• Colorectal disorders

Solesta Generic Name & Formulations

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)

Solesta Indications


Treatment of fecal incontinence in patients who have failed conservative therapy (eg, diet, fiber therapy, antimotility drugs).

Solesta Dosage and Administration


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.


<18yrs: not recommended.

Solesta 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


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


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