Air polymer-type A

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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[edit]

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[edit]

  1. ^ "ExEm Foam- air polymer-type a intrauterine foam kit". DailyMed. 22 November 2019. 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. 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. Retrieved 17 March 2020.
  4. ^ Riganelli L, Casorelli A, Caccetta J, Merlino L, Mariani M, Savone D, Carrone A, Franceschetti S, Aragona C, Pietrangeli D, Aragona A, Capri O, Piccioni MG (April 2018). "Ultrasonography reappraisal of tubal patency in assisted reproduction technology patients: comparison between 2D and 3D-sonohysterosalpingography. A pilot study". Minerva Ginecol. 70 (2): 123–128. doi:10.23736/S0026-4784.17.04161-2. PMID 29083139.
  5. ^ Ludwin, I.; Ludwin, A.; Wiechec, M.; Nocun, A.; Banas, T.; Basta, P.; Pitynski, K. (10 February 2017). "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. doi:10.1093/humrep/dex013. ISSN 0268-1161. PMID 28184447.