NUCEIVA

What it is

NUCEIVA is prabotulinumtoxinA 100 Units powder for solution for injection . NUCEIVA is a white to yellowish vacuum dried powder in a colourless and transparent vial, which when reconstituted in sodium chloride injection is a clear and transparent solution . Botulinum toxin type A blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the docking and release of acetylcholine from vesicles situated within the nerve terminals . Clinical signs usually manifest within 2–3 days, and recovery after intramuscular injection takes place normally within 12 weeks .

Approved indications —

Temporary improvement in the appearance of moderate to severe glabellar lines in adult patients

Dosing overview

NUCEIVA should be reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL . A dose of 0.1 mL (4 Units) is injected intramuscularly into each of five sites: the inferomedial and superior middle of each corrugator, and one in the mid-line of the procerus muscle for a total dose of 20 Units . NUCEIVA should be administered within 24 hours after reconstitution . Retreatment with NUCEIVA should be administered no more frequently than every three months .

Key safety warnings

Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection, with symptoms including asthenia, generalised muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision, and breathing difficulties, which have been reported hours to weeks after injection . Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects . Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders were excluded from clinical studies, and patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalised muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from typical doses of NUCEIVA . Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea . Antibodies to botulinum toxin type A may develop during treatment, and some of these antibodies may be neutralising which may lead to treatment failure . Treatment with botulinum toxin products, including NUCEIVA, can result in swallowing or breathing difficulties, and patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications . Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines, and reduced tear production, reduced blinking, and corneal disorders may occur with use of botulinum toxins, including NUCEIVA . NUCEIVA is subject to additional monitoring in Australia, which will allow quick identification of new safety information .

Contraindications

NUCEIVA is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components listed in section 6.1 List of excipients . NUCEIVA is contraindicated in the presence of infection or inflammation at the proposed injection sites . NUCEIVA is contraindicated in patients with generalised disorders of muscle activity (e.g., myasthenia gravis, Lambert-Eaton syndrome, amylotrophic lateral sclerosis) .

Regulatory history

NUCEIVA was first listed on the ARTG on 25 January 2023 . The TGA approved NUCEIVA for registration on 13 January 2023, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients . During development, NUCEIVA was compared to Botox in clinical and nonclinical studies, which found similar dose response and safety profiles between the two products .