Elmiron

WARNINGS

None.

PRECAUTIONS

General

ELMIRON (pentosan polysulfate sodium capsules) ® 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 of ecchymosis, epistaxis, and gum hemorrhage have been reported (see ADVERSE REACTIONS). 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 (pentosan polysulfate sodium capsules) ®.

A similar product that was given subcutaneously, sublingualis or intramuscularly (and not initially metabolized by the liver) is associated with delayed immunoallergic thrombocytopenia with symptoms of thrombosis and hemorrhage. Caution should be exercised when using ELMIRON (pentosan polysulfate sodium capsules) ® in patients who have a history of heparin induced thrombocytopenia.

Alopecia is associated with pentosan polysulfate and with heparin products. In clinical trials of ELMIRON (pentosan polysulfate sodium capsules) ®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.

Hepatic Insufficiency

ELMIRON (pentosan polysulfate sodium capsules) ® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of ELMIRON (pentosan polysulfate sodium capsules) ®, hepatic impairment may have an impact on the pharmacokinetics of ELMIRON (pentosan polysulfate sodium capsules) ®. Caution should be exercised when using ELMIRON (pentosan polysulfate sodium capsules) ® in this patient population.

Mildly ( < 2.5 x normal) elevated transaminase, alkaline phosphatase, Y-glutamyl transpeptidase, and lactic dehydrogenase occurred in 1.2% of patients. The increases usually appeared 3 to 12 months after the start of ELMIRON (pentosan polysulfate sodium capsules) ® therapy, and were not associated with jaundice or other clinical signs or symptoms. These abnormalities are usually transient, may remain essentially unchanged, or may rarely progress with continued use. Increases in PTT and PT ( < 1 % for both) or thrombocytopenia (0.2%) were noted.

Information for Patients

Patients should take the drug as prescribed, in the dosage prescribed, and no more frequently than prescribed. Patients should be reminded that ELMIRON (pentosan polysulfate sodium capsules) ® has a weak anticoagulant effect. This effect may increase bleeding times.

Laboratory Test Findings

Pentosan polysulfate sodium did not affect prothrombin time (PT) or partial thromboplastin time (PTT) up to 1200 mg per day in 24 healthy male subjects treated for 8 days. Pentosan polysulfate sodium also inhibits the generation of factor Xa in plasma and inhibits thrombin-induced platelet aggregation in human platelet rich plasma ex vivo. (See PRECAUTIONS-Hepatic Insufficiency Section for additional information.)

Carcinogenicity, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies of ELMIRON (pentosan polysulfate sodium capsules) ® in F344/N rats and B6C3F1 mice have been conducted. In these studies, ELMIRON (pentosan polysulfate sodium capsules) ® was orally administered once daily via gavage, 5 days per week, for up to 2 years. The dosages administered to mice were 56, 168 or 504 mg/kg. The dosages administered to rats were 14, 42, or 126 mg/kg for males, and 28, 84, or 252 mg/kg for females. The dosages tested were up to 60 times the maximum recommended human dose (MRHD) in rats, and up to 117 times the MRHD in mice, on a mg/kg basis. The results of these studies in rodents showed no clear evidence of drug-related tumorigenesis or carcinogenic risk.

Pentosan polysulfate sodium was not clastogenic or mutagenic when tested in the mouse micronucleus test orthe Ames test (S. typhimuhum). The effect of pentosan polysulfate sodium on spermatogenesis has not been investigated.

Pregnancy Category B

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 ELMIRON (pentosan polysulfate sodium capsules) ® when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON (pentosan polysulfate sodium capsules) ®. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Nursing Mothers

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 ELMIRON (pentosan polysulfate sodium capsules) ® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 16 years have not been established.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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