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Irinotecan liposomal Pregnancy and Breastfeeding Warnings

Irinotecan liposomal is also known as: Onivyde

Irinotecan liposomal Pregnancy Warnings

No animal reproduction and fetal development studies have been conducted with irinotecan liposome. However, animal data with irinotecan HCl revealed evidence of embryotoxicity and teratogenicity at doses resulting in exposures lower than those achieved with 70 mg/m2 in humans. Adverse effects included increased post-implantation loss; decreased live fetuses; growth delays; decreased learning ability and decreased female body weights in offspring; and a variety of external, visceral, and skeletal abnormalities. Animal fertility studies with irinotecan liposome resulted in atrophy of male and female reproductive organs at doses approximately 0.0007 to 3 times the clinical exposure than those achieved with 70 mg/m2 in humans. 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.

This drug can cause fetal harm based on its mechanism of action and animal data. US FDA pregnancy category: Not Assigned Comments: -Pregnant women should be apprised of the potential risk to a fetus, and women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose. -Due to the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment and for 4 months after the final dose.

See references

Irinotecan liposomal Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 1 month after the final dose. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant and on milk production are unknown.

Radioactivity appeared in rat milk within 5 minutes of IV administration of radiolabeled irinotecan HCl and was concentrated up to 65-fold at 4 hours post-administration relative to plasma concentrations.

See references

References for pregnancy information

  1. "Product Information. Onivyde (irinotecan liposomal)." Merrimack Pharmaceuticals, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Onivyde (irinotecan liposomal)." Merrimack Pharmaceuticals, Cambridge, MA.

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