Letybo®

Botulinum toxin type A

Letybo® (Botulinum toxin type A) is Croma’s neurotoxin, indicated 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.¹

One vial contains 50 units botulinum toxin type A. After reconstitution each 0.1 ml of the solution contains 4 units.

List of excipients:
• Human albumin
• Sodium chloride

References:
* Response rate was defi ned as a ≥ 1-point reduction in FWS at maximum frown based on the investigators assessment.
1 Letybo SmPC
2 Mueller DS, Prinz V, Adelglass J, Cox SE, Gold M, Kaufman-Janette J et al. Effi cacy and Safety of Letibotulinum Toxin A in the Treatment
of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. Aesthet Surg J. 2022; 42(6): 677- 88

LetibotulinumtoxinA has already shown noteworthy performance in the treatment of vertical glabellar lines.*;¹

A new post-hoc analysis, published in the Aesthetic Surgery Journal, now additionally highlights the efficacy and safety of letibotulinumtoxinA in the most frequent patient group (females, 35-50 years of age).**²

• 7 % of females aged between 35-50 presented with a glabellar line severity (GLS ) improvement of ≥ 1 at week 4, this is compared to 95.0% among the remaining female population receiving active treatment.⁺,²
• At week 4, 73.6 % of females aged 35-50 achieved a GLS scoreof 0 upon maximum frowning compared to only 2% of the remaining female population.⁺,²

Females aged 35-50 had a shorter median time to onset of GLSimprovement (2.8 days) compared to the remaining female population (4.2 days).²

* Letybo® is indicated 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.

** A positive response was determined by achieving a GLS score of 0 or 1 as assessed by both subjects and investigators along with at least a 2-point improvement in GLS score relative to baseline at week 4 after the injections.

+ GLS score according to Investigators assessment

References:

1 Mueller DS, Prinz V, Adelglass J, Cox SE, Gold M, Kaufman-Janette J et al. Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. Aesthet Surg J. 2022; 42(6): 677- 88

2 Michael Gold, Susan Taylor, Daniel S Mueller, Jeffrey Adelglass, Joely Kaufman-Janette, Sue E Cox, Michael Cecerle, Konstantin Frank, Mark Nestor, Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35-50 Years of Age: Post – hoc Analyses of the Phase 3 Clinical Study Data, Aesthetic Surgery Journal Open Forum, 2024

Letybo 50 units powder for solution for injection. Abbreviated Prescribing Information Please refer tothe Summary of Product Characteristics (SmPC) before prescribing. Presentation: One vial contains 50 unitsbotulinum 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 structuresmust be avoided. Avoid use when the muscle shows excessive weakness or atrophy. Risk of eyelid ptosisfollowing 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 distantspread 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. MA Holder: Croma-Pharma GmbH, Industriezeile 6, 2100 Leobendorf, Austria.

Date of preparation: June 2023. PLEASE CHECK YOUR LOCAL APPROVAL STATUS. LTLET0723GMX

Adverse events should be reported to pharmacovigilance@croma.at. For medical enquiries please contact medicalservice@croma.at.