Administration Instructions

•

Take ENTOCORT EC capsules once daily in the morning.

•

Swallow ENTOCORT EC delayed-release capsules whole. Do not chew or crush.

•

For patients unable to swallow an intact capsule, ENTOCORT EC delayed-release capsules can be opened and administered as follows:

1.

Place one tablespoonful of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.

2.

Open the capsule(s).

3.

Carefully empty all the granules inside the capsule(s) on the applesauce.

4.

Mix the granules with the applesauce.

5.

Consume the entire contents within 30 minutes of mixing. Do not chew or crush the granules. Do not save the applesauce and granules for future use.

6.

Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to ensure complete swallowing of the granules.

•

Avoid consumption of grapefruit juice for the duration of ENTOCORT EC therapy [see Drug Interactions (7.1)].

Treatment of Mild to Moderate Active Crohn's Disease

The recommended dosage of ENTOCORT EC is:

Adults: 9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of ENTOCORT EC can be given for recurring episodes of active disease.

Pediatric patients 8 to 17 years who weigh more than 25 kg: 9 mg orally once daily for up to 8 weeks, followed by 6 mg once daily for 2 weeks.

Maintenance of Clinical Remission of Mild to Moderate Crohn's Disease

The recommended dosage in adults, following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), is ENTOCORT EC 6 mg orally once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with ENTOCORT EC 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.

Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to ENTOCORT EC with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating ENTOCORT EC treatment.

Dosage Adjustment in Adult Patients with Hepatic Impairment

Consider reducing the dosage of ENTOCORT EC to 3 mg once daily for adult patients with moderate hepatic impairment (Child-Pugh Class B). Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) [see Warnings and Precautions (5.1), Use in Specific Populations (8.6)].