RELIABLE DOSING FOR ON-THE-GO USE

The oral bioavailability in healthy subjects is ~14% under fasting state. Systemic effects may occur.

EOHILIA is provided as a monthly supply of 60 premixed stick packs, each containing 2 mg/10 mL of budesonide (600 mL) to help ensure consistent formulation when taken as recommended in the Prescribing Information.¹

See How to Take EOHILIA

Designed to help fit into your patients’ schedules

EOHILIA is a swallowed suspension—not a pill, injection, or aerosol. It requires no mixing, measuring, or refrigeration. 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

Monthly supply per box

Each box contains a 30-day supply of 2 mg/10 mL single-dose, cherry-flavored stick packs.¹

Flexible storage

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

Twice-daily dosing

EOHILIA should be taken as prescribed for 12 weeks per recommended dosage of 2 mg orally directly from the stick pack once in the morning and once at night.¹

Streamlined administration: no mixing or measuring required

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

DON’T consume grapefruit juice for the duration of therapy with EOHILIA¹
DON’T 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

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.

Please click here for full Prescribing Information.

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

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

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

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

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

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.

Please click here for full Prescribing Information.

Reference:

EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals, Inc.

VIDEO TRANSCRIPT

EOHILIA (budesonide oral suspension) is a corticosteroid 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 treatment of EOE for longer than 12 weeks. EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products. Please see important safety information at the end of this video.

In this video we'll show you how EOHILIA is taken. EOHILIA is the first and only FDA approved oral 12 week treatment for EoE for patients 11 years and older. EOHILIA was assessed in two 12 week trials evaluating histological remission and reduction of dysphagia. Visit EOHILIAHCP.com to see the data.

First, inspect the package and do not take if the carton seal is broken, or if the packet is damaged or leaking, or the expiration date has passed. Now take the packet out of the box and shake it for 10 seconds.

No mixing, measuring, or refrigeration required.

At rest EOHILIA is highly viscous. Upon shaking, it becomes less viscous for swallowing. Then EOHILIA regains its viscosity to flow slower. That's called thixotropy. Thixotropy is an example of how EOHILIA was designed for EOE.

Using scissors cut along the dotted line straight across the top of the packet.

Each packet reliably contains the recommended two milligram dose of budesonide, the active ingredient in EOHILIA. EOHILIA is pre-mixed and taken directly from the packet. Take EOHILIA by squeezing the packet from the bottom to the top directly into the mouth. Make sure to squeeze it two or three times to get all the medicine out. Don't take EOHILIA with food or liquid.

The empty packet can be thrown into the trash.

Patients should not eat or drink anything for at least 30 minutes after taking EOHILIA.

Setting a timer can be a helpful way for patients to keep track.

After 30 minutes, the patient rinses their mouth with water and spits out the contents without swallowing.

EOHILIA is recommended to be taken twice a day, once in the morning, and once at night. No mixing or measuring means it fits into your patients' schedules, whether they're home for the day or on the go.

RELIABLE DOSING FOR ON-THE-GO USE