Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
To ensure that the patient is not pregnant prior to ExEm Foam administration, 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) [see Contraindications (4) ].
5.2 Risk for Post-Procedure Gynecologic Infections There is a risk of post-procedure gynecological infections when ExEm Foam is used in sonohysterosalpingography.
Like all medications, Exem Foam can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: