What are the indications and dosages for Xeomin (Botulinum toxin type A)?

Indications and Dosages for Xeomin (Botulinum Toxin Type A)

Xeomin (incobotulinumtoxinA) is FDA-approved for multiple indications with specific dosing regimens for each condition, primarily for treating neurological and cosmetic conditions through intramuscular or intraglandular injection.

Approved Indications and Dosages

1. Chronic Sialorrhea

• Adults: 100 Units per treatment session (30 Units per parotid gland and 20 Units per submandibular gland)
• Pediatric patients (≥2 years): Dosed based on body weight in a 3:2 ratio into parotid and submandibular glands
• Administration interval: No sooner than every 16 weeks
• Administration technique: Use 27-30 gauge needle (12.5 mm length) for intraglandular injection; ultrasound guidance recommended 1

2. Upper Limb Spasticity

• Adults: Up to 400 Units total, divided among affected muscles
• Pediatric patients (2-17 years): 8 Units/kg (maximum 200 Units) per single upper limb or 16 Units/kg (maximum 400 Units) for both upper limbs
• Note: Pediatric indication excludes spasticity caused by cerebral palsy
• Administration technique: Use electromyographic guidance, nerve stimulation, or ultrasound techniques 1

3. Cervical Dystonia (Spasmodic Torticollis)

• Initial dose: 120 Units per treatment session
• Administration technique: 26-gauge needle for superficial muscles or 22-gauge for deeper musculature
• Efficacy: Significantly improves head position, reduces pain, and enhances quality of life 2, 1
• Dosing range: Clinical studies have found doses up to 400 Units to be safe and effective 3

4. Blepharospasm

• Initial dose: 50 Units total (25 Units per eye)
• Starting dose per injection site: 2.5-5.0 Units 1, 3
• Administration technique: 30-gauge needle (12.5 mm length)
• Efficacy: Produces statistically significant improvements in the Jankovic Rating Scale 4

5. Upper Facial Lines

• Glabellar Lines: 4 Units into each of five sites (20 Units total)
• Horizontal Forehead Lines: 4 Units into each of five sites (20 Units total)
• Lateral Canthal Lines: 4 Units into each of three sites per side (24 Units total)
• Combined treatment: Maximum 64 Units when treating all three areas simultaneously
• Administration interval: No more frequently than every three months 1

Important Clinical Considerations

Administration Guidelines

• Reconstitute with preservative-free 0.9% Sodium Chloride Injection, USP
• Use reconstituted Xeomin for only one injection session and one patient
• Store reconstituted solution in refrigerator (2°C to 8°C) and use within 24 hours 1

Efficacy Duration and Onset

• Onset: Typically 2-7 days after injection
• Duration: 10-16 weeks (approximately 3-4 months) 1, 5
• Studies show therapeutic effects start after approximately 6.1 days and last about 10 weeks 5

Conversion from Other Botulinum Toxins

• Patients can be switched from Botox to Xeomin using a 1:1 conversion ratio
• No loss of efficacy or safety concerns with conversion
• No differences in potency, onset, diffusion profile, or duration of effect 3, 6

Safety Considerations

• Contraindications: Known hypersensitivity to botulinum toxin products or components; infection at proposed injection sites 1
• Warnings: Risk of spread of toxin effect beyond injection site; swallowing and breathing difficulties can be life-threatening
• Common adverse effects: Ptosis (6.1%), dry eye (0.5%), diplopia (0.2%) 5
• Immunogenicity: Low risk of neutralizing antibody formation (0.3% of patients in clinical trials) 1

Unique Features of Xeomin

• Free of complexing proteins (pure 150 kDa neurotoxin)
• Potentially reduced risk of antibody-induced therapy failure with long-term use
• Stable for up to 3 years at room temperature 3, 7

Monitoring

• Assess effectiveness 2-7 days after injection (median onset of effect)
• Monitor for adverse effects, particularly with higher doses
• Evaluate need for retreatment based on return of symptoms, typically after 10-12 weeks 1, 5

Xeomin offers an effective treatment option for multiple neurological and cosmetic conditions with a favorable safety profile and reduced potential for immunogenicity compared to conventional botulinum toxin products.