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Myobloc rimabotulinumtoxinB 5000 [USP'U]/mL Injection, Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Acetylcholine Release Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
RimabotulinumtoxinB injection is used to relieve the symptoms of cervical dystonia (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions). RimabotulinumtoxinB injection is also used to treat chronic sialorrhea (ongoing drooling or excessive salivation). RimabotulinumtoxinB injection is in a class of medications called neurotoxins. When rimabotulinumtoxinB injection is injected into a muscle, it works by blocking the nerve signals that cause uncontrollable tightening and movement of the muscles. When rimabotulinumtoxinB is inj...
Read the full MedlinePlus article ↗- Myobloc is used for two things in adults. First, it treats cervical dystonia — a condition where your neck muscles contract involuntarily, causing your head to twist or tilt and of...
- For most people, the effects of Myobloc last around 3 to 4 months. For cervical dystonia, studies showed effects lasting roughly 12 to 16 weeks. For excessive drooling, effects typ...
- How long does Myobloc last, and how often will I need injections?
- The most common side effects are dry mouth and difficulty swallowing — these can range from mild to bothersome, and in some cases they're enough that people choose to stop treatmen...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 3EN9H0M2FX
A salt form of an amino acid derivative used as a solubilizer and stabilizer in liquid and injectable formulations. It helps keep active ingredients dissolved and protected from degradation during storage.
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UNII 9XTM81VK2B
Sodium caprylate is a salt derived from caprylic acid, a naturally occurring fatty acid. In medicines, it acts as a preservative and antimicrobial agent to help prevent contamination and extend shelf life.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII U16QOD6C4E
Sodium succinate hexahydrate is a salt form of succinic acid that contains water molecules. It functions as a buffer to help maintain stable pH levels in the medicine and may also act as a filler or tonicity agent.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $629.85 | $629.85 / 1 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0587 | $13.287 / J0587 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Myobloc 5000 [USP'U]/mLthis 10454-0711-10 | Solstice | 1 vial | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 10454-0711-10 You're viewing this | 1 VIAL, SINGLE-USE in 1 CARTON (10454-711-10) / 1 mL in 1 VIAL, SINGLE-USE | 2020-01-01 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 [see Warnings and Precautions (5.1) ].
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 ( 5.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE MYOBLOC is an acetylcholine release inhibitor indicated for: Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults ( 1.1 ) Treatment of chronic sialorrhea in adults ( 1.2 )
1.1Cervical Dystonia MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults.
1.2Chronic Sialorrhea MYOBLOC is indicated for the treatment of chronic sialorrhea in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Cervical Dystonia: for patients with demonstrated tolerance of botulinum toxin injection, recommended total dosage is 2,500 Units to 5,000 Units divided among effected muscles ( 2.2 ) Chronic Sialorrhea: recommended dosage is 1,500 Units to 3,500 Units; 500 Units to 1,500 Units per parotid gland and 250 Units per submandibular gland; no more frequent than every 12 weeks ( 2.3 )
2.1Instructions 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 [see Warnings and Precautions (5.2) , Description (11) ] . 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.
2.2Dosing 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 [see Clinical Studies (14.1) ] . Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dosage [see Adverse Reactions (6.1) ] . 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 [see Clinical Studies (14.1) ] .
2.3Dosing for Chronic Sialorrhea Dosing Information 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 [see Clinical Studies (14.2) ] . 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 Gland Recommended Dosage Parotid 500 Units to 1,500 Units per gland Submandibular 250 Units per gland Administration Information A suitable sterile needle (e.g., 30-gauge, 0.5 inch) should be used for intra-salivary gland administration. Figure 1: Glands for Injection in Chronic Sialorrhea Guidelines for locating salivary glands using anatomical landmarks (Figure 1): 1.
To inject the parotid gland, 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). 2.
To inject the submandibular gland, 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). In clinical studies, MYOBLOC was injected using anatomical landmarks to localize the salivary glands, or using ultrasound guidance for gland location.
Both methods produced similar reduction in the unstimulated salivary flow rate. Figure 1
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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 Injection: 2,500 Units/0.5 mL; 5,000 Units/mL; or 10,000 Units/2 mL (5,000 Units/mL) in a single-dose vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS MYOBLOC is contraindicated in patients with: A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) , Description (11) ] Infection at the proposed injection site(s) MYOBLOC is contraindicated in patients with: Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4 , 5.3 ) Infection at the proposed injection site(s) ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur ( 5.1 , 5.4 ) MYOBLOC potency units cannot be compared to or converted into units of other botulinum toxins ( 5.2 ) Patients with neuromuscular disorders should be monitored closely for swallowing/breathing difficulty ( 5.4 )
5.1Spread 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.
5.2Lack 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 [see Description (11) ] .
