Leflunomida Mylan Pregnancy

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Pregnancy of Leflunomida Mylan in details

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[US Boxed Warning]: Leflunomida Mylan is contraindicated in pregnant females because of the potential for fetal harm. Adverse events were observed in animal reproduction studies with doses lower than the expected human exposure. Discontinue Leflunomida Mylan and use an accelerated elimination procedure if pregnancy occurs during treatment. The accelerated elimination procedure may decrease potential risks to the fetus by decreasing the plasma concentration teriflunomide, of the active metabolite of Leflunomida Mylan. Following treatment, pregnancy should be avoided until undetectable serum concentrations (<0.02 mg/L) are verified. Limited outcome information following in utero fetal exposure to Leflunomida Mylan is available (BĂ©rard 2018; Chambers 2010; Weber-Schoendorfer 2017).

Health care providers are encouraged to enroll women exposed to Leflunomida Mylan during pregnancy in the Pregnancy Registry (877-311-8972 or http://www.pregnancystudies.org/participate-ina-study/).

Leflunomida Mylan breastfeeding

AU and UK: Contraindicated. US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes

See references

References for pregnancy information

  1. "Product Information. Arava (Leflunomida Mylan)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Arava (Leflunomida Mylan)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Cerner Multum, Inc. "Australian Product Information." O 0


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References

  1. DailyMed. "LEFLUNOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubMed Health. "Leflunomide (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
  3. Human Metabolome Database (HMDB). "Leflunomide: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).

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