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Rizatriptan Pregnancy and Breastfeeding Warnings

Rizatriptan is also known as: Maxalt, Maxalt-MLT

Rizatriptan Pregnancy Warnings

At doses exceeding maximum recommended daily doses (MRDD), animal studies have revealed evidence of decreased birth, and pre and post weaning weights, increased mortality, altered estrus cyclicity and delays in time to mating, and placental transfer of the drug. In embryofetal development studies in rats and rabbits, a developmental no-effect dose of 10 mg/kg/day was observed in both rats and rabbits, a dose that corresponds with maternal exposures approximately 15 times MRDD. There are no controlled data in human pregnancy AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US 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.

Benefit should outweigh risk AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: A pregnancy registry exists in the US to monitor the pregnancy outcomes of women exposed to this drug while pregnant; healthcare providers are encouraged to report prenatal exposure by calling 1-800-986-8999.

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Rizatriptan Breastfeeding Warnings

Use with caution Excreted into human milk: Unknown Excreted into animal milk: Yes Comment: Infant risk should be minimized by avoiding breastfeeding for 24 hours after administration of this drug.

This drug is extensively excreted into rat milk, at a level 5 or more times maternal plasma levels. Administration to lactating rats at approximately 10 times anticipated maximum clinical exposure resulted in significant reduction in pup body weight gain during lactation.

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Maxalt (rizatriptan)." Merck & Co, Inc, West Point, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Maxalt (rizatriptan)." Merck & Co, Inc, West Point, PA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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