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Talimogene laherparepvec Pregnancy and Breastfeeding Warnings

Talimogene laherparepvec is also known as: Imlygic

Talimogene laherparepvec Pregnancy Warnings

Serious adverse effects (e.g., multi-organ failure and death) have been associated if a fetus or neonate contracts the wild-type herpes infection. There is no clinical data on talimogene laherparepvec infections in pregnant women. A study with pregnant mice did not show any effects on embryofetal development; however, the study design limits application of the animal data to humans. Fertility studies have not been performed. There are no controlled data in human pregnancy. 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.

Use is contraindicated in pregnant patients. US FDA pregnancy category: Not Assigned Comments: -This drug is a live, attenuated Herpes Simplex Virus Type 1 (HSV-1). If a pregnant woman has an infection with primary or reactivated wild-type HSV-1, there is potential for the virus to cross the placental barrier and also a risk of transmission during birth due to viral shedding. -Women of childbearing potential should be apprised of the potential hazards to the fetus/neonate, and advised to use an effective method of contraception to prevent pregnancy during treatment. -Male patients should be instructed to use condoms when engaging in sexual activity to prevent inadvertent transfer of this drug.

See references

Talimogene laherparepvec Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Imlygic (talimogene laherparepvec)." Amgen USA, Thousand Oaks, CA.

References for breastfeeding information

  1. "Product Information. Imlygic (talimogene laherparepvec)." Amgen USA, Thousand Oaks, CA.

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