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WHY MYOBLOC?

MYOBLOC is a unique botulinum toxin therapy, approved by the FDA as an effective treatment for CD in adults.

MYOBLOC is the only botulinum toxin type B available.

In multiple clinical studies, MYOBLOC injections have demonstrated an improvement in abnormal head positioning and neck pain associated with CD.1-3

How does MYOBLOC work?

MYOBLOC disables a protein that would typically trigger the release of excessive acetylcholine, which causes muscles to become tense and spasm.

When your healthcare provider injects MYOBLOC into affected muscles, it blocks the release of acetylcholine, allowing them to relax.4

Over time, your healthcare provider will adjust the dose of MYOBLOC to achieve maximum pain relief and muscle spasm control.

WHAT TO EXPECT FROM YOUR MYOBLOC TREATMENT

PAIN RELIEF AS EARLY AS 2 WEEKS6,7

Patients who respond to MYOBLOC may:

  • Notice improvements to their head and neck position5
  • Feel relief for 12-16 weeks1,2
  • Experience pain relief as early as two weeks after injection6,7
  • Maintain their daily activities between doses

MYOBLOC treatment is administered in your healthcare provider’s office

  • Small amounts of MYOBLOC will be injected into your affected muscles

  • You may need adjustments to your dosing to receive maximum benefit

Possible side effects with MYOBLOC

Side effects are generally mild to moderate and temporary, and are more common with higher doses.

The most frequently reported side effects with MYOBLOC were dry mouth, swallowing difficulties, indigestion and injection site pain. Dry mouth and swallowing difficulties were the side effects that most often resulted in discontinuation of treatment.5

Please refer to the full Prescribing Information, including Boxed Warning and Medication Guide for all the possible side effects, and talk with your doctor.

References:

  1. 1. 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;53:1439–1446.
  2. 2. 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;53:1431–1438.
  3. 3. 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;49:701–707.
  4. 4. Montecucco C, Papini E et al. FEBS Letters 346(1994) 92–981.
  5. 5. MYOBLOC® Us Prescribing Information. Solstice Neurosciences, LLC, Louisville, KY:2010.
  6. 6. Data on file; MYO-021-0907. Solstice Neurosciences, LLC; Louisville, KY: 2007.
  7. 7. Data on file; MYO-022-0907. Solstice Neurosciences, LLC; Louisville, KY: 2007.

INDICATION

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.

IMPORTANT SAFETY INFORMATION FOR MYOBLOC

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.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.