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Midostaurin Pregnancy and Breastfeeding Warnings

Midostaurin is also known as: Rydapt

Midostaurin Pregnancy Warnings

Safety has not been established during pregnancy; this drug may cause fetal harm based on its mechanism of action and findings in animals. US FDA pregnancy category: Not Assigned Comments: -Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating treatment with this drug. -Advise females of reproductive potential and male patients with female sexual partners to use effective contraception during treatment and for at least 4 months after the last dose. -This drug may impair fertility in females and males of reproductive potential.

Animal studies have revealed evidence of embryo-fetal toxicities and fertility impairment at doses lower than the recommended human dose. Embryo-fetal toxicities included late embryo-fetal death and reduced fetal birth weight, with delays in fetal growth. Fertility impairment included reproductive toxicity in males (e.g., testicular degeneration and atrophy, reduced sperm count and motility, decreased reproductive organ weights, spermatogenesis inhibition) and in females (e.g., increased resorptions, decreased pregnancy rate, decreased number of implants and live embryos). It is unknown whether these fertility effects are reversible. 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.

See references

Midostaurin Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for at least 4 months after the last dose of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -This drug and its active metabolites pass into the milk of lactating animals within 1 hour of a 30 mg/kg/day dose, with approximately 5 times more in milk than in plasma. -The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Rydapt (midostaurin)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Rydapt (midostaurin)." Novartis Pharmaceuticals, East Hanover, NJ.

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