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  • Solesta
    (Dextranomer Beads, Sodium Hyaluronate) - Salix

    THERAPEUTIC CLASS

    Device

    DEA CLASS

    RX

    INDICATIONS

    Treatment of fecal incontinence in patients ≥18 yrs of age who have failed conservative therapy (eg, diet, fiber therapy, antimotility medications).

    ADULT DOSAGE

    Adults: ≥18 Yrs: Four 1mL submucosal inj per treatment session. Inject in the deep submucosal layer in the proximal part of the high-pressure zone of the anal canal about 5mm above the dentate line; give in the following order: posterior, left lateral, anterior, and right lateral. Re-treatment: If adequate response not achieved after the 1st inj, procedure may be repeated with a max of 4mL no sooner than 4 weeks after 1st inj. However, point of inj should be made in between the initial inj, shifted 1/8 of a turn (eg, left posterolateral, left anterolateral, right anterolateral, and right posterolateral).

    HOW SUPPLIED

    Inj: (Dextranomer microsphere-Sodium hyaluronate) 50mg-15mg/mL [1mL]

    CONTRAINDICATIONS

    Active inflammatory bowel disease, immunodeficiency disorders or ongoing immunosuppressive therapy, previous radiation treatment to pelvic area, significant mucosal or full thickness rectal prolapse, active anorectal conditions (eg, abscess, fissures, sepsis, bleeding, proctitis, or other infections), anorectal atresia, tumors, stenosis or malformation, rectocele, rectal varices, and presence of existing implant in anorectal region.

    WARNINGS/PRECAUTIONS

    Do not inject intravascularly; may cause vascular occlusion. Avoid injecting in the midline of the anterior wall of the rectum in men with enlarged prostate. Should only be administered by physicians experienced in performing anorectal procedures and who have successfully completed a comprehensive training/certification program in the Solesta inj procedure. Patients with bleeding diathesis may experience increased bleeding at inj sites. Adequate bowel preparation of the rectum using enema is required; give enema immediately prior to inj procedure. Cleanse the inj area with an antiseptic prior to inj. Use of prophylactic antibiotics is recommended. May cause excessive pain if inj is too close to the dentate line or too deep in the tissue. Stop inj if excessive bleeding or pain occurs.

    ADVERSE REACTIONS

    Proctalgia, pyrexia, rectal discharge, abdominal complaints (eg, constipation, diarrhea), anal/rectal hemorrhage, inj-site pain/hemorrhage, anorectal discomfort, perioperative infection.

    DRUG INTERACTIONS

    See Contraindications. May increase bleeding at inj sites in patients using anticoagulant or antiplatelet agents.

    PREGNANCY

    Safety not known in pregnancy/nursing.

    MECHANISM OF ACTION

    Bulking agent; mechanism not established. Stabilized sodium hyaluronate accounts for the viscous properties and acts as a carrier that facilitates the inj of the dextranomer microspheres.

    ASSESSMENT

    Assess for active inflammatory bowel disease, immunodeficiency disorders or ongoing immunosuppressive therapy, previous radiation treatment to pelvic area, significant mucosal or full thickness rectal prolapse, active anorectal conditions, anorectal atresia, tumors, stenosis or malformation, rectocele, rectal varices, presence of existing implant in anorectal region, allergy to hyaluronic acid-based products, enlarged prostate, bleeding diathesis, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for excessive bleeding or pain and other adverse reactions.

    PATIENT COUNSELING

    Advise that the treatment is not effective for all patients with fecal incontinence and that repeat treatment may be required. Inform that implants might be detected during future anorectal examinations and radiographic imaging of the pelvis. Instruct to notify all future treating physicians about the presence of the gel. Advise that implant can be resected if there should be a need for future surgery (eg, hemorrhoidectomy). Instruct to avoid hot baths and physical activity for 24 hrs after treatment. Inform of the risk of infection and bleeding; advise to contact physician immediately if symptoms of rectal bleeding, bloody diarrhea, fever, tenesmus, or problems urinating occur. Instruct to not use antidiarrheal drugs for 1 week after treatment. Instruct to avoid sexual intercourse and strenuous physical activity (eg, horseback riding, bicycling, jogging) for 1 week and anal manipulation (eg, insertion of suppositories or enemas and rectal temperature recording) for 1 month.

    ADMINISTRATION/STORAGE

    Administration: Rectal route. One needle should be used per syringe and inj. Never mix with other products. Refer to PI for method of administration, post-treatment care, and retreatment procedure. Storage: ≤25°C (77°F). Protect from sunlight and freezing.