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Myobloc

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Overview

What is Myobloc?

Myobloc (rimabotulinumtoxinB) injection is a sterile liquid formulation of a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium type B (Bean strain) and exists in noncovalent association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin complex. The neurotoxin complex is recovered from the fermentation process and purified through a series of precipitation and chromatography steps.

MYOBLOC is provided as a clear and colorless to light-yellow sterile injectable solution in 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Units of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, and 0.1 M sodium chloride at approximately pH 5.6.

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.



What does Myobloc look like?



What are the available doses of Myobloc?

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What should I talk to my health care provider before I take Myobloc?

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How should I use Myobloc?

MYOBLOC 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.

The recommended initial dose of MYOBLOC for patients with a prior history of tolerating botulinum toxin injections is 2,500 to 5,000 Units divided among affected muscles (see ). Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. Subsequent dosing should be optimized according to the patient's individual response. MYOBLOC should be administered by physicians familiar and experienced in the assessment and management of patients with CD.

The method described for performing the potency assay is specific to Solstice Neurosciences' manufacture of MYOBLOC. Due to differences in the specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for various potency 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 duration of effect in patients responding to MYOBLOC treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units (see ).


What interacts with Myobloc?

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).



What are the warnings of Myobloc?

Lack of Interchangeability between Botulinum Toxin Products

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 (see ).

Spread of Toxin Effect

Postmarketing safety data from MYOBLOC and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 related to spread of toxin effects. 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, and 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, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

Dysphagia and Breathing Difficulties in Treatment of Cervical Dystonia

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.

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 (see , ).

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 (see ).

Human Albumin

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.


What are the precautions of Myobloc?

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 (see ).

INFORMATION FOR PATIENTS

The physician should provide a copy of the FDA-Approved Patient Medication Guide and review the contents with the patient. Patients should be advised to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any existing symptom worsens.

Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.

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.

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.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term carcinogenicity studies in animals have been performed.

PREGNANCY

Animal reproduction studies have not been conducted with MYOBLOC. It is also 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.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MYOBLOC is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE

In the controlled studies summarized in , for MYOBLOC treated patients, 152 (74.5%) were under the age of 65, and 52 (25.5%) were aged 65 or greater. For these age groups, the most frequent reported adverse events occurred at similar rates in both age groups. Efficacy results did not suggest any large differences between these age groups.

Very few patients aged 75 or greater were enrolled, therefore no conclusions regarding the safety and efficacy of MYOBLOC within this age group can be determined.


What are the side effects of Myobloc?

Overview

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.

Only nine subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Adverse event rates have not been adequately evaluated in these patients, and may be higher than those described in Table 3.

Discussion

Adverse reaction rates observed in the clinical trials for a product cannot be directly compared to rates in clinical trials for another product and may not reflect the rates observed in actual clinical practice. However, adverse reaction information from clinical trials does provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

MYOBLOC was studied in both placebo controlled single treatment studies and uncontrolled repeated treatment studies; most treatment sessions and patients were in the uncontrolled studies. The data described below reflect exposure to MYOBLOC at varying doses in 570 subjects, including more than 300 patients with 4 or more treatment sessions. Most treatment sessions were at doses of 12,500 Units or less. There were 57 patients administered a dose of 20,000 or 25,000 Units. All but nine patients had a prior history of receiving type A botulinum toxin and adequately tolerating the treatment to have received repeated doses.

The rates of adverse events and association with MYOBLOC are best assessed in the results from the placebo controlled studies of a single treatment session with active monitoring. The data in Table 3 reflect those adverse events occurring in at least 5% of patients exposed to MYOBLOC treatment in pooled placebo controlled clinical trials. Annual rates of adverse events are higher in the overall data which includes longer duration follow-up of patients with repeated treatment experience. The mean age of the population in these studies was 55-years-old with approximately 66% being female. Most of the patients studied were Caucasian and all had cervical dystonia that was rated as moderate to severe in severity.

In the overall clinical trial experience with MYOBLOC (570 patients, including the uncontrolled studies), most cases of dry mouth or dysphagia were reported as mild or moderate in severity. Severe dysphagia was reported by 3% of patients. Severe dry mouth was reported by 6% of patients. Dysphagia and dry mouth were the most frequent adverse events reported as a reason for discontinuation from repeated treatment studies. These adverse events led to discontinuation from further treatments with MYOBLOC in some patients even when not reported as severe.

