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Budesonide (systemic): Drug information

Budesonide (systemic): Drug information
(For additional information see "Budesonide (systemic): Patient drug information" and see "Budesonide (systemic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Entocort EC [DSC];
  • Ortikos;
  • Tarpeyo;
  • Uceris
Brand Names: Canada
  • Cortiment;
  • Entocort;
  • Jorveza
Pharmacologic Category
  • Corticosteroid, Systemic
Dosing: Adult

Note: Multiple formulations (with different targeted areas for drug delivery) are available and approved indications vary; interchangeability of products has not been evaluated.

Crohn disease, mild to moderate

Crohn disease, mild to moderate (active): Oral: Capsule (delayed-release particles [Entocort EC], extended release [Ortikos]): 9 mg once daily in the morning for up to 8 weeks; recurring episodes may be treated with a repeat 8-week course of treatment.

Maintenance of remission: Oral: Capsule (delayed-release particles [Entocort EC], extended release [Ortikos]): Following treatment of active disease (control of symptoms with Crohn Disease Activity Index [CDAI] <150), treatment may be continued at a dosage of 6 mg once daily for up to 3 months. If symptom control is maintained for 3 months, tapering of the dosage to complete cessation is recommended. Continued dosing beyond 3 months has not been demonstrated to result in substantial benefit.

Eosinophilic esophagitis

Eosinophilic esophagitis (off-label use):

Note: Individualize dose. Optimal dosing has not been established. Swallow oral budesonide viscous liquid/suspension slowly over 5 to 10 minutes (Ref). In Canada, an orodispersible tablet formulation (Jorveza) is approved for the induction and maintenance of remission of eosinophilic esophagitis.

Induction therapy: Oral: 2 mg/day as an oral budesonide viscous liquid/suspension or an orodispersible tablet [Canadian product]; may divide into 2 doses (Ref). Note: Duration of induction therapy is up to 12 weeks followed by assessment of symptomatic response (eg, dysphagia). Once remission is achieved, the dose may be gradually lowered to an individualized maintenance dose (Ref).

Maintenance therapy: Oral: 0.5 to 1 mg/day as an oral budesonide viscous liquid/suspension or an orodispersible tablet [Canadian product]; may divide into 2 doses (Ref).

Hepatitis, autoimmune

Hepatitis, autoimmune (in combination with azathioprine) (off-label use):

Note: Not for use in patients with acute severe autoimmune hepatitis or concomitant cirrhosis.

Oral: Capsule (delayed-release particles [Entocort EC]): 9 mg/day in 3 divided doses; may reduce to 6 mg/day in 2 divided doses following remission (Ref).

Microscopic colitis

Microscopic (lymphocytic and collagenous) colitis (off-label use):

Induction: Oral: Capsule (delayed-release particles [Entocort EC]): 9 mg once daily for 6 to 8 weeks (Ref). After clinical remission (<3 stools daily and no watery stools) and following at least 8 weeks of therapy, some experts suggest to gradually taper the dose to 6 mg for 2 weeks, followed by 3 mg for 2 weeks, then discontinue (Ref).

Maintenance/relapse therapy: Note: For patients who have had a clinical relapse after cessation of induction therapy (Ref).

Oral: Capsule (delayed-release particles [Entocort EC]): 6 mg once daily, then taper to the lowest effective dose and continue for 6 to 12 months (Ref); alternatively, 3 mg/day alternating with 6 mg/day over 12 months may be used (Ref).

Primary immunoglobulin A nephropathy

Primary immunoglobulin A nephropathy (alternative agent) (adjunctive agent):

Note: For use in patients at risk of rapid disease progression (eg, urine protein-to-creatinine ratio of ≥1.5 g/g). Patients in a phase 3 study were also receiving maximally tolerated renin-angiotensin-system inhibitor therapy (Ref).

Oral: Capsule (delayed release [Tarpeyo]): 16 mg once daily in the morning for 9 months; after 9 months, reduce dose to 8 mg once daily for 2 weeks, then discontinue.

Ulcerative colitis, refractory, mildly to moderately active

Ulcerative colitis, refractory, mildly to moderately active:

Note: For use as alternative monotherapy for distal colitis, or as a component of combination therapy for refractory distal, left-sided, or extensive colitis (Ref).

Initial: Oral: Tablet (extended release [Uceris]): 9 mg once daily in the morning for up to 8 weeks.

