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DOSING & ADMINISTRATION

Easy dosing and administration

MYOBLOC for chronic sialorrhea dosing chart
MYOBLOC can be injected with or without ultrasound guidance
Both methods produced similar efficacy1

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 one 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 one finger breadth medial to the inferior surface of the point of bisection (Injection Site 2)
Anatomical landmarks for injection

The recommended dosage of MYOBLOC for chronic sialorrhea is 1,500 to 3,500 Units divided among the parotid and submandibular glands1

Dose no more frequently than every 3 months

Subsequent dosing and frequency of dosing should be optimized according to the patient’s individual response

Generally no more frequent than every 3 months

DOSING CONSIDERATIONS1


  • Sialorrhea symptom severity
  • Risk of dysphagia—patients with neuromuscular disorders should be monitored closely for severe swallowing/breathing difficulty
Download the guide to learn more about MYOBLOC dosing
Use this convenient form to guide and record your patient’s MYOBLOC treatment

Needed for injection

  • Suitable, sterile needle with syringe for withdrawal
  • Suitable, sterile needle for injection (e.g., 30-gauge, 0.5 inch)
  • Alcohol swabs

Learn more about injection training

In your office or at a MYOBLOC Injector Trainer location One on One

Sign up to learn more about MYOBLOC injection training
MYOBLOC injection training
Dosing syringe showing MYOBLOC Units

MYOBLOC is ready to use and requires no mixing

MYOBLOC vial sizes
Solution contains 5,000 Units of botulinum toxin type B per mL
MYOBLOC solution contians 5,000 units of botulinum toxin type B per mL

SAFETY & TOLERABILITY


Studies 1 and 2: Adverse Reactions in At Least 5% of MYOBLOC-Treated Patients and Greater than Placebo in Pooled Chronic Sialorrhea Studies1

MYOBLOC for chronic sialorrhea safety
  • The most common adverse reaction was dry mouth
    • The majority of dry mouth adverse reactions were mild to moderate
  • The frequency of these common adverse reactions did not appear to be dose-dependent except in the case of dry mouth

Only one patient discontinued due to dry mouth

Only one patient discontinued treatment
Ordering and support link



REFERENCE:

  1. 1. MYOBLOC® US Prescribing Information. Solstice Neurosciences, LLC; Louisville, KY: 2019.

INDICATIONS

MYOBLOC® (rimabotulinumtoxinB) 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 FOR MYOBLOC

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)

WARNINGS 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
Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

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. Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. 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. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

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.