Drug Detail:Daxibotulinumtoxina (Daxibotulinumtoxina (daxxify) [ dax-i-bot-ue-lye-num-tox-in-ay ])
Drug Class: Skeletal muscle relaxants
Usual Adult Dose for Glabellar Lines
Inject 8 units (0.1 mL) intramuscularly into each of 5 sites (two injections in each corrugator muscle and one injection in the procerus muscle) for a total dose of 40 units.
Comments:
- Refer to manufacturer information for specific administration instructions including dilution, needle orientation, and injection site diagrams.
- The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.
Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Dose Adjustments
Potency units of this drug is specific to the preparation and assay method utilized; they are not interchangeable with other botulinum toxin preparations.
Precautions
US BOXED WARNING:
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 any condition other than glabellar lines.
CONTRAINDICATIONS:
- Hypersensitivity to any botulinum toxin preparation or to any product ingredients
- Infection at the proposed injection site(s)
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Indication specific dosage and administration recommendations should be followed.
- The safe and effective use depends upon proper storage, selection of the correct dose, and proper reconstitution and administration techniques; see manufacturer product labeling for indication specific administration recommendations including preparation and dilution instructions.
- This drug is intended to be administered intramuscularly only.
- Administer this drug within 72 hours after reconstitution.
- After reconstitution, only use each vial for only one injection session and for only one patient.
Storage requirements:
- Unopened vials: Store at room temperature 20C to 25C (68F to 77F) or refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light.
- Reconstituted vials: Store refrigerated between 2C to 8C (36F to 46F) and protected from light for up to 72 hours.
Reconstitution/preparation techniques:
- See manufacturer product labeling of this drug.
Monitoring:
- Monitor for distant spread of toxin.
Patient advice:
- Patients are advised to read the US FDA-approved patient labeling (Medication Guide).
- Patients and caregivers should be instructed to inform their health care 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 experiencing loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids should avoid engaging in potentially hazardous activities including driving.
- Patients should inform their physician if symptoms of eye dryness develop.
Frequently asked questions
- What is the new FDA-approved alternative to Botox?