Repeat course (off-label dosing): Note: If symptom relapse occurs <8 weeks after initial course completed, switch to alternative therapy. If symptom relapse occurs ≥8 weeks after initial course completed, some experts use a repeat course as follows (Ref):

Repeat 8-week course without taper: Oral: Tablet (extended release [Uceris]): 9 mg once daily in the morning for 8 weeks (Ref).

Repeat 8-week course with taper: Oral: Tablet (extended release [Uceris]): 9 mg once daily in the morning for 4 weeks, then 9 mg every other day for 2 weeks, then 9 mg every third day for 2 weeks (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Adult

Capsule, delayed release (Tarpeyo):

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate impairment (Child-Pugh class B): There are no specific dosage adjustments provided in the manufacturer's labeling; monitor for signs and/or symptoms of hypercortisolism.

Severe impairment (Child Pugh class C): Avoid use.

Capsule, delayed release particles (Entocort EC):

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate impairment (Child-Pugh class B): Consider reduced dosage to 3 mg once daily and monitor for hypercortisolism.

Severe impairment (Child-Pugh class C): Avoid use.

Capsule, extended release (Ortikos):

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate to severe impairment (Child-Pugh class B and C): Avoid use.

Tablet, extended release (Uceris):

Mild impairment: There are no specific dosage adjustments provided in the manufacturer's labeling; use with caution.

Moderate to severe impairment: There are no specific dosage adjustments provided in the manufacturer's labeling (has not been studied); monitor for hypercortisolism; consider discontinuing use.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Budesonide (systemic): Pediatric drug information")

Crohn disease; treatment

Crohn disease (mild to moderate); treatment:

Children ≥6 years and Adolescents weighing >25 kg: Note: Limited data available for patients <8 years and <25 kg.

Delayed- or extended-release capsule (eg, Entocort EC, Ortikos): Oral: 9 mg once daily for up to 8 weeks, then decrease to 6 mg once daily for 2 to 4 weeks (Ref). Some experts describe another dosage decrease to 3 mg once daily for 1 to 2 weeks prior to discontinuation (Ref). Note: A higher initial dose of 12 mg once daily for 4 weeks has also been reported in pediatric patients ≥10 years of age (Ref).

Eosinophilic esophagitis

Eosinophilic esophagitis: Limited data available:

Note: Requires extemporaneous preparation of oral viscous budesonide suspension using the inhalation suspension (see "Extemporaneous Preparations"). Although there are other dosage forms of oral budesonide, they are enteric coated and should not be used for this indication; therapeutic efficacy for eosinophilic esophagitis requires topical corticosteroid effect in the esophagus. After administration of a budesonide dose, avoid ingesting any solid or liquid food for at least 30 minutes (Ref).

Children <10 years: Oral: Viscous liquid/suspension (using inhalation suspension): Initial: 1 mg once daily or divided twice daily (Ref)

Children ≥10 years and Adolescents: Oral: Viscous liquid/suspension (using inhalation suspension): 2 mg once daily or divided twice daily (Ref)

Protein-losing enteropathy following Fontan

Protein-losing enteropathy (PLE) following Fontan: Limited data available: Children ≥4 years and Adolescents: Oral capsule (eg, Entocort EC): Initial: 9 mg once daily or in divided doses every 8 hours; the dose may be weaned based on clinical improvement and normal albumin concentration or to manage adverse drug reactions; weaning the dose over several weeks in increments of 3 mg/day to a maintenance dose of 3 mg once daily or every other day has been described (Ref). Note: Reported experience in children <7 years is very limited (n=1); in one report, an initial dose of 6 mg once daily was recommended for children <4 years (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Capsule, delayed-release particles (eg, Entocort EC); capsule, extended release (eg, Ortikos): There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

Capsule, delayed-release particles (eg, Entocort EC): Children ≥8 years and Adolescents:

Mild impairment: No dosage adjustment necessary.

Moderate impairment: Budesonide undergoes hepatic metabolism; may be at risk for increased systemic exposure; monitor closely for signs and symptoms of hypercorticism and adrenal axis suppression. In adults, dose reduction to 3 mg once daily is recommended.

Severe impairment: Avoid use.

Capsule, extended release (eg, Ortikos): Children ≥8 years and Adolescents:

Mild impairment: No dosage adjustment necessary.

