Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentation: One vial contains 50 units botulinum toxin type A produced by Clostridium botulinum.

After reconstitution each 0.1 mL of the solution contains 4 units.

Indication: For the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows in adults <75 years old seen at maximum frown (glabellar lines), when the severity of the facial lines has an important psychological impact.

Dosage and administration:

Should only be administered by physicians with expertise in this treatment.

Posology

The recommended dose is a total of 20 units divided into five injections of 4 units (0.1 mL) each: 2 injections in each corrugator supercilii muscle and 1 injection in the procerus muscle. Botulinum toxin units are not interchangeable from one product to another. Doses recommended are different from other botulinum toxin preparations. Treatment interval should not be more frequent than every three months. In the absence of any undesirable effects secondary to the previous treatment session, a further treatment session with at least a three-month interval between the treatment sessions is possible. The efficacy and safety of repeat injections beyond 12 months has not been evaluated.

Special populations

No specific dose adjustment is required for use in the elderly older than 65 years of age. Letybo is contraindicated in patients 75 years or older

There is no relevant use in the paediatric population.

Method of administration: Intramuscular use.

Care should be taken to ensure that Letybo is not injected into a blood vessel.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis). Presence of acute infection or inflammation at the proposed injection sites. Patients with bleeding disorders.

Warnings and Precautions:

Injection into vulnerable anatomic structures must be avoided. Avoid use when the muscle shows excessive weakness or atrophy. Risk of eyelid ptosis following treatment.

Procedure-related events: Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope after treatment with other botulinum toxins.

Pre-existing neuromuscular disorders: Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A.

Hypersensitivity reactions: An anaphylactic reaction may occur after injection of botulinum toxin. Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available.

Local or distant spread of toxin effects: Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported. Patients may experience exaggerated muscle weakness.

Swallowing and breathing difficulties are serious and can result in death. Use not recommended in patients with a history of dysphagia and aspiration. Patients should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.

Pregnancy & Lactation: Not recommended during pregnancy or lactation and in women of childbearing potential not using contraception.

Undesirable effects: Most common effects are headache and injection site reaction. Very rarely aspirational pneumonia. For full list of side effects, consult SmPC.

Legal Category: POM

Pack sizes and pricing: Vials of 1 x 5ml (UK 65GBP), 2 x 5ml (UK 120GBP), or multipack (2 packs of 1) (UK 120GBP)

MA Number: PL 29863/0002

PA Number: PA0846/001/001

MA Holder: Croma-Pharma GmbH, Industriezeile 6, 2100 Leobendorf, Austria

Date of preparation: June 2023

Unique ID no LTLET0623UK