Class: Other Miscellaneous Therapeutic Agents
VA Class: MS900
Chemical Name: Botulin B
Molecular Formula: C6869H10545N1715O2036S34
- 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
Management 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
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
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 .
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 2017, Selected Revisions April 27, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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Other brands: Myobloc