Class: Other Miscellaneous Therapeutic Agents
VA Class: MS900
Chemical Name: Botulin B
Molecular Formula: C6869H10545N1715O2036S34
Medically reviewed by Drugs.com. Last updated on Mar 25, 2019.
- Distant Spread of Toxin Effects
Effects of any botulinum toxin may spread from local sites of injection, producing symptoms consistent with the mechanism of action of botulinum toxin.2 (See Distant Spread of Toxin Effects under Cautions.)
Symptoms reported hours to weeks following injection.2
Swallowing and breathing difficulties may be life-threatening; deaths reported.2
Children treated for limb spasticity probably at highest risk; however, such effects also can occur in adults, particularly those with underlying predisposing conditions.2 (See Pediatric Use under Cautions.)
In both labeled and unlabeled (e.g., spasticity in children) uses, symptoms consistent with the spread of toxin effect reported at doses comparable to or lower than those used in cervical dystonia.2
Neurotoxin produced by Clostridium botulinum;1 2 3 5 31 37 70 79 disrupts neurotransmission by inhibiting release of acetylcholine from peripheral and ganglionic autonomic cholinergic nerve terminals.2 3 16 31 32 37 70 250 399
Uses for RimabotulinumtoxinB
Currently, 3 botulinum toxin type A preparations (abobotulinumtoxinA [Dysport], incobotulinumtoxinA [Xeomin], and onabotulinumtoxinA [Botox, Botox Cosmetic]) and one botulinum toxin type B preparation (rimabotulinumtoxinB [Myobloc]) are commercially available in the US.1 2 5 403 408 409 These preparations are not interchangeable; assay methods used to determine potency of botulinum toxins are specific to each individual manufacturer and/or formulation.1 2 5 381 384 403 410
Treatment of cervical dystonia (spasmodic torticollis) to decrease severity of associated abnormal head position and neck pain;2 3 9 14 16 32 37 65 69 81 95 96 122 designated an orphan drug by FDA for this use.81
Botulinum toxins considered first-line therapy for cervical dystonia because of efficacy, relatively low incidence of adverse effects, and temporary dose-related therapeutic effects (compared with surgery).3 15 296 297 500
Blepharospasm and Associated Facial Nerve Disorders
Has been used in the management of blepharospasm† or hemifacial spasm†, but efficacy evidence and experience are limited; used principally in patients who have responded previously to onabotulinumtoxinA.283 297 354 355
The American Academy of Neurology (AAN) states that onabotulinumtoxinA and incobotulinumtoxinA should be considered as treatment options, and abobotulinumtoxinA may be considered for the treatment, of blepharospasm; AAN does not make a recommendation about rimabotulinumtoxinB for this use due to a lack of data.500
Has been used for symptomatic management of severe primary axillary hyperhidrosis†157 160 261 and focal palmar hyperhidrosis†;157 261 369 however, efficacy evidence and experience are limited.160 296 297
Has been used for temporary improvement in appearance of vertical glabellar facial (“frown”) lines†,156 301 302 337 lateral canthal lines† (“crow’s feet”†)152 156 310 337 338 and horizontal forehead lines†156 338 in a limited number of individuals; efficacy evidence and experience are limited.152 156 310 337 338
RimabotulinumtoxinB Dosage and Administration
Generally, the effective IM dose depends on muscle mass; the larger the muscle, the higher the required dose.120
Controlling Injection Pain
Dilution with 0.9% sodium chloride injection containing a preservative (benzyl alcohol)† has been reported to reduce pain on injection;157 297 344 however, the manufacturer recommends use of 0.9% sodium chloride injection without preservative for dilution.1 2 5 298
Some clinicians suggest that injection pain (possibly due to acidity of the solution)152 157 286 may be decreased by adding a small amount of sodium bicarbonate to the injection solution†.152 157 However, the compatibility and stability of such solutions remain to be fully elucidated.157 296 297
Myobloc vials are overfilled to ensure delivery of the labeled volume of drug: the vial labeled as containing 2500 units in 0.5 mL actually contains approximately 4100 units in 0.82 mL, the vial labeled as containing 5000 units in 1 mL actually contains approximately 6800 units in 1.36 mL, and the vial labeled as containing 10,000 units in 2 mL actually contains approximately 12,650 units in 2.53 mL.2 156 297 338 Do not dilute drug solutions in the vial since this may result in a solution with a higher concentration than expected due to overfill.297 338
May be diluted with 0.9% sodium chloride injection to obtain desired concentration; however, since the drug solution does not contain a preservative, use diluted solutions within 4 hours of preparation.2 296 297 Diluted solutions reportedly stable for at least 24 hours at 25°C.157 172
Vials are for single use only; discard any unused portions.2
Carefully dispose of all used vials, including expired vials and/or equipment used in preparation and administration, as medical waste.2
Injection Techniques/Precautions (General)