5.3Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment [see Adverse Reactions (6.3) ]. 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 [see Contraindications (4) , Adverse Reactions (6.3) ].
5.4Dysphagia 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. 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 di…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions to MYOBLOC are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect [see Warnings and Precautions (5.1) ] Lack of Interchangeability Between Botulinum Toxin Products [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Dysphagia and Breathing Difficulties [see Warnings and Precautions (5.4) ] Human Albumin and Transmission of Viral Diseases [see Warnings and Precautions (5.5) ] The most common adverse reactions (>5% of MYOBLOC-treated patients at any dose and >5% more common than placebo) include: Cervical Dystonia: dry mouth, dysphagia, injection site pain, and headache ( 6.1 ) Chronic Sialorrhea: dry mouth and dysphagia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solstice Neurosciences at 1-888-461-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Cervical Dystonia In the treatment of cervical dystonia, MYOBLOC was studied in both placebo-controlled single treatment studies and open-label repeated treatment studies; most treatment sessions and patients were in the uncontrolled studies.
The data described below reflect exposure to MYOBLOC at varying dosages in 570 subjects, including more than 300 patients with 4 or more treatment sessions. Most treatment sessions were at dosages of 12,500 Units or less. Adverse reactions occurring in at least 5% of patients exposed to MYOBLOC treatment in pooled placebo-controlled clinical trials are shown in Table 2.
The mean age of the population in these studies was 55 years, and approximately 66% were female. Most of the patients studied were Caucasian, and all had moderate to severe symptoms of cervical dystonia. The most common adverse reactions (greater than 5% of MYOBLOC-treated patients at any dosage and at least 5% more common than placebo) in studies of cervical dystonia (Studies 1, 2, and 4) were dry mouth, dysphagia, injection site pain, and headache.
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.
In the cervical dystonia program, only nine patients without a prior history of tolerating injections of type A botulinum toxin have been studied. Adverse reaction rates have not been adequately evaluated in these patients and may be higher than those described in Table 2. Table 2: Adverse Reactions in at Least 5% of MYOBLOC-Treated Patients and Greater than Placebo, Following Single Treatment Session in Controlled Cervical Dystonia Studies (Studies 1, 2, and 4) Adverse Reaction MYOBLOC 2,500 Units (N=31) % MYOBLOC 5,000 Units (N=67) % MYOBLOC 10,000 Units (N=106) % Placebo (N=104) % Dry Mouth 3 12 34 3 Dysphagia 16 10 25 3 Injection Site Pain 16 12 15 9 Pain 6 6 13 10 Headache 10 16 11 8 Dyspepsia 3 0 10 5 Flu Syndrome 6 9 8 4 Arthralgia 0 1 7 5 Back Pain 3 4 7 3 Cough Increased 3 6 7 3 Asthenia 3 0 6 4 Dizziness 3 3 6 2 In the overall clinical trial experience with MYOBLOC in cervical dystonia (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 [see Warnings and Precautions (5.4) ]. Severe dry mouth was reported by 6% of patients. Dysphagia and dry mouth were the most frequent adverse reactions reported as a reason for discontinuation from repeated treatment studies.
These adverse reactio…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with aminoglycosides or other agents interfering with neuromuscular transmission may potentiate effects of MYOBLOC ( 7.1 ) Co-administration or overlapping of botulinum toxin serotypes (within 4 months) may potentiate neuromuscular paralysis ( 7.3 )
7.1Aminoglycosides 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.
7.2Anticholinergic Drugs Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects.
7.3Other 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.
7.4Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary 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. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When MYOBLOC was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 Units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or
1.0Units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. The highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (MRHD) for cervical dystonia (5000 Units) on a body weight (Units/kg) basis. The highest dose tested in rabbit was substantially less than the MRHD for cervical dystonia on a Units/kg basis; maternal toxicity was observed at all but the lowest dose tested.
8.2Lactation Risk Summary 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.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Cervical Dystonia In the controlled studies for MYOBLOC in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see Clinical Studies (14.1) ] . For these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. Efficacy results did not suggest any large differences between these age groups.
Very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of MYOBLOC within this age group can be determined. Chronic Sialorrhea Of the 166 MYOBLOC-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see Clinical Studies (14.2) ] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary 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. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When MYOBLOC was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 Units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or
1.0Units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. The highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (MRHD) for cervical dystonia (5000 Units) on a body weight (Units/kg) basis. The highest dose tested in rabbit was substantially less than the MRHD for cervical dystonia on a Units/kg basis; maternal toxicity was observed at all but the lowest dose tested.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Cervical Dystonia In the controlled studies for MYOBLOC in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see Clinical Studies (14.1) ] . For these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. Efficacy results did not suggest any large differences between these age groups.
