DAXXIFY

What it is

DAXXIFY (daxibotulinumtoxinA) is a sterile lyophilised powder for injection containing 100 Units per vial. DaxibotulinumtoxinA is a 150 kDa botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A. Each vial contains daxibotulinumtoxinA along with histidine, histidine hydrochloride monohydrate, polysorbate 20, RTP004 peptide, and trehalose dihydrate.

Approved indications

— The temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. — The treatment of cervical dystonia in adult patients.

Dosing overview

DAXXIFY should be administered no more frequently than every three months. Reconstituted DAXXIFY must be administered within 72 hours after reconstitution.

Key safety warnings

Botulinum toxin effects may be observed beyond the site of local injection, with symptoms consistent with the mechanism of action including asthenia, generalised muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties, reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death related to the spread of toxin effects. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur. Patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders should be monitored for increased neuromuscular compromise, as they may be at increased risk of clinically significant effects including generalised muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise. Serious and/or immediate hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea have been reported for botulinum toxin products; if such a reaction occurs, discontinue further injection of DAXXIFY and immediately institute appropriate medical therapy. The potency Units of DAXXIFY are specific to the preparation and assay method utilised and are not interchangeable with other botulinum toxin products; Units of biological activity of DAXXIFY cannot be compared to or converted to Units of any other botulinum toxin products.

Contraindications

DAXXIFY is contraindicated in patients with known hypersensitivity to DAXXIFY or any of the components in the DAXXIFY formulation. DAXXIFY is contraindicated in the presence of infection at the proposed injection sites.

Regulatory history

DAXXIFY was first listed on the ARTG on 17 December 2024 under licence category RE. The TGA approved Daxxify on 3 December 2024 for the temporary improvement of moderate to severe glabellar lines and the treatment of cervical dystonia in adult patients. The approval was based on a comprehensive evaluation of the quality, nonclinical, and clinical data, concluding that the benefits of the medicine outweigh its risks for the approved indications. This medicinal product is subject to additional monitoring in Australia.