Targeting the injection to the appropriate muscle(s) may be facilitated by active electromyography (EMG), ultrasonography, palpation of muscle belly, and/or use of anatomic landmarks (e.g., evidence of muscular hypertrophy, stiffness, tenderness, visible abnormal muscular activity).120 229
EMG-guided injections often are recommended to ensure optimal placement of toxin, particularly in patients who have not responded adequately to previous injections, and to minimize adverse effects on nonaffected tissue.120 296 297
Injection into midbelly of larger muscles where motor end plates are located may enhance benefit.296
Injection Techniques/Precautions (Cervical Dystonia)
Clinicians who administer rimabotulinumtoxinB should be familiar with and experienced in the assessment and management of cervical dystonia.2
Identify affected muscles by careful clinical evaluation, including physical examination (e.g., for areas of hypertrophy, pain) and palpation.9 65 Palpation of contracting muscles while patient’s head is placed in position most favored by dystonic pulling of neck muscles is reportedly helpful.9 65
Injection Techniques/Precautions (Facial Cosmesis)
Appears to have increased diffusion within the muscle (potentially reducing the number of injections and complications)142 157 301 302 353 354 and a somewhat faster onset of action (e.g., within 24–48 hours) than botulinum toxin type A;142 152 157 160 297 353 however, additional experience needed to establish the optimal dose, number of injection sites, and frequency of treatment for facial cosmesis.142 156 301 310 337
Avoid eyelid ptosis by asking individual to remain upright (e.g., avoid naps in reclining position) for 4 hours following treatment, avoid rubbing or massaging treated area for 4 hours (to prevent excess diffusion and possible weakness of adjacent muscles), and frown and smile repeatedly for at least 1–4 hours296 297 following treatment.296 297
If concurrent cosmetic alteration of the eyebrow† is planned,157 296 297 defer treatment of the lateral eyebrow until after treatment of lateral canthal lines (“crow’s feet”)†; increased diffusion may accomplish sufficient cosmetic alteration of the eyebrow to eliminate the need for further treatment.157 296 297
Potency of rimabotulinumtoxinB expressed in units of biologic activity; each unit is equivalent to the median intraperitoneal lethal dose (LD50) in mice.2
Because of differences in assay methods, units of biologic activity of rimabotulinumtoxinB cannot be compared with or converted to units of any other botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA).1 2 5 381 384 403 410
Titrate initial and subsequent dosage considering previous response, adverse reactions, and severity of dystonia based on head and neck position, localization of pain, mass of target muscles and their proximity to critical toxin-sensitive anatomic structures (e.g., larynx, pharynx), and muscular hypertrophy.296 297
Patients with a history of tolerating botulinum toxin treatment: Initially, total recommended dose per treatment session is 2500–5000 units divided among affected muscles.2 Total initial doses as high as 10,000 units per treatment session have been used.2 296 297
Primary Axillary Hyperhidrosis†Intradermal
Anhidrosis following rimabotulinumtoxinB injection may occur within 3–5 days, with peak effect in 1–2 weeks and duration 9–16 weeks; duration of response with 2000 or 4000 units per axilla does not appear dose related.160 296 297
Duration of muscle weakness (e.g., 2–3 weeks) following treatment with rimabotulinumtoxinB appears similar to that with onabotulinumtoxinA.157
Glabellar Facial (“Frown”) Lines†IM
Lateral Canthal Lines (“Crow’s Feet”)†IM
1500 units divided among 3 injection sites per side (total dosage 3000 units) has been used;310 wrinkle severity was reduced by day 30 and generally had returned to baseline between days 90 and 120.310
750 units divided among 3 injection sites per side also has been used (total dosage 1500 units if both sides treated); resolution of wrinkles occurred at 7 days.152
Horizontal Forehead Lines†IM
1000–2500 units on each side of forehead suggested.157 296 Some clinicians suggest that injections be placed slightly higher than the equator of the brow (no lower than 2.5–4 cm above the brow) to account for increased diffusion of rimabotulinumtoxinB.157 296 297
If planning to treat both glabellar and horizontal forehead lines, may treat glabellar facial lines first and reevaluate again in 2 weeks to determine if further treatment needed.157
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.296
Cautions for RimabotulinumtoxinB
Hypersensitivity to rimabotulinumtoxinB or any ingredient in the formulation.2
Infection at proposed injection site(s).2
Distant Spread of Toxin Effects
Potential for systemic spread of toxin effects beyond local sites of injection; manifested as unintended muscular weakness in noncontiguous anatomic structures and other potentially life-threatening adverse effects.2 31 32 37 65 142 371 373 381 382 383 (See Boxed Warning.)
