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Sonidegib Pregnancy and Breastfeeding Warnings

Sonidegib is also known as: Odomzo

Sonidegib Pregnancy Warnings

This drug can cause fetal harm based on its mechanism of action and data from animal studies; avoid use during pregnancy. US FDA pregnancy category: Not Assigned Comments: -Females of reproductive potential should have their pregnancy status verified before treatment initiation, and be advised to use effective contraception during treatment and for at least 20 months after the last dose. -It is not known if this drug is present in semen; however, it is recommended that males be advised to not donate semen and to use a condom (even after a vasectomy) during treatment and for at least 8 months after the last dose. -All patients should be advised not to donate blood or blood products during treatment and for at least 20 months after the last dose to protect females of reproductive potential who may receive donated blood/blood products.

Animal studies revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity at doses below the recommended human dose. Adverse effects included vertebral, distal limb, and digit malformations; severe craniofacial malformations; other severe midline defects; and complete resorption of fetuses. Additionally, animal studies demonstrated female fertility impairment (adverse effects included atrophy of the uterus and ovaries); no effects on male fertility were noted. There are no controlled data in human pregnancy. Pregnancies during treatment with this drug should be reported to Novartis Pharmaceuticals Corporation at 1-888-669-6682. 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

Sonidegib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 20 months after the last dose. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Odomzo (sonidegib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Odomzo (sonidegib)." Novartis Pharmaceuticals, East Hanover, NJ.

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