Very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of MYOBLOC within this age group can be determined. Chronic Sialorrhea Of the 166 MYOBLOC-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see Clinical Studies (14.2) ] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE 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 Warnings and Precautions (5.1 , 5.4) ] .
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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action MYOBLOC blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerved terminals. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of synaptic Vesicle Associated Membrane Protein (VAMP, also known as synaptobrevin), a presynaptic target protein essential for the release of acetylcholine.
In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.
12.2Pharmacodynamics In responders, the return of increased muscle tone or saliva production typically starts within 3 to 4 months after injection.
12.3Pharmacokinetics Using currently available analytical technology, it is not possible to detect MYOBLOC in the peripheral blood following intramuscular or intraglandular injection at the recommended doses.
🧬 Mechanism of Action ▾
12.1Mechanism of Action MYOBLOC blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerved terminals. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of synaptic Vesicle Associated Membrane Protein (VAMP, also known as synaptobrevin), a presynaptic target protein essential for the release of acetylcholine.
In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied MYOBLOC (rimabotulinumtoxinB) injection is supplied as a clear and colorless to light-yellow solution in single-dose glass vials. MYOBLOC is available in three presentations (Table 10). Table 10: MYOBLOC Presentations Strength per Vial Single-Vial Carton 2,500 Units/0.5 mL NDC 10454-710-10 5,000 Units/mL NDC 10454-711-10 10,000 Units/2 mL NDC 10454-712-10 No U.S. Standard of Potency
16.2Storage and Handling Store under refrigeration at 2°C to 8°C (36°F- 46°F) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. All vials of expired MYOBLOC and equipment used in the administration of MYOBLOC should be carefully discarded according to standard medical waste practices. Do not use after the expiration date stamped on the vial.
📦 Storage and Handling ▾
16.2Storage and Handling Store under refrigeration at 2°C to 8°C (36°F- 46°F) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. All vials of expired MYOBLOC and equipment used in the administration of MYOBLOC should be carefully discarded according to standard medical waste practices. Do not use after the expiration date stamped on the vial.
📋 Description ▾
11 DESCRIPTION RimabotulinumtoxinB is an acetylcholine release inhibitor. RimabotulinumtoxinB is a 700 kDA botulinum toxin type B complex produced from fermentation of the bacterium Clostridium botulinum 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 (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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Swallowing, Speaking, or Breathing Difficulties or Other Unusual Symptoms Advise patients to inform their healthcare provider if they develop any unusual symptoms, including difficulty with swallowing, speaking or breathing, or if any existing symptom worsens [see Box Warning and Warnings and Precautions (5.1 , 5.4) ]. Inform patients of the risk of aspiration.
Ability to Operate Machinery or Vehicles Counsel patients that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.
💬 Medication Guide ▾
MEDICATION GUIDE MYOBLOC ® (My-o-block) (rimabotulinumtoxinB) injection, for intramuscular or intraglandular use This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev: 3/2021 What is the most important information I should know about MYOBLOC?
MYOBLOC may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with MYOBLOC: Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of MYOBLOC if the muscles that you use to breathe and swallow become weak after the injection.
Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with MYOBLOC. People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with MYOBLOC.
Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs.
People who already have swallowing or breathing problems before receiving MYOBLOC have the highest risk of getting these problems. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism.
The symptoms of botulism include: loss of strength and muscle weakness all over the body double vision blurred vision and drooping eyelids hoarseness or change or loss of voice (dysphonia) trouble saying words clearly (dysarthria) loss of bladder control trouble breathing trouble swallowing (dysphagia) These symptoms can happen hours to weeks after you receive an injection of MYOBLOC. These problems could make it unsafe for you to drive a car or do other dangerous activities. See " What should I avoid while receiving MYOBLOC? " What is MYOBLOC?
MYOBLOC 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. Do not receive MYOBLOC if you: are allergic to MYOBLOC or any of the ingredients in MYOBLOC.
See the end of this Medication Guide for a list of ingredients in MYOBLOC. had an allergic reaction to any other botulinum toxin product such as BOTOX® , BOTOX® Cosmetic (onabotulinumtoxinA), DYSPORT® (abobotulinumtoxinA), or XEOMIN® (incobotulinumtoxinA). have a skin infection at the planned injection site. Before receiving MYOBLOC, tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome).
See " What is the most important information I should know about MYOBLOC? " had any side effect from any botulinum toxin product in the past. a breathing problem, such as asthma or emphysema. a history of swallowing problems or inhaling food or fluid into your lungs (aspiration). bleeding problems. drooping eyelids. plans to have surgery. had surgery on your face. Tell your doctor if you: are pregnant or plan to become pregnant. It is not known if MYOBLOC can harm your unborn baby. are breastfeeding or plan to breastfeed.
It is not known if MYOBLOC passes into breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicine after you receive MYOBLOC.
Using MYOBLOC with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received M…