Moderate to severe impairment: Avoid use.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Hypertension (16%), peripheral edema (14%)

Dermatologic: Acne vulgaris (5% to 15%)

Endocrine & metabolic: Bruise (5% to 15%), moon face (3% to 11%)

Gastrointestinal: Nausea (5% to 11%)

Nervous system: Headache (15% to 21%)

Neuromuscular & skeletal: Muscle spasm (13%)

Respiratory: Respiratory tract infection (11%)

1% to 10%:

Cardiovascular: Ankle edema (7%), chest pain (<5%), edema (<5%), facial edema (6%), flushing (<5%), palpitations (<5%), tachycardia (<5%)

Dermatologic: Alopecia (<5%), atrophic striae (2%), dermatitis (7%), dermatological disease (<5%), diaphoresis (<5%), eczema (<5%)

Endocrine & metabolic: Adrenocortical insufficiency (≥1%), decreased cortisol (2% to 4%), hirsutism (≤5%), hypokalemia (≥1%), intermenstrual bleeding (<5%), menstrual disease (<5%), redistribution of body fat (1%), weight gain (7%)

Gastrointestinal: Abdominal distention (2%), anal disease (<5%), constipation (2%), diarrhea (10%), dyspepsia (5% to 6%), enteritis (<5%), epigastric pain (<5%), flatulence (3%), gastrointestinal fistula (<5%), glossitis (<5%), hemorrhoids (<5%), increased appetite (<5%), intestinal obstruction (<5%), oral candidiasis (<5%), upper abdominal pain (3% to 4%)

Genitourinary: Dysuria (<5%), hematuria (≥1%), nocturia (<5%), pyuria (≥1%), urinary frequency (<5%), urinary tract infection (2%)

Hematologic & oncologic: Abnormal neutrophils (≥1%), anemia (≥1%), C-reactive protein increased (≥1%), increased erythrocyte sedimentation rate (≥1%), leukocytosis (≥1%), purpuric disease (<5%)

Hepatic: Increased serum alkaline phosphatase (≥1%)

Hypersensitivity: Tongue edema (<5%)

Infection: Abscess (<5%), viral infection (6%)

Nervous system: Agitation (<5%), amnesia (<5%), confusion (<5%), dizziness (7%), drowsiness (<5%), fatigue (3% to 5%), insomnia (<5%), malaise (<5%), mood changes (7%), nervousness (<5%), paresthesia (<5%), sleep disorder (<5%), vertigo (<5%)

Neuromuscular & skeletal: Arthralgia (5%), arthritis (≤5%), asthenia (<5%), back pain (7%), hyperkinetic muscle activity (<5%), muscle cramps (<5%), myalgia (<5%), tremor (<5%)

Ophthalmic: Eye disease (<5%), visual disturbance (<5%)

Otic: Otic infection (<5%)

Respiratory: Bronchitis (<5%), dyspnea (6%), flu-like symptoms (<5%), pharyngeal disease (<5%), rhinitis (<5%), sinusitis (8%)

Miscellaneous: Fever (<5%)

Postmarketing:

Dermatologic: Skin rash

Hematologic & oncologic: Rectal hemorrhage

Hypersensitivity: Anaphylaxis

Nervous system: Emotional lability, idiopathic intracranial hypertension

Contraindications

Hypersensitivity to budesonide or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Note: Contraindications may vary by product/formulation; also refer to manufacturer's labeling: Tuberculosis (TB) disease (active TB); uncontrolled infections; systemic or local bacterial, fungal, or viral infections; hypersensitivity to soya, lecithin (derived from soya oil, peanut oil), or peanut.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, viral hepatitis. Close observation is required in patients with tuberculosis (TB) infection (latent TB) and/or TB reactivity; restrict use in TB disease (active TB) (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression or psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute myocardial infarction; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with prediabetes or diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk.

• Hepatic impairment: Use in patients with hepatic impairment may vary based on formulation and/or indication; monitor for hypercortisolism. Long-term use of corticosteroids in patients with hepatic impairment, including cirrhosis, has been associated with fluid retention.

• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and renal function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Product Availability

Tarpeyo delayed release capsules: FDA approved December 2021; availability anticipated in the first quarter of 2022.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Delayed Release, Oral:

Tarpeyo: 4 mg

Capsule Delayed Release Particles, Oral:

Entocort EC: 3 mg [DSC]

Generic: 3 mg

Capsule Extended Release 24 Hour, Oral:

Ortikos: 6 mg, 9 mg [contains corn starch]

Tablet Extended Release 24 Hour, Oral:

Uceris: 9 mg [contains soybean lecithin]

Generic: 9 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Capsule ER 24 Hour Therapy Pack (Ortikos Oral)

6 mg (per each): $48.00

9 mg (per each): $48.00

Capsule, delayed release (Tarpeyo Oral)

4 mg (per each): $151.23

Capsule, enteric pellets (Budesonide Oral)

3 mg (per each): $1.18 - $24.86

Tablet, 24-hour (Budesonide ER Oral)

9 mg (per each): $64.47 - $68.13

Tablet, 24-hour (Uceris Oral)

9 mg (per each): $71.71

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Delayed Release Particles, Oral:

Entocort: 3 mg [contains corn starch]

Generic: 3 mg

Tablet Disintegrating, Oral:

Jorveza: 1 mg

Tablet Extended Release 24 Hour, Oral:

Cortiment: 9 mg [contains soybean lecithin]

Administration: Adult

Oral:

Capsule, delayed release (Tarpeyo): Administer in the morning at least 1 hour before a meal. Swallow whole; do not open, crush, or chew.

Capsule, delayed-release particles (Entocort EC): Administer in the morning without regard to meals. Swallow whole; do not crush or chew. However, if unable to swallow capsule, may be opened and granules sprinkled onto 1 tablespoonful of applesauce (applesauce should be soft enough to swallow without chewing and should not be hot); mix granules with applesauce and consume within 30 minutes of mixing; do not save the mixture for later use. Do not chew or crush granules. Follow with 8 oz of cool water.

Capsule, extended release (Ortikos): Administer in the morning without regard to meals. Swallow whole; do not crush or chew.

Orodispersible tablet [Canadian product]: Immediately use tablet once removed from blister. Administer after meals; avoid administering with food or liquid and allow at least 30 minutes after administration before drinking, eating, or performing oral hygiene. Do not chew or swallow undissolved. Allow to dissolve by placing on the tip of the tongue and gently pressing against the top of the mouth. Once dissolved (2 to 20 minutes) swallow little by little with saliva until disintegration complete. Space use of chewable tablets, oral solutions, or oral sprays at least 30 minutes before or after administering the orodispersible tablet.

Tablet, extended release (Uceris): Swallow whole; do not crush, chew, or break. Administer in the morning without regard to meals.

Viscous liquid/suspension (off-label use): Swallow viscous liquid/suspension (oral inhalation preparation) slowly over 5 to 10 minutes immediately after preparation. Avoid ingesting any solid or liquid food, brushing teeth, or rinsing mouth for at least 30 minutes after budesonide administration (Ref). When administering twice daily, preferably take after breakfast and before bedtime (Ref).

Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate.

Capsule, delayed-release particles (Entocort EC): Capsule may be opened and contents sprinkled onto soft food of choice. Patient should be instructed to swallow the mixture without biting down or chewing.

Tablet, extended release (Uceris): Do not cut, crush, or chew. Switch to Entocort EC; capsule may be opened and contents sprinkled onto soft food of choice. Mixture should be swallowed immediately without chewing.

Administration: Pediatric

Oral: May be administered without regard to meals.

Capsule, delayed-release particles (eg, Entocort EC): Administer in morning without regard to meals. Swallow whole; do not chew or crush. For patients unable to swallow capsule whole, the capsule may be opened and granules sprinkled onto 1 tablespoonful of applesauce; mix granules with applesauce and consume within 30 minutes of mixing; do not chew or crush granules in applesauce mixture and do not save the mixture for later use; follow with 8 oz of cool water. Note: Applesauce should not be hot and should be soft enough to be able to swallow it without chewing (Ref).

Capsule, extended release (Ortikos): Administer in the morning. Swallow whole; do not crush or chew.

Viscous liquid/suspension: Swallow extemporaneously prepared liquid immediately after preparation; avoid ingesting any solid or liquid food for at least 30 minutes after budesonide administration (Ref).

Use: Labeled Indications

Crohn disease, mild to moderate (delayed-release capsule particles [Entocort EC], ER capsules [Ortikos]): Treatment of active Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in patients ≥8 years of age; maintenance of clinical remission (for up to 3 months) of Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in adults.

Eosinophilic esophagitis (orodispersible tablet [Canadian product]): Induction and maintenance of remission in adults with eosinophilic esophagitis.

Primary immunoglobulin A nephropathy (delayed-release capsules [Tarpeyo]): To reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression of disease, generally a urine protein-to-creatinine ratio ≥1.5 g/g.

