CHOOSING EOHILIA

FOR YOUR APPROPRIATE

EoE PATIENTS

Do these patients seem similar to yours?

Previous swallowed aerosol steroid user

Meet Mike, 35

Diagnosed: 4 years ago
Comorbidities: Yes
Previous therapy: Stopped taking swallowed steroid aerosols 4 weeks ago
Symptom complaints: Dysphagia

Steroid-naïve in EoE

Meet Luke, 25

Diagnosed: 5 months ago
Comorbidities: None
Previous therapy: Has been on a stable dose of proton pump inhibitors (PPIs) for the past month
Symptom complaints: Vomiting to relieve dysphagia symptoms and food avoidance

Previous slurry user

Meet Jackie, 41

Diagnosed: 6 years ago
Comorbidities: None
Previous therapy: Steroid slurries ceased 1 month ago
Symptom complaints: Dysphagia and food impaction

Failed to control EoE symptoms with diet modification

Meet Kiana, 11

Diagnosed: 2 years ago
Comorbidities: Yes
Previous therapy: Diet modification ceased 3 months ago
Symptom complaints: Choking and gagging with certain foods

All patients are hypothetical.

Not an actual patient.

Meet Mike

A patient with EoE who is currently experiencing a flare

“I struggle with swallowing while eating and want to explore another oral option.”

Clinical History

EoE diagnosis confirmed 4 years ago by a gastroenterologist following referral by his allergist
Allergist manages his EoE, and has controlled his allergic rhinitis and asthma
Before stopping a month ago, he used swallowed steroids for EoE

Notes

Asthma and allergic rhinitis are controlled
Reports excessive chewing, avoiding meals out with friends, and needing to drink water to relieve dysphagia symptoms several times in the last month
Comfortable with oral therapies and wants to try another oral option

Not an actual patient.

Meet Luke

A newly diagnosed, steroid-naïve in EoE patient

“My work requires frequent travel, so I need a therapy I can take on the move.”

Clinical History

His primary care physician (PCP) referred him to a gastroenterologist for evaluation of dysphagia symptoms that increase with meat and bread
Has been on a stable dose of PPIs for the past month

Notes

Requested an oral option that does not have to be refrigerated

Not an actual patient.

Meet Jackie

A previous slurry user looking for another oral treatment option

“I can’t find a treatment that fits in my daily routine. I’m a busy working parent, and every minute matters.”

Clinical History

Diagnosed after experiencing food impaction requiring emergency medical attention
Has tried food elimination and different doses of PPIs in the past
2 prior esophageal dilations

Notes

Complains about time it takes to make slurries and reports that consequently she’d miss doses
Stopped taking steroid slurries 1 month ago

Not an actual patient.

Meet Kiana

A pediatric patient who hasn’t found an EoE management strategy that works for her

“Our daughter is starting to avoid eating. We are sensitive to her age and want a treatment that she could learn to manage on her own.”

Clinical History

Suspected EoE after her mother noticed she was avoiding solid foods
Diagnosis was confirmed by pediatric gastroenterologist 2 years ago based on dysphagia symptoms, endoscopy, and histology
Has struggled with food elimination diets and is still experiencing EoE symptoms
Deferred additional EGDs

Notes

Needs to gag to get relief from her dysphagia symptoms several times a week
Her parents report that Kiana cuts food into small pieces, chews excessively, and drinks water with most bites of food
Kiana and her family would prefer a premixed oral option

~1 in 2,000

people in the U.S. are diagnosed with EoE⁵

See how EOHILIA may help

DSQ=Dysphagia Symptom Questionnaire; EGD=esophagogastroduodenoscopy; eos/hpf=eosinophils per high-power field; PPI=proton pump inhibitor.

Safety Profile

Dosing + Administration

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.

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

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

Effect on Growth

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Other Corticosteroid Effects

Kaposi’s Sarcoma

ADVERSE REACTIONS

DRUG INTERACTIONS

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.

References:

EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals, Inc.
Muir AB, Brown-Whitehorn T, Godwin B, et al. Clin Exp Gastroenterol. 2019;12:391-399.
Underwood B, Troutman TD, Schwartz JT. Ann Allergy Asthma Immunol. 2023;130(1):28-39.
Carr S, Chan ES, Watson W. Allergy Asthma Clin Immunol. 2018;14(suppl 2):58.
O’Shea KM, Aceves SS, Dellon ES, et al. Gastroenterology. 2018;154(2):333-345.

CHOOSING EOHILIA

FOR YOUR APPROPRIATE

EoE PATIENTS

Do these patients seem similar to yours?

Meet Mike

A patient with EoE who is currently experiencing a flare

Clinical History

Notes

Meet Luke

A newly diagnosed, steroid-naïve in EoE patient

Clinical History

Notes

Meet Jackie

A previous slurry user looking for another oral treatment option

Clinical History

Notes

Meet Kiana

A pediatric patient who hasn’t found an EoE management strategy that works for her

Clinical History

Notes

~1 in 2,000

people in the U.S. are diagnosed with EoE5

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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people in the U.S. are diagnosed with EoE⁵