Myobloc 10000 [USP'U]/2mL
rimabotulinumtoxinB · INJECTION, SOLUTION · Solstice Neurosciences, LLC
Myobloc is a injection, solution containing rimabotulinumtoxinb at 10000 [USP'U]/2mL, taken intramuscular. Manufactured by Solstice Neurosciences, LLC.
Key Facts
- Brand Name
- Myobloc
- Generic Name
- rimabotulinumtoxinB
- NDC Code (Product)
10454-712- Manufacturer
- Solstice Neurosciences, LLC
- Strength
- 10000 [USP'U]/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA103846
- Drug Class
- Acetylcholine Release Inhibitor [EPC]
- Marketing Start
- 12/08/2000
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 ) 1.1 Cervical 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. 1.2 Chronic Sialorrhea MYOBLOC is indicated for the treatment of chronic sialorrhea in adults.
Dosage & 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 ) 2.1 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 [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. 2.2 Dosing for Cervical Dystonia The recommended initial dosage of MYOBLOC for cervical dystoni…
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 )
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 ) 7.1 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. 7.2 Anticholinergic Drugs Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. 7.3 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. 7.4 Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after…
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. 6.1 Clinical 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 rat…
Frequently Asked Questions
What is Myobloc used for?
Myobloc contains rimabotulinumtoxinB. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Myobloc a controlled substance?
Myobloc is not classified as a controlled substance by the DEA.
What is the generic name for Myobloc?
The generic name for Myobloc is rimabotulinumtoxinB. There are no other listed brand versions of rimabotulinumtoxinB.
What is the NDC code for Myobloc 10000 [USP'U]/2mL?
The NDC (National Drug Code) for Myobloc 10000 [USP'U]/2mL is 10454-712, listed by Solstice Neurosciences, LLC.
Other Myobloc Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)