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Janssen-Cilag

Filmdragerad tablett 5 mg
(brun, rund, bikonvex filmdragerad tablett, 8,6 mm i diameter, präglad med ”5” på ena sidan och ”EF” på andra sidan)

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Delbarhetsinformation

antineoplastiska medel, proteinkinashämmare

Aktiv substans:
ATC-kod: L01EN01
Utbytbarhet: Ej utbytbar
Läkemedel från Janssen-Cilag omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Erdafitinib

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


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Detaljerad miljöinformation

Detailed background information

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 = 0.00000681575 μg/L


Where:

A =                  0.04975 kg (total forecasted amount API sold the coming 5 years for Sweden (2024-2029))


R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.


P = number of inhabitants in Sweden = 10 *106


V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. 1)


D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. 1)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies

No data available


Environmental risk classification (PEC/PNEC ratio)

Calculation of Predicted No Effect Concentration (PNEC)


No available, thus the PNEC cannot be calculated.


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Erdafitinib 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.


Conclusion for environmental risk:

Risk of environmental impact of Erdafitinib cannot be excluded, since no ecotoxicity data are available.


Degradation

Biotic degradation

Ready biodegradation


No data available


Inherent biodegradation


No data available


Conclusion for degradation:

The potential for persistence of Erdafitinib cannot be excluded, due to lack of data.


Bioaccumulation

Partition coefficient octanol/water

Data according to Ref 2

  • Log DOW (pH 7): 1.77


Bioconcentration

Data according to open literature [Ref. 3]:

  • ChemSpider reports:

    • ACD/BCF (pH 7.4): 3.58


Conclusion for bioaccumulation:

Erdafitinib has low potential for bioaccumulation.


Excretion (metabolism)

No data available.


PBT/vPvB assessment

No data available.


References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Janssen Report No DS-TEC-42756493] PDMS Drug Development. Physicochemical Characterization of JNJ-42756493-AAA. DS-TEC-110422. Version 1.0. August 1, 2017

  3. ChemSpider 2024. http://www.chemspider.com/

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