XEOMIN

What it is

Xeomin is incobotulinumtoxinA, purified botulinum toxin type A, free from complexing proteins. In contrast to conventional preparations containing the botulinum toxin A complex, Xeomin contains pure toxin since it is free from complexing proteins and thus has a low foreign protein content. Each vial contains 50 or 100 units of incobotulinumtoxinA. This medicine is subject to additional monitoring in Australia.

Approved indications Xeomin is indicated in adults for the treatment of:

— Cervical dystonia (spasmodic torticollis) — Blepharospasm — Spasticity of the upper limb — Unilateral spasticity of the lower limb affecting the ankle joint — Chronic sialorrhea due to neurological disorders — Upper facial lines (glabellar frown lines, lateral periorbital lines (crow's feet), and horizontal forehead lines)

Xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of: — Chronic sialorrhea due to neurological/neurodevelopmental disorders — Spasticity of the lower and/or upper limbs

Dosing overview

The optimum dosage, frequency and number of injection sites in the treated muscle(s) should be individualised for each patient and determined by the physician, including the patient's response to previous treatment and adverse event history with botulinum toxins. For cervical dystonia in adults, normally no more than 200 units should be injected for the first course of therapy, with adjustments made in subsequent courses depending on response. A total dose of 300 units at any one sitting should not be exceeded. No more than 50 U should be given at any one injection site. For blepharospasm in adults, the initial dose is 1.25 to 2.5 U per injection site, with an initial dose not exceeding 25 U per eye. Normally, the total dose should not exceed 50 U per eye per treatment session. For spasticity of the upper limb in adults, standard treatment doses per muscle vary by clinical pattern, ranging from 5 to 200 units depending on the muscle involved and number of injection sites. The maximum total dose for the treatment of upper limb spasticity in adults should not exceed 500 units per treatment session, and no more than 250 units should be administered to the shoulder muscles. For unilateral spasticity of the lower limb affecting the ankle joint, the maximum total dose should not exceed 400 units per treatment session. For chronic sialorrhea in adults, the dose is divided with a ratio of 3:2 between the parotid and submandibular glands (30 units per parotid side, 20 units per submandibular side). The recommended and total maximum dose per treatment session is 100 units. For glabellar frown lines, the standard dose is 20 units (4 units into each of 5 injection sites). The dose may be increased by the physician to up to 30 units if required by the individual needs of patients.

Key safety warnings

The recommended dosages and frequencies of administration for Xeomin should not be exceeded. Extensive or inappropriate doses outside the recommended dosage range may lead to an increased risk of adverse effects. Undesirable effects may occur from misplaced injections that temporarily paralyse nearby muscle groups. There have been reports of undesirable effects that might be related to the spread of the toxin to sites distant from the injection site, with symptoms consistent with the mechanism of action of botulinum toxin, including asthenia, generalised muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 related to the spread of toxin effects. Patients should be informed that injections of Xeomin for the management of cervical dystonia may cause mild to severe dysphagia with the risk of aspiration and dyspnoea. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Patients with neuromuscular disorders may be at increased risk of excessive muscle weakness. The botulinum toxin type A product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk. As with all therapeutic proteins, there is a potential for immunogenicity. Formation of neutralising antibodies to the 150kDa toxin may reduce the effectiveness of Xeomin treatment by inactivating the biological activity of the toxin. Higher foreign protein load, higher doses and shorter treatment intervals may increase the risk of antibody formation, which can result in treatment failure even if the product is being used to treat other indications.

Contraindications

Xeomin is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is contraindicated in generalised disorders of muscle activity such as myasthenia gravis and Lambert-Eaton Syndrome. Xeomin is contraindicated in infection or inflammation at the proposed injection sites.

PBS listing

Xeomin 50 units and 100 units are listed on the PBS for spasticity of the upper limb following a stroke and other acute events, with Authority Required (Streamlined) restriction. Xeomin is recommended by PBAC for treatment of chronic sialorrhea due to neurological disorders. Xeomin is recommended by PBAC for moderate to severe spasticity of the upper limb and dynamic equinus foot deformity due to spasticity in patients with cerebral palsy aged 2 years and older.

Regulatory history

The TGA approved Xeomin for registration on 17 March 2014, with initial registration on the Australian Register of Therapeutic Goods on 21 March 2014. Initial approved indications were cervical dystonia in adults, blepharospasm in adults, post-stroke spasticity of the upper limb in adults, and glabellar frown lines in adults. In November 2019, PBAC recommended extension of the Section 100 (Botulinum Toxin Program) Authority Required (Streamlined) listing to include spasticity following acute events other than stroke, with the product found to be non-inferior to Dysport and cost neutral to PBS. In November 2024, a PBAC application for chronic sialorrhea due to neurological disorders was deferred pending price reduction and MSAC application for administration. This was subsequently recommended by PBAC in May 2025. In July 2025, PBAC recommended Xeomin for moderate to severe spasticity of the upper limb and dynamic equinus foot deformity in patients with cerebral palsy aged 2 years and older, finding it as effective and safe as Botox and cost-effective if cost-minimised to the lowest cost alternative therapy.