BOTOX 50 Allergan Units Powder for Solution for Injection

BOTOX

Prescription-only medicine

Botulinum toxin type A (onabotulinumtoxinA) injectable \u2013 50 Allergan Units vial

UK prescription Only medicine (POM).
Authorised in the UK under PL 41042/0059 (BOTOX 50 Allergan Units).
Manufactured in compliance with EU and UK Good Manufacturing Practice (GMP) standards.
Classified under ATC codes M03AX01 and D11AX for neurological and dermatological indications.

UK prescription Only medicine (POM).
Authorised in the UK under PL 41042/0059 (BOTOX 50 Allergan Units).
Manufactured in compliance with EU and UK Good Manufacturing Practice (GMP) standards.
Classified under ATC codes M03AX01 and D11AX for neurological and dermatological indications.

Botulinum toxin type A (onabotulinumtoxinA) injectable \u2013 50 Allergan Units vial

Description

BOTOX 50 Allergan Units is a prescription-only presentation of botulinum toxin type A (onabotulinumtoxinA) supplied as a lyophilised powder for solution for injection. Each clear glass vial contains 50 Allergan Units of botulinum toxin type A from Clostridium botulinum. After reconstitution with sterile 0.9% sodium chloride, it is injected by trained healthcare professionals into muscles, the bladder wall or intradermally depending on indication. In aesthetics, BOTOX is used for temporary improvement of moderate to severe forehead lines, crow’s feet and glabellar frown lines in adults. Therapeutically, it is indicated for various neurologic movement disorders, chronic migraine, overactive bladder and neurogenic detrusor overactivity, and primary axillary hyperhidrosis. Its effect is mediated by inhibition of acetylcholine release at neuromuscular junctions and autonomic nerve endings, resulting in decreased muscle contraction or glandular secretion.

Bnefits

Highly purified botulinum toxin type A with well-established safety and efficacy profile.
Indicated for both cosmetic (facial lines) and multiple therapeutic conditions (spasticity, chronic migraine, bladder disorders, hyperhidrosis).
Predictable onset of effect typically within 1–2 weeks depending on indication.
Clinical benefit commonly lasts around 3–4 months for upper facial lines and longer (4–10 months) for some therapeutic indications.
Lyophilised powder allows flexible dilution and dosing tailored to individual indications and patient needs.
Extensive clinical experience and post-marketing data over many years of use worldwide.

Indications

Temporary improvement in the appearance of vertical lines between the eyebrows (glabellar lines) seen at maximum frown in adults when the severity has an important psychological impact.
Temporary improvement in the appearance of fan-shaped lines from the corner of the eyes (crow’s feet) seen at maximum smile in adults when the severity has an important psychological impact.
Temporary improvement in the appearance of forehead lines seen at maximum eyebrow elevation in adults when the severity has an important psychological impact.
Persistent muscle spasms (focal spasticity) in the elbow, wrist and hand in children aged 2 years or older with cerebral palsy, as an adjunct to rehabilitative therapy.
Persistent muscle spasms (focal spasticity) in the ankle and foot in children aged 2 years or older with cerebral palsy who can walk, as an adjunct to rehabilitative therapy.
Persistent focal spasticity in the hand, arm, shoulder, ankle or foot in adult patients.
Blepharospasm, hemifacial spasm and associated focal dystonias in adults.
Cervical dystonia (spasmodic torticollis) in adults.
Prevention of headaches in adult patients with chronic migraine (headache on 15 days or more per month of which at least 8 days have migraine features).
Idiopathic overactive bladder with symptoms of urinary incontinence, urgency and frequency in adults who have an inadequate response to or are intolerant of anticholinergic medication.
Urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury or multiple sclerosis.
Persistent severe primary hyperhidrosis of the axillae which interferes with activities of daily living and is resistant to topical treatment.

Composition

Botulinum toxin type A (from Clostridium botulinum), 50 Allergan Units per vial.
Human albumin.
Sodium chloride.

Formulation

Lyophilised white powder for solution for injection.
Reconstituted with sterile unpreserved normal saline (0.9% sodium chloride for injection) before use.

