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Bocouture

Bocouture

Bocouture

Pharmaceutical Product
  • Prescription Only medicine (POM) in the UK and EU
  • UK marketing authorisation granted (e.g. PL 29978/0005 for Bocouture 100 Units powder for solution for injection)
  • Manufactured in compliance with Good Manufacturing Practice (GMP) for medicinal products
  • Subject to pharmacovigilance monitoring via national medicines agencies (e.g. MHRA Yellow Card scheme in the UK)
Botulinum toxin type A (neurotoxin) injectable

Description

Bocouture 100 Units is a high-purity botulinum toxin type A injectable (incobotulinumtoxinA) supplied as a powder for solution for injection in a single-use vial containing 100 units. It is designed for both aesthetic and therapeutic applications, where it temporarily relaxes targeted muscles by blocking acetylcholine release at the neuromuscular junction. Bocouture is unique in that it is free from complexing proteins, which reduces the likelihood of neutralising antibody formation and treatment resistance. It is indicated for the temporary improvement of upper facial lines such as glabellar frown lines, and for a range of neurological and functional conditions when used by appropriately trained prescribers.

Bnefits

  • High-purity botulinum toxin type A formulation free from complexing proteins to reduce immunogenicity risk
  • Effective temporary reduction of dynamic facial wrinkles such as glabellar (frown) lines, crow’s feet and forehead lines
  • Clinically proven efficacy for a range of therapeutic neuromuscular indications (e.g. dystonia, spasticity, sialorrhoea depending on local approvals)
  • Consistent and predictable onset and duration of effect when administered by trained professionals
  • Non-surgical, minimally invasive treatment with little to no downtime
  • Suitable for repeat treatments due to low risk of neutralising antibody development
  • Single 100-unit vial allows flexible dosing across multiple injection sites as per SmPC

Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) seen at maximum frown in adult patients when the severity of the facial lines has an important psychological impact (aesthetic indication; subject to local labelling)
  • Treatment of upper facial dynamic wrinkles including crow’s feet and horizontal forehead lines when used off-label or where locally approved
  • Blepharospasm and hemifacial spasm (neurological indication; refer to local Xeomin/Bocouture labelling)
  • Cervical dystonia of a predominantly rotational form (spasmodic torticollis)
  • Focal spasticity of the upper or lower limb in adults (where licensed under national SmPC)
  • Chronic sialorrhoea in adults and, in some regions, in children and adolescents with neurological/neurodevelopmental disorders
  • Other botulinum toxin-responsive movement or hyperactivity disorders as defined in local prescribing information

Composition

  • Botulinum toxin type A (150 kD) – 100 units per vial, free from complexing proteins
  • Human albumin
  • Sucrose

Formulation

  • Powder for solution for injection in a type I glass vial
  • Lyophilised white powder to be reconstituted with sterile sodium chloride 9 mg/mL (0.9%) solution for injection prior to use
  • Neurotoxin preparation intended for intramuscular and/or intraglandular injection depending on indication

Packaging

  • Single-use glass vial containing 100 units Bocouture (botulinum toxin type A) powder for solution for injection
  • Type I glass vial with bromobutyl rubber stopper and tamper-proof aluminium seal
  • Supplied as 1 x 100 unit vial per pack, with package insert / SmPC

Usage

  • Bocouture 100 Units must only be used by physicians with appropriate qualifications and experience in the use of botulinum toxin preparations.
  • Reconstitute the vial with the appropriate volume of sterile 0.9% sodium chloride solution as specified in the official Summary of Product Characteristics (SmPC) to achieve the desired concentration (units per mL).
  • Use a sterile syringe and needle to withdraw the reconstituted solution; gently invert, do not shake vigorously.
  • Administer by intramuscular injection into the specific muscles indicated for treatment (e.g. corrugator and procerus muscles for glabellar lines), or via other routes such as intraglandular injection for sialorrhoea, following SmPC guidance.
  • Dose, number of injection sites and retreatment intervals must follow the official SmPC and be tailored to the individual patient, indication, muscle mass and response.
  • Maintain strict aseptic technique during reconstitution and injection. Discard any unused reconstituted solution appropriately.
  • Do not exceed the maximum total dose per treatment session and per defined treatment interval specified in the SmPC.
  • Patients should be informed about expected onset, duration of effect, possible adverse reactions, and advised to seek medical attention if systemic or unexpected symptoms occur.

Contraindications

  • Known hypersensitivity to botulinum toxin type A or to any of the excipients (human albumin, sucrose)
  • Presence of infection or inflammation at the proposed injection site(s)
  • Generalised disorders of muscle activity such as myasthenia gravis, Lambert–Eaton myasthenic syndrome or amyotrophic lateral sclerosis, where not recommended by the SmPC
  • Patients with bleeding disorders or receiving anticoagulant therapy should be treated with caution and according to clinical judgement
  • Not recommended during pregnancy or breastfeeding; use is contraindicated in many jurisdictions for pregnant and lactating women
  • Contraindications specific to certain indications as detailed in the national SmPC (e.g. severe neuromuscular junction disorders, significant swallowing or respiratory compromise)

Adverse Effects

  • Local injection site reactions such as pain, tenderness, redness, swelling, bruising or pruritus
  • Headache or flu-like symptoms following injection
  • Temporary muscle weakness in the injected or adjacent muscles (e.g. eyelid ptosis, brow ptosis, asymmetry of facial expression with facial injections)
  • Dry mouth, dysphagia, dysphonia or changes in voice when used in cervical dystonia or sialorrhoea indications
  • Rare systemic botulinum toxin effects such as widespread muscle weakness, dysphagia or respiratory difficulties if toxin spreads from the injection site
  • Visual disturbances such as blurred vision or diplopia with periocular injections
  • Hypersensitivity reactions including rash or pruritus; very rarely, serious allergic reactions such as anaphylaxis
  • Additional adverse reactions specific to each indication are detailed in the official SmPC and patient information leaflet

Storage Conditions

  • Store unopened vials according to the conditions stated in the national SmPC (commonly in a refrigerator at 2–8°C or at controlled room temperature if indicated as non-fridge line; check pack and SmPC for local requirements).
  • Keep vial in outer carton to protect from light.
  • Use reconstituted solution within the time frame specified in the SmPC (often within 24 hours) and store at 2–8°C if not used immediately, discarding any unused solution thereafter.
  • Keep out of sight and reach of children.
  • Handle and dispose of vials, needles and syringes as cytotoxic or biohazardous waste according to local regulations for botulinum toxin products.

Duration

Single treatment session with effects typically lasting up to approximately 3\u20134 months depending on indication, dose, injection sites and individual response. Retreatment is usually not recommended more frequently than every 3 months in line with the SmPC.

Onset

Clinical effects usually become apparent within 2\u20133 days after injection, with maximal effect typically observed by around 7\u201314 days and full results by approximately 30 days, varying by indication and individual response.

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