Monitor patients for possible systemic effects (e.g., dysphagia, dysphonia, respiratory compromise, generalized weakness) following administration.371
Adverse effects consistent with mechanism of botulinum toxin action (e.g., asthenia/unexpected loss of strength or generalized muscle weakness, blurred vision, breathing difficulties/respiratory impairment, diplopia, dysarthria, dysphagia, dysphonia, hoarseness, ptosis, urinary incontinence) reported2 70 250 in both children and adults receiving botulinum toxin for a variety of conditions in a wide range of dosages.1 5 371 372 373 381 382 403
In some cases, swallowing and breathing difficulties required hospitalization, mechanical ventilation, or feeding tubes and/or resulted in death.2 381 (See Dysphagia and Breathing Difficulties under Cautions.)
Lack of Interchangeability Among Botulinum Toxin Preparations
The method used to determine potency of each botulinum toxin is specific to the individual manufacturer and/or preparation; therefore, units of biologic activity for rimabotulinumtoxinB cannot be compared with or converted to units of any other botulinum toxin.2 381 410
Dysphagia and Breathing Difficulties
Dysphagia is most common serious adverse effect reported in patients with cervical dystonia.2 14 15 16 17 65 69 95 96 122 261 Results from diffusion of the toxin to tissues (e.g., posterior pharyngeal muscles) outside the injected muscles.58 60 65 371 Rarely, dysphagia may require placement of gastric feeding tube.2 410
Immediate medical attention may be required if patients develop problems with swallowing, speech, or respiratory disorders.2
Preexisting Neuromuscular Disorders
Increased risk of serious adverse systemic effects (e.g., severe dysphagia, muscle weakness, respiratory compromise) with recommended doses in patients with neuromuscular disorders (e.g., peripheral motor neuropathic diseases [e.g., amyotrophic lateral sclerosis, motor neuropathy] or neuromuscular junction disorders [e.g., myasthenia gravis, Lambert-Eaton syndrome]); exercise caution in such patients.2 18 37 58 219 371 375 376 May be related to use of higher dosages in such patients.376
Rarely, extreme sensitivity to systemic effects of usual doses reported in patients with known or unrecognized neuromuscular disorders; some patients experienced several months of severe dysphagia and required a gastrostomy or nasogastric tube.2 9 69
Risk of Viral Disease Transmission
Botulinum Toxin-naive Patients
Initiate treatment with lower doses than those recommended for patients with a history of tolerating such treatment.2
Neutralizing antibodies generally not detected until after 6 months of treatment.2
Patients who develop tolerance to botulinum toxin type A may respond to botulinum toxin type B or other botulinum toxin serotypes (e.g., botulinum toxin type F);3 32 60 65 79 however, long-term response to other serotypes in such patients not fully elucidated.14 32
Reporting Adverse Effects or Overdosage
If the patient receives an overdose of rimabotulinumtoxinB or the drug is injected into the wrong muscle (i.e., misinjection), contact the local or state health department to process a request for botulism antitoxin through the CDC Drug Service.2 If a response is not received within 30 minutes, contact the CDC Emergency Operations Center directly at 770-488-7100.2 Information about the antitoxin is available at [Web].
Botulism antitoxin will not reverse any botulinum toxin-induced muscle weakness evident at the time of antitoxin administration but may stabilize the deficits.2
Serious systemic toxicity resembling botulism (e.g., dysphagia, respiratory failure) reported during postmarketing experience in children <16 years of age.371 Such effects observed with rimabotulinumtoxinB doses of 388–625 units/kg.371 Severe cases involving death or hospitalization or requiring use of gastric feeding tubes and/or mechanical ventilation have occurred, principally in children with cerebral palsy-associated limb spasticity.371 372 373 No deaths or serious complications requiring intubation or ventilatory support reported among such cases of botulism in adults.371
Safety and/or efficacy in those ≥65 years of age similar to that in younger adults.2
Safety and efficacy data in patients ≥75 years of age insufficient for any comparison to that in younger adults.2
Common Adverse Effects
Interactions for RimabotulinumtoxinB
Potential for prolonged paralytic effect of toxin296
Anti-infective agents interfering with neuromuscular transmission (aminoglycosides, lincosamides, polymyxins)
Botulinum toxin treatment, concurrent or sequential
Magnesium salts (magnesium sulfate)
Potential for prolonged paralytic effect of toxin296
Neuromuscular blocking agents (e.g., atracurium, succinylcholine)
Potential for prolonged paralytic effect of toxin296
No formal pharmacokinetic studies; manufacturer states that drug is not expected to be present in peripheral circulation in measurable concentrations following IM or intradermal injection of recommended doses.2 14
For information on systemic interactions resulting from concomitant use, see Interactions.
