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Licence update for BOTOX® increases involvement of MDT

Posted in Industry News on 30th Mar 2020

Allergan receives licence update for BOTOX® (botulinum toxin type A) increasing multidisciplinary team involvement in treatment of debilitating conditions

– Medicines and Healthcare Products Regulatory Agency (MHRA) grants licence update for BOTOX® permitting more healthcare practitioners to administer treatment for people with chronic migraine, post-stroke spasticity and bladder dysfunction

– Licence change marks positive step forward for patients suffering with these debilitating conditions

MARLOW, UNITED KINGDOM – 24 MARCH 2020 – Allergan has announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for BOTOX® (botulinum toxin type A) across all of its approved indications in the UK. The product licence update makes clear that appropriately trained and qualified healthcare professionals, including specialist nurses and physiotherapists, are able to administer the product to patients. This update should help to remove any barriers in practice that may have been experienced by nurses and other therapists involved with the use of the product across neurology, rehabilitation and urology – ensuring easier access to treatment for these patients.

“The decision to increase the pool of healthcare professionals that can administer the product is positive, not only for the patient but also for us as healthcare practitioners. This announcement acknowledges the significant role that nurses, as part of a multidisciplinary team, play in treating chronic migraine patients, while also making it easier for patients to receive this important therapy.

Susie Lagrata, Headache and Neuromodulation Lead Nurse, The National Hospital for Neurology and Neurosurgery.

“The management and care of patients with muscle spasticity after stroke is complex, with physiotherapists playing an integral role in rehabilitation,” said Dr. Rhoda Allison, Consultant Stroke Physiotherapist, Torbay and South Devon NHS Foundation Trust. “Ensuring that we are included as healthcare practitioners who can administer the product will allow us to more effectively treat patients who can benefit from treatment, and improve access to treatment.”

“This licence update reflects the work being undertaken by urology nurses – as recognised in the recently published supplement to the ‘Getting It Right First Time’ (GIRFT) Urology National Report, which showcases good practice case studies including establishing a nurse-led service. The GIRFT National report highlighted the need to reduce variations, improve productivity, quality and most importantly patient safety within the NHS,” said Julia Taylor, Past President of the British Association of Urological Nurses, Macmillan Consultant Nurse and Clinical Governance Lead, Urology, Salford Royal NHS Foundation Trust. “This is a significant step towards improvements and efficiencies within the NHS through innovations such as nurse-led clinics, which can ultimately lead to the delivery of high quality care whilst maintaining patient safety.”

Nancy Ghattas, UK & Ireland Associate Vice President and Country Manager, Allergan, said:

This licence change reflects the important role that all members of a multidisciplinary team have in disease management, and ensures appropriate access to the product for patients who need it most in the UK.

Important Safety Information

BOTOX® is a prescription medicine that is injected into muscles and used in the treatment of: focal spasticity, including dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older; wrist and hand disability due to upper limb spasticity associated with stroke in adults; ankle and foot disability due to lower limb spasticity associated with stroke in adults; symptomatic relief of blepharospasm, hemifacial spasm and idiopathic cervical dystonia (spasmodic torticollis); prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine); management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics; overactive bladder with symptoms of urinary incontinence, urgency and frequency; neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.

Adverse Effects: See Summary of Product Characteristics for full information on side effects, including details of uncommon, rare and very rare events. Adverse events usually occur within the first few days following injection and are transient, but may persist for several months or, rarely, longer. Local muscle weakness represents the expected pharmacological action. Localised pain, tenderness and/or bruising may be associated with the injection. Fever and flu syndrome have been reported. Frequency: Defined as Very Common (≥ 1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100). Blepharospasm: Nervous system disorders (Uncommon: Dizziness, facial paresis and facial palsy). Eye Disorders (Very common: Eyelid ptosis. Common: Punctate keratitis, lagophthalmos, dry eye, photophobia, eye irritation and lacrimation increase. Uncommon: Keratitis, ectropion, diplopia, entropion, visual disturbance and vision blurred. Skin and subcutaneous tissue disorders (Common: Ecchymosis.

