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Cerdelga

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Miljöinformation
Receptstatus
Förmånsstatus
Sanofi AB

Kapsel, hård 84 mg
(Blågrön pärlemorskimrande, opak överdel och pärlemorsvit, opak underdel med “GZ02” tryckt i svart på kapseln. Kapselns storlek är “storlek 2” (18,0x6,4 mm).)

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Miljöpåverkan

Eliglustat

Miljörisk: Risk för miljöpåverkan av eliglustat kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att eliglustat är persistent, då data saknas.
Bioackumulering: Eliglustat har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A*(100-R)

PEC = 1,88*10-5 µg/L


Where:


A = 0,1371 kg (total sold amount API in Sweden year 2023, data from IQVIA)

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 10*106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)

D = factor of dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of eliglustat is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 µg/L.


Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data available.

Environmental risk classification (PEC/PNEC ratio)
Since it is not possible to calculate the environmental risk classification (PEC/PNEC ratio), the summary phrase for the environmental risk is:
"Risk of environmental impact of eliglustat cannot be excluded, since no ecotoxicity data are available."


Degradation

No data available.
Therefore, the summary phrase for degradation to be used is:
”The potential for persistence of eliglustat cannot be excluded, due to lack of data”.


Bioaccumulation

Partitioning coefficient

Log Kow = 2.84 (potentiometric method, pH unknown)
(Ref. II).


Justification of chosen bioaccumulation phrase:

Since log Kow < 4, eliglustat has low potential for bioaccumulation
(Ref. II).


Excretion (metabolism)

Eliglustat is extensively metabolized with high clearance, mainly by CYP2D6 and to a lesser extent CYP3A4. Primary metabolic pathways of eliglustat involve sequential oxidation of the octanoyl moiety followed by oxidation of the 2,3-dihydro-1,4-benzodioxane moiety, or a combination of the two pathways, resulting in multiple oxidative metabolites.

After oral administration, the majority of the administered dose is excreted in urine (41.8 %) and faeces (51.4 %), mainly as metabolites.
(Ref. III)


References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment, find here.

  2. Cerdelga - Assessment report for an initial marketing authorisation application. 20 November 2014. Retrieved November 17, 2021 from EMA, find here.

  3. SmPC of Cerdelga. Retrieved November 17, 2021 from EMA, find here.

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