Note: Patients in the approval study were systemic immunosuppressive therapy naive and had an eGFR ≥35 mL/minute/1.73 m2 with persistent proteinuria (mean baseline urine protein-to-creatinine ratio 1.6 g/g) despite stable doses of maximally tolerated renin-angiotensin-system inhibitor therapies.

Ulcerative colitis, refractory, mildly to moderately active (ER tablets [Uceris]): Induction of remission in patients with active ulcerative colitis (mild to moderate).

Use: Off-Label: Adult

Eosinophilic esophagitis; Hepatitis, autoimmune; Microscopic (lymphocytic and collagenous) colitis

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider therapy modification

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and CYP3A4 inhibitors, they should be closely monitored for signs and symptoms of corticosteroid excess. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and a strong CYP3A4 inhibitor, they should be closely monitored for signs and symptoms of corticosteroid excess. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Grapefruit Juice: May increase the serum concentration of Budesonide (Systemic). Risk X: Avoid combination

Food Interactions

Grapefruit juice may double systemic exposure of orally administered budesonide. Management: Avoid grapefruit juice with oral capsules or tablets.

Reproductive Considerations

Fertility may be decreased in females with active inflammatory bowel disease. Corticosteroids used for the management of inflammatory bowel disease are not expected to decrease fertility in patients who could become pregnant (AGA [Mahadevan 2019]).

Immunoglobulin A nephropathy is associated with adverse pregnancy outcomes. Immunosuppressants may be used when supportive care is not sufficient in controlling disease in patients planning to become pregnant. Effective contraception is recommended until disease is controlled (KDIGO 2021).

Pregnancy Considerations

Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy (monitor).

Because systemic corticosteroids may increase the risk of gestational diabetes and other adverse pregnancy outcomes, use for maintenance therapy in pregnant patients with inflammatory bowel disease is not recommended. However, corticosteroids may be used to treat disease flares in pregnant patients (AGA [Mahadevan 2019]).

Breastfeeding Considerations

Budesonide is present in breast milk (following maternal inhalation).

According to the manufacturer, the decision to breastfeed following oral use should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Corticosteroids used for inflammatory bowel disease are considered compatible with breastfeeding (AGA [Mahadevan 2019]). If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breastfeeding in order to decrease potential exposure to the breastfed infant (based on a study using prednisolone) (Habal 2012; Ost 1985).

Dietary Considerations

Avoid grapefruit juice.

Monitoring Parameters

Serum glucose, electrolytes; blood pressure, weight and other growth parameters, presence of infection; monitor IOP with therapy >6 weeks; bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test).

Adult patients receiving treatment for primary IgA nephropathy: Baseline and periodically during therapy: SCr, eGFR, urine protein excretion (spot urine protein-to-creatinine ratio or 24-hour urine protein collection) and urinalysis.

Mechanism of Action

Budesonide, a glucocorticoid with high topical potency and limited systemic effects, depresses the activity of endogenous chemical mediators of inflammation (eg, kinins, prostaglandins). Oral budesonide formulations indicated for the treatment of inflammatory bowel disease (eg, Crohn disease, ulcerative colitis) allow for targeted, pH-dependent budesonide release in the GI tract. The delayed-release capsule particles (Entocort EC) contain enteric coated granules that dissolve at a pH ≥5.5, delivering budesonide to the ileum and ascending colon. The multimatrix enteric-coated ER tablet (Uceris) dissolves at a pH ≥7, delivering budesonide to the entire colon (Abdalla 2016; Iborra 2014). Although not fully elucidated, when used for treatment of primary immunoglobulin A nephropathy, budesonide presumably targets mucosal B-cells in the ileum and/or systemically to suppress production of galactose-deficient IgA1 antibodies implicated in causing IgA nephropathy.

Pharmacokinetics (Adult Data Unless Noted)

Distribution:

Children ≥9 years of age and adolescents ≤14 years of age: IV: 2.2 ± 0.4 L/kg.

Adults: 2.2 to 4 L/kg.

Protein binding: 85% to 90%.

Metabolism: Hepatic via CYP3A4 to two metabolites: 16 alpha-hydroxyprednisolone and 6 beta-hydroxybudesonide; both are <1% as active as parent.

Bioavailability: Oral: High first-pass effect; Capsule (delayed-release particles [Entocort EC], extended release [Ortikos]): Children ≥9 years of age and adolescents ≤14 years of age: 3% to 17%; Adults: 9% to 21%. Data not reported for other formulations.