The following additional adverse events were reported in 2% or greater of patients participating in any of the clinical studies (COSTART terms, by body system):

Body as a Whole

Musculoskeletal

Cardiovascular System

Respiratory

Nervous System

Digestive System

Skin and Appendages

Urogenital System

Special Senses

Metabolic and Nutritional Disorders

Hemic and Lymphatic System

Table 3—Treatment-Emergent AEs Reported by at Least 5% of MYOBLOC Treated Patients by Dose Group, Following Single Treatment Session in Controlled Studies 09, 301 and 302
Dosing Groups
Adverse Event(COSTART Term)Placebo(N=104)2,500 Units(N=31)5,000 Units(N=67)10,000 Units(N=106)
Dry Mouth3 (3%)1 (3%)8 (12%)36 (34%)
Dysphagia3 (3%)5 (16%)7 (10%)27 (25%)
Neck Pain related to CD 17 (16%)0 (0%) 11 (16%)18 (17%)
Injection Site Pain9 (9%)5 (16%)8 (12%)16 (15%)
Infection16 (15%)4 (13%)13 (19%)16 (15%)
Pain10 (10%)2 (6%)4 (6%)14 (13%)
Headache8 (8%)3 (10%)11(16%)12 (11%)
Dyspepsia5 (5%)1 (3%)0 (0%)11(10%)
Nausea5 (5%)3 (10%)2 (3%)9 (8%)
Flu Syndrome4 (4%)2 (6%)6 (9%)9 (8%)
Torticollis7 (7%)0 (0%)3 (4%)9 (8%)
Pain Related to CD/Torticollis4 (4%)3 (10%)3 (4%)7 (7%)
Arthralgia5 (5%)0 (0%)1 (1%)7 (7%)
Back Pain3 (3%)1 (3%)3 (4%)7 (7%)
Cough Increased3 (3%)1 (3%)4 (6%)7 (7%)
Myasthenia3 (3%)1 (3%)3 (4%)6 (6%)
Asthenia4 (4%)1 (3%)0 (0%)6 (6%)
Dizziness2 (2%)1 (3%)2 (3%)6 (6%)
Accidental Injury4 (4%)0 (0%)3 (4%)5 (5%)
Rhinitis6 (6%)1 (3%)1 (1%)5 (5%)


Postmarketing

The following adverse events have been reported during postmarketing use for approved and unapproved indications: angioedema, urticaria, rash and constipation.

Immunogenicity

A two-stage assay was used to test for immunogenicity and neutralizing activity induced by treatment with MYOBLOC. In order to account for varying lengths of follow-up, life-table analysis methods were used to estimate the rates of development of immune responses and neutralizing activity. During the repeated treatment studies, 446 subjects were followed with periodic ELISA based evaluations for development of antibody responses against MYOBLOC. Only patients who showed a positive ELISA assay were subsequently tested for the presence of neutralizing activity against MYOBLOC in the mouse neutralization assay (MNA). 12% of patients had positive ELISA assays at baseline. Patients began to develop new ELISA responses after a single treatment session with MYOBLOC. By six months after initiating treatment, estimates for ELISA positive rate were 20%, which continued to rise to 36% at one year and 50% positive ELISA status at 18 months. Serum neutralizing activity was primarily not seen in patients until after 6 months. Estimated rates of development were 10% at one year and 18% at 18 months in the overall group of patients, based on analysis of samples from ELISA positive individuals. The effect of conversion to ELISA or MNA positive status on efficacy was not evaluated in these studies, and the clinical significance of development of antibodies has not been determined.

The data reflect the percentage of patients whose test results were considered positive for antibodies to MYOBLOC in both an and assay. The results of these antibody tests are highly dependent on the sensitivity and specificity of the assays. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to MYOBLOC with the incidence of antibodies to other products may be misleading.


What should I look out for while using Myobloc?

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).


What might happen if I take too much Myobloc?

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 (see and ).Symptomatic treatment may be necessary.

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.


How should I store and handle Myobloc?

MYOBLOC is provided as a clear and colorless to light-yellow sterile injectable solution in single-use 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Units of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, 0.1 M sodium chloride at approximately pH 5.6.MYOBLOC is available in the following three presentations.MYOBLOC is provided as a clear and colorless to light-yellow sterile injectable solution in single-use 3.5-mL glass vials. Each single-use vial of formulated MYOBLOC contains 5,000 Units of botulinum toxin type B per milliliter in 0.05% human serum albumin, 0.01 M sodium succinate, 0.1 M sodium chloride at approximately pH 5.6.MYOBLOC is available in the following three presentations.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Using currently available analytical technology, it is not possible to detect MYOBLOC in the peripheral blood following intramuscular injection at the recommended doses.

Non-Clinical Toxicology
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).

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.

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 (see ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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