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Perampanel Pregnancy and Breastfeeding Warnings

Perampanel is also known as: Fycompa

Perampanel Pregnancy Warnings

Use is not recommended during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Comments:
-Encourage women of reproductive potential to use effective contraception while taking this drug.
-Advise patients taking contraceptives containing levonorgestrel or ethinylestradiol to use additional non-hormonal forms of contraception (e.g., intrauterine device) during treatment and for 1 month after treatment discontinuation.

This drug may reduce the efficacy of contraceptives containing levonorgestrel or ethinylestradiol as it has been show to decrease levonorgestrel Cmax and AUC by 40% and decrease ethinylestradiol Cmax by 18% following 12 mg once daily dosing for 21 days in healthy women.

This drug and/or its metabolites cross the placenta in animals. Animal studies have revealed maternal toxicity and developmental toxicity at clinically relevant doses; teratogenic effects were not observed. Animal data did not show clear effects on fertility, but prolonged and/or irregular estrus cycles occurred. There are limited amounts of data in human pregnancy, and the effect on human fertility has not been established.

To monitor the pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), a pregnancy registry has been established. Pregnant women taking this drug are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by visiting http://www.aedpregnancyregistry.org.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Perampanel Breastfeeding Warnings

In animal milk, this drug and/or its metabolites have been detected at concentrations 4 times higher than that in maternal plasma.

Safety has not been established; benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects on the nursing infant and on milk production are unknown.
-If this drug is required by the mother, monitor the infant for drowsiness, agitation, and adequate weight gain. Also monitor for developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of drugs.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Fycompa (perampanel)." Eisai Inc, Teaneck, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Fycompa (perampanel)." Eisai Inc, Teaneck, NJ.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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