Letibotulinumtoxina Dosage

Usual Adult Dose for Glabellar Lines

Inject 4 Units (0.1 mL) IM into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle, for a total dose of 20 Units per treatment session

Comments:

• Potency Units are specific to this drug and are not interchangeable with other botulinum toxin products.
• The cumulative dose of botulinum toxin should be considered if other botulinum toxin products are (or have been) used for other indications.
• Do not administer this drug more frequently than every 3 months.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS: DISTANT SPREAD OF TOXIN EFFECT

• The effects of all botulinum toxin products, including this drug, 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.
• This drug is not approved for the treatment of spasticity or any conditions other than glabellar lines.

CONTRAINDICATIONS:

• Known hypersensitivity to any botulinum toxin product or any components in the product formulation
• Infection at the proposed injection sites

Safety and effectiveness have not been established in pediatric patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intramuscular injection only
• Safe and effective use depends upon selection of the correct dose and proper reconstitution and administration techniques.
• See manufacturer product information for illustrated administration instructions.
• Careful examination of upper eyelid muscular function is recommended before administration.

To Reduce the Complication of Eyelid Ptosis:

• Avoid injection near the levator palpebrae superioris, especially in patients with larger brow depressor complexes.
• Ensure the injected volume/dose is accurate and administered in a steady, controlled manner.
• Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
• Avoid injecting closer than 1 cm above the central eyebrow.

Storage requirements:

• This product is supplied as single-dose, freeze-dried vials; protect from light.
• Unopened vials: Store refrigerated at 2C to 8C (36F to 46F) in the original carton.
• Reconstituted vials (unused): Store refrigerated at 2C to 8C (36F to 46F) in the original carton and use within 24 hours.
• Do not freeze.

Reconstitution/preparation techniques:

• Consult the manufacturer product information before product reconstitution.
• After reconstitution, administer the dose within 24 hours.
• The reconstituted vial should be used for 1 injection session and 1 patient only; discard any remainder.

General:

• Botulinum toxin poisoning: Contact your local or state health department to process a request for antitoxin through the CDC (1-770-488-7100).

Monitoring:

• General: For the distant spread of botulinum toxin effects (after treatment)
• Nervous system: For neuromuscular compromise in patients with neuromuscular disorders (after treatment)

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide).
• Inform your health care provider if you develop any unusual symptoms or if existing symptoms worsen.
• Seek immediate medical attention if you have trouble swallowing, speaking, or breathing.
• This drug may cause eye dryness; contact your health care provider if your symptoms are persistent or bothersome.
• Avoid driving or engaging in potentially hazardous activities if loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids should occur.

Frequently asked questions

• What is botulinum toxin used to treat?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer