Air Polymer-Type A Intrauterine Foam
FDA Drug Information • Also known as: Exem Foam
- Brand Names
- Exem Foam
- Route
- INTRAUTERINE
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION ExEm Foam (air polymer-type A) intrauterine foam, is an ultrasound contrast agent. It is provided to the user for preparation as a single-dose kit containing: 5 mL sterile clear Gel [polymer-type A (80.97 mg hydroxyethyl cellulose), 434.80 mg glycerin 85%, and purified water]; with a pH of 6 to 7.5. 5 mL Sterile Purified Water; with a pH of 6 to 7.5. After preparation, ExEm Foam is a milky-white, water-soluble intrauterine foam with an osmolality of approximately 462 mOsm and will contain between 10,000 to 127,000 bubbles per mL with a median size of 45.6 to 60.6 micrometers (for bubbles between 20 to 200 micrometers).
What Is Air Polymer-Type A Intrauterine Foam Used For?
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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Confirm the patient is not pregnant prior to ExEm Foam administrations ( 2.1 ) 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 ( 2.2 ) See Full Prescribing Information for preparation and administration instructions. ( 2.3 ) 2.1 Important Pre-Administration Information To ensure that the patient is not pregnant prior to ExEm Foam administration [see Contraindications (4) and Warnings and Precautions (5.1) ]: Confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration . Confirm the patient is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11). 2.2 Recommended Dosage The recommended initial dose of ExEm Foam is 2 mL to 3 mL by intrauterine infusion using a 5-Fr or larger catheter with luer connection. The dose may be repeated in increments of 2 mL to 3 mL, as needed, to achieve visualization of the fallopian tubes. Maximum total dose is 10 mL. 2.3 Preparation and Administration The ExEm Foam kit includes the following components: Syringe A containing 5 mL clear Gel [polymer type A (hydroxyethyl cellulose), glycerin and purified water] Syringe B containing 5 mL Sterile Purified Water Combifix Adapter (coupling device) Preparation Examine the package and do not use if package has been previously opened or damaged. Ensure the kit is at room temperature. Handle products following aseptic practices (e.g. sterile gloves). Generate foam by mixing Syringe A (Gel) with Syringe B (Sterile Purified Water) included in the package as described in Figure 1. Infuse foam within 5 minutes of reconstitution. FIGURE 1: Reconstitution of ExEm Foam Unscrew and discard the caps from each syringe when ready to prepare the foam. Push and screw Syringe A to one end of the Combifix Adapter. Push and screw Syringe B to the other end of the Combifix Adapter. Make sure these syringes are attached tightly to avoid loss of liquid when mixing. Push the plunger of one syringe vigorously to transfer, and begin mixing the contents from one syringe to the other syringe. Repeat this process at least 10 times. The reconstituted foam is completely milky white (opaque) in color After mixing, transfer all of the foam into one syringe, then disconnect the adapter and other syringe. Approximately 10 mL of ExEm Foam is created by mixing Syringe A of clear Gel with Syringe B of Sterile Purified Water. Infuse within 5 minutes of mixing to ensure adequate imaging. Figure Figure Administration Administer through a 5-Fr or larger catheter with luer connection only. If there is resistance when infusing foam use a larger catheter. Do not infuse forcefully. Infuse 1 mL of foam to confirm proper placement of the catheter tip in the cervix and access to the uterine cavity. Slowly infuse 2 mL to 3 mL of the foam...
Side Effects (Adverse Reactions)
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. 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
Contraindications
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) ]. 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 )
Pregnancy and Breastfeeding
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Supplied ExEm Foam is supplied as a single-dose kit, NDC 73254-310-01. Each kit contains: Syringe A: One sterile syringe containing 5 mL of clear Gel [polymer-type A (hydroxyethyl cellulose), glycerin and purified water Syringe B: One sterile syringe containing 5 mL of Sterile Purified Water One sterile Combifix Adaptor (coupling device) Storage and Handling Store the kit and components at controlled room temperature between 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]; excursions permitted at 15° to 30°C (59° to 86°F). Do not store in refrigerator. Do not freeze.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.