Eohilia Drug Information
Generic name: BUDESONIDE
Corticosteroid [EPC]
Uses of Eohilia
EOHILIA ™ is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
Dosage & Administration of Eohilia
Recommended Dosage
The recommended dosage is 2 mg orally twice daily for 12 weeks.
Preparation and Important Administration Instructions Do
NOT take EOHILIA with food or liquid at the time of ingestion. Wait for at least 30 minutes to eat or drink after taking EOHILIA. Administer EOHILIA as follows: Do NOT mix EOHILIA with food or liquid.
Shake the EOHILIA packet for at least 10 seconds prior to opening. Squeeze the packet from the bottom to the top directly into the mouth. Repeat 2 to 3 times until the EOHILIA packet is empty.
Swallow all the EOHILIA suspension. Do not eat or drink for 30 minutes after taking EOHILIA. After 30 minutes, rinse mouth with water and spit out the contents without swallowing.
Avoid consumption of grapefruit juice for the duration of therapy with EOHILIA.
Side Effects of Eohilia
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In these studies, 263 subjects received EOHILIA. Common Adverse Reactions The most common adverse reactions reported in Study 1 are shown in Table 1.
These subjects had no erosions present at the baseline esophagogastroduodenoscopy (EGD). All but one of the four subjects developed erosive esophagitis while receiving concomitant therapy with a PPI. No cases of erosive esophagitis were reported in Study 2.
Less Common Adverse Reactions Adverse reactions reported in less than 2% of subjects treated with EOHILIA and at a greater rate than placebo in Study 1 are listed below: Cardiac disorders: Palpitations Gastrointestinal disorders: Dry mouth, dyspepsia, erosive duodenitis, gastrointestinal motility disorder, esophageal food impaction, palatal swelling General disorders and administration site conditions: Fatigue, feeling abnormal Infections and infestations: Fungal skin infection, paronychia, pneumonia, sepsis, bronchitis Investigations: Transaminases increased, hyperkalemia Metabolism and nutrition disorders: Dyslipidemia Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms Nervous system disorders: Dysgeusia, syncope, tremor Psychiatric disorders: Depression, irritability, restlessness Respiratory, thoracic, and mediastinal disorders: Nasal congestion Skin and subcutaneous tissue disorders: Hirsutism, dermatitis acneiform Vascular disorders: Hypertension The safety profile of EOHILIA in Study 2 was generally similar to Study 1.
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of oral budesonide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions: Anaphylaxis Nervous System Disorders: Benign intracranial hypertension Psychiatric Disorders: Mood swings
| ADVERSE REACTIONS | EOHILIA 2 mg Twice Daily N = 213 | Placebo N = 105 |
|---|---|---|
| Respiratory tract infection includes acute sinusitis, sinusitis, nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection, rhinitis | 13% | 11% |
| Gastrointestinal mucosal candidiasis includes esophageal candidiasis, oropharyngeal candidiasis, oral candidiasis | 8% | 2% |
| Headache includes headache, migraine | 5% | 2% |
| Gastroenteritis | 3% | 1% |
| Throat irritation includes throat irritation, oropharyngeal pain | 3% | 2% |
| Adrenal suppression includes adrenal suppression, adrenal insufficiency | 2% | 0 |
| Erosive esophagitis includes esophagitis only where erosions were present at the esophagogastroduodenoscopy conducted after 12 weeks of treatment | 2% | 0 |
Warnings & Cautions for Eohilia
Hypercorticism and Adrenal Axis Suppression
Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including EOHILIA. Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression and consider reducing the dosage of EOHILIA. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide.
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, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.
Monitor patients for the development of infection and consider discontinuation of EOHILIA if the patient develops an infection while on treatment. Tuberculosis If corticosteroids are used in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation while receiving EOHILIA.
Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune pediatric and adult patients taking corticosteroids. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If an EOHILIA-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered.
Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Prior to starting treatment with 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.
Fungal Infections Corticosteroids may exacerbate systemic fungal infections; therefore, avoid EOHILIA use in the presence of such infections. Amebiasis Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating EOHILIA in patients who have spent time in the tropics or patients with unexplained diarrhea.
