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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
Efficacy
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)
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 waning 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)*
-
Rating at week 4 of follow-up cycle
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Rating at week 16 of follow-up cycle
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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.
Tolerability
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
Dosing and administration
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
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Ultrasound imaging should be used to guide needle placement into the salivary glands2
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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
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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
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
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