Strength Units in Botulinum Toxin Medicinal Products

SNOMED Groups Drugs Extension User Group
1

Hi All,

We are currently looking at botulinum toxin products in Ireland and wondering how people manage the product/brand specific units for these products in the extension level?

These products typically include a statement in the SmPC that the units are product specific and non-interchangeable with other botulinum toxin units.

By default we would not include any proprietary dose forms, units of presentation etc. but these are treated slightly differently by the EMA referential database, which does recognise these product specific units (‘speywood units’ and ‘allergan units’ based on the products available in Ireland)

Including them where mentioned by the product literature would then create a situation where some real clinical drugs would get their own clinical drug, while multiple other brands would classify under a different clinical drug.

Product SmPC contains statement on non-interchangeability of units Units specified Units recognised in EMA RMS
Alluzience, 200 Speywood units / mL, solution for injection Yes Speywood Units Yes
Azzalure, 125 Speywood units, powder for solution for injection Yes Speywood units Yes
BOCOUTURE 100 units powder for solution for injection Yes Units Yes
BOTOX 100 Allergan Units powder for solution for injection Yes Allergan Units Yes
BOTOX 200 Allergan Units powder for solution for injection Yes Allergan Units Yes
BOTOX 50 Allergan Units powder for solution for injection Yes Allergan Units Yes
Dysport 300 units Powder for solution for injection Yes Units Yes
Dysport 500 units Powder for solution for injection Yes Units Yes
Letybo 50 units powder for solution for injection Yes Units Yes
Nuceiva 100 U Powder for solution for injection Yes Units Yes
Nuceiva 50 U Powder for solution for injection Yes Units Yes
Relfydess, 100 units / mL, solution for injection Yes Units Yes
VISTABEL, 4 Allergan Units / 0.1ml, Powder for solution for injection Yes Allergan Units Yes
XEOMIN 200 units powder for solution for injection Yes Units Yes
XEOMIN 50 units powder for solution for injection Yes Units Yes

Thanks, Shane

2

In crossborder services, we have mapped all the quirky special units to UCUM arbitrary unit [arb’U] which maps to 258766007 |Arbitrary unit|.

Not sure if this technical workaround is sufficient for anything. It would still keep them separated from normal units, but at least you don’t have a different unit for every funky unit manufacturers come up with.
It’s also fair to have them as separate clinical drugs, because they imply they are different: unmeasurable with the same units, so effectively uncomparable.

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In AMT all* our products are modelled using “mouse LD50 units”, but the preferred terms simply use the word “unit”. (*Two are modelled with the “arbitrary unit”) - this was on advice from our user group as to their preference.

While we might have the same unit, the specific ingredients do vary (e.g. letibotulinumtoxinA vs daxibotulinumtoxinA) - so that contributes to the decision if the products are interchangeable - but that is something third parties determine (not AMT modelling).

In general even if the ingredients and units are the same for a product - that doesn’t necessarily imply interchangability (though often it is).

Concept Id Preferred Term Fully Specified Name
720851000168109 Botox 100 units powder for injection, 100 units vial Botox (botulinum toxin type A 100 mouse LD50 units) powder for injection, 100 mouse LD50 units vial (branded clinical drug)
720941000168103 Botox 200 units powder for injection, 200 units vial Botox (botulinum toxin type A 200 mouse LD50 units) powder for injection, 200 mouse LD50 units vial (branded clinical drug)
880731000168103 Botox 50 units powder for injection, 50 units vial Botox (botulinum toxin type A 50 mouse LD50 units) powder for injection, 50 mouse LD50 units vial (branded clinical drug)
933448511000036103 Daxxify 100 units powder for injection, 100 units vial Daxxify (daxibotulinumtoxinA 100 units) powder for injection, 100 units vial (branded clinical drug)
1209721000168101 Dysport 125 units powder for injection, 125 units vial Dysport (clostridium botulinum type A toxin-haemagglutinin complex 125 mouse LD50 units) powder for injection, 125 mouse LD50 units vial (branded clinical drug)
721091000168101 Dysport 300 units powder for injection, 300 units vial Dysport (clostridium botulinum type A toxin-haemagglutinin complex 300 mouse LD50 units) powder for injection, 300 mouse LD50 units vial (branded clinical drug)
721021000168103 Dysport 500 units powder for injection, 500 units vial Dysport (clostridium botulinum type A toxin-haemagglutinin complex 500 mouse LD50 units) powder for injection, 500 mouse LD50 units vial (branded clinical drug)
1679111000168101 Letybo 100 units powder for injection, 100 units vial Letybo (letibotulinumtoxinA 100 mouse LD50 units) powder for injection, 100 mouse LD50 units vial (branded clinical drug)
1679061000168102 Letybo 50 units powder for injection, 50 units vial Letybo (letibotulinumtoxinA 50 mouse LD50 units) powder for injection, 50 mouse LD50 units vial (branded clinical drug)
1675151000168103 Nuceiva 100 units powder for injection, 100 units vial Nuceiva (prabotulinumtoxinA 100 mouse LD50 units) powder for injection, 100 mouse LD50 units vial (branded clinical drug)
933310741000036108 Relfydess 150 units/1.5 mL injection, 1.5 mL vial Relfydess (relabotulinumtoxinA 150 units / 1.5 mL) injection, 1.5 mL vial (branded clinical drug)
682751000168100 Xeomin 100 units powder for injection, 100 units vial Xeomin (incobotulinumtoxinA 100 mouse LD50 units) powder for injection, 100 mouse LD50 units vial (branded clinical drug)
173581000036107 Xeomin 50 units powder for injection, 50 units vial Xeomin (incobotulinumtoxinA 50 mouse LD50 units) powder for injection, 50 mouse LD50 units vial (branded clinical drug)
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