Elmiron

Semisynthetic low molecular weight heparinoid; a uroprotective agent resembling glycosaminoglycans.1 4 5 6 8

Storage

Oral

15–30°C.1

Pentosan is used to relieve the symptoms of the bladder condition called interstitial cystitis.

This medicine is available only with your doctor's prescription.

Use Elmiron as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Take with a full glass of water.
• Follow up with your doctor after using this medicine for 3 months.
• To gain the most benefit, do not miss doses.
• Keep taking Elmiron as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Elmiron or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Elmiron. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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

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.

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

The following adverse reactions have been identified during postapproval use of pentosan polysulfate sodium; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: weight gain and edema.

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.

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

NDC NUMBER 50458-098-01

Storage

Store at controlled room temperature 15°–30°C (59°–86°F).

Keep out of reach of children.

Elmiron® is a Registered Trademark of Teva Branded Pharmaceutical Products R&D, Inc. under license to Janssen Pharmaceuticals, Inc.

© 2002 Janssen Pharmaceutical Companies

(logo)

Product of Germany

Manufactured by:
Janssen Ortho LLC
Gurabo, Puerto Rico 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560

Revised July 2017

PHARMACIST: PLEASE DISPENSE ONE PATIENT LEAFLET PER PRESCRIPTION

Applies to pentosan polysulfate sodium: oral capsule

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included nausea, diarrhea, dyspepsia, vomiting, and rectal hemorrhage.[Ref]

In a phase 4 study of patients with interstitial cystitis (n=380) taking pentosan polysulfate sodium, the incidence of rectal hemorrhage was reported at 15% in patients taking doses of 900 mg/day versus 6.3% in patients taking the recommended daily dosage of 300 mg/day.[Ref]

Dermatologic

Dermatologic side effects have included alopecia, pruritus, and urticaria.[Ref]

Nervous system

Nervous system side effects have included headache (3%) and dizziness (1%). Hyperkinesia, insomnia, and depression have also been reported.[Ref]

Hematologic

Hematologic side effects have included anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, and thrombocytopenia.[Ref]

There have been case reports of thrombocytopenia similar to heparin induced thrombocytopenia associated with a parenteral form of pentosan polysulfate sodium. It should be used with caution in patients with a history of heparin induced thrombocytopenia.[Ref]

Hepatic

Hepatic side effects have included liver function abnormalities: mildly elevated (

There are no data on the excretion of pentosan polysulfate sodium into breast milk. The manufacturer recommends that caution be used when administering pentosan polysulfate sodium to nursing women.