total dose per treatment session: 10 to 15 units/kg per limb. Maximum total dose per treatment session: 15 units/kg for unilateral injections, 30 units/kg for bilateral injections, or 1,000 units, whichever is less. Divide total dose administered between the affected muscles; distribute dose across >1 injection site in any single muscle if possible; do not administer >0.5 mL in any single injection site. Recommended dose range per muscle per limb:

Gastrocnemius: 6 to 9 units/kg (up to 4 injections per muscle per limb)

Soleus: 4 to 6 units/kg (up to 2 injections per muscle per limb)

Dietary Considerations

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

ALERT U.S. Boxed Warning

Distant 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 upper limb 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.

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

Patient Handout

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For Healthcare Professionals

Applies to abobotulinumtoxinA: injectable powder for injection, intramuscular powder for injection

Nervous system

Very common (10% or more): Dysphonia (up to 28%), headache (11%), facial paresis (up to 11%)
Common (1% to 10%): Dizziness, convulsion, syncope, hypoesthesia, partial seizures[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Gastrointestinal

Very common (10% or more): Dysphagia (up to 39%), dry mouth (up to 39%)
Common (1% to 10%): Nausea, diarrhea, constipation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, blood present in urine[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, urticaria, soft tissue edema[Ref]

Metabolic

Frequency not reported: Blood triglycerides increased[Ref]

Ocular

Very common (10% or more): Eye disorders (e.g., vision blurred, diplopia, visual acuity reduced, eye pain, eyelid disorder, accommodation disorder, dry eye, eye pruritus) (up to 17%)
Common (1% to 10%): Eyelid edema, eyelid ptosis, about 3% of patients developed antibodies to this drug
Postmarketing reports: Photophobia[Ref]

Local

Very common (10% or more): Injection site discomfort (e.g., pain, bruising, hemorrhage, injection site erythema/hematoma) (up to 22%)[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (10%)
Common (1% to 10%): Breathing difficulty, dyspnea, upper respiratory tract infection, sinusitis, cough[Ref]

Musculoskeletal

Very common (10% or more): Muscular weakness (up to 56%)
Common (1% to 10%): Musculoskeletal pain, muscle atrophy, pain in extremity, back pain
Uncommon (0.1% to 1%): Gait disturbance, hypertonia
Postmarketing reports: Amyotrophy, facial paresis[Ref]

Immunologic

Common (1% to 10%): Infection, influenza[Ref]

Dermatologic

Frequency not reported: Excessive granulation tissue, erythema[Ref]

Other

Very common (10% or more): Fatigue (12%)
Common (1% to 10%): Fall, injury, contusion
Uncommon (0.1% to 1%): Sensation of heaviness
Frequency not reported: Distant spread of toxin effects
Postmarketing reports: Vertigo, burning sensation, hypoesthesia

Psychiatric

Common (1% to 10%): Depression[Ref]

Some side effects of abobotulinumtoxinA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Other Comments

General:
-During treatment of strabismus, the dosage of this drug should be administered with electromyographic guidance.
-During treatment of blepharospasm, avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues and can be prevented by applying pressure at the injection site immediately after the injection.
-This drug is contraindicated in the presence of infection at the proposed injection site. Caution is advised if it is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscles.
-Dysphagia is a commonly reported adverse event following treatment of cervical dystonia with all botulinum toxins. Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech or respiratory difficulties occur

Storage requirements:
Once reconstituted, this drug should be stored in the original container in the refrigerator (2 to 8 degrees C), protected from light, and used within 4 hours.

Reconstitution/preparation techniques:
This drug has reconstitution instructions specific for the 300 Unit and 500 Unit vials.

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