Air Polymer-type A Intrauterine Foam

1 INDICATIONS AND USAGE 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 )

6 ADVERSE REACTIONS 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.

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.

5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS 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) ].