Induces chemical denervation and flaccid paralysis by disruption of neurotransmission; inhibits release of acetylcholine at presynaptic cholinergic nerve terminals of the peripheral nervous system and at ganglionic nerve terminals of the autonomic nervous system.2 3 16 31 32 37
At therapeutic doses, muscular paralysis limited to injected muscle; however, weakness or paralysis of adjacent muscles may occur as a result of local diffusion.31
Response in autonomic disorders involving excessive glandular secretion (e.g., hyperhidrosis) may be longer than in conditions involving overactivity of striated or smooth muscle;296 297 additional study needed to elucidate mechanism in glandular and non-muscle tissue.
Advice to Patients
Inform patients with cervical dystonia of possibility of dysphagia (typically mild to moderate);9 14 69 402 rarely, severe dysphagia occurs, sometimes associated with aspiration, dyspnea, pneumonia, and need to reestablish an airway.2 402
Advise patients and/or caregivers to seek immediate medical attention if unexpected muscle weakness or swallowing, speech, or respiratory disorders occur.2 371 402 Advise patients to avoid driving a car or engaging in other potentially hazardous activities if they have such symptoms.2 402
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., neuromuscular disorders).2 402
Importance of informing patients of other important precautionary information.2 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS DI Essentials™. © Copyright 2019, Selected Revisions March 25, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
1. Allergan. Botox (onabotulinumtoxinA) for injection prescribing information. Irvine, CA; 2017 Apr.
2. Solstice Neurosciences. Myobloc (rimabotulinumtoxinB) injection prescribing information. South San Francisco, CA; 2010 May.
3. Bell MS, Vermeulen LC, Sperling KB. Pharmacotherapy with botulinum toxin: harnessing nature’s most potent neurotoxin. Pharmacotherapy. 2000; 20:1079-91. http://www.ncbi.nlm.nih.gov/pubmed/10999501?dopt=AbstractPlus
5. Allergan. Botox Cosmetic (onabotulinumtoxinA) for injection prescribing information. Irvine, CA; 2017 Oct.
9. Jankovic J, Brin MF. Therapeutic uses of botulinum toxin. N Engl J Med. 1991; 324:1186-94. http://www.ncbi.nlm.nih.gov/pubmed/2011163?dopt=AbstractPlus
14. Figgit DP, Noble S. Botulinum toxin B: A review of its therapeutic potential in the management of cervical dystonia. Drugs. 2002; 62:705-2. http://www.ncbi.nlm.nih.gov/pubmed/11893235?dopt=AbstractPlus
15. Lew MF, Adornato BT, Duane DD et al. Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology. 1997; 49:701-7. http://www.ncbi.nlm.nih.gov/pubmed/9305326?dopt=AbstractPlus
16. Brashear A, Lew MF, Dykstra DD et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology. 1999; 53:1439-46. http://www.ncbi.nlm.nih.gov/pubmed/10534248?dopt=AbstractPlus
17. Brin MF, Lew MF, Adler CH et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999; 53:1431-8. http://www.ncbi.nlm.nih.gov/pubmed/10534247?dopt=AbstractPlus
18. Blackie JD, Lees AJ. Botulinum toxin treatment in spasmodic torticollis. J Neurol Neurosurg Psychiatry. 1990; 53:640-3. http://www.ncbi.nlm.nih.gov/pubmed/2213040?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=488163&blobtype=pdf
26. Bhatia KP, Munchau A, Thompson PD et al. Generalised muscular weakness after botulinum toxin injections for dystonia: a report of three cases. J Neurol Neurosurg Psychiatry. 1999; 67:90-3. http://www.ncbi.nlm.nih.gov/pubmed/10369829?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1736426&blobtype=pdf
31. Johnson EA. Clostridial toxins as therapeutic agents: benefits of nature’s most toxic proteins. Annu Rev Microbiol. 1999; 53:551-75. http://www.ncbi.nlm.nih.gov/pubmed/10547701?dopt=AbstractPlus
32. Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997; 6:S146-68.
