air polymer type A (Rx)

Brand and Other Names:ExEm Foam
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intrauterine foam

  • Syringe A: 5 mL of gel (polymer type A [hydroxyethyl cellulose], glycerin, purified water)
  • Syringe B: 5 mL sterile purified water
  • Combifix adaptor (coupling device)

Infertility Diagnostic

Ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility

2-3 mL via intrauterine infusion; may repeat in 2- to 3-mL increments as needed to achieve fallopian tube visualization

Not to exceed total dose of 10 mL

Dosing Considerations

Ensure that patient is not pregnant before administration by confirming a negative pregnancy test within 24 hr beforehand

Confirm the patient is in preovulatory phase of her menstrual cycle (cycle days 6 through 11)

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Pelvic and abdominal pain

Vasovagal reactions and associated symptoms (eg, nausea, faintness)

Postprocedure spotting

Postmarketing Reports

Gynecologic infections: Pelvic inflammatory disease, salpingitis, and tubo-ovarian abscess

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Warnings

Contraindications

Pregnancy

Known or suspected lower genital tract inflammation or infection

Gynecologic procedure within last 30 days

Known or suspected reproductive tract neoplasia, owing to the risk of peritoneal spread of neoplasm

Patients with vaginal bleeding

  • Owing to risk of intravasation of foam as a result of exposure of the endometrial vessels during bleeding, and
  • Owing to the potential risk of endometriosis as a result of seeding the peritoneum with endometrial tissue

Cautions

Risk of postprocedure gynecological infections

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Pregnancy & Lactation

Pregnancy

Contraindicated for use in pregnancy owing to potential fetal risk from an intrauterine procedure

Confirm a negative pregnancy test within 24 hr before administration and patient is in the preovulatory phase of her menstrual cycle (days 6 through 11)

Lactation

Data are not available regarding presence in human milk

No adverse effects in breastfed infants are anticipated following maternal administration based on the wide safety margin for glycerol in infants and the expected negligible absorption of hydroxyethyl cellulose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Air polymer type A intrauterine foam is formed by mixing the clear (polymer type A [hydroxyethyl cellulose], glycerin, purified water) with air and sterile purified water

When mixed, an echogenic contrast agent is created, which when visualized with ultrasound, the foam appears echogenic or bright within the fallopian tubes and peritoneal cavity

Absorption

No literature data are available regarding hydroxyethyl cellulose (HEC) absorption from the female reproductive tract and peritoneum

HEC is poorly permeable across GI epithelial mucosa; therefore, HEC is expected to exhibit very low permeability after administration and to produce negligible HEC systemic exposure

Metabolism

Unknown

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Administration

Foam Preparation

Examine package and do not use if previously opened or damaged

Ensure all components are at room temperature

Handle products following aseptic practices (eg, sterile gloves)

Generate foam by mixing syringe A (gel) with syringe B (sterile purified water) included in the kit as precisely described in the prescribing information

Infuse foam within 5 minutes of reconstitution

Intrauterine 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 2-3 mL of the foam at a time to avoid patient discomfort; not to exceed total dose of 10 mL

Discard unused portion after use

Imaging guidance

  • Conduct transvaginal ultrasound imaging in accordance with ultrasound manufacturer recommendations
  • Foam in the fallopian tube appears as an echogenic line along the length of the tube on the image
  • A fallopian tube is classified as patent if foam is observed to pass from the tube and spill into the peritoneal cavity; tube appears as a thin, bright line
  • A fallopian tube is classified as occluded if foam is not observed to pass from the tube and spill into the peritoneal cavity; as secondary findings, (1) there may be no bright line due to no flow into the fallopian tube, or (2) the tubal lumen may appear distended and contrast flow might be observed only in the intramural or isthmic part of the tube

Storage

Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

Do not refrigerate or freeze

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.