Generic drug: botulinum toxin
Brand name: Myobloc
What is Myobloc (botulinum toxin), and how does it work?
Myobloc (botulinum toxin) is a prescription medicine used in adults that is injected into:
- muscles and used to treat the abnormal head position and neck pain that happens with cervical dystonia (CD).
- glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).
It is not known whether Myobloc is safe or effective in children.
What are the side effects of Myobloc?
Myobloc can cause serious side effects including:
- allergic reactions. Symptoms of an allergic reaction to Myobloc may include:
- Tell your doctor or get medical help right away if you get wheezing, or trouble breathing, or if you get dizzy or faint.
The most common side effects of Myobloc in people with cervical dystonia include:
These are not all the possible side effects of Myobloc. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Solstice Neurosciences at 1-888-461-2255.
Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of Myobloc (botulinum toxin type b) and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include
- generalized muscle weakness,
- blurred vision,
- 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.
What is the dosage for Myobloc?
Instructions For Safe Use
- 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 cannot be compared to or converted into units of any other botulinum toxin products.
- Each single-dose vial should only be used during one session and only for one patient. Discard any remaining solution in the vial.
- Myobloc is ready to use; no reconstitution required.
- Myobloc may be diluted with 0.9% Sodium Chloride Injection. Once diluted, the product must be used within 4 hours as the formulation does not contain a preservative.
Dosing For Cervical Dystonia
- The recommended initial dosage of Myobloc for cervical dystonia patients with a prior history of tolerating botulinum toxin injections is 2,500 Units to 5,000 Units divided among affected muscles.
- Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dosage. Subsequent dosing should be determined by the patient’s individual response.
- Myobloc should be administered by physicians familiar with and experienced in the assessment and management of patients with cervical dystonia.
- The duration of effect in patients responding to Myobloc treatment for cervical dystonia has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units.
Dosing For Chronic Sialorrhea
- The recommended dosage of Myobloc for chronic sialorrhea is 1,500 Units to 3,500 Units, divided among the parotid and submandibular glands (Table 1). Patient response to treatment should be considered when determining subsequent Myobloc dosage.
- The typical duration of effect of each treatment is up to 3 months; however, the effect may vary in individual patients.
- The frequency of Myobloc repeat treatments should be determined by clinical response but should generally be no more frequent than every 12 weeks.
Table 1: Dosing by Gland for Chronic Sialorrhea in Adults
|Parotid||500 Units to 1,500 Units per gland|
|Submandibular||250 Units per gland|
What drugs interact with Myobloc?
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.
- 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.
- Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of Myobloc.
Is Myobloc safe to use while pregnant or breastfeeding?
- There are no adequate data on the developmental risks associated with the use of Myobloc in pregnant women.
- No developmental toxicity was observed in pregnant rats administered Myobloc by intramuscular injection during gestation and lactation, at doses producing maternal toxicity.
- There are no data on the presence of Myobloc in human milk, the effects on the breastfed infant, or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Myobloc and any potential adverse effects on the breastfed infant from Myobloc or from the underlying maternal condition.
Latest Neurology News
Daily Health News
Multimedia: Slideshows, Images & Quizzes
The Stages of Dementia: Alzheimer's Disease and Aging Brains
What are the symptoms of dementia? What causes dementia? Dementia includes many disorders, such as Lewy Body dementia,...
Brain Health: Foods that May Lower Dementia Risk
What foods are associated with Alzheimer's disease and other forms of dementia? Cognitive function is predicated on good...
10 Facts About the Amazing Brain Quiz
Take this brain quiz to learn about your amazing brain! It's the most complex part of your body, and is responsible for many...
Brain and Nervous System: How Conditions Change Your Brain
The brain doesn’t always stay the same. Mental disorders, health issues, and lifestyle habits can alter the way it looks and...
Picture of Brain
The brain is one of the largest and most complex organs in the human body. See a picture of the Brain and learn more about the...
Picture of Brain Layers
That part of the central nervous system that is located within the cranium (skull). See a picture of Brain Layers and learn more...
Dementia and Alzheimer's: 13 Bad Brain Health Habits
Good brain health depends on exercising regularly, eating well, and getting enough sleep. Learn how to develop good health habits...
Brain and Nervous System: What's Causing My Loss of Smell and Taste?
If you plug your nose, nothing tastes the same. Taste and smell issues are common with age and allergies, but they could also be...
Related Disease Conditions
Muscle spasms are involuntary muscle contractions that come on suddenly and are usually quite painful. Dehydration, doing strenuous exercise in a hot environment, prolonged muscle use, and certain diseases of the nervous system may cause muscle spasms. Symptoms and signs of a muscle spasm include an acute onset of pain and a possible bulge seen or felt beneath the skin where the muscle is located. Gently stretching the muscle usually resolves a muscle spasm.
