Air Polymer-Type A Intrauterine Foam

ExEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. ExEm ® Foam is an ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. ( 1 )

Intrauterine Foam, single-dose kit containing: Syringe A: one syringe with 5 mL clear Gel [polymer-type A (hydoxyethyl cellulose), glycerin and purified water] Syringe B: one syringe with 5 mL Sterile Purified Water One Combifix Adaptor (coupling device) When prepared as directed ExEm Foam will contain between 10,000 to 127,000 bubbles per mL. Intrauterine Foam, single-dose kit containing: one syringe with 5 mL clear Gel [polymer type A (hydroxyethyl cellulose), glycerin and purified water] one syringe with 5 mL Sterile Purified Water one Combifix ® Adaptor (coupling device) ( 3 )

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 result of exposure of the endometrial vessels during bleeding, and Due to the potential risk of endometriosis as a result of seeding the peritoneum with endometrial tissue. Patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm . ExEm Foam is contraindicated in: Pregnancy ( 4 ) Patients with known or suspected lower genital tract inflammation or infection ( 4 ) Patients who have had a gynecologic procedure within the last 30 days ( 4 ) Patients with vaginal bleeding ( 4 ) Patient with known or suspected reproductive tract neoplasia. ( 4 )

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 risk of fetal harm from an intrauterine procedure. To ensure that the patient is not pregnant prior to ExEm Foam administration, 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) [see Contraindications (4) ].

5.2 Risk for Post-Procedure Gynecologic Infections There is a risk of post-procedure gynecological infections when ExEm Foam is used in sonohysterosalpingography. ExEm Foam is contraindicated for use in patients with known or suspected genital tract inflammation or infections (e.g. including pelvic inflammatory disease (PID) or suspected sexually transmitted disease) even if the patient is receiving antimicrobial therapy. ExEm Foam is contraindicated in patients who have had a gynecologic procedure within the past 30 days (e.g. curettage or conization) due to the risk of post-procedure infections [see Contraindications (4) and Adverse Reactions (6.2) ] .

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 the rates observed in practice. The common adverse reactions associated with ExEm Foam when used as indicated in sonohysterosalpingography are: pelvic and abdominal pain; vasovagal reactions and associated symptoms such as nausea and faintness; and post-procedure spotting.

6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of (air polymer-type A) intrauterine foam outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gynecologic Infections: pelvic inflammatory disease, salpingitis, and tubo-ovarian abscess

8.1 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.

8.2 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 [see Clinical Pharmacology (12.3) ]. 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.

8.3 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 (2.1) and Use in Specific Populations (8.1) ].

8.4 Pediatric Use The safety and effectiveness of ExEm Foam have not been established in pediatric patients.

ExEm Foam (air polymer-type A) intrauterine foam is formed by mixing the clear Gel [polymer-type A (hydroxyethyl 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.