Unique mechanism of action1,2
Neurospecific binding of the toxin on the presynaptic nerve surface
of the toxin by receptor-mediated endocytosis
Subsequent translocation of the toxin light chain into the cystol
Modification of an intracellular target substrate that governs the docking and fusion of ACh‑containing vesicle
*VAMP is a component of the protein complex responsible for docking and fusion of the synaptic vesicle to the presynaptic membrane, a necessary step to neurotransmitter release.
Relieves symptom severity and neck pain from cervical dystonia (CD) in adults1–4
Clinical Data: MYOBLOC relieves symptom severity and neck pain from cervical dystonia (CD)1–4
Results support that MYOBLOC can be an effective first-line treatment for patients with CD who list pain as a predominant complaint8
* P < 0.05 vs placebo
† TWSTRS-Total and TWSTRS-Pain scores in Study #402 were numerically greater with MYOBLOC than Botox, but these differences were not statistically significant7
Study #9 - A randomized, double-blind, placebo-controlled safety and efficacy study of MYOBLOC. A total of 122 patients were enrolled and randomized between doses of placebo, 2,500 Units, 5,000 Units, and 10,000 Units.
Study #301 - A randomized, double-blind, multicenter, placebo-controlled, 16-week trial to determine the safety and efficacy of MYOBLOC in patients with cervical dystonia who were responsive to Botox. A total of 109 patients were randomized to receive injections of MYOBLOC 5,000 Units, MYOBLOC 10,000 Units, or placebo.
Study #302 - A randomized, double-blind, multicenter, placebo-controlled, 16-week trial to determine the safety and efficacy of MYOBLOC in patients with cervical dystonia who were resistant to Botox. A total of 77 patients were randomized to receive injections of MYOBLOC 10,000 Units or placebo. The most frequent, clinically relevant adverse events were dry mouth and dysphagia.
Study #402 - A randomized, double-blind, multicenter, noninferiority trial comparing the efficacy, safety, and duration of effect of Botox with MYOBLOC in patients with cervical dystonia. Subjects, who were new to treatment with botulinum toxins, were randomized to receive injections of Botox 150 Units or MYOBLOC 10,000 Units.
Botox® marks owned by Allergan, Inc.
Clinical Data: MYOBLOC provides consistent pain relief with repeated administration7
The mean TWSTRS-Pain scores at week 4 appear to be maintained across treatment sessions compared with baseline scores7
Four-hundred twenty-seven subjects with a mean age of 55.1 years enrolled in the study, which represented the largest prospective report of long-term open-label MYOBLOC treatment in CD9
On the first injection, subjects were administered 5,000 Units (toxin-naïve subjects who previously received placebo), 10,000 Units, or the highest MYOBLOC dose previously received. Re-injection occurred when the patient returned to approximate CD baseline status at least 3 months out from the last injection9
TWSTRS scales were performed at baseline and 4 weeks post-treatment9
TWSTRS: A validated scale for assessing cervical dystonia10–12
TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients.13 It is frequently used in clinical trials for cervical dystonia, including trials for MYOBLOC.
It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0–87 (best to worst).
Effect of cervical dystonia on ability to perform activities, including:
Abbreviation: TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale.
Visual Analog Scale (VAS)14
The VAS is a subjective scale for assessing a variable such as patient-reported pain. It is a 100-mm line, usually horizontal, anchored on both ends with descriptors (see figure). A patient marks the point that he/she feels represents the variable being measured (e.g., pain). The score, from 0 to 100, is determined by measuring from the end of the line to the patient’s mark.
MYOBLOC® (rimabotulinumtoxinB) Injection is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of MYOBLOC and 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, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions].
MYOBLOC is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
MYOBLOC is contraindicated for use in patients with infection at the proposed injection site(s).
The potency Units of MYOBLOC are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved.
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Only 9 subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Treatment of botulinum toxin naïve patients should be initiated at lower doses of MYOBLOC.
Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
The effect of administering different botulinum neurotoxin serotypes at the same time or within less than 4 months of each other is unknown. However, neuromuscular paralysis may be potentiated by co-administration or overlapping administration of different botulinum toxin serotypes.
It is not known whether MYOBLOC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC should be given to a pregnant woman only if clearly needed.
The most commonly reported adverse events associated with MYOBLOC treatment in all studies were dry mouth, dysphagia, dyspepsia, and injection site pain. Dry mouth and dysphagia were the adverse reactions most frequently resulting in discontinuation of treatment. There was an increased incidence of dysphagia with increased dose in the sternocleidomastoid muscle. The incidence of dry mouth showed some dose-related increase with doses injected into the splenius capitis, trapezius and sternocleidomastoid muscles.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-461-2255, Option 2. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.