IMPORTANT SAFETY INFORMATION
Who should not take EOHILIA?
Do not take EOHILIA if you are allergic to budesonide.
What are the possible side effects of EOHILIA?
EOHILIA may cause serious side effects, including:
Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of EOHILIA may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
- Acne
- Bruise easily
- Rounding of your face
- Ankle swelling
- Thicker body hair and facial hair
- A fatty pad or hump between your shoulders (buffalo hump)
- Pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
Adrenal suppression. Long-term use of EOHILIA can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
- Tiredness
- Weakness
- Nausea and vomiting
- Low blood pressure
Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including EOHILIA, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including EOHILIA can also:
- Make current infections worse
- Increase the risk of infections spreading (disseminated)
- Increase the risk of making infections active again or making infections worse that have not been active (latent)
- Hide (mask) some signs of infection
These infections can be mild but can be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking EOHILIA. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking EOHILIA, including flu-like symptoms such as:
- Fever
- Chills
- Stomach area (abdominal) pain
- Aches
- Diarrhea
- Cough
- Pain
- Feeling tired
- Nausea and vomiting
- Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking EOHILIA. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking EOHILIA.
- Chicken pox and measles: People taking corticosteroid medicines, including EOHILIA, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
- Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking EOHILIA. Your healthcare provider will test you for HBV before you start taking EOHILIA.
- Amebiasis: Inactive (latent) amebiasis may become an active infection while taking EOHILIA. Your healthcare provider should check you for amebiasis before you start taking EOHILIA if you have spent time in the tropics or have unexplained diarrhea.
- Fungal infections of the mouth (thrush), throat, and esophagus in patients using EOHILIA may occur. Symptoms of infection include white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or swallowing, loss of taste, and cotton feeling in your mouth. Tell your healthcare provider if any of the above symptoms occur.
- Erosive esophagitis. EOHILIA can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms: heartburn, chest pain, and trouble swallowing.
- Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking EOHILIA.
- Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to EOHILIA may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking EOHILIA.
- Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.
The most common side effects of EOHILIA include:
- Respiratory tract infection
- Fungal infections of the mouth, throat, and esophagus (thrush)
- Headache
- Infection of the stomach or intestine (gastroenteritis)
- Sore throat
- Adrenal suppression
- Acid-related damage to the lining of esophagus (erosive esophagitis)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of EOHILIA. You may report side effects to the FDA at 1-800-FDA-1088.
What should I avoid while taking EOHILIA?
- Avoid drinking grapefruit juice while taking EOHILIA. Drinking grapefruit juice can increase the level of EOHILIA in your blood.
Before you take EOHILIA, tell your healthcare provider if you have any medical conditions, including if you have:
- Liver problems
- Are planning to have surgery
- Chicken pox, measles, or recently been near anyone with either
- Certain kinds of infection that have not been treated including:
- Fungal infections
- Bacterial infections
- Viral infections
- Parasitic infections, including threadworm (Strongyloides) infections.
- Herpes simplex infection of the eye (ocular herpes simplex)
- Have or had tuberculosis
- Malaria of the brain (cerebral malaria)
- Infection of the mouth, throat, or esophagus
- Diabetes, glaucoma, or family history of either
- Cataracts
- High blood pressure (hypertension)
- Low bone mineral density or osteoporosis
- Stomach ulcers
- Are pregnant, plan to become pregnant, or think you may be pregnant. EOHILIA may harm your unborn baby. Talk to your healthcare provider about the possible risks.
- Are breastfeeding or plan to breastfeed. It is unknown if EOHILIA passes into your breast milk or affects your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What is EOHILIA?
EOHILIA (budesonide oral suspension) is a prescription oral corticosteroid medicine used for 12 weeks of treatment of Eosinophilic Esophagitis (EoE), in people 11 years and older.
EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
It is not known if EOHILIA is safe and effective in children under 11 years of age.
Please click here for EOHILIA Prescribing Information, including Patient Information and Instructions for Use and talk with your healthcare provider.
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