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For Most Mild to Moderate Crohn's Patients

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For Crohn's disease involving the ileum and/or ascending colon, ENTOCORT EC is indicated for the treatment of mild to moderate active disease (up to 8 weeks with repeated 8-week courses as necessary) and the maintenance of clinical remission of mild to moderate disease for up to an additional 3 months.

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150.

Important Safety Information

  • Since ENTOCORT EC is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitary-adrenal axis to stress. Supplementation with a systemic GCS is recommended before surgery or other stress situations.
  • Adrenocortical function monitoring may be required in patients being transferred to ENTOCORT EC from a systemic GCS, and the dose of the systemic GCS should be reduced cautiously.
  • Patients on drugs that suppress the immune system are more susceptible to infections and should avoid exposure to infections such as chicken pox or measles.
  • Caution should be taken in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.
  • Patients with moderate to severe liver disease and patients who are concomitantly taking ketoconazole or any other CYP3A4 inhibitor should be closely monitored for increased signs and/or symptoms of hypercorticism.
  • Safety and effectiveness in pediatric, geriatric, and pregnant patients have not been established. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue ENTOCORT EC, taking into account the clinical importance of ENTOCORT EC to the mother and the potential risk to the nursing infant.
  • The adverse-event profile of ENTOCORT EC in 6 mg once daily clinical trial treatment (52-week) was similar to that of 9 mg once daily clinical trial treatment (8-week). The most frequently reported adverse events in clinical trials with ENTOCORT EC were headache, respiratory infection, nausea, and symptoms of hypercorticism.

Please read the full Prescribing Information.