ペラムパネル

Warning

H302 (88.4%): Harmful if swallowed [Warning Acute toxicity, oral]；H413 (88.4%): May cause long lasting harmful effects to aquatic life [Hazardous to the aquatic environment, long-term hazard]

P264, P270, P273, P301+P317, P330, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 43 reports by companies from 6 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.；Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website.

Limited data are available on the hepatotoxicity of perampanel. In clinical trials, therapy with perampanel was not associated with an increased frequency of serum aminotransferase elevations as compared to placebo treatment, and there were no reported instances of clinically apparent liver injury. No individual case reports of perampanel hepatotoxicity have been published since its general clinical availability. Perampanel has been implicated in rare instances of severe cutaneous hypersensitivity reactions including DRESS syndrome, which can be associated with variable degrees of liver injury. Thus, clinically apparent liver injury due to perampanel may occur, but must be very rare.；Likelihood score: E (unlikely cause of clinically apparent liver injury).

Drug Induced Liver Injury Rank (DILIrank 2.0)

Perampanel

vNo-DILI-concern

0

N03AX22

N - Nervous system；N03 - Antiepileptics；N03A - Antiepileptics；N03AX - Other antiepileptics；N03AX22 - Perampanel

QN - Nervous system；QN03 - Antiepileptics；QN03A - Antiepileptics；QN03AX - Other antiepileptics；QN03AX22 - Perampanel

H821664NPK

PERAMPANEL

Established Pharmacologic Class [EPC] - Noncompetitive AMPA Glutamate Receptor Antagonist

Mechanisms of Action [MoA] - AMPA Receptor Antagonists

Mechanisms of Action [MoA] - UGT2B7 Inhibitors

Mechanisms of Action [MoA] - UGT1A9 Inhibitors

After oral adminitration, perampanel is absorbed rapidly and completely.

Perampanel is eliminated mostely in the feces (48%) and to a lesser exten in the urine (22%).

The volume of distribution of perampanel was not quantified.

In healthy patients, perampanel has a clearance of about 12 mL/min.