Eohilia
Generic: BUDESONIDE
Basic Information
Manufacturer
TAKEDA PHARMACEUTICALS AMERICA, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
56f2023a-69b2-4470-b4ad-af7ec1be527a
Indications & Usage
1 INDICATIONS AND USAGE 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 [see Dosage and Administration (2.1) , Clinical Studies (14) ].
EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).
( 1 ) Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
( 1 , 2.1 , 14 )
Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1) , Clinical Studies (14) ].
EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).
( 1 ) Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
( 1 , 2.1 , 14 )
Adverse Reactions
6 ADVERSE REACTIONS 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 Warnings and Precautions (5.5) ] Other corticosteroid effects [see Warnings and Precautions (5.6) ] Kaposi’s sarcoma [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc.
at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of EOHILIA in 410 adults and pediatric subjects 11 years of age and older with EoE was evaluated in two 12-week, double-blind, placebo-controlled studies (Study 1 and Study 2).
In these studies, 263 subjects received EOHILIA [see Clinical Studies (14) ] .
Common Adverse Reactions The most common adverse reactions reported in Study 1 are shown in Table 1.
Table 1: Common Adverse Reactions reported in at least 2% of subjects in the EOHILIA group and at a rate greater than placebo.
in Adult and Pediatric Subjects 11 Years of Age and Older with EoE in Study 1 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 Specific Adverse Reactions Erosive Esophagitis Erosive esophagitis occurred in 4/213 (2%) of EOHILIA-treated subjects in Study 1.
These subjects had no erosions present at the baseline esophagogastroduodenoscopy (EGD).
At EGD after 12 weeks of treatment with EOHILIA, 2 subjects had Los Angeles (LA) classification grade A, 1 subject had LA grade B, and 1 subject had LA grade C erosive esophagitis.
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 [see Warnings and Precautions (5.3) ] .
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.
6.2 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
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc.
at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of EOHILIA in 410 adults and pediatric subjects 11 years of age and older with EoE was evaluated in two 12-week, double-blind, placebo-controlled studies (Study 1 and Study 2).
In these studies, 263 subjects received EOHILIA [see Clinical Studies (14) ] .
Common Adverse Reactions The most common adverse reactions reported in Study 1 are shown in Table 1.
Table 1: Common Adverse Reactions reported in at least 2% of subjects in the EOHILIA group and at a rate greater than placebo.
in Adult and Pediatric Subjects 11 Years of Age and Older with EoE in Study 1 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 Specific Adverse Reactions Erosive Esophagitis Erosive esophagitis occurred in 4/213 (2%) of EOHILIA-treated subjects in Study 1.
These subjects had no erosions present at the baseline esophagogastroduodenoscopy (EGD).
At EGD after 12 weeks of treatment with EOHILIA, 2 subjects had Los Angeles (LA) classification grade A, 1 subject had LA grade B, and 1 subject had LA grade C erosive esophagitis.
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 [see Warnings and Precautions (5.3) ] .
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.
6.2 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