Biology:Air polymer-type A
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| Trade names | ExEm Foam |
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Air polymer-type A, sold under the brand name ExEm Foam, is a drug for the detection of fallopian tube patency (openness) in people with known or suspected infertility.[1][2] It was approved for use in the United States in November 2019.[2][3]
Air polymer-type A is infused into the uterus to allow for visual assessment of fallopian tubes during an ultrasound examination called a sonohysterosalpingography.[2]
The most common adverse reactions are pelvic pain and abdominal pain, nausea and faintness (caused by a nerve and blood vessel reaction called vasovagal reaction) and post-procedure spotting.[2]
History
The U.S. Food and Drug Administration (FDA) approved air polymer-type A based on literature reports.[2] To evaluate how well air polymer-type A works, the FDA primarily used data from two trials.[2] Trial A[4] was conducted at a site in Italy and Trial B[5] at three sites in Poland .[2]
Evaluation of side effects was based on multiple literature reports and collected safety reports from countries where air polymer-type A is already approved.[2]
References
- ↑ "ExEm Foam- air polymer-type a intrauterine foam kit". DailyMed. U.S. National Library of Medicine. 22 November 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b8cb3e4d-ed22-4e88-abca-508c794b4b91.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "Drug Trials Snapshots: ExEm Foam". 7 November 2019. http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-exem-foam.
This article incorporates text from this source, which is in the public domain.
- ↑ "Drug Approval Package: ExEm Foam". 3 December 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212279Orig1s000TOC.cfm.
- ↑ "Ultrasonography reappraisal of tubal patency in assisted reproduction technology patients: comparison between 2D and 3D-sonohysterosalpingography. A pilot study". Minerva Ginecologica 70 (2): 123–128. April 2018. doi:10.23736/S0026-4784.17.04161-2. PMID 29083139.
- ↑ "Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye". Human Reproduction (Oxford University Press (OUP)) 32 (4): 758–769. April 2017. doi:10.1093/humrep/dex013. PMID 28184447.
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