IMPORTANT SAFETY INFORMATION
- Contraindications: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
- 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 reminded that ELMIRON® has a weak anticoagulant effect. This effect may increase bleeding times.
- Pregnancy and Lactation: 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. It is not known if ELMIRON® is excreted in human milk. Caution should be exercised when ELMIRON® is administered to a nursing woman.
- 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%).