EXEM FOAM KIT

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 a...

Clinical studies reported in the scientific literature have assessed the performance of sonohysterosalpingography with ExEm Foam (a technique referred to as HyFoSy) for the diagnosis of tubal patency in women with infertility. The studies used laparoscopy with chromotubation as the reference standard. Study A compared 2D- and 3D-HyFoSy to previous laparoscopy with chromotubation in 50 women (median age 35 years) with at least 12 months of infertility (median duration of infertility 28 months). The women were randomly assigned to either HyFoSy with 2D imaging or HyFoSy with 3D imaging. The oper...

Common adverse reactions are: pelvic and abdominal pain; vasovagal reactions and associated symptoms such as nausea and faintness; and post-procedure spotting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ExEm Foam Inc. at 1-844-963-EXEM (1-844-963-3936) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect th...

ExEm Foam is contraindicated for use in: Pregnancy [see Warnings and Precautions (5.1) ] . Patients with known or suspected lower genital tract inflammation or infection [see Warnings and Precautions (5.2) ]. Patients who have had a gynecologic procedure within the last 30 days [see Warnings and Precautions (5.2) ]. Patients with vaginal bleeding Due to the risk of intravasation of ExEm Foam as a ...

Risk for fetal harm: Confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration and confirm that the patient is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11). ( 4 , 5.1 ) Risk for Post-Procedure Gynecologic Infections: Do not use in contraindicated situations even if the patient is receiving antimicrobial therapy. ( 4 , 5.2 ) 5.1 Risk for Fetal Harm ExEm Foam is contraindicated for use in pregnancy due to the potential...