Leflunomid AbZ Pregnancy

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Pregnancy of Leflunomid AbZ in details

Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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-Animal studies have revealed signs of teratogenicity and embryolethality. There are no controlled data in human pregnancy. -The active metabolite of this drug, A771726 is suspected to cause serious birth defects when administered during pregnancy. -Women should wait to become pregnant for at least 2 years after discontinuation of treatment and plasma levels of A771726 should be less than 0.02 mg/L. If this is not feasible, the manufacturer suggests a washout. Following discontinuation of Leflunomid AbZ, all women of childbearing potential should undergo the following drug elimination procedure: 1) Administer cholestyramine 8 grams, 3 times daily for 11 days. (The 11 days only need to be consecutive when there is a need (such as pregnancy) to lower the cholesterol levels rapidly.) 2) Verify plasma levels less than 0.02 mg/L by 2 separate tests at least 14 days apart. If plasma levels are higher than 0.02 mg/L, additional cholestyramine treatment should be considered. -Human plasma levels less than 0.02 mg/L are expected to have minimal risk based on available animal data. Without the drug elimination procedure, it may take up to 2 years to reach plasma M1 metabolite levels less than 0.02 mg/L due to individual variation in drug clearance. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. US: To monitor fetal outcomes of pregnant women exposed to Leflunomid AbZ, health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

Use is contraindicated. AU TGA pregnancy category: X US FDA pregnancy category: X Comments: -This drug can cause fetal harm when administered to a pregnant woman. -Pregnancy should be excluded before starting therapy. -This drug should not be used in women who are or may become pregnant, or prior to the completion of the drug elimination procedure after treatment. -Patients should be notified to contact their doctor immediately if they suspect they may be pregnant.

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Leflunomid AbZ breastfeeding

When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!
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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 (Leflunomid AbZ)." 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 (Leflunomid AbZ)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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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Information checked by Dr. Sachin Kumar, MD Pharmacology

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