Pentosan Polysulfate Sodium Capsules

ELMIRON® was evaluated in clinical trials in a total of 2627 patients (2343 women, 262 men, 22 unknown) with a mean age of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the 2627 patients, 128 patients were in a 3-month trial and the remaining 2499 patients were in a long-term, unblinded trial.

Deaths occurred in 6/2627 (0.2%) patients who received the drug over a period of 3 to 75 months. The deaths appear to be related to other concurrent illnesses or procedures, except in one patient for whom the cause was not known.

Serious adverse events occurred in 33/2627 (1.3%) patients. Two patients had severe abdominal pain or diarrhea and dehydration that required hospitalization. Because there was not a control group of patients with interstitial cystitis who were concurrently evaluated, it is difficult to determine which events are associated with ELMIRON® and which events are associated with concurrent illness, medicine, or other factors.

Adverse Experience in Placebo-Controlled Clinical Trials of ELMIRON® 100 mg Three Times a Day for 3 Months

The adverse events described below were reported in an unblinded clinical trial of 2499 interstitial cystitis patients treated with ELMIRON®. Of the original 2499 patients, 1192 (48%) received ELMIRON® for 3 months; 892 (36%) received ELMIRON for 6 months; and 598 (24%) received ELMIRON® for one year, 355 (14%) received ELMIRON® for 2 years, and 145 (6%) for 4 years.

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

Frequency ( ≤ ; 1%):

Digestive: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, gum hemorrhage.

Hematologic: Anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, leukopenia, thrombocytopenia.

Hypersensitive Reactions: Allergic reaction, photosensitivity.

Respiratory System: Pharyngitis, rhinitis, epistaxis, dyspnea.

Skin and Appendages: Pruritus, urticaria.

Special Senses: Conjunctivitis, tinnitus, optic neuritis, amblyopia, retinal hemorrhage.

Post-Marketing Experience

ELMIRON® was evaluated in a randomized, double-blind, parallel group, Phase 4 study conducted in 380 patients with interstitial cystitis dosed for 32 weeks. At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. The severity of the events was described as “mild” in most patients. Patients in that study who were administered ELMIRON® 900 mg daily, a dose higher than the approved dose, experienced a higher incidence of rectal hemorrhage, 15%.

A randomized, double-blind, parallel group, phase 2 study was conducted in 100 men (51 ELMIRON® and 49 placebo) dosed for 16 weeks. At a daily dose of 900 mg, a dose higher than the approved dose, elevated liver function tests were reported as an adverse event in 11.8% (n = 6) of ELMIRON®-treated patients and 2% (n = 1) of placebo-treated patients.

PHARMACIST: PLEASE DISPENSE ONE PATIENT LEAFLET PER PRESCRIPTION

Questions and Answers About

ELMIRON® (Generic name = pentosan polysulfate sodium) Capsules

What is the most important information I should know about ELMIRON®?

ELMIRON® (pronounced EL ma ron) is used to treat the pain or discomfort of interstitial cystitis (IC).

You must take ELMIRON® as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed.

ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding.

Call your doctor if you will be undergoing surgery or will begin taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

What is ELMIRON®?

ELMIRON® is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how ELMIRON® works, but it is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed.

Who should not take ELMIRON®?

• Patients undergoing surgery should speak with their doctor about when to discontinue ELMIRON® prior to surgery.
• ELMIRON® should be used during pregnancy only if clearly needed.

What does your doctor need to know?

• If you are taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.
• If you are pregnant.
• If you have any liver problems.

How should I take ELMIRON®?

You should take 1 capsule of ELMIRON® by mouth three times a day, with water at least 1 hour before meals or 2 hours after meals. Each capsule contains 100 mg of ELMIRON®.

What should I avoid while taking ELMIRON®?

Anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin or anti-inflammatory drugs such as ibuprofen until you speak with your doctor.

What are the most common side effects of ELMIRON®?

The most common side effects are hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness and bruising.

Call your doctor if these side effects persist or are bothersome or if there is blood in your stool.

If you suspect that someone may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

This leaflet provides a summary of information about ELMIRON®. Medicines are sometimes prescribed for uses other than those listed in a Patient Leaflet. If you have any questions or concerns, or want more information about ELMIRON®, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about ELMIRON® that is written for health professionals that you can ask to read.

• Interstitial Cystitis (IC)

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© Elmiron Patient Information is supplied by Cerner Multum, Inc. and Elmiron Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.