For healthcare professionals only

This webpage focuses on chronic sialorrhea in children and
adolescents aged 2-17yrs with neurological / neurodevelopmental
disorders, further information on chronic sialorrhea
in adults is available on the adult webpage

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XEOMIN® (botulinum neurotoxin type A)

Xeomin is indicated for the symptomatic treatment
in children and adolescents aged 2 to 17 years
and weighing ≥ 12 kg of chronic sialorrhea due to
neurological/neurodevelopmental disorders.2

XEOMIN® showed significant reduction in unstimulated salivary flow rate from baseline vs. placebo for 16 weeks3

  • The co-primary efficacy endpoint for uSFR was reached demonstrating XEOMIN®’s
    superiority vs placebo (age 6-17 yrs)

Mean changes in uSFR from baseline to study visit (main period)

Mean changes in uSFR Graph

50% greater
reduction in

uSFR from
baseline with
XEOMIN®
treatment than
with placebo.

  • XEOMIN® significantly reduced uSFR vs. placebo at each 4-week assessment from
    week 4 to week 16, with no substantial warning of effect seen for up to 16 weeks

LS, least squares; uSFR, unstimulated salivary flow rate.

XEOMIN® resulted in cumulative improvement of sialorrhea with repeated injections up to 64 weeks3

Mean change from baseline in uSFR following repeated administrations
XEOMIN® (age 6-17 yrs)*

Mean change from baseline in uSFR Graph
  • Rating at week 4 of follow-up cycle
  • Rating at week 16 of follow-up cycle
  • The outcomes for 2-5 year olds in the OLEX phase also showed a sustained effect over time3

*Data shown for patients age 6-17 years in the XEOMIN® treatment group.
MP, main period; OLEX, open-label extension; uSFR, unstimulated salivary flow rate; Wk, week.

XEOMIN® is well tolerated in children and adolescents aged 2-17 years with neurological / neurodevelopmental disorders for the treatment of chronic sialorrhea3

Treatment-emergent adverse events (main study phase)4,5

Type of adverse event Age 2-5 years Age 6-17 years
XEOMIN® (n=35) XEOMIN® (n=148) Placebo® (n=72)
Any adverse event [n,(%)] 5 (14.3) 27 (18.2) 11 (15.3)
Any treatment-related adverse event [n,(%)]* 1 (2.9) 1 (2.9) 0
Any serious adverse event [n,(%)] 1 (2.9) 0 1 (1.4)
Any treatment-related serious adverse event [n,(%)] 0 0 0

*As assessed by clinical investigator.

  • Adverse events were mild to moderate3
  • No treatment-related serious adverse events were reported

XEOMIN® is injected directly into the salivary glands, providing targeted treatment for paediatric chronic sialorrhea2

XEOMIN® is injected
directly into the salivary
glands, providing targeted
treatment for paediatric
chronic sialorrhea2

  • Total dose ranges from 20 to 75 units depending on the individual body weight. The dose is distributed by a 3:2 ratio to the parotid and the submandibular glands2
  • Ultrasound imaging should be used to guide needle placement into the salivary glands2
  • Local anaesthesia, sedation, or anaesthesia in combination with sedation may be offered prior to injection after a careful benefit-risk evaluation and per local site practice2
  • Treatment intervals should be determined based on the actual clinical need of the individual patient. Repeat treatment should be no more frequent than every 16 weeks2
clara gland diagram

XEOMIN® individualised weight adapted dosing scheme2

Body weight
(kg)
Parotid gland,
each side
Submandibular gland,
each side
Total dose
(both glands, both sides)
Dose per
gland
(units)
Volume per
injection
(ml)
Dose per
gland
(units)
Volume per
injection
(ml)
≥ 12 to < 15 6 0.24 4 0.16 20 units
≥ 15 to < 19 9 0.36 6 0.24 30 units
≥ 19 to < 23 12 0.48 8 0.32 40 units
≥ 23 to < 27 15 0.60 10 0.40 50 units
≥ 27 to < 30 18 0.72 12 0.48 60 units
≥ 30 22.5 0.90 15 0.60 75 units

Local anaesthesia, sedation, or anaesthesia in combination with sedation may be offered prior to injection after a careful benefit-risk evaluation and per local site practice.2 In total 162 (64%) subjects received local anaesthetic, 59 (23%) had a general anaesthetic and hypnotics/sedatives were received by 63 (25%) of subjects.6

ATC Class Level 3 Placebo group
(6-17 years)
(N=72)
n (%)
Xeomin group
(6-17 years)
(N=148)
n (%)
Xeomin group
(2-5 years)
(N=35)
n (%)
Local Anaesthetic 42 (58.3) 95 (64.2) 25 (71.4)
General Anaesthetic 17 (23.6) 38 (25.7) 4 (11.4)
Hypnotics and sedatives 16 (22.2) 41 (27.7) 6 (17.1)

Resources

The following resources are available for download

Contact Us

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If you would like further information or to arrange a call with a local key account manager,
please contact Merz Pharma on 0333 200 4140 or xeominUKinfo@merz.com
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For medical information please email: medical.information@merz.com
To register for training events please complete the form below and submit here
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By emailing and registering my data with Merz, I acknowledge that Merz Therapeutics may process my personal data in accordance with their privacy policy. I also acknowledge that Merz Therapeutics may use my personal data to contact me via email for marketing purposes.

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THIS WEBSITE IS FOR
HEALTHCARE PROFESSIONALS ONLY

Are you a UK healthcare professional?

PLEASE CONSULT YOUR HEALTHCARE PROFESSIONAL FOR FURTHER
INFORMATION. For safety and patient information relating to
XEOMIN, please refer to the electronic Medicines Compendium website.
https://www.medicines.org.uk/emc/product/2162/pil
https://www.medicines.ie/medicines/xeomin-50-100-200-units-powder-for-solution-for-injection-34858/patient-info

Date of preparation: May 2022 M-XEO-UKI-1336

THIS WEBSITE IS FOR
XEOMIN IMPROVING SALIVA
CONTROL IN PAEDIATRICS

Would you like to explore saliva control in adult or paediatrics?

Date of preparation: May 2022 M-XEO-UKI-1336

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