HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use EXEM® FOAM safely and effectively.

See full prescribing information for EXEM® FOAM. EXEM FOAM (air polymer-type A) intrauterine foam

Initial U.S. Approval: 2019

INDICATIONS AND USAGE

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

ADVERSE REACTIONS-

 Common adverse reactions are: pelvic and abdominal pain; vasovagal reactions and associated symptoms such as nausea and faintness; and post-procedure spotting.

CONTRAINDICATIONS

• ExEm Foam is contraindicated in: o Pregnancy 

o Patients with known or suspected lower genital tract inflammation or infection

 o Patients who have had a gynecologic procedure within the last 30 days

 o Patients with vaginal bleeding (4) o Patient with known or suspected reproductive tract neoplasia.

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).

 • Risk for Post-Procedure Gynecologic Infections: Do not use in contraindicated situations even if the patient is receiving antimicrobial therapy.

DOSAGE AND ADMINISTRATION

 • Confirm the patient is not pregnant prior to ExEm Foam administration

 • Recommended dose is 2 mL to 3 mL of ExEm Foam by intrauterine infusion using a 5-Fr or larger catheter. Dose may be repeated in 2 mL to 3 mL increments, as needed, to achieve visualization of the fallopian tubes. Maximum total dose is 10 mL 

• See Full Prescribing Information for preparation and administration instructions. 

DOSAGE FORMS AND STRENGTHS-

 Intrauterine Foam, single-dose kit containing: • one syringe with 5 mL clear Gel [polymer type A (hydoxyethyl cellulose), glycerin and purified water] • one syringe with 5 mL Sterile Purified Water • one Combifix® Adaptor (coupling device)

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 

(6.1)] Manufactured for and Distrbuted By: ExEm Foam Inc. 228 East 45th Street, Suite 9E New York, NY 10017 ExEm® is a registered trademark of GISKIT B.V.

 CLINICAL PHARMACOLOGY

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.

3. Pharmacokinetics-                                                                                                          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.

 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

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.

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