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Prescribing Information

FOR US HEALTHCARE PROFESSIONALS

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  • ABOUT INTERSTITIAL CYSTITIS
    • IC Overview
    • Patient Evaluation
    • Mimicking Conditions
  • ABOUT ELMIRON®
    • ELMIRON® and IC
    • Proven Efficacy
    • Dosing Information
  • PATIENT SUPPORT
    • Patient Counseling
    • Counseling Materials
    • Follow Up
    • Managed Care
    • Additional Resources
  • PRACTICE RESOURCES
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  • Important Safety Information
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  • For US Healthcare Professionals Only

Counseling Materials

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Healthcare Professional Photo

The information available here may help you counsel patients about interstitial cystitis (IC). It is important that patients are counseled about their condition and about realistic IC treatment expectations in order to increase the chances of treatment success.1

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DESCRIPTION

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Patient Education Flyer

This flyer provides information to educate patients about IC and treatment with ELMIRON®.

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Journey to Relief ®
Easy to enroll and absolutely FREE

This e-newsletter series offers helpful guidance for those who are just starting treatment. It also delivers helpful patient materials, including savings cards, right to your patient's inbox.

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IC Diet Guide

A handy guide to help your patients make “IC-smart” meal choices.

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Pelvic Pain & Urgency/Frequency (PUF) Questionnaire

Use the PUF Questionnaire to assess a patient’s condition initially and throughout the course of his or her therapy.

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O’Leary-Sant IC Symptom and Problem Index

Have patients complete this questionnaire that focuses on voiding symptoms to help in patient assessment.

Reprinted from Urology, Vol 49, O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J, The interstitial Cystitis Symptom Index and Problem Index, Page 62, Copyright 1997, with permission from Elsevier.

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ELMIRON® Patient Brochure

Counsel patients about IC and what to expect from treatment with ELMIRON® using this informational brochure.

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ELMIRON® Symptom Journal

Highlight the importance of tracking IC symptoms in this convenient and easy-to-use journal for patients.

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Reference:

  • Kahn BS, Stanford EJ, Mishell DR Jr, et al. Management of patients with interstitial cystitis or chronic pelvic pain of bladder origin: a consensus report. Curr Med Res Opin. 2005;21(4):509-516.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

WARNINGS

  • Retinal Pigmentary Changes: Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with preexisting ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and autofluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and autofluorescence imaging) is suggested for all patients within 6 months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be reevaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

PRECAUTIONS

  • Anticoagulant Activity: ELMIRON® is a weak anticoagulant which may increase bleeding. Rectal hemorrhage was reported as an adverse event in 6.3% of patients. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting ELMIRON®.
  • Heparin-Induced Thrombocytopenia: Caution should be exercised when using ELMIRON® in patients who have a history of heparin-induced thrombocytopenia.
  • Alopecia: In clinical trials of ELMIRON®, 97% of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
  • Hepatic Insufficiency: ELMIRON® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of ELMIRON®, hepatic impairment may have an impact on the pharmacokinetics of ELMIRON®. Caution should be exercised when using ELMIRON® in this patient population.
  • Information for Patients: Patients should take the drug as prescribed, in the dosage prescribed, and no more frequently than prescribed. Patients should be informed that changes in vision should be reported and evaluated. Retinal examinations including optical coherence tomography (OCT) and autofluorescence imaging are suggested for all patients within 6 months of starting ELMIRON® and periodically during long-term treatment (see WARNINGS). Patients should be reminded that ELMIRON® has a weak anticoagulant effect. This effect may increase bleeding times.
  • Pregnancy and Nursing Mothers: Adequate and well-controlled studies have not been performed in pregnant women. This drug should be used in pregnancy only if clearly needed. It is not known if ELMIRON® is excreted in human milk. Caution should be exercised when ELMIRON® is administered to a nursing woman.
  • Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 years have not been established.

MOST COMMON ADVERSE REACTIONS (frequency 1% to 4%)

  • Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), and dizziness (1%).

Please click here to see full Prescribing Information for ELMIRON®.

cp-59277v2

ELMIRON® is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

INDICATION

ELMIRON® is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

Janssen

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Last Updated December 2019 cp-55422v4

The information contained in this section of the site is intended for US healthcare professionals only.