| Clinical data | |
|---|---|
| Trade names | ExEm Foam |
| License data | |
|
Pregnancy category |
|
| ATC code |
|
| 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
- ^ "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.
- ^
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.
This article incorporates text from this source, which is in the
public domain.
- ^ "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.
-
^ 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) - ^ 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.
 | This pharmacology-related article is a stub. You can help Wikipedia by expanding it. |
| Clinical data | |
|---|---|
| Trade names | ExEm Foam |
| License data | |
|
Pregnancy category |
|
| ATC code |
|
| 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
- ^ "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.
- ^
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. This article incorporates text from this source, which is in the
public domain.
- ^ "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.
-
^ 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) - ^ 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.
|
| This pharmacology-related article is a stub. You can help Wikipedia by expanding it. |