dextranomer/hyaluronate

Therapeutic Classification: fecal incontinence treatments

Pharmacologic Classification: bulk forming agents

Indications ⬆ ⬇

REMS

Management of fecal incontinence in patients who have failed conventional therapy (diet, fiber therapy and/or anti-motility agents.

Action ⬆ ⬇

Dextranomer microspheres act as a bulking agent; hyaluronate provides a viscous vehicle that serves as a carrier to facilitate injection.

Therapeutic effects:

Decreased episodes of fecal incontinence.

Pharmacokinetics ⬆ ⬇

Absorption: Provides local effect at injection site

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
rectal submucosal injection	within days	within days-mos	12 mo or more

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Allergy to hyaluronic acid-based products;
Active inflammatory bowel disease;
Immunodeficiency disorders/immunosuppressant therapy;
Previous pelvic radiation;
Active anorectal abscesses, fissures, sepsis, bleeding, proctitis or other infections;
Anorectal atresia, tumors, stenosis or malformation;
Rectocele;
Rectal varices;
Present existing anorectal implant.

Use Cautiously in:

Previous surgical procedures involving the anorectal region, complete anorectal disruption, significant chronic anorectal pain (safety and effectiveness not established);
Concurrent anticoagulants or bleeding diatheses (↑ risk of bleeding following procedure);
OB: Safety and effectiveness during pregnancy not established);
Lactation: Safety and effectiveness during breast-feeding not established);
Pedi: Safe and effective use in children <18 yr not established.

Adv. Reactions/Side Effects ⬆ ⬇

GI: constipation, defecation urgency, diarrhea, painful defecation

GU: dyspareunia

Local: proctalgia, anal fissure, anal hemorrhage, anal prolapse, anal pruritus, anorectal discomfort, injection site hemorrhage, injection site pain, proctitis, rectal abscess, rectal discharge

Misc: chills, fever

Interactions ⬆ ⬇

Drug-drug:

None noted.

Route/Dosage ⬆ ⬇

Anorectal submucosal injection(Adults ): Four 1 mL injections: posterior, left lateral, anterior and right lateral.

Availability ⬆ ⬇

Microspheres in solution for submucosal injection: dextranomer microspheres 50 mg/mL and hyaluronate 15 mg/mL in 1 mL disposable syringe

Assessment ⬆ ⬇

Assess frequency of fecal incontinence before and after therapy.

Implementation ⬆ ⬇

Dextranomer hyaluronate should only be administered by physicians experienced in performing anorectal procedures and having successfully completed a comprehensive training and certification program in injection procedure.
Injections are made in midline of anterior wall of rectum. Use a new needle and syringe with each injection. Hold needle at injection site for additional 15–30 seconds to minimize leakage. May require repeated injections. Avoid in men with enlarged prostate.
- Do not inject IV; may cause vascular occlusion.
Pre-treatment—evacuate rectum with an enema immediately prior injection. Follow by cleansing area with antiseptic. Prophylactic antibiotics are recommended.

Patient/Family Teaching ⬆ ⬇

Explain purpose and procedure to patient.
Inform patient that dextranomer hyaluronate is not effective for all patients with fecal incontinence and repeat treatment may be required for treatment effect.
Explain post-treatment care and potential adverse events to patient.
Advise patient that implants might be detected during future anorectal examinations and radiographic imaging of pelvis. Instruct patient to inform all future treating physicians about presence of Solesta gel. If future surgery (e.g., hemorrhoidectomy) is needed Solesta implant can be resected.

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Pronunciation ⬇

Classifications ⬆ ⬇