Brand Name

Myobloc

Generic Name
rimabotulinumtoxinB
View Brand Information
FDA approval date: December 08, 2000
Classification: Acetylcholine Release Inhibitor
Form: Injection

What is Myobloc (rimabotulinumtoxinB)?

Muscle stiffness, involuntary spasms, and pain can make daily tasks such as writing, eating, or even holding your head upright incredibly difficult. For people living with certain neurological or movement disorders, these symptoms can significantly affect independence and quality of life. Myobloc (rimabotulinumtoxinB) is a medication designed to help ease those burdens by providing targeted, long-lasting relief from muscle overactivity. 

Myobloc is an injectable neurotoxin belonging to a class of drugs known as botulinum toxin type B products. It is used to treat cervical dystonia (spasmodic torticollis), a condition that causes abnormal muscle contractions and painful twisting of the neck and shoulders. By temporarily relaxing overactive muscles, Myobloc helps restore more natural movement and reduce pain. 

Approved by the U.S. Food and Drug Administration (FDA), Myobloc offers an alternative to botulinum toxin type A formulations, such as Botox or Dysport, especially for patients who may no longer respond to those treatments. It plays an important role as a specialized therapy for managing chronic muscle spasticity and movement disorders. 

What does Myobloc do? 

Myobloc is primarily prescribed to reduce the muscle contractions and abnormal postures caused by cervical dystonia. This condition can make it difficult to turn or hold the head upright, often leading to severe neck pain and social or emotional distress. 

By relaxing the targeted muscles, Myobloc allows patients to experience improved mobility, reduced pain, and greater comfort in daily activities. Many people report that tasks such as driving, reading, or maintaining eye contact become easier after treatment. 

Clinical studies have shown that Myobloc provides significant symptom relief within days of injection, with effects lasting up to 12 to 16 weeks (FDA, 2023). Repeated treatments at appropriate intervals help maintain these benefits over time. 

In addition to cervical dystonia, Myobloc has also been used off-label to treat conditions like excessive drooling (sialorrhea) associated with Parkinson’s disease or neurological disorders. In this use, the medication helps reduce saliva production by affecting specific glands in the mouth. 

How does Myobloc work? 

Myobloc works by blocking nerve signals that contract muscles. It contains rimabotulinumtoxinB, a purified form of botulinum toxin type B, derived from the bacterium Clostridium botulinum

When injected directly into the overactive muscles, Myobloc prevents the release of acetylcholine, a neurotransmitter responsible for sending signals from nerves to muscles. Without acetylcholine, the targeted muscles temporarily relax, easing stiffness and spasms. 

This mechanism allows for precise, localized control, only the treated muscles are affected, leaving surrounding muscles to function normally. Clinically, this helps patients regain smoother, more controlled movement without systemic effects. 

Over time, the body gradually restores nerve communication, which is why the effects of Myobloc wear off and require repeat injections every few months. This reversible nature allows physicians to adjust doses and injection sites based on individual response and symptom patterns. 

Myobloc side effects 

While Myobloc is generally safe when administered by a trained healthcare professional, it can cause side effects. Most are mild to moderate and improve as the body adjusts to treatment. 

Common side effects may include: 

  • Dry mouth 
     
  • Difficulty swallowing (dysphagia) 
     
  • Sore throat or mild neck pain 
     
  • Headache 
     
  • Flu-like symptoms such as tiredness or muscle aches 

Less common but serious side effects can include: 

  • Severe swallowing or breathing difficulties 
     
  • Allergic reactions (rash, itching, swelling, or shortness of breath) 
     
  • Weakness spreading beyond the injection site 

Myobloc, a neurotoxin, carries a small but serious risk of spreading and causing muscle weakness, leading to difficulty breathing, talking, or swallowing. Seek immediate medical attention if these symptoms occur.  

Patients with neuromuscular disorders or pre-existing swallowing/breathing issues should use Myobloc under close medical supervision.  

Despite these risks, most tolerate it well, and its benefits often outweigh temporary side effects. Regular follow-ups ensure safety and effectiveness. 

Myobloc dosage 

Myobloc is an intramuscular injection given by a healthcare professional in a clinical setting. Dosage and injection patterns are individualized based on affected muscles, symptom severity, and prior treatment. Improvement is seen within days, peaking at 2-3 weeks. Effects last, and repeat injections are typically scheduled every 3-4 months. 

Doctors monitor treatment and adjust injections for optimal muscle relaxation and functional movement. Patients should report any swallowing or breathing changes promptly. Older or at-risk individuals may need cautious dosing and closer observation. 

Does Myobloc have a generic version? 

As of 2025, Myobloc (rimabotulinumtoxinB) does not have a generic version approved in the United States. It is currently available only as the brand-name product, manufactured by Supernus Pharmaceuticals, Inc. However, international versions may exist in other markets. 

