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Nilotinib Pregnancy and Breastfeeding Warnings

Nilotinib is also known as: Tasigna

Nilotinib Pregnancy Warnings

Use is not recommended unless clearly needed. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Female patients of reproductive potential and male patients with female partners should be advised to use highly effective contraception during treatment and for up to 2 weeks after ending treatment. Pregnant patients, or patients who become pregnant during treatment, should be informed of the potential hazard to the fetus.

This drug did not induce teratogenicity in animals, but there is evidence of embryofetal toxicities at doses that also showed maternal toxicity. The effect of this drug on human fertility is unknown; however an animal study noted no effect on fertility in male and female animals. There are no controlled data in human pregnancy. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Nilotinib Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.

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