ELMISAN® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
ELMISAN® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
ELMISAN® is a weak anticoagulant (1/15 the activity of heparin). At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. Bleeding complications such as ecchymosis, epistaxis, and gum hemorrhage have been reported. Patients undergoing invasive procedures or those with signs/symptoms of underlying coagulopathy or an 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 ELMISAN®. A similar product, when administered subcutaneously, sublingually, or intramuscularly (and not initially metabolized by the liver), has been associated with delayed immunoallergic thrombocytopenia, presenting with symptoms of thrombosis and hemorrhage.
Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of ELMISAN® when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMISAN®. This drug should be used in pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELMISAN® is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 16 years have not been established.
ELMISAN® was evaluated in clinical trials involving a total of 2,627 patients (2,343 women, 262 men, and 22 unknown) with a mean age of 47 years (range: 18 to 88), including 581 patients (22%) over 60 years of age. Among these patients, 128 participated in a 3-month trial, while the remaining 2,499 were enrolled in a long-term, unblinded trial. Deaths occurred in 6 out of 2,627 (0.2%) patients who received the drug over a period of 3 to 75 months. These deaths appear to be related to other concurrent illnesses or procedures, except for one patient, for whom the cause of death was unknown.
Adverse Experience in Placebo-Controlled Clinical Trials of ELMISAN® 100 mg Three Times a Day for 3 Months
The clinical trials revealed adverse experiences, including bleeding events and elevated liver function tests, particularly at higher doses.
Overdose has not been reported. Based on the pharmacodynamics of the drug, toxicity is likely to manifest as anticoagulation, bleeding, thrombocytopenia, liver function abnormalities, and gastric distress. In a clinical trial where patients received a daily dose of 900 mg for 32 weeks (n = 127), rectal hemorrhage was reported as an adverse event in 15% of patients. Another clinical trial, in which patients took ELMISAN® 900 mg daily for 16 weeks, reported elevated liver function tests in 11.8% of patients in the ELMISAN® group and 2% in the placebo group. In the event of acute overdosage, gastric lavage should be performed if possible, and the patient should be carefully observed and provided with symptomatic and supportive treatment.
The recommended dose of ELMISAN® is 100 mg, taken orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals. Patients receiving ELMISAN® should be reassessed after 3 months. If no improvement occurs and if limiting adverse events are not present, ELMISAN® may be continued for another 3 months.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
