Entocort® EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn's disease involving the ileum and/or the ascending colon. Entocort EC consists of an encapsulated formulation of budesonide granules, a glucocorticosteriod. The granules are coated to protect dissolution in gastric juice, but dissolve at pH >5.5, normally when the granules reach the duodenum. Thereafter, a matrix controls the release of the drug into the intestinal lumen in a time-dependent manner. Eighty to ninety percent of Entocort EC does not enter the systemic circulation. Entocort EC may reduce the incidence of some corticosteroid-associated side effects such as acne and moon face compared to prednisolone(2).
Important Safety Information
Since Entocort® EC (budesonide) Capsules is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitaryadrenal 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, which may be more severe, 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 GCSs may have unwanted effects.
Reduced liver function affects the elimination of GCSs, and increased systemic availability of oral budesonide has been observed in patients with liver cirrhosis. 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. Reduction in the dose of Entocort EC should be considered in these patients. Patients should be advised to avoid consuming grapefruits and grapefruit juice while being treated with Entocort EC.
Safety and effectiveness in pediatric, geriatric, and pregnant patients have not been established. Entocort EC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.
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 for serious adverse reactions in 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 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.
Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus' corporate offices are located in San Diego, California.
Proleukin is a registered trademark of Novartis.
ENTOCORT is a registered trademark of the AstraZeneca group of companies.
CIMZIA is a registered trademark of the UCB group of companies.
HUMIRA is a registered trademark of Abbott Laboratories.
REMICADE is a registered trademark of Centocor Ortho Biotech Inc.
(1) Afif W et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9.
(2) ENTOCORT EC (budesonide) Capsules Prescribing Information