Strongyloides Infestation Avoid EOHILIA in patients with known or suspected Strongyloides (threadworm) infection. Corticosteroid-induced immunosuppression may lead to Strongyloides superinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including EOHILIA, in patients with cerebral malaria.
Ocular Herpes Simplex Avoid corticosteroids, including EOHILIA, in patients with active ocular herpes simplex. Localized Infections In clinical trials with EOHILIA, localized infections with Candida albicans occurred in the mouth, throat, and esophagus in some subjects. 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 local or systemic antifungal therapy and consider discontinuing treatment with 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) during the trial. 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 corticosteroid treatment 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), which were previously controlled by the systemic drug.
Other Corticosteroid Effects
Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition 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.
Drug Interactions with Eohilia
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 increase systemic budesonide concentrations. Avoid concomitant use of CYP3A4 inhibitors, including grapefruit juice, with EOHILIA.
Pregnancy Safety for Eohilia
Pregnancy Risk Summary The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal outcomes. Infants exposed to in-utero corticosteroids, including EOHILIA, are at risk for hypoadrenalism (see Clinical Considerations ). In animal reproduction studies, subcutaneous administration of budesonide during organogenesis in pregnant rats (at doses up to approximately 1.2 times the maximum recommended human dose, based on body surface area ) or pregnant rabbits (at doses approximately 0.14 times the maximum recommended human dose, based on body surface area ) resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities.
Maternal toxicity was observed in both rats and rabbits at these dose levels (see Data ). Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage in the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.
Infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly. Data Animal Data Budesonide was teratogenic and embryolethal in rabbits and rats. In an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis from gestation days 6-15, there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg/day in rats (approximately 1.2 times the maximum recommended human dose, based on body surface area ).
In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses up to approximately 25 mcg/kg/day (approximately 0.14 times the MRHD, based on BSA). Maternal toxicity, including reduction in body weight gain, was observed at subcutaneous doses of 5 mcg/kg in rabbits (approximately 0.03 times the MRHD, based on BSA) and 500 mcg/kg in rats (approximately 1.2 times the MRHD, based on BSA). In a peri- and post-natal development study, rats dosed subcutaneously with budesonide during the period of Day 15 post coitum to Day 21 postpartum, budesonide had no effects on delivery but did have an effect on growth and development of offspring.
In addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures 0.05 times the MRHD (on a mg/m 2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity.
Pediatric Use of Eohilia
Pediatric Use The safety and effectiveness of EOHILIA for 12 weeks of treatment for EoE have been established in pediatric patients 11 years of age and older. Use of EOHILIA for this indication is supported by adequate and well controlled studies in adults and pediatric subjects 11 years of age and older (Studies 1 and 2) with pharmacokinetic data in pediatric subjects aged 11 to 17 years of age. Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including EOHILIA.
Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The recommended duration of treatment with EOHILIA is 12 weeks.
The safety and effectiveness of EOHILIA in pediatric patients less than 11 years of age have not been established. Juvenile Animal Toxicity Data In a juvenile rat study, budesonide was administered orally at doses of mg/kg/day starting on postnatal day (PND) 22 for 91 consecutive days. All of the effects noted were associated with the pharmacology of the drug and manifested in a dose related manner, typical of corticosteroids.
These included decreased body weight gain, adrenal atrophy, and effects on bone (decreased cellularity and bone length) and lymphoid tissues (decreased cellularity). The no observed adverse effect level (NOAEL) in juvenile rats was determined to be the 0.05 mg/kg/day. The observations were dose-related and consistent with corticosteroid treatment.
The effects included decreased body weight gain, distended abdomen and swelling associated with inguinal hernias, lymphocytic and leukocytic changes, adrenal atrophy, depletion in lymphoid organs (lymph nodes, spleen, thymus), and effects on skeletal development (decreased cellularity in bone marrow, bone growth, and skeletal muscle atrophy). The incidence and severity of the majority of the pharmacologically mediated effects decreased or resolved completely following the recovery period. A NOAEL could not be defined in juvenile dogs.
