XEOMIN (IncobotulinumtoxinA)
XEOMIN (IncobotulinumtoxinA)
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XEOMIN (IncobotulinumtoxinA)

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What is this medication?

XEOMIN (IncobotulinumtoxinA)
Neuromuscular Blocking Agent

XEOMIN (IncobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of adult patients with chronic sialorrhea, upper limb spasticity, cervical dystonia, blepharospasm with onabotulinumtoxinA (Botox® ) prior treatment, and temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity.

The effects of XEOMIN (IncobotulinumtoxinA) and all botulinum toxin products may spread from the area of injection and 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.

How does this medication work? 

Botulinum toxin is a neurotoxin that prevents 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? 

Cervical dystonia
IM: Initial 500 units injected intramuscularly 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 intramuscularly 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? 

Before starting make sure your physician is aware of any allergies or medications you currently take. XEOMIN (IncobotulinumtoxinA) has been associated with respiratory, speech, or swallowing difficulties when administered to bilateral neck muscles or when used in a patient with a pre-existing muscle disorder.

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.

How should I store this medication?

Refrigeration of unopened vials is not required, but should be stored at or below 25°C (77°F). Reconstituted XEOMIN may be stored in a refrigerator at 2° to 8°C (36° to 46°F) for up to 24 hours until time of use. Do not use after the expiration date on the vial.

What are the possible side effects of using this medication?

The reported adverse and side effects are dependent on the site of injection and indicated use and include dry mouth, diarrhea, hypertension, seizure, nasopharyngitis, dysphagia, neck pain, muscle weakness, injection site pain, musculoskeletal pain, eyelid ptosis, headache, visual impairment, dyspnea, fatigue, voice disorder.

Note this is not a complete list of side effects for XEOMIN (IncobotulinumtoxinA), only common ones.