Air polymer-type A
| 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. It was approved for use in the United States in November 2019.
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 U.S. 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 was conducted at a site in Italy and Trial B 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.