To help control
symptoms
of
mild to
moderate
Crohn’s disease*
CHOOSE ORTIKOS

one pill once a day
  • 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.

ORTIKOS is the first and only one pill, once-daily budesonide for the treatment of mild to moderate Crohn’s disease.

Budesonide Demonstrated Clinical Improvement After 8 Weeks of Treatment1-6

Efficacy Established in 5 Randomized Clinical Trials (N=994)1-6

Study 11,2*
Budesonide
9 mg QD
(n=91)
69%
Comparator†
(n=83)
 
45%
P=0.0004
Study 21,3*
Budesonide
4.5 mg BID
(n=61)
51%
Placebo
(n=64)
 
20%
P=0.001
Study 31,5
Budesonide
9 mg QD
(n=79)
48%
Budesonide
4.5 mg BID
(n=78)
53%
Placebo
(n=40)
 
33%
P=NS
Study 41,4
Budesonide
9 mg QD
(n=58)
60%
Budesonide
4.5 mg BID
(n=60)
42%
Prednisolone
40 mg QD
(n=58)
60%
P=NS
Study 51,6
Budesonide
9 mg QD
(n=86)
52%
Prednisolone
40 mg QD
(n=85)
65%
P=NS
  • 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)

Clinical Remission Chart Mobile Clinical Remission Chart Tablet Clinical Remission Chart

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; 2019. 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
Ortikos Initiation Pill 9 mg QD up to 8 weeks

8-week treatment course can be repeated if there are recurring episodes of active disease

NDC Code: 55566-1020-1

Ortikos Initiation Pill
Maintenance of Clinical Remission
Ortikos Maintenance Pill 6 mg QD for up to 3 months

Tapering to complete cessation is recommended if symptom control is still maintained at 3 months*

NDC Code: 55566-1002-1

Ortikos Maintenance Perscription
  • 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; 2019.

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)
Headache21%18%21%13%
Respiratory infection11%7%14%6%
Nausea11%9%12%8%
Back pain7%9%12%6%
Dyspepsia6%4%12%3%
Dizziness7%5%12%6%
Abdominal pain6%17%4%11%
Flatulence6%6%8%6%
Vomiting6%6%4%7%
Fatigue5%7%8%0%
Pain5%7%12%2%
Adverse Reaction, %*Budesonide
9 mg
(n=520)		Placebo
(n=107)		Prednisolone†
40 mg
(n=145)		Comparator‡
(n=88)
Headache21%18%21%13%
Respiratory infection11%7%14%6%
Nausea11%9%12%8%
Back pain7%9%12%6%
Dyspepsia6%4%12%3%
Dizziness7%5%12%6%
Abdominal pain6%17%4%11%
Flatulence6%6%8%6%
Vomiting6%6%4%7%
Fatigue5%7%8%0%
Pain5%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)
Total34%27%48%
Acne15%13%23%†
Bruising easily15%11%9%
Moon face11%4%37%†
Swollen ankles7%6%9%
Hirsutism‡5%2%3%
Buffalo hump1%2%3%
Skin striae1%2%0%
Adverse Events, %Budesonide
9 mg
(n=427)		Placebo
(n=107)		Prednisolone*
40 mg
(n=145)
Total34%27%48%
Acne15%13%23%†
Bruising easily15%11%9%
Moon face11%4%37%†
Swollen ankles7%6%9%
Hirsutism‡5%2%3%
Buffalo hump1%2%3%
Skin striae1%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; 2019.

Help Patients Save on Their Prescriptions

Commercially Insured Patients May Pay as Little as $10 for a 30-Day Supply*

ORTIKOS Coupon
Co-pay Savings
  • Valid for eligible commercially insured patients
  • Patients can present their savings card to the pharmacist and start saving today!
Download Savings Card
  • 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.
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INDICATIONS

ORTIKOS is a corticosteroid indicated for:

  • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older
  • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ORTIKOS is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of the capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred.

WARNINGS AND PRECAUTIONS

  • Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids, pediatrics, and patients with hepatic impairment may be at increased risk. Pediatric patients with Crohn’s disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression. Avoid use of ORTIKOS in patients with moderate or severe hepatic impairment.
  • Symptoms of Steroid withdrawal in Patients Transferred from Other Systemic Corticosteroids: Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema).
  • Increased Risk of Infection, including Serious and Fatal Chicken Pox and Measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
  • Other Corticosteroid Effects: Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma).

ADVERSE REACTIONS

Most common adverse reactions (≥ 5%) in adults are: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

DRUG INTERACTIONS

Avoid use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) as they can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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INDICATIONS

ORTIKOS is a corticosteroid indicated for:

  • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older
  • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ORTIKOS is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of the capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred.

WARNINGS AND PRECAUTIONS

  • Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids, pediatrics, and patients with hepatic impairment may be at increased risk. Pediatric patients with Crohn’s disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression. Avoid use of ORTIKOS in patients with moderate or severe hepatic impairment.
  • Symptoms of Steroid withdrawal in Patients Transferred from Other Systemic Corticosteroids: Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema).
  • Increased Risk of Infection, including Serious and Fatal Chicken Pox and Measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
  • Other Corticosteroid Effects: Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma).

ADVERSE REACTIONS

Most common adverse reactions (≥ 5%) in adults are: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

DRUG INTERACTIONS

Avoid use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) as they can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.