Entocort EC and Ortikos:

• Treatment of mild to moderate active Crohn’s disease involving ileum and/or ascending colon.

Entocort EC and Ortikos:

• Maintenance of clinical remission for up to 3 mo of mild to moderate Crohn's disease involving ileum and/or ascending colon.

Uceris:

• Induction of remission of active, mild to moderate ulcerative colitis.

Tarpeyo:

• Reduction of proteinuria in patients with primary immunoglobulin A nephropathy who are at risk of rapid disease progression (i.e. a urine protein-to-creatinine ratio [UPCR] 1.5 g/g).

Contraindicated in:

• Hypersensitivity
• Severe hepatic impairment
• Moderate hepatic impairment (Ortikos and Uceris only).

Use Cautiously in:

• History of diabetes (or family history), tuberculosis, osteoporosis, hypertension, peptic ulcer, glaucoma (or family history) or cataracts (conditions may be exacerbated)
• Stress, including surgery or infections; supplemental doses of corticosteroid may be needed
• Active untreated infections
• Immunosuppression
• Potential infections (may mask signs such as fever or inflammation)
• Moderate hepatic impairment (Entocort EC and Tarpeyo only) (↓ dose of Entocort EC)
• OB: Use during pregnancy only if maternal benefit outweighs potential fetal risk; monitor infants for signs/symptoms of hypoadrenalism
• Lactation: Use while breastfeeding only if maternal benefit outweighs potential risk to infant
• Pedi: Safety and effectiveness not established in children <18 yr (Tarpeyo and Uceris) and <8 yr (Entocort EC and Ortikos)
• Geri: ↑risk of adverse reactions.

CV: edema, hypertension, palpitations, tachycardia.

Derm: acne, easy bruising, hirsutism, alopecia, dermatitis, eczema, flushing, striae, sweating.

EENT: abnormal vision, conjunctivitis.

Endo: ADRENAL SUPPRESSION, hypokalemia.

GI: nausea, abdominal pain, dyspepsia, flatulence, vomiting.

GU: dysuria, irregular menses, nocturia, urinary frequency.

Hemat: leukocytosis.

Metab: weight gain.

MS: back pain, cramps, myalgia.

Neuro: hyperkinesia, paresthesia, tremor, headache, agitation, confusion, dizziness, drowsiness, fatigue, ↑ appetite, insomnia, malaise, nervousness, vertigo.

Resp: bronchitis, dyspnea.
Misc: infection, cushingoid appearance, flu-like syndrome.

Drug-Drug:

• Known inhibitors of the CYP3A4 enzyme system including ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, and erythromycin; may ↑ levels; ↓ dose may be necessary.

Drug-Natural Products:

• St. John's wort may ↓ levels.

Drug-Food:

• Grapefruit juice significantly ↑ blood levels; concurrent use should be avoided.

(Generic available)

• Delayed-release capsules (Entocort EC): 3 mg;
• Delayed-release capsules (Tarpeyo): 4 mg;
• Extended-release capsules (Ortikos): 6 mg; 9 mg;
• Extended-release tablets (Uceris): 9 mg;

Treatment of Active Crohn's Disease (Entocort EC and Ortikos)

• PO (Adults): 9 mg once daily in the morning for up to 8 wk; recurring episodes of active disease can be treated with a repeat 8–wk course of therapy.
• PO (Children 8 yr and >25 kg): 9 mg once daily in the morning for up to 8 wk, then 6 mg once daily in the morning for 2 wk.

Maintenance of Remission of Crohn's Disease (Entocort EC and Ortikos)

• PO (Adults): Following treatment of active disease and once patient's symptoms controlled, continue treatment with 6 mg once daily for up to 3 mo. If symptom control maintained at 3 mo, dose should be tapered to complete discontinuation. Continuing treatment for > 3 mo does not produce significant clinical benefit.

Induction of Remission of Ulcerative Colitis (Uceris)

• PO (Adults): 9 mg once daily in the morning for up to 8 wk.

Reduction in Proteinuria Associated with Primary Immunoglobulin A Nephropathy (Tarpeyo)

• PO (Adults): 16 mg once daily in the morning for 9 mo, then 8 mg once daily in the morning for 2 wk.

Entocort EC, Ortikos, Tarpeyo, Uceris

• Has high local anti-inflammatory activity in the lumen of the GI tract, but is rapidly inactivated following absorption. Action in Crohn's disease and ulcerative colitis is primarily local. Modulates activity of B-cells in ileum to decrease production of galactose-deficient IgA1 antibodies, which cause IgA nephropathy.

• Improvement in symptoms/sequelae of Crohn’s disease.
• Induction of remission of ulcerative colitis
• Reduction in UPCR.

Therapeutic Classification: gastrointestinal anti-inflammatories

Pharmacologic Classification: corticosteroids

Absorption: Well absorbed following oral administration (9–21% bioavailability).

Distribution: Widely distributed to extravascular tissues; enters breast milk.

Protein Binding: 85–90%.

Metabolism/Excretion: Rapidly and extensively metabolized during first pass hepatic metabolism by the CYP3A4 enzyme system to inactive metabolites which are excreted in urine and feces.

Half-life: 2.0–3.6 hr; Tarpeyo — 5–6.8 hr.

Cortiment, Entocort, Jorveza

(improvement in symptoms of Crohn’s disease or induction of remission of ulcerative colitis)

• Instruct patient to take medication as directed. Do not share medication with others, even if they have similar symptoms; may be harmful. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
• Advise patient to avoid grapefruit juice during therapy; may increase budesonide blood levels.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional if signs and symptoms of hypercorticism (acne, thicker or more hair on body and face; bruise easily; fatty pad or hump between shoulders (buffalo hump); rounding of face (moon face); pink or purple stretch marks on skin of abdomen, thighs, breasts and arms; ankle swelling), adrenal suppression (tiredness, weakness, nausea and vomiting, low blood pressure), worsening of allergies (eczema, rhinitis), and infection (fever, chills, pain, feeling tired, aches, nausea and vomiting). May worsen existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications, especially St. John's wort.
• Instruct patient to notify health care professional immediately if exposed to chicken pox or measles.
• May cause fetal harm. Instruct patient to notify health care professional if pregnancy if planned or suspected or if breastfeeding. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Observe infant for signs of hypoadrenalism (poor feeding, irritability, weakness, vomiting).

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