Air polymer-type A

Air polymer-type A
Clinical data
Trade namesExEm Foam
License data
Pregnancy
category
  • Contraindicated
ATC code
  • none
Legal status
Legal status
Identifiers
UNII

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 US 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

  1. ^ "ExEm Foam- air polymer-type a intrauterine foam kit". DailyMed. U.S. National Library of Medicine. 22 November 2019. Archived from the original on 24 October 2020. Retrieved 17 March 2020.
  2. ^ a b c d e f g h "Drug Trials Snapshots: ExEm Foam". U.S. Food and Drug Administration (FDA). 7 November 2019. Archived from the original on 13 December 2019. Retrieved 17 March 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "Drug Approval Package: ExEm Foam". U.S. Food and Drug Administration (FDA). 3 December 2019. Archived from the original on 29 October 2020. Retrieved 17 March 2020.
  4. ^ Riganelli L, Casorelli A, Caccetta J, Merlino L, Mariani M, Savone D, et al. (April 2018). "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. doi:10.23736/S0026-4784.17.04161-2. PMID 29083139.{{cite journal}}: CS1 maint: overridden setting (link)
  5. ^ Ludwin I, Ludwin A, Wiechec M, Nocun A, Banas T, Basta P, et al. (April 2017). "Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye". Human Reproduction. 32 (4). Oxford University Press (OUP): 758–769. doi:10.1093/humrep/dex013. PMID 28184447.


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