Half-life elimination:

Children ≥9 years of age and adolescents ≤14 years of age: IV: 1.9 hours.

Adults:

IV: 2 to 3.6 hours.

Capsule (delayed-release particles [Entocort EC]): 6.3 ± 1.6 hours (range: 2 to 8 hours).

Capsule (delayed release [Tarpeyo]): 5 to 6.8 hours.

Capsule (extended release [Ortikos]), tablet (extended release [Uceris]): Not reported.

Tablet (orodispersible [Canadian product]): Median: 2.13 hours (following 1 mg dose in healthy subjects) and 4.56 hours (following 4 mg dose in patients with eosinophilic esophagitis).

Time to peak:

Capsule (delayed-release particles [Entocort EC]): Children ≥9 years of age and adolescents ≤14 years of age: Median: 5 hours; Adults: 0.5 to 10 hours.

Capsule (delayed release [Tarpeyo]): Median: 5.1 hours (range: 4.5 to 10 hours).

Capsule (extended release [Ortikos]): 2.5 to 8 hours.

Tablet (extended release [Uceris]): 13.3 ± 5.9 hours.

Tablet (orodispersible [Canadian product]): Median: 1 hour (range: 0.5 to 2 hours following a 1 mg dose in healthy subjects or a 4 mg dose in patients with eosinophilic esophagitis).

Excretion: Urine (60%) and feces as metabolites.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic impairment: AUC is multiplied by 1.4 and 3.5 in mild and moderate impairment, respectively, compared to healthy volunteers.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Cortiment mmx;
  • (AR) Argentina: Cortiment mmx | Enterocort | Entocort;
  • (AT) Austria: Budosan uno | Cortiment mmx | Entocort | Jorveza;
  • (AU) Australia: Cortiment;
  • (BD) Bangladesh: Budicort er;
  • (BE) Belgium: Budenofalk | Budesonide ferring | Jorveza;
  • (BR) Brazil: Corament;
  • (CH) Switzerland: Cortiment mmx | Jorveza;
  • (CL) Chile: Cortiment mmx;
  • (CO) Colombia: Cortiment mmx;
  • (CZ) Czech Republic: Cortiment;
  • (DE) Germany: Budenofalk | Cortiment | Cortiment mmx | Intesticort | Jorveza;
  • (DO) Dominican Republic: Cortiment;
  • (EE) Estonia: Cortiment | Cortiment mmx;
  • (ES) Spain: Cortiment;
  • (FI) Finland: Cortiment | Jorveza;
  • (FR) France: Cortiment | Mikicort | Rafton;
  • (GB) United Kingdom: Budenofalk | Cortiment | Jorveza;
  • (GR) Greece: Budenofalk | Cortiment | Jorveza;
  • (HR) Croatia: Budosan | Cortiment mmx;
  • (HU) Hungary: Cortiment;
  • (IE) Ireland: Cortiment | Entocort | Entocort cr;
  • (IN) India: Budez od | Rafacol;
  • (IT) Italy: Cortiment | Intesticort | Rafton;
  • (JO) Jordan: Cortiment;
  • (KR) Korea, Republic of: Cortiment;
  • (KW) Kuwait: Cortiment;
  • (LB) Lebanon: Cortiment mmx;
  • (LT) Lithuania: Budesonide ferring | Jorveza;
  • (LU) Luxembourg: Budesonide ferring | Jorveza;
  • (LV) Latvia: Jorveza;
  • (MX) Mexico: Cortiment mmx;
  • (MY) Malaysia: Cortiment;
  • (NL) Netherlands: Cortiment | Jorveza;
  • (NO) Norway: Cortiment | Jorveza;
  • (NZ) New Zealand: Cortiment;
  • (PH) Philippines: Cortiment;
  • (PL) Poland: Budenofalk | Cortiment;
  • (PR) Puerto Rico: Uceris;
  • (RO) Romania: Cortiment;
  • (RU) Russian Federation: Cortiment;
  • (SA) Saudi Arabia: Cortiment mmx;
  • (SE) Sweden: Budenofalk | Budesonid orifarm | Cortiment | Intesticort | Jorveza;
  • (SG) Singapore: Cortiment mmx;
  • (SI) Slovenia: Budezonid Ferring | Jorveza;
  • (SK) Slovakia: Cortiment;
  • (TW) Taiwan: Cortiment;
  • (UY) Uruguay: Budenofalk | Cortiment mmx
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