Midostaurin Pregnancy and Breastfeeding Warnings

Brand names: Rydapt

Medically reviewed by Drugs.com. Last updated on Jan 4, 2024.

Midostaurin Pregnancy Warnings

Use is not recommended.

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

Risk summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman.

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.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-888-669-6682.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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:
-Breast-feeding should be discontinued during treatment and for at least 4 months after stopping treatment.
-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

Further information

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