Botulinum Toxin Type B — Active Pharmaceutical Ingredient

Botulinum Toxin Type B is an active pharmaceutical ingredient found in 1 FDA-approved drug product. Forms: VIAL. Routes: various.

This content is for informational purposes only. Always consult a healthcare professional.

Botulinum Toxin Type B (1 brand name, 1 dosage form, 0 routes)

Available dosage forms: VIAL.

Brand Names

  • MYOBLOC

Boxed Warning

The effects of all botulinum toxin products, including DAXXIFY, 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, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms[seeWarnings and Precautions (5.1)].

Contraindications

DAXXIFY is contraindicated in: patients with known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation[seeWarnings and Precautions (5.4)]. the presence of infection at the proposed injection sites.

Adverse Reactions

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect[seeWarnings and Precautions (5.1)] Hypersensitivity Reactions[seeWarnings and Precautions (5.4)] Cardiovascular System Adverse Reactions[seeWarnings and Precautions (5.5)] Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders[seeWarnings and Precautions (5.6)] Dysphagia and Breathing Difficulties[seeWarnings and Precautions (5.7)] Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines[seeWarnings and Precautions (5.9)]

Drug Interactions

No formal drug interaction studies have been conducted with DAXXIFY. However, the potential for certain drugs to potentiate the effects of DAXXIFY warrants consideration given the potential risks involved and should be used with caution. Aminoglycosides or other agents interfering with neuromuscular transmission Anticholinergic drugs Botulinum neurotoxin products Muscle relaxants

Mechanism of Action

DAXXIFY blocks neuromuscular transmission at the neuromuscular junction by inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein necessary for the successful docking and release of acetylcholine vesicles within nerve endings. Recovery of neurotransmission occurs gradually as the neuromuscular junction recovers from SNAP-25 cleavage and as new nerve endings are formed.

Overdosage

Excessive doses of DAXXIFY may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms or excessive muscle weakness or muscle paralysis[seeWarnings and Precautions (5.1),(5.7)]. Symptomatic treatment may be necessary. Symptoms of overdose are not likely 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 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 1-770-488-7100.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.