To help control
symptoms
of
mild to
moderate
Crohn’s disease*
CHOOSE ORTIKOS®
- Crohn's disease involving the ileum and/or the ascending colon.
- In adults, 9 mg once daily for up to 8 weeks in active disease; 6 mg once daily for up to 3 months for maintenance. Please see full Prescribing Information for additional dosing information.
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- Terms and conditions apply.
Budesonide Demonstrated Clinical Improvement After 8 Weeks of Treatment1-6
Efficacy Established in 5 Randomized Clinical Trials (N=994)1-6
- Studies 1 and 2 demonstrated statistical significance.
- This drug is not approved for the treatment of Crohn's disease in the United States.
Study Description1-6
The safety and efficacy of ORTIKOS have been established in clinical studies of another oral budesonide. These studies included 5 randomized, 8-week, double-blind studies in 994 patients with mild to moderate active Crohn’s disease of the ileum and/or ascending colon. Clinical improvement, defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 after 8 weeks of treatment, was the primary efficacy variable in these 5 trials. Study 1 compared the efficacy of budesonide (9 mg QD) to a comparator (2 g BID) (baseline CDAI: 272). Study 2 assessed twice-daily doses of budesonide (1.5, 4.5, and 7.5 mg BID) versus placebo (baseline CDAI: 290). Study 3 was a 3-armed parallel group study; the groups were treated with budesonide 9 mg QD, budesonide 4.5 mg BID, and placebo for 8 weeks, followed by a 2-week, double-blind taper phase (baseline CDAI: 263). Study 4 was a 3-armed parallel group study; the groups were treated with budesonide 9 mg QD, budesonide 4.5 mg BID, and prednisolone 40 mg (tapered dose) for 8 weeks, followed by a 4-week, double-blind taper phase (baseline CDAI: 277). Study 5 compared oral budesonide with oral prednisolone; the budesonide group received 9 mg QD for 8 weeks, followed by 6 mg QD for 2 weeks; the prednisolone group received 40 mg QD for 2 weeks, followed by a 1-week taper phase (baseline CDAI: 275).
Budesonide Sustained Clinical Remission for Nearly 1 Year (N=380)1,3
When compared with placebo, budesonide prolonged the median time to relapse to nearly 1 year (268 vs 154 days)
Study Description1
Maintenance of clinical remission was evaluated in 4 double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with 3 or 6 mg of budesonide or placebo. In the pooled population of the 4 studies, patients had a CDAI reduction of at least 60 units, total score >150 or withdraw due to disease deterioration.
References: 1. ORTIKOS [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; 2022. 2. Thomsen OO, Cortot A, Jewell D, et al. A comparison of budesonide and mesalamine for active Crohn’s disease. N Engl J Med. 1998;339:370-374. 3. Greenberg GR, Feagen BG, Martin F, et al. Oral budesonide for active Crohn’s disease. N Engl J Med. 1994;331:836-841. 4. Campieri M, Ferguson A, Doe W, et al. Oral budesonide is as effective as oral prednisolone in active Crohn’s disease. Gut. 1997;41:209-214. 5. Tremaine WJ, Hanauer SB, Katz S, et al. Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn’s disease: a randomized placebo-controlled study in the United States. Am J Gastroenterol. 2002;97:1748-1754. 6. Rutgeerts P, Lofberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn’s disease. N Engl J Med. 1994;331:842-845.
ORTIKOS® Is Available in Once-Daily 9- and 6-mg Doses1
Dosing
Initiation Therapy

8-week treatment course can be repeated if there are recurring episodes of active disease
NDC Code: 55566-1020-1
Maintenance of Clinical Remission