37. Tsui JK. Botulinum toxin as a therapeutic agent. Pharmacol Ther. 1996; 72:13-24. http://www.ncbi.nlm.nih.gov/pubmed/8981568?dopt=AbstractPlus
38. Cobb DB, Watson WA, Fernandez MC. Botulism-like syndrome after injections of botulinum toxin. Vet Hum Toxicol. 2000 Jun; 42:163.
39. Callaway JE, Oregozo P, Gore N et al. Long-term stability of a new liquid formulation of botulinum toxin type b (BoNT-B). Neurology. 2001; 56(suppl 3): A346.
43. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med. 2001; 344:488-93. http://www.ncbi.nlm.nih.gov/pubmed/11172190?dopt=AbstractPlus
58. Erbguth F, Claus D, Engelhardt A et al. Systemic effect of local botulinum toxin injections unmasks subclinical Lambert-Eaton myasthenic syndrome. J Neurol Neurosurg Psychiatry. 1993; 56:1235- 6. http://www.ncbi.nlm.nih.gov/pubmed/8229041?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=489831&blobtype=pdf
60. Klein AW. Complications and adverse reactions with the use of botulinum toxin. Semin Cutan Med Surg. 2001; 20:109-20. http://www.ncbi.nlm.nih.gov/pubmed/11474743?dopt=AbstractPlus
65. Berardelli A, Abbruzzese G, Bertolasi L et al. Guidelines for the therapeutic use of botulinum toxin in movement disorders. Italian Study Group for Movement Disorders, Italian Society of Neurology. Ital J Neurol Sci. 1997; 18:261-9. http://www.ncbi.nlm.nih.gov/pubmed/9412849?dopt=AbstractPlus
69. Anon. Botulinum toxin for cervical dystonia. Med Lett Drugs Ther. 2001; 43:63-4. http://www.ncbi.nlm.nih.gov/pubmed/11468603?dopt=AbstractPlus
70. Arnon SS, Schechter R, Inglesby TV et al for the Working Group on Civilian Biodefense. Botulinum toxin as a biologic weapon: medical and public health management. JAMA. 2001; 285:1059-70. http://www.ncbi.nlm.nih.gov/pubmed/11209178?dopt=AbstractPlus
79. Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000; 43:249-59. http://www.ncbi.nlm.nih.gov/pubmed/10906647?dopt=AbstractPlus
81. Food and Drug Administration. Search orphan designations and approvals. Rockville, MD. From FDA web site accessed Dec 27, 2013. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm
95. Lew MF. Botulinum toxin type B: an open-label, dose-escalation, safety and preliminary efficacy study in cervical dystonia patients. Adv Neurol. 1998; 78:227-30. http://www.ncbi.nlm.nih.gov/pubmed/9750919?dopt=AbstractPlus
96. Truong DD, Cullis PA, O’Brien CF et al. BotB (Botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study). Mov Disorders. 1997; 12:772-5.
103. Elston JS, Russell RWR. Effect of treatment with botulinum toxin on neurogenic blepharospasm. BMJ. 1985; 290:1857-9. http://www.ncbi.nlm.nih.gov/pubmed/3924284?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1416821&blobtype=pdf
120. Schwartz M, Freund B. Treatment of temporomandibular disorders with botulinum toxin. Clin J Pain. 2002; 18(6 Suppl):S198-203.
122. Tsui JKC, Hayward M, Mak EKM et al. Botulinum toxin type B in the treatment of cervical dystonia: a pilot study. Neurology. 1995; 45:2109-10. http://www.ncbi.nlm.nih.gov/pubmed/7501169?dopt=AbstractPlus
142. Matarasso A, Deva AK. Botulinum toxin. Plast Reconstr Surg. 2002; 109:1191-7. http://www.ncbi.nlm.nih.gov/pubmed/11884859?dopt=AbstractPlus
152. Matarasso SL. Comparison of botulinum toxin types A and B: a bilateral and double-blind randomized evaluation in the treatment of canthal rhytides. Dermatol Surg. 2003; 29:7-13.