Uncommon: Rash/dermatitis). General disorders and administration site conditions (Common: Irritation and face oedema. Uncommon: Fatigue). Hemifacial Spasm: as for blepharospasm (as above). Cervical Dystonia: Infections and infestations (Common: Rhinitis and upper respiratory infection). Nervous system disorders (Common: Dizziness, hypertonia, hypoaesthesia, somnolence and headache). Eye Disorders (Uncommon: Diplopia and eyelid ptosis). Respiratory, thoracic and mediastinal disorders (Uncommon: Dyspnoea and dysphonia). Gastrointestinal disorders (Very common: Dysphagia. Common: Dry mouth and nausea). Musculoskeletal and connective tissue disorders (Very common: Muscular weakness. Common: Musculoskeletal stiffness and soreness). General disorders and administration site conditions (Very common: Pain. Common: Asthenia, influenza like illness and malaise. Uncommon: Pyrexia). Paediatric cerebral palsy: Infections and infestations (Very common: Viral infection and ear infection). Nervous system disorders (Common: Somnolence, gait disturbance and paraesthesia). Skin and subcutaneous tissue disorders (Common: Rash). Musculoskeletal and connective tissue disorders (Common: Myalgia, muscular weakness and pain in extremity). Renal and urinary disorders (Common: Urinary incontinence). Injury, poisoning and procedural complications (Common: Fall). General disorders and administration site conditions (Common: Malaise, injection site pain and asthenia). Focal upper limb spasticity associated with stroke: Psychiatric disorders (Uncommon: Depression and insomnia). Nervous system disorders (Common: Hypertonia. Uncommon: Hypoaesthesia, headache, paraesthesia, incoordination and amnesia). Ear and labyrinth disorders (Uncommon: Vertigo). Vascular disorders (Uncommon: Orthostatic hypotension). Gastrointestinal disorders (Uncommon: Nausea and paraesthesia oral). Skin and subcutaneous tissue disorders (Common: Ecchymosis and purpura. Uncommon: Dermatitis, pruritus and rash). Musculoskeletal and connective tissue disorders (Common: Pain in extremity and muscle weakness. Uncommon: Arthralgia and bursitis). General disorders and administration site conditions (Common: Injection site pain, pyrexia, influenza-like illness, injection site haemorrhage and injection site irritation. Uncommon: Asthenia, pain, injection site hypersensitivity, malaise and peripheral oedema). Focal lower limb spasticity associated with stroke: Skin and subcutaneous tissue disorders (Common: Rash). Musculoskeletal and connective tissue disorder (Common: Arthralgia, musculoskeletal stiffness, muscular weakness). General disorders and administration site conditions (Common: Peripheral oedema). Injury, poisoning and procedural complications (Common: Fall). Primary hyperhidrosis of the axillae: Nervous system disorders (Common: Headache and paraesthesia). Vascular disorders (Common: Hot flushes). Gastrointestinal disorders (Uncommon: Nausea). Skin and subcutaneous tissue disorders (Common: Hyperhidrosis (non-axillary sweating) skin odour abnormal, pruritus, subcutaneous nodule and alopecia). Musculoskeletal and connective tissue disorders (Common: Pain in extremity. Uncommon: Muscular weakness, myalgia and arthropathy). General disorders and administration site conditions (Common: Injection site pain. Uncommon: Pain, injection site oedema, injection site haemorrhage, injection site hypersensitivity, injection site irritation, asthenia and injection site reactions). Chronic Migraine: Nervous system disorders (Common: Headache, migraine, facial paresis). Eye disorders (Common: Eyelid ptosis. Uncommon: Eyelid oedema). Skin and subcutaneous tissue disorders (Common: Pruritus, rash. Uncommon: Pain of skin). Musculoskeletal and connective tissue disorders (Common: Neck pain, myalgia, musculoskeletal pain, musculoskeletal stiffness, muscle spasms, muscle tightness, muscular weakness. Uncommon: Pain in jaw). Generaldisorders and administration site conditions (Common: Injection site pain). Gastrointestinal disorders (Uncommon: Dysphagia). Overactive bladder: Infections and infestations (Very common: Urinary tract infection. Common: Bacteriuria). Renal and urinary disorders (Very common: Dysuria. Common: Urinary retention, residual urine volume, pollakiuria, leukocyturia). Urinary incontinence due to neurogenic detrusor overactivity: Infections and infestations (Very common: Urinary tract infection). Psychiatric disorders (Common: Insomnia). Gastrointestinal disorders (Common: Constipation). Musculoskeletal and connective tissue disorders (Common: Muscular weakness, muscle spasm). Renal and urinary disorders (Very common: Urinary retention. Common: Haematuria, bladder diverticulum). General disorders and administration site conditions (Common: Fatigue, gait disturbance). Injury, poisoning and procedural complications (Common: Autonomic dysreflexia, fall). Please see BOTOX® Summary of Product Characteristics for full product information.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan’s website at https://www.allergan.co.uk/.