Ortikos Dosage

Administration Instructions

• Take ORTIKOS once daily in the morning.
• Swallow ORTIKOS whole. Do not chew or crush.
• Avoid consumption of grapefruit juice for the duration of therapy with ORTIKOS [see Drug Interactions (7.1)].

Treatment of Mild to Moderate Active Crohn's Disease

The recommended dosage of ORTIKOS is:

Adults: 9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of ORTIKOS 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 ORTIKOS 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 ORTIKOS 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 ORTIKOS with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating ORTIKOS treatment.