Myobloc, a biologic, won’t have a generic but may have a biosimilar, a highly similar version. Other botulinum toxin products like Botox, Dysport, or Xeomin (all type A) exist, but Myobloc is type B. Switching types requires medical supervision due to non-interchangeable dosing and effects. 

Conclusion 

Myobloc offers a powerful and proven option for individuals struggling with painful, involuntary muscle contractions caused by cervical dystonia and related conditions. By targeting overactive muscles at their source, it helps restore mobility, comfort, and confidence, often improving quality of life in meaningful ways. 

Myobloc is a safe, effective, and long-acting therapy for chronic muscle spasticity. Side effects are usually temporary and manageable. With regular follow-ups and expert administration, Myobloc can improve movement and quality of life. Always follow your healthcare provider’s guidance. 

References 

  1. U.S. Food and Drug Administration (FDA). (2023). Myobloc (rimabotulinumtoxinB) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). RimabotulinumtoxinB (injection route) drug overview. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). RimabotulinumtoxinB injection: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Botulinum toxins in movement disorders: Mechanisms and clinical applications. Retrieved from https://www.nih.gov 
     

Brand Information

Myobloc (rimabotulinumtoxinB)
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
1DOSAGE FORMS AND STRENGTHS
MYOBLOC is a clear and colorless to light-yellow solution available as:
  • Injection: 2,500 Units/0.5 mL in a single-dose vial
  • Injection: 5,000 Units/mL in a single-dose vial
  • Injection: 10,000 Units/2 mL (5,000 Units/mL) in a single-dose vial
2CONTRAINDICATIONS
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)
3ADVERSE REACTIONS
The following clinically significant adverse reactions to MYOBLOC are discussed in greater detail in other sections of the labeling:
  • Spread of Toxin Effect
  • Lack of Interchangeability Between Botulinum Toxin Products
  • Hypersensitivity Reactions
  • Dysphagia and Breathing Difficulties
  • Human Albumin and Transmission of Viral Diseases
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
3.2Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other rimabotulinumtoxinB products may be misleading.
3.3Postmarketing Experience
The following adverse reactions have been reported during postmarketing use of MYOBLOC: angioedema, urticaria, rash, constipation, dry eye, and accommodation disorder. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4OVERDOSAGE
Excessive doses of MYOBLOC may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis
Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or muscle paralysis.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at http://cdc.gov/ncidod/srp/drugs/drug-service.html.
5DESCRIPTION
RimabotulinumtoxinB is an acetylcholine release inhibitor. RimabotulinumtoxinB is a 700 kDA botulinum toxin type B complex produced from fermentation of the bacterium
MYOBLOC (rimabotulinumtoxinB) injection is a sterile, preservative-free, clear and colorless to light-yellow solution in a single-dose vial for intramuscular or intraglandular use. Each vial contains 2,500 Units/0.5 mL; 5,000 units/mL; or 10,000 Units/2 mL of rimabotulinumtoxinB at a concentration of 5,000 Units/mL at approximately pH 5.6.
Each 2,500 Units/0.5 mL vial of MYOBLOC contains 2,500 Units rimabotulinumtoxinB, 0.235 mg albumin human, 2.9 mg sodium chloride and 1.35 mg sodium succinate.
Each 5,000 Units/mL vial of MYOBLOC contains 5,000 Units rimabotulinumtoxinB, 0.47 mg albumin human, 5.8 mg sodium chloride and 2.7 mg sodium succinate.
Each 10,000 Units/2 mL vial of MYOBLOC contains 10,000 Units rimabotulinumtoxinB, 0.94 mg albumin human, 11.6 mg sodium chloride and 5.4 mg sodium succinate.
One unit of MYOBLOC corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specific to Solstice Neurosciences' manufacture of MYOBLOC. Due to differences in specific details such as the vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, Units of biological activity of MYOBLOC cannot be compared to or converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species sensitivities to different botulinum neurotoxin serotypes preclude extrapolation of animal dose-activity relationships to human dose estimates. The specific activity of MYOBLOC ranges between 70 to 130 Units/ng.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
7PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
NDC 10454-710-10
Rx Only
rimabotulinumtoxinB
FOR INTRAMUSCULAR AND
2,500 Units/0.5 mL
WARNING: Dosing units of botulinum toxins are
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE
US WorldMeds
PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
8PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
NDC 10454-711-10
Rx Only
rimabotulinumtoxinB
FOR INTRAMUSCULAR AND
5,000 Units/1 mL
WARNING: Dosing units of botulinum toxins are
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE
US WorldMeds
PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
9PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
NDC 10454-712-10
Rx Only
rimabotulinumtoxinB
FOR INTRAMUSCULAR AND
10,000 Units/2 mL
WARNING: Dosing units of botulinum toxins are
Single-dose Vial
Discard Unused Portion
Dispense the accompanying Medication Guide to each patient.
SOLSTICE
US WorldMeds
PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton