Solesta Generic Name & Formulations
Legal Class
Rx
General Description
Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel for submucosal injection.
Pharmacological Class
Tissue bulking agent.
How Supplied
Syringe (1mL)—4 (w. needles)
Manufacturer
Solesta Indications
Indications
Treatment of fecal incontinence in patients who have failed conservative therapy (eg, diet, fiber therapy, antimotility drugs).
Solesta Dosage and Administration
Adult
See literature. Bowel preparation of rectum using enema required prior to injection. Prophylactic antibiotics are recommended. Inject slowly in deep submucosal layer in the proximal part of the high pressure zone of the anal canal about 5mm above the dentate line. Four 1mL injections are to be given in the following order: posterior, left lateral, anterior, right lateral. Keep needle in place for 15–30 seconds to minimize leakage. A new needle should be used for each syringe and injection site. Post-treatment: Avoid hot baths and physical activity during first 24 hours, antidiarrheal drugs, sexual intercourse, strenuous physical activity for 1 week, anal manipulation for 1 month. Retreatment: If needed, may repeat with max 4mL no sooner than 4 weeks after first injection. Point of injection should be made in between initial injections, shifted 1/8 of a turn.
Children
<18yrs: not recommended.
Solesta Contraindications
Contraindications
Active inflammatory bowel disease. Immunodeficiency disorders or ongoing immunosuppressive therapy. Previous radiation treatment to the pelvic area. Significant mucosal or full thickness rectal prolapse. Active anorectal conditions (eg, abscess, fissures, sepsis, bleeding, proctitis, other infections). Anorectal atresia, tumors, stenosis or malformation. Rectocele. Rectal varices. Presence of existing implant in anorectal region.
Solesta Boxed Warnings
Not Applicable
Solesta Warnings/Precautions
Warnings/Precautions
Should only be used by physicians experienced in anorectal procedures who have successfully completed training and a certification program in Solesta injection procedure. Do not inject intravascularly; may cause vascular occlusion. Avoid injecting in midline of anterior wall of rectum in men with enlarged prostate. Complete external sphincter disruption. Significant chronic anorectal pain. Previous anorectal procedures. Bleeding diathesis. Pregnancy. Nursing mothers.
Solesta Pharmacokinetics
See Literature
Solesta Interactions
Interactions
Concomitant anticoagulants, antiplatelets: increased risk of bleeding at injection site.
Solesta Adverse Reactions
Adverse Reactions
Anal hemorrhage, anorectal discomfort, chills, diarrhea, injection site hemorrhage, pain.
Solesta Clinical Trials
See Literature
Solesta Note
Not Applicable
Solesta Patient Counseling
See Literature