156. Ramirez AL, Reeck J, Maas CS. Botulinum toxin type B (MyoBloc) in the management of hyperkinetic facial lines. Otolaryngol Head Neck Surg. 2002; 126:459-67. http://www.ncbi.nlm.nih.gov/pubmed/12075218?dopt=AbstractPlus
157. Glogau RG. Review of the use of botulinum toxin for hyperhidrosis and cosmetic purposes. Clin J Pain. 2002; 18(6 Suppl):S191-7. http://www.ncbi.nlm.nih.gov/pubmed/12569968?dopt=AbstractPlus
160. Dressler D, Adib Saberi F, Benecke R. Botulinum toxin type B for treatment of axillar hyperhidrosis. J Neurol. 2002; 249:1729-32. http://www.ncbi.nlm.nih.gov/pubmed/12529798?dopt=AbstractPlus
172. Callaway JE, Arezzo JC, Grethlein AJ. Botulinum toxin type B: an overview of its biochemistry and preclinical pharmacology. Semin Cutan Med Surg. 2001; 20:127-36. http://www.ncbi.nlm.nih.gov/pubmed/11474745?dopt=AbstractPlus
217. Stein E. Botulinum toxin and anal fissure. Curr Probl Dermatol. 2002; 30:218-26. http://www.ncbi.nlm.nih.gov/pubmed/12471714?dopt=AbstractPlus
219. Moore AP. Botulinum toxin A (BoNT-A) for spasticity in adults. What is the evidence? Eur J Neurol.2002; 9(Suppl 1):42-7.
229. Koman LA, Smith BP, Balkrishnan R. Spasticity associated with cerebral palsy in children. Pediatr Drugs. 2003; 5:11-23.
230. Corry IS, Cosgrove AP, Walsh EG et al. Botulinum toxin A in the hemiplegic upper limb: a double-blind trial. Dev Med Child Neurol. 1997; 39:185-93. http://www.ncbi.nlm.nih.gov/pubmed/9112968?dopt=AbstractPlus
234. Corry IS, Cosgrove AP, Duffy CM et al. Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: a randomised prospective trial. J Pediatr Orthop. 1998; 18:304-11. http://www.ncbi.nlm.nih.gov/pubmed/9600553?dopt=AbstractPlus
249. Setler PE. Therapeutic use of botulinum toxins: background and history. Clin J Pain. 2002; 18(Suppl):S119-24. http://www.ncbi.nlm.nih.gov/pubmed/12569958?dopt=AbstractPlus
250. Terranova W, Breman JG, Locey RP et al. Botulism type B: epidemiologic aspects of an extensive outbreak. Am J Epidemiol. 1978; 108:150-6. http://www.ncbi.nlm.nih.gov/pubmed/707476?dopt=AbstractPlus
261. Dressler D, Benecke R. Autonomic side effects of botulinum toxin type B treatment of cervical dystonia and hyperhidrosis. Eur Neurol. 2003; 49:34- 8. http://www.ncbi.nlm.nih.gov/pubmed/12464716?dopt=AbstractPlus
283. Colosimo C, Chianese M, Giovannelli M et al. Botulinum toxin type B in blepharospasm and hemifacial spasm. J Neurol Neurosurg Psychiatry. 2003; 74:687-91. http://www.ncbi.nlm.nih.gov/pubmed/12700325?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1738417&blobtype=pdf
286. Jost WH. Botulinum toxin type B in the treatment of anal fissures: first preliminary results. Dis Colon Rectum. 2001; 44:1721-2. http://www.ncbi.nlm.nih.gov/pubmed/11719933?dopt=AbstractPlus
291. Dykstra DD, Pryor J, Goldish G. Use of botulinum toxin type B for the treatment of detrusor hyperreflexia in a patient with multiple sclerosis: a case report. Arch Phys Med Rehabil. 2003; 84:1399-400. http://www.ncbi.nlm.nih.gov/pubmed/13680581?dopt=AbstractPlus
