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%).

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cp-59277v2

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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

INDICATION