Elmiron

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  • Miscellaneous urogenital disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Elmiron Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pentosan polysulfate sodium 100mg; caps.

    Pharmacological Class

    Bladder protectant.

    How Supplied

    Caps—100

    How Supplied

    Elmiron is supplied in white opaque hard gelatin capsules imprinted “BNP7600” containing 100 mg pentosan polysulfate sodium. Supplied in bottles of 100 capsules.

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

    Manufacturer

    Janssen Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known.

    Elmiron Indications

    Indications

    Bladder pain/discomfort due to interstitial cystitis.

    Elmiron Dosage and Administration

    Adult

    Take with water 1 hr before or 2 hrs after meals. ≥16yrs: 100mg 3 times daily. Reevaluate at 3 and 6 months.

    Children

    <16yrs: not established.

    Elmiron Contraindications

    Not Applicable

    Elmiron Boxed Warnings

    Not Applicable

    Elmiron Warnings/Precautions

    Warnings/Precautions

    Retinal pigmentary changes. Do retinal exam (including OCT, auto-fluorescence imaging) at baseline, within 6 months of initiation, periodically during and after treatment completion. Bleeding or risk of bleeding (eg, surgery, aneurysm, hemophilia, GI ulcers, polyps, diverticula). History of heparin-induced thrombocytopenia. Hepatic insufficiency. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Retinal Pigmentary Changes

    • Long-term use has been associated with pigmentary changes in the retina; most of which has occurred after 3 years of use or longer, but there have been cases with a shorter duration of use. The etiology is unclear, but cumulative dose appears to be a risk factor.

    • Visual symptoms include: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. 

    • Obtain a detailed ophthalmologic history in all patients prior to initiation. Consider genetic testing if there is a family history of hereditary pattern dystrophy.

    • For patients with pre-existing ophthalmologic conditions: obtain a retinal exam (including color fundoscopic photography, OCT, auto-fluorescence imaging) at baseline prior to initiation.

    • For all patients: obtain retinal exam (including OCT, auto-fluorescence imaging) at baseline, within 6 months of initiation, periodically during and after treatment completion. 

    • Re-evaluated the risks and benefits of continuing treatment if pigmentary changes in the retina develop.

    General

    • Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported.

    • Evaluate for hemorrhage in patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other therapies with increased risk for bleeding (eg, coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or NSAIDs).

    • Prior to initiation, carefully evaluate patients with the following diseases such as  aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula. 

    • Exercise caution in patients with a history of heparin induced thrombocytopenia.

    Pregnancy Considerations

    • No adequate and well-controlled studies have been performed in pregnant women. 

    • Elmiron should only be used during pregnancy if clearly needed.

    Nursing Mother Considerations

    • It is not known whether Elmiron is excreted in human milk; use caution in nursing women.

    Pediatric Considerations

    Safety and efficacy have not been established in pediatric patients less than 16 years of age.

    Hepatic Impairment Considerations

    • Elmiron has not been studied in patients with hepatic impairment; use caution in this population.

    • Increases in liver abnormalities (eg, transaminase, alkaline phosphatase, γ-glutamyl transpeptidase, lactic dehydrogenase) have typically occurred 3 to 12 months after initiating treatment, and were not associated with jaundice or other clinical signs/symptoms.

    Elmiron Pharmacokinetics

    Absorption

    • After a single oral dose of 300 or 450 mg pentosan polysufate sodium, maximal levels of plasma radioactivity were observed at a median of approximately 2 hours (range, 0.6–120 hours) after dosing.

    Distribution

    • Preclinical studies have shown that pentosan polysulfate was distributed to the uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow.

    Metabolism

    • Metabolized by partial desulfation in the liver and spleen, and by partial depolymerization in the kidney to a large number of metabolites. 

    • Both the desulfation and depolymerization can be saturated with continued dosing. 

    Elimination

    • Fecal (mean 84% in the 300 mg group; mean 58% in the 450 mg group), renal (mean 6%).

    • Mean half-life: 27 hours (for 300 mg dose); 20 hours (for 450 mg dose).

    Elmiron Interactions

    Interactions

    Caution with drugs that increase bleeding risk (eg, anticoagulants, tPA, aspirin, NSAIDs).

    Elmiron Adverse Reactions

    Adverse Reactions

    Alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, dizziness, increased prothrombin time, hemorrhage.

    Elmiron Clinical Trials

    Clinical Trials

    Two clinical trials evaluated the efficacy and safety of Elmiron for the relief of pain in patients with chronic interstitial cystitis (IC).

    • Trial 1: The blinded, randomized, placebo-controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years. Patients were randomly assigned 1:1 to receive either placebo or Elmiron 100 mg three times a day for 3 months. 

      • 38% of patients treated with Elmiron showed greater than 50% improvement in bladder pain vs 18% of patients treated with placebo (P =.005).

    • Trial 2: The second clinical trial was a prospectively designed retrospective analysis of 2499 patients (2220 women, 254 men, 25 unknown) with a mean age of 47 years who received Elmiron 300 mg/day without blinding.

      • At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by 1 or 2 categories. 

      • By 6 months, in the 892 patients who continued taking Elmiron, an additional 116/2499 (5%) of patients had improved pain scores. 

      • After 6 months, the percent of patients who reported the first onset of pain relief was less than 1.5% of patients who originally entered in the study.

    Elmiron Note

    Not Applicable

    Elmiron Patient Counseling

    Patient Counseling

    • Inform patients that changes in vision may occur and be evaluated if occurs. Retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging are suggested for all patients within 6 months of starting Elmiron and periodically during long-term treatment.

    • Advise patients that Elmiron is a weak anticoagulant and may increase bleeding times. 

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