Air polymer-type A explained

Tradename:ExEm Foam
Dailymedid:ExEm
Pregnancy Category:Contraindicated
Atc Prefix:none
Legal Us:Rx-only
Unii:PDC6A3C0OX
Unii2:M825OX60H9

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.[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.

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.

History

The US Food and Drug Administration (FDA) approved air polymer-type A based on literature reports. To evaluate how well air polymer-type A works, the FDA primarily used data from two trials. Trial A[4] was conducted at a site in Italy and Trial B[5] at three sites in Poland.

Evaluation of side effects was based on multiple literature reports and collected safety reports from countries where air polymer-type A is already approved.

Notes and References

  1. Web site: ExEm Foam- air polymer-type a intrauterine foam kit . DailyMed . U.S. National Library of Medicine . 22 November 2019 . 17 March 2020 . 24 October 2020 . https://web.archive.org/web/20201024031220/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b8cb3e4d-ed22-4e88-abca-508c794b4b91 . live .
  2. Web site: Drug Trials Snapshots: ExEm Foam . U.S. Food and Drug Administration (FDA) . 7 November 2019 . 17 March 2020 . 13 December 2019 . https://web.archive.org/web/20191213225030/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-exem-foam . live .
  3. Web site: Drug Approval Package: ExEm Foam . U.S. Food and Drug Administration (FDA) . 3 December 2019 . 17 March 2020 . 29 October 2020 . https://web.archive.org/web/20201029220437/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212279Orig1s000TOC.cfm . live .
  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 . 6 . 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 . 29083139 . 10.23736/S0026-4784.17.04161-2 .
  5. Ludwin I, Ludwin A, Wiechec M, Nocun A, Banas T, Basta P, Pitynski K . Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye . Human Reproduction . 32 . 4 . 758–769 . April 2017 . 28184447 . 10.1093/humrep/dex013 . Oxford University Press (OUP) . free .

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