1. What is the mechanism of action of ELMIRON®?
    Although the mechanism of action of ELMIRON® in interstitial cystitis is not fully understood, ELMIRON® is believed to adhere to the protective lining, preventing potentially irritating solutes in the urine from reaching the bladder wall.
  2. How should ELMIRON® be taken?
    ELMIRON® should be taken by mouth, 1 capsule 3 times a day, with water, at least 1 hour before meals or 2 hours after meals. Each capsule contains
    100 mg of ELMIRON®.
  3. How long does it take ELMIRON® to work?
    Symptom improvement with ELMIRON® tends to be gradual. Optimal clinical response may require 3 to 6 months of continuous therapy, although some patients have responded in as early as 4 weeks. Discussing this with patients right from the start of therapy is important and may help with compliance. The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.
  4. Can ELMIRON® be taken during pregnancy?
    ELMIRON® is a Pregnancy Category B drug. Animal reproduction studies have been performed and did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON®. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
  5. What are the most common side effects of ELMIRON®?
    Pentosan polysulfate sodium is a weak anticoagulant which may increase bleeding. Patients undergoing surgery or who have an increased risk of bleeding should be evaluated for the risk of hemorrhage.

    In an 8-year retrospective study, adverse events tended to be infrequent, mild, and transient. Diarrhea, nausea, alopecia (reversible upon discontinuation), headache, rash, dyspepsia, abdominal pain, liver function abnormalities, and dizziness occurred at a frequency of 1% to 4%.

    In a 32 week study, 6.3% of 128 patients reported rectal hemorrhage. The severity was described as “mild” in most patients.

    ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
  6. What is included in a multimodal approach to interstitial cystitis (IC) therapy?
    When treating patients with IC, clinicians should consider that both pharmacologic and nonpharmacologic therapy may be needed for optimal symptom control. ELMIRON® is the only FDA-approved oral agent indicated for bladder pain or discomfort associated with IC and is recommended as the foundation of IC therapy. Dimethyl sulfoxide, an intravesical instillation, is the only FDA-approved intravesical therapy indicated for IC. However, other adjunctive agents not indicated for IC, such as tricyclic antidepressants, antihistamines, or anticonvulsants have been used “off label” for IC symptom management. Additionally, it may be appropriate to introduce physical therapy, dietary modifications, or bladder retraining into the patient’s treatment plan. Treatment should always be tailored to the patient’s individual needs.