MY PLAN:
Use a treatment that is right for me.

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DELIVER WITH CONFIDENCE

CHRONIC SIALORRHEA DOSING GUIDELINES1

Recommended dosage:

1,500 to 3,500 Units divided among the parotid and submandibular glands

Gland

Starting Dose

Range (Units)

Undiluted

Volume (mL)

Gland

Starting Dose

Range (Units)

Undiluted

Volume (mL)

Parotid

500-1,500
per gland

0.1-0.3
per gland

Submandibular

250
per gland

0.05
per gland

Gland

Parotid

Submandibular

Starting Dose Range (Units)

500-1,500 per gland

250 per gland

Undiluted Volume (mL)

0.1-0.3 per gland

0.05 per gland

GUIDELINES FOR ANATOMICAL LANDMARKS

  • Parotid gland injection
    • Bisect the distance between the tip of the tragus (Site A) and the angle of the mandible (Site B)
    • Inject 1 finger breadth anterior to this site (Injection Site 1)
  • Submandibular gland injection
    • Bisect the distance between the angle of the mandible (Site B) and the tip of the chin (Site C)
    • Inject 1 finger breadth medial to the inferior surface of the point of bisection (Injection Site 2)

MYOBLOC can be injected with or without ultrasound guidance—both methods produced similar efficacy1

Diagram of a man's head showing injection locations

MYOBLOC can be injected with or without ultrasound guidance—both methods produced similar efficacy1

INSTRUCTIONS FOR SAFE USE

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units 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 8 other botulinum toxin products assessed with any other specific assay method.

DOSING RECOMMENDATION1

  • Subsequent dosing and frequency of dosing should be optimized according to the patient’s individual response
    • Generally, no more frequent than every 12 weeks
    • Individual patient responses may vary

DOSING CONSIDERATIONS1

  • Sialorrhea symptom severity
  • Risk of dysphagia—patients with neuromuscular disorders should be monitored closely for severe swallowing or breathing difficulty

MYOBLOC is ready to use and requires no mixing

Illustration of the 2,500 unit, 5,000 unit, and 10,000 unit vials of MYOBLOC

3 single-dose
vial sizes*

*For single-patient use.

Illustration of a syringe marked every 500 units from 500 to 5,000

*For single-patient use.

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DOWNLOAD

MYOBLOC Dosing Guide

NEEDED FOR INJECTION

  • Suitable, sterile needle for injection (eg, 30-gauge, 0.5 inch)
  • Alcohol swabs

LEARN MORE ABOUT INJECTION TRAINING

in your office or 1-on-1 at a MYOBLOC trainer location.

SIGN UP TO LEARN MORE

Phone

To order MYOBLOC, call 1-888-461-2255, Option 1 For information on reimbursement for MYOBLOC, including billing and coding, visit www.MYOBLOC.com.

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

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 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units 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.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing 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.
    • Cervical Dystonia: 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.
    • Pre-Existing Neuromuscular Disorders: 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.
  • Human Albumin and Transmission of Viral Diseases
    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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission: 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. Anticholinergic Drugs: Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. Other Botulinum Neurotoxin Products: The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Muscle Relaxants: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

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

Reference:

1. MYOBLOC® US Prescribing Information. Solstice Neurosciences, LLC.

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

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 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units 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.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing 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.
    • Cervical Dystonia: 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.
    • Pre-Existing Neuromuscular Disorders: 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.
  • Human Albumin and Transmission of Viral Diseases
    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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission: 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. Anticholinergic Drugs: Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. Other Botulinum Neurotoxin Products: The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Muscle Relaxants: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

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