Botox (OnabotulinumtoxinA) 100U

Neuromuscular Blocking Agent

“ALERT: US 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 and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.”

CSA NA – FDA Approved – REMS (N) – Can Ship

Botulinum toxin is a neurotoxin that prevent the calcium-dependent release of acetylcholine at the presynaptic membrane of the neuromuscular junction and consequently produces a state of denervation.  Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the sarcolemma.

Formulations: Two serotypes of botulinum toxin have been formulated for clinical use, including botulinum toxin type A (the most common serotype used for cosmetic applications) and botulinum toxin type B. In order to prevent confusion between products, in 2009, the US Food and Drug Administration (FDA) recommended the use of specific names, rather than serotypes, to refer to the available formulations of botulinum toxin

Officially indicated for cervical dystonia, glabellar lines, and spasticity depending on the product used.  Some formulations are also used off-label to treat acquired nystagmus, sialorrhea, and tardive dyskinesia.

Do not use if cases of serious anaphylaxis and/or hypersensitivity to any component of botulinum toxin type A and B

Use with caution in patients with pre-existing cardiovascular disease.

Systemic toxicity has been reported beyond the injection site.  Dysphagia and breaking difficulties have occurred and may be life threatening.

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

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 (e.g., 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.

*Only an experienced licensed trained medical professional should be administering Botulinum Toxin.

The reported adverse and side effects is dependant on the site of injection and indicated use.  We will only be including the most common side effects:

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

Local: Discomfort at the injection site (13% to 22%)

Nervous System: Voice disorder (6% to 28%), fatigue (12%), headache (11%)

Neuromuscular and Skeletal: Myasthenia (11% to 56%)

Ophthalmic: Eye disease (6% to 17%)

1. Is there a difference between the commercially available botulinum toxin A drugs?
   OnabotulinumtoxinA — Of the formulations of botulinum toxin type A that are available or in development, onabotulinumtoxinA (Botox, Botox Cosmetic, Vistabel, Vistabex) has been studied most extensively. OnabotulinumtoxinA is supplied as a preservative-free, vacuum-dried powder that contains the C. botulinum type A neurotoxin complex (50 or 100 units per vial) plus human albumin and sodium chloride. The FDA has approved onabotulinumtoxinA for the treatment of glabellar rhytids, lateral canthal lines (crow’s feet), and forehead lines, but the toxin also is widely used for the treatment of other skin lines and for facial contouring. AbobotulinumtoxinA — Initially marketed in Europe, abobotulinumtoxinA (Dysport) is another formulation of botulinum toxin type A utilized for cosmetic therapy. AbobotulinumtoxinA is supplied in vials that contain 300 or 500 units of lyophilized abobotulinumtoxinA plus serum albumin and lactose. AbobotulinumtoxinA became commercially available in North America in 2009 and has FDA approval for the treatment of glabellar lines. IncobotulinumtoxinA — IncobotulinumtoxinA (Xeomin or Bocouture), a newer formulation of botulinum toxin type A, is approved for medical use and for injection of glabellar lines in multiple countries, including the United States. IncobotulinumtoxinA is supplied as a lyophilized powder that contains botulinum toxin A (50 or 100 units), human albumin, and sucrose. IncobotulinumtoxinA is free of complexing proteins, which some authors believe may result in a reduced risk of sensitization and antibody formation against the toxin.             PrabotuliumtoxinA — In 2019, the FDA approved prabotulinumtoxinA-xvfs (Jeuveau) for the treatment of moderate to severe glabellar lines in adults. PrabotulinumtoxinA is supplied as a vacuum-dried powder in a single-dose vial containing 100 units. RimabotulinumtoxinB — RimabotulinumtoxinB is commercially available as Myobloc or NeuroBloc. Myobloc, which is distributed in the United States, Canada, and Korea, is supplied in liquid form in vials that contain 5000 units of botulinum toxin type B per milliliter plus human serum albumin, sodium succinate, and sodium chloride. It is the primary agent used for the treatment of cervical dystonia, and compared to botulinum toxin type A, has been less studied for cosmetic indications. However, rimabotulinumtoxinB has been used successfully for the treatment of facial rhytids.