A brain hemorrhage is a type of stroke caused when an artery bursts in the brain, causing localized bleeding in the surrounding tissue. Causes of brain hemorrhage include aneurysm, liver disease, brain tumor, head trauma, high blood pressure, and blood vessel abnormalities. Symptoms include sudden severe headache, nausea, vomiting, loss of balance, tingling, numbness, vision changes, loss of consciousness, and loss of fine motor skills. Treatment depends upon the cause, location, and size of the brain hemorrhage.
Left Brain vs. Right Brain (Characteristics, Differences, and Functions)
Are left brain vs. right brain theories myth or fact? They actually are a little of both! Scientists and researchers have tried to answer this question since the 1800s. In the 1960s, neuroscientist Roger Sperry began to research the right brain vs. left brain theory. In 1981, together with neuroscientist Torsten Wiesel, he won the won the Nobel Prize for his "split-brain" theory. In the split-brain theory, the left and right sides of the brain are connected by the corpus callosum (where place each side of the brain meets and sends signals and communicates with other), and that both the left and right sides of the brain have specific functions. What is an example of right-brain vs. left brain theory? Scientists now know that for most people who are right-handed, the language center of their brain is located in the Broca are of the left side of the brain. Moreover, research suggests that that emotions and creativity are located in the right-side of the brain. The medical field calls this "brain lateralization." While researchers and scientists don't fully understand the functions of the right-and -left sides of the brain or hemispheres, but through ongoing research there are endless possibilities in learning how the brain functions.REFERENCE: Corballis, MC. "Left Brain, Right Brain: Facts and Fantasies." PLoS Biol. 2014 Jan; 12(1): e1001767.
Dystonia disorders cause involuntary movements and prolonged muscle contraction, resulting in twisting body motions, tremor, and abnormal posture. There are many forms of dystonia. Some types of dystonia respond to dopamine, or can be controlled with dedative-type medications, or surgery.
Brain Damage: Symptoms, Causes, Treatment
Brain damage causes destruction or deterioration of brain cells. Traumatic brain injury (TBI) and acquired brain injury (ABI) are two kinds of brain damage. Symptoms may include headaches, confusion, memory problems, nausea, and more. Treatment includes patient stabilization and ensuring that blood and oxygen are flowing to the brain. Adequate blood pressure control is also necessary. In cases of severe brain damage, surgery and rehabilitation may be required.
What Are Shoulder Muscles Called?
Shoulder muscles are required for movements of the upper limb. They also give the shoulders their characteristic shape. The shoulder has multiple muscles. Shoulder muscles include the intrinsic muscles or scapulohumeral group, including the deltoid, teres major and four rotator cuff muscles. The extrinsic shoulder muscles are the trapezius, latissimus dorsi, levator scapula and rhomboids (rhomboid major and rhomboid minor).
Brain and Spinal Cord Tumors in Adults (Symptoms, Signs, Causes, Treatment Options, Life Expectancy)
Brain and spinal tumor are diseases in which cancer (malignant) cells begin to grow in the tissues of the brain. Tumors that start in the brain are called primary brain tumors. Tumors that start in the brain and spread to other organs are called primary brain tumors. Symptoms may include headaches, personality changes, dizziness, and trouble walking. Treatment depends upon the type and grade of tumor.
What Causes Laryngeal Dystonia?
As per research, laryngeal dystonia or spasmodic dysphonia is a neurological disorder usually caused because of an abnormal nervous system or a brain disorder. Spasmodic dysphonia most often affects women, particularly between the ages of 30 and 50 years.
Periodic Limb Movement Disorder
Periodic limb movement disorder (PLMD) is a sleep disorder characterized by rhythmic movements of the limbs during sleep. The movements typically involve the legs, but upper extremity movements may also occur. Movements occur periodically throughout the night and can fluctuate in severity from one night to the next. They tend to cluster in episodes that last anywhere from a few minutes to several hours. These movements are very different from the normal spasms, called hypnic myoclonia, that we often experience initially while trying to fall asleep.
Treatment for Periodic Limb Movement Disorder
Periodic limb movement disorder (PLMD) is a sleep disorder characterized by jerky movements of the legs when a person is asleep. It is a sleep disorder that disrupts sleep and leads to daytime drowsiness.
What Is Neck Muscle Called?
Several muscles are present in the neck to allow the movement of the neck and maintain its shape and structure. One of the major muscles in the neck is the trapezius. The trapezius muscles are the large muscles of the upper back.
Is Dystonia a Form of Parkinson's?
Dystonia can be one of the symptoms of Parkinson’s disease (PD). PD is a long-term neurological movement disorder with various symptoms ranging from slowness of movement (bradykinesia), rigidity of muscles, tremor, loss of balance, memory impairment, personality changes and others.
What Causes Periodic Limb Movement Disorder?
Periodic limb movement disorder or PLMD is a medical condition in which a person’s limbs, legs, and sometimes arms move repetitively and uncontrollably during sleep. Most of the people who suffer from this condition are unaware of these abnormal movements occurring during sleep.
Treatment & Diagnosis
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.