VA CFU Criteria Formulary Advisor Reference
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BUDESONIDE SUSP,ORAL

Generic Name
BUDESONIDE SUSP
Brand Names
EOHILIA
Drug Class
GLUCOCORTICOIDS
Formulary Status
N
Copay Tier
3
Last Updated
2024-02-22

Clinical Criteria Summary

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Exclusion Criteria

  • CYP3A4 inhibitors including grapefruit juice or other unmanageable drug interactions
  • Severe (Child-Pugh C) hepatic impairment

Inclusion Criteria

  • Diagnosis of eosinophilic esophagitis (EoE) including histologic evidence of eosinophilic inflammation (≥ 15 eosinophils / high power field) made or confirmed by a VA / VA Community Care gastroenterologist
  • Prescribed by a VA / VA Community Care gastroenterologist OR an immunologist, allergist, or other designated expert in the management of EoE in consultation with a VA / VA Community Care gastroenterologist

Additional Inclusion Criteria

  • For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment.

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Indication & Population

  • Adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE)
  • Limited to a 12-week treatment duration; safety and efficacy for longer than 12 weeks have not been established

Dosage & Administration

  • 2 mg orally twice daily for 12 weeks
  • Administered as an oral suspension (2 mg/10 mL single-dose stick packs)
  • Do not take with or mix with food or liquid
  • Wait at least 30 minutes after administration before eating, drinking, or rinsing the mouth with water
  • When rinsing the mouth, spit out water without swallowing

Contraindications

  • Hypersensitivity to budesonide

Warnings & Precautions

  • Hypercorticism and adrenal axis suppression
  • Immunosuppression and increased risk of infection
  • Erosive esophagitis
  • Reduction in growth velocity (pediatric patients)
  • Symptoms of steroid withdrawal in patients transferred from other systemic glucocorticoids
  • Other glucocorticoid effects
  • Kaposi’s sarcoma

Adverse Reactions

  • Respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation (≥3% incidence)

Special Populations & Organ Impairment

  • Severe hepatic impairment (Child-Pugh Class C): Use is not recommended
  • Moderate hepatic impairment (Child-Pugh Class B): Monitor for hypercorticism
  • Pregnancy: May cause fetal harm
  • Lactation: Insufficient studies in humans; weigh risks vs benefits

Formulary/VA Clinical Context

  • Preferred over oral viscous budesonide (OVB) due to a standardized formulation and reduced time, effort, and cost burdens for patients self-preparing swallowed topical glucocorticoids (STGs) or obtaining them from compounding pharmacies
  • May be considered as an alternative to swallowed aerosolized fluticasone (SAF) for 12-week treatment of EoE
  • Evidence supports large histologic effects and moderate full (histologic and symptomatic) response in patients with EoE
  • No active-controlled trials directly comparing BOS to patient-mixed STGs or SAF to inform relative efficacy, safety, mucosal contact time, and place in therapy

Source Documents

Document 610 Document 611