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Nitisinone Pregnancy and Breastfeeding Warnings

Nitisinone is also known as: Nityr, Orfadin

Medically reviewed on April 4, 2017

Nitisinone Pregnancy Warnings

Animal studies have shown incomplete skeletal ossification of fetal bones (at 0.4 to 20 times the recommended human dose), increased gestational length (at 4 to 20 times the recommended human dose), and decreased offspring survival (at 0.4 times the recommended human dose). In addition, reduced litter size, decreased birth weight, and decreased survival after birth was observed in animals receiving 12 times the recommended clinical dose based on relative body surface area.

There are no controlled data in human pregnancy.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C

Potential benefit should outweigh the potential risk.

See references

Nitisinone Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

Animals exposed to nitisinone in breast milk showed signs of ocular toxicity and decreased body weight.

See references

References for pregnancy information

  1. "Product Information. Orfadin (nitisinone)." Orphan Pharmaceuticals USA, Inc, Nashville, TN.

References for breastfeeding information

  1. "Product Information. Orfadin (nitisinone)." Orphan Pharmaceuticals USA, Inc, Nashville, TN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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