296. Reviewers’ comments (personal observations).
297. Elan Pharmaceuticals. South San Francisco, CA: Personal communication.
298. Allergan. Irvine, CA: Personal communication on onabotulinumtoxinA monograph.
301. Sadick NS. Prospective open-label study of botulinum toxin type B (Myobloc) at doses of 2,400 and 3,000 U for the treatment of glabellar wrinkles. Dermatol Surg. 2003; 29:501-7. http://www.ncbi.nlm.nih.gov/pubmed/12752518?dopt=AbstractPlus
302. Sadick NS. Botulinum toxin type B for glabellar wrinkles: a prospective open-label response study. Dermatol Surg. 2002; 28:817-21. http://www.ncbi.nlm.nih.gov/pubmed/12269875?dopt=AbstractPlus
310. Baumann L, Slezinger A, Vujevich J et al. A double-blinded, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B)-purified neurotoxin complex for the treatment of crow’s feet: a double-blinded, placebo-controlled trial. Dermatol Surg. 2003; 29:508-15. http://www.ncbi.nlm.nih.gov/pubmed/12752519?dopt=AbstractPlus
320. Racette BA, Good L, Sagitto S et al. Botulinum toxin B reduces sialorrhea in parkinsonism. Mov Disord. 2003; 18:1059-61. http://www.ncbi.nlm.nih.gov/pubmed/14502678?dopt=AbstractPlus
337. Lowe NJ, Yamauchi PS, Lask GP et al. Botulinum toxins types A and B for brow furrows: preliminary experiences with type B toxin dosing. J Cosmet Laser Ther. 2002; 4:15-8. http://www.ncbi.nlm.nih.gov/pubmed/12079632?dopt=AbstractPlus
338. Baumann L, Black L. Botulinum toxin type B (Myobloc). Dermatol Surg. 2003; 29:496-500. http://www.ncbi.nlm.nih.gov/pubmed/12752517?dopt=AbstractPlus
339. Argoff CE. A focused review on the use of botulinum toxins for neuropathic pain. Clin J Pain. 2002; 18(Suppl):S177-S181. http://www.ncbi.nlm.nih.gov/pubmed/12569966?dopt=AbstractPlus
340. Brashear A, McAfee AL, Kuhn ER et al. Treatment with botulinum toxin type B for upper-limb spasticity. Arch Phys Med Rehabil. 2003; 84:103-7. http://www.ncbi.nlm.nih.gov/pubmed/12589629?dopt=AbstractPlus
341. O’Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002; 18: S182-90.
344. van Laborde S, Dover JS, Moore M et al. Reduction in injection pain with botulinum toxin type B further diluted using saline with preservative: a double-blind, randomized controlled trial. J Am Acad Dermatol. 2003; 48:875-7. http://www.ncbi.nlm.nih.gov/pubmed/12789177?dopt=AbstractPlus
345. Dressler D, Bigalke H, Benecke R. Botulinum toxin type B in antibody-induced therapy failure. J Neurol. 2003; 250:967-9. http://www.ncbi.nlm.nih.gov/pubmed/12928917?dopt=AbstractPlus
351. Racette BA, Stambuk M, Perlmutter JS. Secondary nonresponsiveness to new bulk botulinum toxin A (BCB2024). Mov Disord. 2002; 17:1098-100. http://www.ncbi.nlm.nih.gov/pubmed/12360571?dopt=AbstractPlus
352. Racette BA, Lopate G, Good L et al. Ptosis as a remote effect of therapeutic botulinum toxin B injection. Neurology. 2002; 59:1445-7. http://www.ncbi.nlm.nih.gov/pubmed/12427903?dopt=AbstractPlus
353. Evers S, Rahmann A, Vollmer-Haase J et al. Treatment of headache with botulinum toxin A--a review according to evidence-based medicine criteria. Cephalalgia. 2002; 22:699-710. http://www.ncbi.nlm.nih.gov/pubmed/12421155?dopt=AbstractPlus
354. Sataloff RT, Heman-Ackah YD, Simpson LL et al. Botulinum toxin type B for treatment of spasmodic dysphonia: a case report. J Voice. 2002; 16:422-4. http://www.ncbi.nlm.nih.gov/pubmed/12395995?dopt=AbstractPlus
355. Guntinas-Lichius O. Injection of botulinum toxin type B for the treatment of otolaryngology patients with secondary treatment failure of. Laryngoscope. 2003 Apr; 113:743-5.
357. Arezzo JC, Litwak MS, Gasper CA et al. The spread of paralytic activity in juvenile monkeys: a comparison of and botulinum toxin type B. Paper presented at the World Congress of Neurological Rehabilitation, Venice, Italy: 2002 Apr 2-6.
369. Baumann L, slezinger A, Halem M et al. Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. Dermatol Surg. 2005; 31:263-70. http://www.ncbi.nlm.nih.gov/pubmed/15841624?dopt=AbstractPlus
371. Food and Drug Administration. Early communication about an ongoing safety review: Botox and Botox Cosmetic (botulinum toxin type A) and Myobloc (botulinum toxin type B). Rockville, MD; 2008 Feb 8. From FDA website. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070366.htm
372. Food and Drug Administration. FDA notifies public of adverse reactions linked to Botox use. FDA News. February 8, 2008. From FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116857.htm
373. Food and Drug Administration. Botox, Botox Cosmetic (botulinum toxin type A), Myobloc (botulinum toxin type B). Medwatch safety information alerts 2008. Rockville, MD; February 8, 2008. From FDA website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079766.htm
375. Barbehenn E, Lurie P, Stark S et al. Petition to the FDA requesting regulatory action concerning the possible spread of botulinum toxin (Botox, Myobloc) from the site of injection to other parts of the body. Washington, DC: Public Citizen’s Health Research Group; 2008 Jan.
