Adult Dosing
Cervical dystonia
- Initial total dose: 120 U IM in affected muscles; may repeat q12 wks if required
Note:
- Individualize dose based on severity of condition, number/location of the muscle(s) to be treated, muscle mass, body weight, and response to any prior botulinum toxin therapy
Blepharospasm
- Patients previously treated w/ onabotulinumtoxinA
- Initial total dose: Dose should be same as previous dose of onabotulinumtoxinA
- Treatment-naive patients
- Initial dose: 1.25-2.5 U/injection site IM; may repeat q12 wks if required
- Max: 35 U/eye
Notes:- Number and location of sites depend on severity of condition, and previous dose and response to onabotulinumtoxinA therapy
Moderate-to-severe glabellar lines
- 20 U IM divided in 5 injection sites; i.e. 2 inj in each corrugator muscle and 1 inj in procerus muscle
- May repeat therapy q3 months
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- According to postmarketing reports, botulinum toxin effects may spread away from injection site, producing symptoms such as asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing diffculties. Associated dysphagia and dyspnea may be life-threatening or even fatal [US Black Box Warning]
- Children treated for spasticity are at highest risk of developing such symptoms, although symptoms may also be seen in adults with underlying conditions which make them susceptible to these symptoms [US Black Box Warning]
- Instruct patients/caregivers to seek prompt medical care if swallowing, speech, or respiratory disorders occur
- Potency units of incobotulinumtoxinA are specific to the preparation and assay method utilized and are not comparable to potency of any other botulinum toxin products assessed by a different assay method
- Hypersensitivity reactions characterized by anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported with the use of incobotulinumtoxinA. If serious/immediate hypersensitivity reactions occur, discontinue further injections and initiate appropriate treatment measures
- IncobotulinumtoxinA therapy may cause dysphagia and breathing difficulties, especially in patients with similar pre-existing conditions
- Severe dysphagia may last for several months, requiring use of a feeding tube to maintain adequate nutrition and hydration. Aspiration and death may occur as complications of severe dysphagia. Risk of dysphagia is higher in patients with smaller neck muscle mass and those who require bilateral injections into the sternocleidomastoid muscles
- Use of incobotulinumtoxinA for treatment of cervical dystonia may weaken accessory muscles of ventilation, resulting in serious breathing difficulties and respiratory failure in such patients
- Closely monitor patients with pre-existing peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders during therapy, as they are at a greater risk of developing severe dysphagia and respiratory compromise
- Corneal exposure, persistent epithelial defect and corneal ulceration may occur due to reduced blinking resulting from botulinum toxin injection, particularly in patients with VII nerve disorders
- It is recommended to monitor corneal sensation in eyes operated previously; avoid injection into the medial lower lid area to prevent ectropion and correct any epithelial defect
- Use cautiously in patients at risk of developing narrow angle glaucoma
- Ecchymosis that may easily occur in the eyelid soft tissues may be reduced by applying of immediate gentle pressure at the injection site
- To reduce risk of ptosis, avoid injection near the levator palpebrae superioris and administer corrugator injections at least 1 cm above bony supraorbital ridge
- Due to the presence of albumin derived from human blood, there is a risk for transmission of viral diseases and of Creutzfeldt-Jakob disease (CJD). However, this risk is extremely remote due to effective donor screening and manufacturing processes
Cautions: Use cautiously in
- Dysphagia or risk of dysphagia
- Impaired respiratory function
- Facial nerve disorder
Supplemental Patient Information
- Instruct patients/caregivers to seek prompt medical care if swallowing, speech, or respiratory disorders occur
- Advise immobile/sedentary patients to slowly resume activities following injection for treatment of cervical dystonia and blepharospasm
- Warn patients about the risk of dyspnea, mild-to-severe dysphagia, and aspiration following treatment
- Advise patients to avoid driving automobiles or engaging in hazardous tasks, if loss of strength, muscle weakness, blurred vision, or drooping eyelids are observed during therapy
- Inform patients to seek prompt medical attention if eye pain or irritation develops following treatment
Pregnancy Category:C
Breastfeeding: Safety unknown. No information available regarding the use of incobotulinumtoxinA during nursing. Amounts ingested by the infants, if any, are not expected to cause any adverse effects in breastfed infants, as the therapeutic doses are much lower than those that cause botulism. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 August 2011). Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Xeomin 100 UNIT SOLR [Vial] (MERZ PHARMACEUTICAL)
1 unit = $505.97
3 unit = $1489.91
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
