Drug Detail:Prabotulinumtoxina (Prabotulinumtoxina [ pra-bot-ue-lye-num-tox-in-ay ])
Drug Class: Skeletal muscle relaxants
Usual Adult Dose for Glabellar Lines
20 Units per treatment session divided into 5 equal IM injections of 4 Units each:
- Two injections in each corrugator muscle (one into inferomedial and one into superior middle)
- One injection in the procerus muscle
Retreatment should be administered no more frequently than every three months
Comments:
- The cumulative dose of botulinum toxin should be considered if other botulinum toxin products are or have been used for other indications.
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
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
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:
- Hypersensitivity to any botulinum toxin product or any product excipients
- 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, proper reconstitution and administration technique
- The healthcare provider administering this drug should be familiar with the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures
To Reduce the Complication of Eyelid Ptosis:
- Avoid injection near the levator palpebrae superioris, especially in patients with larger brow depressor complexes
- Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge
- Ensure the injected volume/dose is accurate and where feasible kept to a minimum
- Avoid injecting closer than 1 cm above the central eyebrow
Reconstitution/preparation techniques:
- See package labeling for reconstitution and administration instructions including an illustration of dosing sites
- Dose should be administered within 24 hours after reconstitution
Storage requirements:
- Unopened vials: Store refrigerated 36F to 46F (2C to 8C); store in original carton to protect from light
- Once reconstituted, store refrigerated and use within 24 hours; protect from light; do not freeze reconstituted solution, discard unused portion
- Vials should be used for 1 injection session and 1 patient only
General:
- Potency Units are specific to preparation and assay method utilized; botulinum toxins are not interchangeable.
Monitoring:
- Monitor for distant spread of toxin
Patient advice:
- Patients should read the FDA-approved patient labeling (Medication Guide).
- Patients and caregivers should be instructed to inform their healthcare provider if they develop any unusual symptoms or if any existing symptoms worsen; they should be instructed to seek immediate medical attention if they have trouble swallowing, speaking, or breathing.
- Patients should advised that they may experience dry eyes; if their symptoms are persistent or bothersome, they should contact their healthcare provider.
- Patients experiencing loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids should avoid engaging in potentially hazardous activities.
Frequently asked questions
- What is botulinum toxin used to treat?