Tapering to complete cessation is recommended if symptom control is still maintained at 3 months*
NDC Code: 55566-1002-1
- Continued treatment for >3 months has not been shown to provide substantial clinical benefit.
Administration
- ORTIKOS should be taken once daily in the morning
- Swallow the capsule whole; do not chew or crush
- When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating ORTIKOS
- Consumption of grapefruit juice should be avoided for the duration of therapy
Reference: 1. ORTIKOS [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; 2022.
Most Common Adverse Events in 8-Week Treatment Clinical Trials1
Adverse Events in 8 Weeks vs Placebo, Prednisolone, and Comparator
Adverse Reaction, %* | Budesonide 9 mg (n=520) | Placebo (n=107) | Prednisolone† 40 mg (n=145) | Comparator‡ (n=88) |
---|---|---|---|---|
Headache | 21% | 18% | 21% | 13% |
Respiratory infection | 11% | 7% | 14% | 6% |
Nausea | 11% | 9% | 12% | 8% |
Back pain | 7% | 9% | 12% | 6% |
Dyspepsia | 6% | 4% | 12% | 3% |
Dizziness | 7% | 5% | 12% | 6% |
Abdominal pain | 6% | 17% | 4% | 11% |
Flatulence | 6% | 6% | 8% | 6% |
Vomiting | 6% | 6% | 4% | 7% |
Fatigue | 5% | 7% | 8% | 0% |
Pain | 5% | 7% | 12% | 2% |
Adverse Reaction, %* | Budesonide 9 mg (n=520) | Placebo (n=107) | Prednisolone† 40 mg (n=145) | Comparator‡ (n=88) |
---|---|---|---|---|
Headache | 21% | 18% | 21% | 13% |
Respiratory infection | 11% | 7% | 14% | 6% |
Nausea | 11% | 9% | 12% | 8% |
Back pain | 7% | 9% | 12% | 6% |
Dyspepsia | 6% | 4% | 12% | 3% |
Dizziness | 7% | 5% | 12% | 6% |
Abdominal pain | 6% | 17% | 4% | 11% |
Flatulence | 6% | 6% | 8% | 6% |
Vomiting | 6% | 6% | 4% | 7% |
Fatigue | 5% | 7% | 8% | 0% |
Pain | 5% | 7% | 12% | 2% |
- Occurring in ≥5% of the patients in any treated group.
- Prednisolone tapering scheme: Either 40 mg in week 1 to 2, thereafter tapering with 5 mg per week; or 40 mg in week 1 to 2, 30 mg in week 3 to 4, thereafter tapering with 5 mg per week.
- This drug is not approved for the treatment of Crohn’s disease in the United States.
Fewer glucocorticosteroid (GCS)-related side effects than prednisolone in 8 weeks1
Adverse Events of Hypercorticism in 8-Week Treatment Clinical Trials
Adverse Events, % | Budesonide 9 mg (n=427) | Placebo (n=107) | Prednisolone* 40 mg (n=145) |
---|---|---|---|
Total | 34% | 27% | 48% |
Acne | 15% | 13% | 23%† |
Bruising easily | 15% | 11% | 9% |
Moon face | 11% | 4% | 37%† |
Swollen ankles | 7% | 6% | 9% |
Hirsutism‡ | 5% | 2% | 3% |
Buffalo hump | 1% | 2% | 3% |
Skin striae | 1% | 2% | 0% |
Adverse Events, % | Budesonide 9 mg (n=427) | Placebo (n=107) | Prednisolone* 40 mg (n=145) |
---|---|---|---|
Total | 34% | 27% | 48% |
Acne | 15% | 13% | 23%† |
Bruising easily | 15% | 11% | 9% |
Moon face | 11% | 4% | 37%† |
Swollen ankles | 7% | 6% | 9% |
Hirsutism‡ | 5% | 2% | 3% |
Buffalo hump | 1% | 2% | 3% |
Skin striae | 1% | 2% | 0% |
- Prednisolone tapering scheme: Either 40 mg in week 1 to 2, thereafter tapering with 5 mg/week; or 40 mg in week 1 to 2, 30 mg in week 3 to 4, thereafter tapering with 5 mg/week.
- Statistically significantly different from budesonide 9 mg.
- Including hair growth increased, local and hair growth increased, general.
Reference: 1. ORTIKOS [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; 2022.
Help Patients Save on Their Prescriptions
Commercially Insured Patients May Pay as Little as $10 for a 30-Day Supply*

Co-pay Savings
- Valid for eligible commercially insured patients
- Patients can present their savings card to the pharmacist and start saving today!
- Terms and conditions apply. If for any reason you do not have an ORTIKOS savings card, an eVoucher may also be available at the pharmacy if you are deemed eligible.