RELFYDESS

What it is

RELFYDESS is a solution for injection containing relabotulinumtoxinA, purified botulinum toxin type A, free from complex proteins. Each vial contains 150 units in 1.5 mL of solution for injection. RELFYDESS is ready-to-use with a concentration of 10 units per 0.1 mL and no reconstitution is required. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications

RELFYDESS is indicated in adult patients for the temporary improvement in the appearance of: — Moderate to severe glabellar lines at maximum frown — Moderate to severe lateral canthal lines seen at maximum smile

Dosing overview

Re-treatment with RELFYDESS should be administered no more frequently than every twelve weeks. Onset of action is reported within 1 day, with an effect demonstrated for 6 months after injection.

Key safety warnings

Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea. Emergency facilities including appropriate equipment and drugs (such as epinephrine) to treat anaphylaxis should be available. Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely, with symptoms including asthenia, generalised muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. Swallowing and breathing difficulties are serious and can result in death. Very rare cases of death have been reported in patients with dysphagia, pneumopathy, or significant asthenia, so treatment in such patients must be administered under specialist control and only if the benefit outweighs the risk. Patients with pre-existing neuromuscular disorders such as myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis may have increased sensitivity to botulinum toxin and should only receive treatment with caution and under close medical supervision. Dry eye, reduced tear production, reduced blinking, and corneal disorders may occur with the use of botulinum toxins. If symptoms of dry eye persist, consider referring the patient to an ophthalmologist.

Contraindications

Hypersensitivity to any botulinum toxin or to any of the excipients. Presence of infection at the proposed injection sites.

PBS listing

No PBS listing information is available in the provided sources.

Regulatory history

RELFYDESS (relabotulinumtoxinA 100 units/mL solution for injection) was first listed on the ARTG on 2024-07-01. The approval date was 2024-06-07. The TGA approved RELFYDESS for its proposed indications, concluding that the benefits of the medicine in temporarily improving the appearance of moderate to severe glabellar and lateral canthal lines outweigh the identified risks. The TGA's evaluation found that RELFYDESS demonstrated efficacy in temporarily improving the appearance of moderate to severe glabellar and lateral canthal lines, with a safety profile consistent with other botulinum toxin products, with most adverse events being mild, moderate, and transient.