CONTRAINDICATIONS
EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products.
WARNINGS AND PRECAUTIONS
Hypercorticism and Adrenal Axis Suppression
Monitor patients for signs and symptoms and consider reducing the EOHILIA dosage. Use is not recommended in severe hepatic impairment (Child-Pugh Class C). Monitor for hypercorticism in moderate hepatic impairment (Child-Pugh Class B). Where patients are subject to stress situations (e.g., trauma, surgery, infection) supplementation with a systemic corticosteroid is recommended.
Immunosuppression and Increased Risk of Infection
Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation if infection develops.
Tuberculosis and Hepatitis B Virus (HBV) reactivation may occur. Closely monitor EOHILIA patients. Screen for HBV.
Varicella Zoster (VZ) and Measles can be serious or fatal. Avoid exposure. If a patient is exposed to varicella, consider prophylaxis with VZ immune globulin (IG); if varicella develops, consider antiviral treatment. If a patient is exposed to measles, consider prophylaxis with IG.
Rule out amebiasis before starting EOHILIA in patients who were in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides infection, cerebral malaria, and active ocular herpes simplex.
Localized Infections: In clinical trials, some patients developed Candida albicans infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. Treat candidiasis infections with appropriate antifungal therapy and consider discontinuing EOHILIA.
Erosive Esophagitis
Patients who experienced erosive esophagitis in clinical trials did not have erosions at baseline and most were receiving a proton pump inhibitor. Advise patients or caregivers to report new onset or worsening of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation.
Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids
Adrenocortical function monitoring may be required in patients who are transferred from high systemic effects corticosteroids to EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop.
Taper slowly from high systemic effects corticosteroids. Replacing systemic corticosteroids with EOHILIA may unmask previously controlled allergies (e.g., rhinitis and eczema).
Other Corticosteroid Effects
Monitor patients with or family history of: hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts or with other conditions where corticosteroids may have unwanted effects.
Additional Established Class Effects of Corticosteroids not seen in EOHILIA 12-week clinical trials. The maximum recommended duration of treatment with EOHILIA is 12 weeks:
Effect on Growth: Use of corticosteroids may cause a reduction of growth velocity. Monitor the growth of pediatric patients on EOHILIA.
Kaposi’s Sarcoma: Reported to occur with corticosteroids, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.
ADVERSE REACTIONS
Most common adverse reactions (≥2%) are: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%).
DRUG INTERACTIONS
Avoid concomitant use with CYP3A4 inhibitors (including grapefruit juice), which can increase systemic budesonide concentrations.
USE IN SPECIFIC POPULATIONS
Pregnancy: Hypoadrenalism may occur in infants whose mothers received corticosteroids during pregnancy. Carefully observe infants for hypoadrenalism and manage accordingly.
Lactation: Lactation studies have not been conducted. Consider the benefits of breastfeeding, the mother’s need for EOHILIA, and any potential adverse effects on the infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in severe hepatic impairment (Child-Pugh Class C). Monitor for hypercorticism in moderate hepatic impairment (Child-Pugh Class B).
Indication and Limitations of Use
EOHILIA (budesonide oral suspension) is indicated for 12 weeks of treatment in patients 11 years and older with eosinophilic esophagitis (EoE).
EOHILIA has not been shown to be safe and effective for more than 12 weeks.
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