AbobotulinumtoxinA

Name: AbobotulinumtoxinA

What Is AbobotulinumtoxinA?

AbobotulinumtoxinA (Dysport), also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Dysport is used to treat cervical dystonia (severe spasms in the neck muscles).

Dysport is also used to temporarily lessen the appearance of facial wrinkles.

Dysport may also be used for purposes not listed in this medication guide.

You should not receive this medicine if you are allergic to botulinum toxin or cow's milk, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

You should not receive this medicine if you are allergic to botulinum toxin or cow's milk, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected. Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past

To make sure Dysport is safe for you, tell your doctor if you have:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
  • myasthenia gravis;
  • Lambert-Eaton syndrome;
  • a breathing disorder such as asthma or emphysema;
  • problems with swallowing;
  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
  • a change in the normal appearance of your face;
  • a seizure disorder;
  • bleeding problems;
  • heart disease;
  • diabetes;
  • if you have had or plan to have surgery (especially on your face); or
  • if you have ever received other botulinum toxin injections such as Botox or Myobloc (especially in the last 4 months).

Dysport is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Dysport passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What should I avoid after receiving Dysport?

Dysport may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid going back to your normal physical activities too quickly after receiving an injection.

Interactions for AbobotulinumtoxinA

No formal drug interaction studies to date.384

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Potential for additive anticholinergic effects.384

Anti-infective agents interfering with neuromuscular transmission (e.g., aminoglycosides)

Potential for additive botulinum toxin effects384

Closely monitor for adverse effects384

Botulinum toxin treatment, concurrent or sequential

Possible excessive muscle weakness with concurrent or sequential use within several months of abobotulinumtoxinA384

Data on concurrent or sequential use of botulinum toxins lacking384

Muscle relaxants

Potential for excessive muscular weakness when administered prior to, concurrently with, or following abobotulinumtoxinA384

AbobotulinumtoxinA Pharmacokinetics

Absorption

Bioavailability

Not detectable in peripheral circulation following IM administration.384

Duration

Cervical dystonia: Usual duration of effect ≥12–16 weeks or more.384

Glabellar lines: Median duration of effect approximately 85 days following single IM injections of 50 units; reductions in glabellar line severity may be observed for up to 4 months.384 393

Actions

  • Purified neurotoxin type A complex produced by fermentation of Clostridium botulinum (Hall strain).384 388 391 396 Differs from other currently available preparations of botulinum toxin type A in molecular size, pharmacologic properties, dosing requirements, and adverse effect profile.384 388 391 396 (See Lack of Interchangeability Among Botulinum Toxin Preparations under Cautions.)

  • Disrupts neurotransmission by inhibiting release of acetylcholine at peripheral cholinergic nerve terminals, inducing a chemical denervation and reduction of muscle activity.384 388 392 396 399

  • Neurotoxic effects occur in 3 phases: binding, internalization, and inhibition of acetylcholine from nerve terminals resulting in neuromuscular blockade.384

  • May also have a direct analgesic effect through modulation of certain peptide neurotransmitters.391

  • Weakness or paralysis of adjacent or distant muscles may occur as a result of toxin diffusion.381 384

  • Recovery of neuromuscular activity occurs slowly through regeneration and recovery of nerve endings.384 396

Uses of AbobotulinumtoxinA

  • It is used to lower the number of lines and wrinkles of the face.
  • It is used to treat spasms of the neck.
  • It is used to treat muscle stiffness in the elbow, wrist, or finger muscles.
  • It is used to treat muscle stiffness in calf muscles in children 2 years old and older.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take AbobotulinumtoxinA?

  • Tell all of your health care providers that you take abobotulinumtoxinA. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
  • Do not switch between different forms of abobotulinumtoxinA without first talking with the doctor.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using abobotulinumtoxinA while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Contraindications

Known hypersensitivity (eg, anaphylaxis) to botulinum toxin or any component of the formulation, including cow milk protein; infection at the proposed injection site(s)

Dosing Adult

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 1,000 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

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). For upper limb spasticity, total doses of 500 and 1,000 units divided among selected muscles were used in clinical trials. For lower limb spasticity, total doses of 1,000 and 1,500 units divided among selected muscles were used in clinical trials. The maximum recommended total dose (upper and lower limbs combined) is 1,500 units.

Upper limbs:

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)

Lower limbs:

Flexor digitorum longus: 130 to 200 units (1 to 2 injections per muscle)

Flexor halluces longus: 70 to 200 units (1 injection per muscle)

Gastrocnemius, medial head: 100 to 150 units (1 injection per muscle)

Gastrocnemius, lateral head: 100 to 150 units (1 injection per muscle)

Soleus: 330 to 500 units (3 injections per muscle)

Tibialis posterior: 200 to 300 units (2 injections per muscle)

Anal fissure (off-label use): IM: 90 to 150 units in 2 divided doses injected into the internal anal sphincter on each side of the anterior midline (Brasinda 2004; Yiannakopoulou 2012)

Sialorrhea (off-label use): Intraglandular (Ventral) (off-label route): 15 to 75 units injected per gland (submandibular, parotid or both) either unilaterally or bilaterally with intervals of 4 to 6 months between treatments (Reddihough 2010; Vashishta 2010).

Tardive dyskinesia (off-label use): IM: 20 to 50 units injected per site (total dosage range: 80 to 100 units). Dose, duration, and number of injections are dependent on muscle size and severity (Hennings 2008; Rapaport 2000). Subsequent doses up to 80 units have been used in order to find the optimum dosage (Slotema 2008). Additional data may be necessary to further define the role of abobotulinumtoxinA in the treatment of this condition.

Dosing 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 intramuscular (IM) injection.

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

AbobotulinumtoxinA Brand Names

AbobotulinumtoxinA may be found in some form under the following brand names:

  • Dysport

AbobotulinumtoxinA Drug Class

AbobotulinumtoxinA is part of the drug class:

  • Other peripherally acting muscle relaxants in ATC

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