1. What is the mechanism of action of ELMIRON®?

Although the mechanism of action of ELMIRON® in interstitial cystitis is not fully understood, ELMIRON® is believed to replenish the protective lining, preventing potentially irritating solutes in the urine from reaching the bladder wall.

2. How should ELMIRON® be taken?

ELMIRON® should be taken by mouth, 1 capsule 3 times a day, with water, at least
1 hour before meals or 2 hours after meals. Each capsule contains
100 mg of ELMIRON®.

3. How long does it take ELMIRON® to work?

Symptom improvement with ELMIRON® tends to be gradual. Optimal clinical response may require 3 to 6 months of continuous therapy, although some patients have responded in as early as 4 weeks. Discussing this with patients right from the start of therapy is important and may help with compliance. The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.

4. Can ELMIRON® be taken during pregnancy?

ELMIRON® is a Pregnancy Category B drug. Animal reproduction studies have been performed and did not reveal evidence of impaired fertility or harm to the fetus
from ELMIRON®. 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.

5. What are the most common adverse reactions of ELMIRON®?

In clinical trials of ELMIRON®, the most common adverse reactions (frequency 1% to 4%) were alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).

6. What is the important safety information about ELMIRON®?

• Contraindications: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients
• Anticoagulant Activity: ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding. Patients undergoing invasive surgery or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to anticoagulant therapy or high doses of anti-inflammatory drugs) should be evaluated for the risk of hemorrhage
• Alopecia: In clinical trials of ELMIRON®, 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
• Use in Pregnancy: ELMIRON® is a Pregnancy Category B drug
• 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%), dizziness (1%)

7. What is included in a multimodal approach to interstitial cystitis
(IC) therapy?

When treating patients with IC, clinicians should consider that both pharmacologic and nonpharmacologic therapy may be needed for symptom control. ELMIRON® is the only FDA-approved oral agent indicated for bladder pain or discomfort associated with IC. Dimethyl sulfoxide, an intravesical instillation, is the only FDA-approved intravesical therapy indicated for IC. However, other adjunctive agents not indicated for IC, such as tricyclic antidepressants, antihistamines, or anticonvulsants have been used “off label” for IC symptom management. Additionally, it may be appropriate to introduce physical therapy, dietary modifications, or bladder retraining into the patient’s treatment plan. Treatment should always be tailored to the patient’s individual needs.

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 (blood thinner) which may increase bleeding. Patients undergoing invasive surgery or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to anticoagulant therapy or high doses of anti-inflammatory drugs) should be evaluated for the risk of hemorrhage
• Alopecia: In clinical trials of ELMIRON®, 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
• Use in Pregnancy: ELMIRON® is a Pregnancy Category B drug
• 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%), dizziness (1%)