Exem Foam

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Exem Foam Generic Name & Formulations

General Description

Air polymer-type A (80.97mg hydroxyethyl cellulose), 434.80mg glycerin 85%, purified water; intrauterine foam; for infusion after reconstitution.

Pharmacological Class

Contrast media.

How Supplied

Kit—1 (one syringe of clear gel + one syringe of sterile purified water + one Combifix adaptor)

Manufacturer

Generic Availability

NO

Exem Foam Indications

Indications

For sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.

Exem Foam Dosage and Administration

Adult

See full labeling. Give by slow intrauterine infusion using a 5-Fr or larger catheter with luer connection. Initially 2–3mL, may be repeated in increments of 2–3mL as needed to achieve visualization. Max total dose: 10mL.

Children

Not established.

Exem Foam Contraindications

Contraindications

Pregnancy. Known or suspected lower genital tract inflammation or infections (eg, pelvic inflammatory disease, suspected sexually transmitted disease). Gynecologic procedure within the last 30 days (eg, curettage, conization). 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. Known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm.

Exem Foam Boxed Warnings

Not Applicable

Exem Foam Warnings/Precautions

Warnings/Precautions

Risk for fetal harm. Exclude pregnancy status within 24 hours prior to administration. Confirm patient is in the pre-ovulatory phase of menstrual cycle (cycle days 6–11). Risk for post-procedure gynecological infections. Nursing mothers.

Exem Foam Pharmacokinetics

See Literature

Exem Foam Interactions

Not Applicable

Exem Foam Adverse Reactions

Adverse Reactions

Pelvic/abdominal pain, vasovagal reactions (nausea, faintness), post-procedure spotting; gynecologic infections.

Exem Foam Clinical Trials

See Literature

Exem Foam Note

Not Applicable

Exem Foam Patient Counseling

See Literature

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