Packaging

Clear glass vial with rubber stopper and tamper-proof aluminium seal containing powder for solution for injection.
Each vial contains 50 Allergan Units botulinum toxin type A.
Carton typically comprising one 50 Allergan Unit vial and package leaflet; packs of multiple cartons (e.g. 1, 2, 3 or 6) may be marketed.

Usage

BOTOX 50 Allergan Units must only be prescribed and administered by appropriately qualified healthcare professionals experienced with botulinum toxin and the relevant indication.
Reconstitute the lyophilised powder with sterile unpreserved 0.9% sodium chloride solution following the dilution guidance in the official SmPC; use a gentle technique to avoid denaturation and check that the solution is clear and particle-free.
Administer by intramuscular injection into selected muscles, intradermally (for axillary hyperhidrosis) or into the detrusor muscle via cystoscope (for bladder indications), using appropriate needle size and injection technique for the indication.
Dose, number of injection sites and treatment intervals must follow the indication-specific recommendations in the SmPC; the lowest effective dose should be used and recommended maximum total doses must not be exceeded.
In aesthetic facial indications (glabellar, crow’s feet, forehead lines), inject small intramuscular doses into the specific facial muscles responsible for the lines, maintaining at least the minimum recommended interval of 3 months between treatments.
Patients should be informed that effect is temporary and repeat treatments are required once the clinical effect has diminished; re-treatment intervals are generally no shorter than 12 weeks (or longer depending on indication).
The product is for single use only; discard any unused reconstituted solution after up to 24 hours refrigerated storage if not used immediately, in accordance with local guidelines for cytotoxic/biological waste.

Contraindications

Known hypersensitivity (allergy) to botulinum toxin type A or to any of the excipients (human albumin or sodium chloride).
Presence of infection at the proposed injection site(s).
For bladder indications: urinary tract infection at the time of treatment.
For bladder indications: acute urinary retention at the time of treatment in patients who are not routinely catheterising.
For bladder indications: presence of bladder calculi (stones).
For bladder indications: patients who are not willing and/or able to initiate catheterisation post-treatment if required.

Adverse Effects

Local injection site reactions such as pain, burning or stinging, swelling, erythema, tenderness, bruising or bleeding.
Headache and flu-like symptoms (e.g. tiredness, malaise).
Eyelid ptosis (drooping), brow ptosis, dry eye, blurred vision or visual disturbances after periocular or upper facial injections.
Muscle weakness or decreased muscle strength in the injected or adjacent muscles; generalised weakness in cases of toxin spread or high cumulative dose.
Dysphagia (difficulty swallowing), dysphonia (voice changes) or dysarthria, particularly with cervical dystonia treatment or in predisposed patients.
Respiratory symptoms including dyspnoea, respiratory depression or, rarely, respiratory failure in severe cases of toxin spread or in high-risk patients.
Allergic/hypersensitivity reactions including rash, pruritus, urticaria, angioedema and very rarely anaphylaxis.
Gastrointestinal effects such as nausea, vomiting, diarrhoea, constipation, abdominal pain and dry mouth.
Autonomic effects such as excessive sweating or, conversely, decreased sweating depending on site and indication.
Urinary retention or increased need for catheterisation, particularly in bladder indications.
Systemic effects possibly related to distant spread of toxin such as generalised muscle weakness, aspiration pneumonia, fatigue, dizziness or flu-like syndrome.

Storage Conditions

Store unopened vials in a refrigerator at 2°C–8°C or in a freezer at -5°C to -20°C.
Keep vials in the outer carton to protect from light and keep out of the sight and reach of children.
After reconstitution, use immediately where possible; if not used immediately, the reconstituted solution may be stored for up to 24 hours at 2°C–8°C in a refrigerator.
From a microbiological point of view, responsibility for in-use storage beyond immediate use lies with the user and should not normally exceed 24 hours at 2°C–8°C.

Duration

Effects typically last around 3\u20134 months for upper facial lines, about 4\u20137 months for primary axillary hyperhidrosis and approximately 6\u201310 months for some bladder indications, with re-treatment generally no more frequently than every 3\u20134 months depending on indication and clinical response.

Onset

Initial clinical improvement usually appears within 1\u20132 weeks after injection depending on indication (around 1 week for upper facial lines, within about 2 weeks for spasticity, bladder indications and axillary hyperhidrosis), with peak effect for some indications at around 4\u20136 weeks.