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Incyte Biosciences

Filmdragerad tablett 15 mg
(Vit, bikonvex, rund, filmdragerad tablett med en diameter på cirka 6 mm, med ”A5” präglat på ena sidan.)

Antineoplastiskt medel, proteinkinashämmare.

Aktiv substans:
ATC-kod: L01XE24
Utbytbarhet: Ej utbytbar
Läkemedel från Incyte Biosciences omfattas inte av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Ponatinib

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


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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is based on following data:

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

PEC (µg/L) = 1.5*10-6*A*(100-R)

A (kg/year) = total sold amount API in Sweden year 2016, data from Quintiles IMS.

R (%) = 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 = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref.1)

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

(Note: The factor 109 converts the quantity used from kg to μg).

A = 0,09315 kg. The total sold amount of ponatinib hydrochloride in Sweden year 2016, data from Quintiles IMS. (Ref.2)

R =0

PEC = 1.5 * 10-6 * 0,09315 *(100-0) = 0,0000139725 µg/L


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

Predicted No Effect Concentration (PNEC)


The risk of environmental impact of ponatinib cannot be excluded, since no ecotoxicity data are available.


Degradation


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


Bioaccumulation


Ponatinib has an estimated log Kow = 4,32. (Ref.3)


The Log Kow is thus >4, which indicates that “Ponatinib has high potential for bioaccumulation.”



References

  1. ECHA, European Chemicals Agency.

    October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment.

    http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Data from Quintiles IMS ”Consumption assessment in kg for input to environmental classification - updated 2017”.

  3. Ponatinib, National Center for Biotechnology Information. Pubchem Compound Database, Estimation Program Interface (EPI); https://pubchem.ncbi.nlm.nih.gov/compound/24826799#section=LogP (accessed Sep 13, 2018).