Air polymer-type A- (Ex EmFoam)-@- (Nov- 2019)- Diagnostic agent to assess Fallopian Tube FunctionDrug Name:
Air polymer-type A- (Ex EmFoam)-@- (Nov- 2019)- Diagnostic agent to assess Fallopian Tube Function
List Of Brands:
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
Common adverse reactions are:
pelvic and abdominal pain; vasovagal reactions and associated symptoms such as nausea and faintness; and post-procedure spotting.
Dosages/ Overdosage Etc:
PATIENT COUNSELING INFORMATION
Risk for Post-Procedure Gynecologic Infections
Patients should be counseled regarding the risk of post-procedure gynecologic infections. Instruct patients to report to their healthcare provider any continued pelvic and abdominal pain, significant vaginal discharge and/or fever post-procedure
Abdominal and Pelvic Pain
Inform patients of the potential for transient abdominal and pelvic pain during and after ExEm Foam sonohysterosalpingography
Manufactured for and Distrbuted By: ExEm Foam Inc. 228 East 45th Street, Suite 9E New York, NY 10017
1. Mechanism of Action
ExEm Foam (air polymer-type A) intrauterine foam is formed by mixing the clear Gel [polymer-type A (hydoxyethyl cellulose), glycerin, and purified water] with air and Sterile Purified Water, creating an echogenic contrast agent. When visualized with ultrasound, the foam appears echogenic or bright within the fallopian tubes and peritoneal cavity.
2. Pharmacodynamics ExEm Foam has no known pharmacological activity.
Assuming that a full 10 mL of ExEm Foam is used, and all glycerol is absorbed, the normal fasting endogenous glycerol plasma levels would not be affected.
No literature data is found on absorption of hydroxyethyl cellulose (HEC) from the female reproductive tract and peritoneum. HEC is poorly permeable across GI epithelial mucosa; therefore, HEC is expected to exhibit very low permeability after administration and to produce negligible HEC systemic exposure.
The metabolism and excretion of HEC are not known.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary
ExEm Foam is contraindicated for use in pregnancy due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) and Warnings and Precautions (5.1)]. There are no available data on the use of ExEm Foam in pregnant women. Animal reproduction studies have not been conducted with ExEm Foam.
2. Lactation Risk Summary
There are no data on the presence of the components used to generate ExEm Foam (glycerin and hydroxyethyl cellulose) in human milk, the effects on the breastfed infant, or the effects on milk production.
No adverse effects in breastfed infants are anticipated following maternal administration of ExEm Foam, based on the wide safety margin for glycerol in infants and the expected negligible absorption of hydroxyethyl cellulose
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ExEm Foam and any potential adverse effects on the breastfed infant from ExEm Foam or from the underlying maternal condition.
3. Females and Males of Reproductive Potential
Confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration [see Dosage and Administration
4. Pediatric Use
The safety and effectiveness of ExEm Foam have not been established in pediatric patients.