EOHILIA

Budesonide geometric mean (%CV) maximum plasma concentration (C max ) was 915 (59) pg/mL and area under the time concentration curve at 12 hours (AUC 0-12h ) was 5071 (58) pg

• h/mL after repeated oral administration of EOHILIA 2 mg twice daily in adult subjects with EoE. Based on population pharmacokinetic analysis, there was no difference in pharmacokinetics between healthy adults and adult subjects with EoE.

AbsorptionThe median (range) time to reach budesonide peak plasma concentration (t max...

The efficacy and safety of EOHILIA 2 mg twice daily were evaluated in two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 [NCT02605837] and Study 2 [NCT01642212]). Eligible subjects in Study 1 and Study 2 had esophageal inflammation defined as ≥15 eosinophils/high-power field (hpf) from at least 2 levels of the esophagus at baseline following a treatment course of a proton pump inhibitor (PPI) either prior to or during screening and at least 4 days of dysphagia as measured by the Dysphagia Symptom Questionnaire (DSQ) over a 2-week period prior...

The following serious adverse reactions are described in greater detail in other sections of the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] Immunosuppression and increased risk of infections [see Warnings and Precautions (5.2) ] Erosive esophagitis [see Warnings and Precautions (5.3) ] Effect on growth [see Warnings and Precautions (5.4) ] Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids [see Warning...

EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products [see Adverse Reactions (6.2) ] . Hypersensitivity to budesonide. ( 4 )

Hypercorticism and Adrenal Axis Suppression : May occur with treatment; monitor for signs and symptoms and consider reducing the dosage. ( 5.1 , 8.6 ) Immunosuppression and Increased Risk of Infection : Increased risk of viral, bacterial, fungal, protozoan, and helminthic infections, including potentially fatal varicella and measles infection. Monitor patients for new or worsening localized or systemic infection, including oropharyngeal and esophageal candidiasis and consider drug discontinuatio...

7 DRUG INTERACTIONS CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations. Avoid concomitant use. ( 2.2 , 7.1 ) 7.1 CYP3A4 Inhibitors Budesonide is a substrate for CYP3A4. Concomitant use of budesonide with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice) can incr...