Contraindications for Eohilia
EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products. Hypersensitivity to budesonide.
Overdosage Information for Eohilia
Treatment of acute overdosage consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy. Use of corticosteroids, such as EOHILIA, at excessive doses or for prolonged periods, increases the risk of systemic corticosteroid effects such as hypercorticism and adrenal axis suppression.
Clinical Studies of Eohilia
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 and Study 2 ). 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 to randomization. Concomitant use of stable doses of inhaled or intranasal steroids (for conditions other than EoE), PPIs, H 2 -receptor antagonists, antacids, antihistamines or anti-leukotrienes, and maintenance immunotherapy was allowed.
In Study 1, subjects were enrolled after maintaining a stable diet for at least 3 months prior to screening and were instructed to maintain a stable diet throughout the study. Subjects were excluded if they were on a full liquid or 6-food elimination diet. In Study 1 and Study 2, subjects were instructed to not eat or drink for 30 minutes after taking the drug and then to rinse their mouth with water and spit out the contents without swallowing prior to resuming normal oral intake.
The mean age of the study population was 34 years (range 11 to 56 years). Sixty percent of subjects were male, 95% were White, and 3% were Hispanic or Latino. Over 80% of the subjects were on concomitant PPI.
The mean (SD) DSQ combined scores at baseline were 30.3 and 30.4 in the EOHILIA and placebo groups, respectively. The mean age of the study population was 22 years (range 11 to 42 years). Over 65% of the subjects were on concomitant PPI.
The mean (SD) DSQ combined scores at baseline were 30.7 and 29.0 in the EOHILIA and placebo groups, respectively. Study 1 and Study 2 evaluated efficacy endpoints of histologic remission (defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels) and the absolute change from baseline in subject-reported DSQ combined score after 12 weeks of treatment. Efficacy results for Study 1 and Study 2 are presented in Table 2.
Table 2: Efficacy Results of EOHILIA in Adult and Pediatric Subjects 11 Years of Age and Older with EoE after 12 Weeks During the last 2 weeks of the 12-week treatment periods in Study 1 and Study 2, a greater proportion of subjects randomized to EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared to placebo, as measured by the subject-reported DSQ. Additional Study After completing Study 1, 48 subjects from the EOHILIA 2 mg treatment arm entered a double-blind randomized withdrawal extension study. These subjects received EOHILIA 2 mg twice daily or placebo for up to an additional 36 weeks.
Treatment with EOHILIA did not demonstrate a statistically significant difference compared to subjects re-randomized to placebo for prespecified efficacy endpoints based on eosinophil count and/or clinical symptoms measured by the DSQ at Week 36.
| Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|
| EOHILIA 2 mg Twice Daily N=213 | Placebo N=105 | Treatment difference and 95% CI For histological remission, the difference in percentages and 95% Newcombe confidence intervals are estimated using Mantel Haenszel weights, adjusting for age group and diet restriction. For absolute change in DSQ score, the LS mean changes, standard errors, and differences are estimated using an ANCOVA model with treatment group, age group, diet restriction, and baseline measurement as covariates. | EOHILIA 2 mg Twice Daily N=50 | Placebo N=42 | Treatment difference and 95%CI | |
| Efficacy Endpoints | ||||||
| Proportion of subjects achieving histological remission (peak esophageal intraepithelial eosinophil count ≤6 eos/hpf) | 53.1% | 1.0% | 52.4% (43.3, 59.1) | 38.0% | 2.4% | 35.8% (17.2, 50.0) |
| Absolute change from baseline in DSQ combined score (0-84 Total biweekly DSQ scores range from 0 to 84, higher scores indicate greater frequency and severity of dysphagia ), LS mean (SE) | -10.2 (1.5) | -6.5 (1.8) | -3.7 (-6.8, -0.6) | -14.5 (1.8) | -5.9 (2.1) | -8.6 (-13.7, -3.5) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
Ready to save on Eohilia?
Compare prescription prices at over 70,000 pharmacies and start saving today—no enrollment required.
Compare Eohilia Prices