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Kyprolis

Utökad övervakningMiljöinformationReceptstatusFörmånsstatus
Amgen

Pulver till infusionsvätska, lösning 10 mg
(Vitt till benvitt frystorkat pulver)

Antineoplastiska medel

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ATC-kod: L01XX45
Utbytbarhet: Ej utbytbar
Läkemedel från Amgen omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Karfilzomib

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


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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC) 

­PEC is calculated according to the following formula (FASS, 2012, p. 11): PEC (μg/L) = (A x 109 x (100-R))/(365 x P x V x D x 100) = 1.5x10-6 x A x (100-R) where:

A = 0.4 kg x 0.5% = 2 x 10-3 Kg =total sold amount API in Sweden year 2017, data from IQVIA 2018 adjusted, based on metabolism data (<0.5% Carfilzomib detected in excreta of patients).

R = 0 % 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 x106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA, 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA, 2008)

PEC (μg/L) = 1.5 x 10-6 x 2 x10-3x (100)

PEC = 3x10-7μg/L


Predicted No Effect Concentration (PNEC) 

Ecotoxicological studies ­

No ecotoxicity data are available.


Environmental risk classification (PEC/PNEC ratio) 

­As there are no data to calculate the PEC/PNEC ratio the phrase: "Risk of environmental impact of carfilzomib cannot be excluded, since no ecotoxicity data are available." is used. However, use of carfilzomib is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is more than 10,000 times below the European Medicines Agency’s action limit 0.01 μg/L stated in its guideline on environmental risk assessment (EMEA, 2006).


Degradation

­No degradation data are currently available. However, the applicant is currently conducting a laboratory study of the transformation of carfilzomib in aquatic sediments (OECD 308). As no degradation data are currently available the phrase:

"The potential for persistence of carfilzomib cannot be excluded due to lack of data" is used.


Abiotic degradation­

No abiotic degradation data are available.


Bioaccumulation

­Partitioning coefficient:

Data from OECD 107 Study: Octanol/Water Partition Coefficient of carfilzomib*


Buffer Solution

Pow­

¶­

log10 Pow ­

¶­

pH 4

3580

3.6

pH 7

40100

4.6

pH 9

29000

4.5

*(ENVIGO, 2015)


As log Dow > 4 at pH 7 the phrase:

"Carfilzomib has high potential for bioaccumulation." is used.


Excretion (metabolism)

­The reduction of 1 kg (total sold amount API in Sweden year 2020, data from Amgen (projected sales)) by a factor of 200 (i.e., 1/0.5%) in the PEC calculation based on metabolism is justified as follows.

Carfilzomib was rapidly and extensively metabolized. The predominant metabolites measured in human plasma and urine, and generated in vitro by human hepatocytes, were peptide fragments and the diol of carfilzomib, suggesting that peptidase cleavage and epoxide hydrolysis were the principal pathways of metabolism. Cytochrome P450-mediated mechanisms played a minor role in overall carfilzomib metabolism. Carfilzomib is excreted to 0.5% as parent compound and up to 35% as quantifiable metabolites in urine. The metabolites have no known pharmacological activity (Wang et al., 2013).


PBT/vPvB assessment

­Carfilzomib does not fulfil the criteria for PBT and/or vBvP classification as no data is available.


References

­ECHA. (2008). Guidance on Information Requirements and Chemical Safety Assessment. Helsinki, Finland: European Chemicals Agency.

EMEA. (2006). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA CHMP/SWP/4447/00 corr 2). London, UK: European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP). ENVIGO. (2015). Carfilzomib Partition Coefficient (Envigo Study Number: DZL0024). Suffolk, UK: Envigo CRS Limited.

FASS, (2012). Environmental classification of pharmaceuticals in www.fass.se – guidance for pharmaceutical companies.

Wang, Z., Yang, J., Kirk, C., Fang, Y., Alsina, M., Badros, A., Papadopoulos, K., Wong, A., Woo, T., Bomba, D., Li, J., & Infante, J. R. (2013). Clinical pharmacokinetics, metabolism, and drug-drug interaction of carfilzomib. Drug Metab Dispos, 41(1), 230-237.

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