376. Coté TR, Mohan AK, Polder JA et al. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005; 53:407-15. http://www.ncbi.nlm.nih.gov/pubmed/16112345?dopt=AbstractPlus
379. Tugnoli V, Eleopra R, Quatrale R et al. Botulism-like syndrome after injections for focal hyperhidrosis. Br J Dermatol. 2002; 147:808-9. http://www.ncbi.nlm.nih.gov/pubmed/12366438?dopt=AbstractPlus
381. Food and Drug Administration. Follow-up to the February 8, 2008, early communication about an ongoing safety review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). Rockville, MD; 2009 May 1. From FDA website. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm143819.htm
382. Food and Drug Administration. FDA requires boxed warning for all botulinum toxin products. FDA News. April 30, 2009. From FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm
383. Woodcock J (US Food and Drug Administration). Response to Public Citizen’s petition on botulinum toxin re: docket no: FDA-2008-P-0061. Rockville, MD; 2009 April 30. From FDA website. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/UCM143989.pdf
384. Ipsen Biopharmaceuticals, Inc. Dysport for injection (abobotulinumtoxinA) prescribing information. Basking Ridge, NJ; 2017 Sep.
385. Truong D, Duane DD, Jankovic J et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005; 20:783-91. http://www.ncbi.nlm.nih.gov/pubmed/15736159?dopt=AbstractPlus
386. Ferreira JJ, Costa J, Coelho M et al. The management of cervical dystonia. Expert Opin Pharmacother. 2007; 8:129-40. http://www.ncbi.nlm.nih.gov/pubmed/17257084?dopt=AbstractPlus
387. Costa J, Espirito-Santo CC, Borges AA et al. Botulinum toxin type A therapy for cervical dystonia (review). Cochrane Database of Systematic Reviews. 2005, Issue 1. Article No: CD003633.
388. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers’ product summaries. J Clin Pharm Ther. 2007; 32:387-402. http://www.ncbi.nlm.nih.gov/pubmed/17635341?dopt=AbstractPlus
391. Chapman MA, Barron R, Tanis DC et al. Comparison of botulinum neurotoxin preparations for the treatment of cervical dystonia. Clin Ther. 2007; 29:1325-37. http://www.ncbi.nlm.nih.gov/pubmed/17825685?dopt=AbstractPlus
399. Cheng CM, Chen JS, Patel RP. Unlabeled uses of botulinum toxins: a review, part 1. Am J Health Syst Pharm. 2006; 63:145-52. http://www.ncbi.nlm.nih.gov/pubmed/16390928?dopt=AbstractPlus
402. Solstice Neurosciences. Myobloc (rimabotulinumtoxinB) injection medication guide. South San Francisco, CA; 2009 Jul.
403. Merz Pharmaceuticals. Xeomin (incobotulinumtoxinA) for injection, intramuscular use prescribing information. Raleigh, NC; 2015 Dec.
405. Benecke R, Jost WH, Kanovsky P et al. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005; 64(11):1949-51. http://www.ncbi.nlm.nih.gov/pubmed/15955951?dopt=AbstractPlus
408. . A new botulinum toxin (Xeomin) for cervical dystonia and blepharospasm. Med Lett Drugs Ther. 2010; 52:90-1. http://www.ncbi.nlm.nih.gov/pubmed/21068703?dopt=AbstractPlus
409. Park J, Lee MS, Harrison AR. Profile of Xeomin (incobotulinumtoxinA) for the treatment of blepharospasm. Clin Ophthalmol. 2011; 5:725-32. http://www.ncbi.nlm.nih.gov/pubmed/21691580?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3116796&blobtype=pdf
410. US Food and Drug Administration. Follow-up to the February 8, 2008, early communication about an ongoing safety review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). Rockville, MD; 2009 Apr 1. From FDA website (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm143819.htm)
500. Simpson DM, Hallett M, Ashman EJ et al. Practice guideline update: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adults spasticity, and headache: report of the guideline development subcommittee of the American Academy of Neurology. 2016. Available from American Academy of Neurology website. http://n.neurology.org/content/neurology/suppl/2016/04/18/WNL.0000000000002560.DC1/Manuscript.pdf
More about rimabotulinumtoxinB
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- Drug class: skeletal muscle relaxants
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Other brands: Myobloc