and feminine Idursulfase Pregnancy and Breastfeeding Warnings Idursulfase is also known as: Elaprase Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Idursulfase Pregnancy Warnings Animal studies have failed to reveal evidence of adverse effects on pre- and postnatal development at doses up to 12.5 mg/kg IV administered twice a week (about 4 times the recommended human weekly dose of 0.5 mg/kg based on body surface area). Teratogenicity studies have not been conducted. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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. UK: Use should be avoided. AU and US: This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C See references Idursulfase Breastfeeding Warnings AU and UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown. There is no information available on the clinical use during breastfeeding. Since this drug is a large protein molecule, the amount in milk is likely very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. See references References for pregnancy information "Product Information. Elaprase (idursulfase)." Shire US Inc, Florence, KY. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Cerner Multum, Inc. "Australian Product Information." O 0 References for breastfeeding information "Product Information. Elaprase (idursulfase)." Shire US Inc, Florence, KY. Cerner Multum, Inc. "Australian Product Information." O 0 Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 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 -]): Print this page See Also... idursulfase Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Idursulfase Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Lysosomal enzymes Help and Support Looking for answers? Ask a question or go join the idursulfase support group to connect with others who have similar interests. currently
prompted Idursulfase Pregnancy and Breastfeeding Warnings which in retrospect
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