What is this medication?
OnabotulinumtoxinA, Botox/Botox Cosmetic/Vistabel/Vistabex
Neuromuscular Blocking Agent
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.
“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.”
How does this medication work?
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
How should I take this medication?
IM: Initial 500 units divided among affected muscles in toxin-naïve or toxin-experienced patients. May re-treat at intervals of ≥12 weeks.
Adjust dosage in 250-unit increments; do not administer at intervals <12 weeks; dosage range used in studies: 250 to 1,000 units.
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.
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.
What should I watch for while using this medication?
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.
What if I miss a dose?
Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.
Do not take an extra dose or increase your dose to make up for your missed dose.
How should I store this medication?
Botox should be administered within twenty-four hours after reconstitution. During this time period, reconstituted Botox should be stored in a refrigerator (2° to 8° C). Reconstituted Botox should be clear, colorless and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and whenever the solution and the container permit.
What are the possible side effects of using this medication?
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%)
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