RELIABLE DOSING

FOR ON-THE-GO USE

Portable + consistent formulation

Designed to help fit into your patients’ daily routines—no mixing, measuring, or refrigeration required. Each 10 mL of EOHILIA contains 2 mg of budesonide, helping to ensure the exact dose is administered when Instructions for Use are followed.¹

2x daily dosing

EOHILIA is taken twice daily for 12 weeks per recommended dosage of 2 mg / 10 mL for patients 11 years and older.¹

Portable with flexible storage

EOHILIA can be refrigerated or stored at room temperature (36°F to 77°F) for on-the-go use. Excursions up to 86°F are acceptable. Do NOT freeze.¹

30-day supply per box

EOHILIA comes with a 1-month supply of 2 mg / 10 mL single-dose, cherry-flavored stick packs with 60 per box.¹

Once in the morning. Once in the evening.

This is not all the information you need to know about administering EOHILIA. For detailed administration instructions please refer to the Prescribing Information and Instructions for Use. Do not take EOHILIA with food or liquid.¹

STEP 1

Shake and cut open the stick pack¹

Patients should shake the stick pack well for at least 10 seconds prior to opening¹
Using scissors, they should cut along the dotted line at the top of the stick pack¹

STEP 2

Squeeze the stick pack from bottom to top directly into mouth¹

Repeat 2 to 3 times until the EOHILIA stick pack is empty¹
Swallow all of the EOHILIA suspension¹
Discard the empty stick pack in the household trash¹

STEP 3

Wait 30 minutes before eating or drinking¹

Do not eat or drink for 30 minutes after taking EOHILIA¹
After 30 minutes, rinse out mouth with water and spit out contents without swallowing¹

Additional DO’s and DON’Ts

EOHILIA is for oral use only. Only take it by mouth¹
Keep EOHILIA out of reach of children¹

DO NOT consume grapefruit juice for the duration of therapy with EOHILIA¹
DO NOT use EOHILIA after the expiration date on the carton, if the carton seal is broken, or if the stick pack is damaged¹

Please see full Instructions for Use in Prescribing Information.

Patient Profiles

Patient Access

IMPORTANT SAFETY INFORMATION

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

Systemic effects such as hypercorticism and adrenal axis suppression may occur. Monitor patients for signs and symptoms and consider reducing the dosage of EOHILIA. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B).

Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended.

Immunosuppression and Increased Risk of Infection

Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen. Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation of EOHILIA if the patient develops an infection.

Tuberculosis reactivation may occur. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA.
Varicella Zoster and Measles can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.
Hepatitis B Virus Reactivation can occur. Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
Amebiasis: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea.
Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides (threadworm) 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. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI). Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate.

Effect on Growth

Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Monitor patients who are transferred from corticosteroids with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema) previously controlled by the systemic drug.

Other Corticosteroid Effects

Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts, or with family history of diabetes, glaucoma, or with other conditions where corticosteroids may have unwanted effects.

Kaposi’s Sarcoma

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.

DRUG INTERACTIONS

Budesonide is a substrate for CYP3A4. Avoid concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice), which can increase systemic budesonide concentrations.

USE IN SPECIFIC POPULATIONS

Pregnancy: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly.
Lactation: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition.
Hepatic Impairment: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism.

Indication and Limitations of Use

EOHILIA (budesonide oral suspension) is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).

EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.

Please click here for full Prescribing Information.