Safety for
BREZTRI

IMPORTANT SAFETY INFORMATION

• BREZTRI combines 3 medicines, an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta₂-adrenergic agonist (LABA) medicine (formoterol fumarate). LABA medicines, such as formoterol fumarate, when used alone can increase the risk of hospitalizations and death from asthma problems. When an ICS and LABA are used together, this risk is not significantly increased
• Do not use BREZTRI to treat sudden severe symptoms of COPD or asthma, or if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the ingredients in BREZTRI
• Do not take BREZTRI with other medicines that contain a long-acting beta₂-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take
• Do not use BREZTRI more than prescribed
• Do not use in children younger than 12 years of age
• Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms
• BREZTRI can cause serious side effects, including:
  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREZTRI to help reduce your chance of getting thrush
  • Pneumonia. People with COPD have a higher chance of getting pneumonia. Call your healthcare provider if you notice an increase in mucus (sputum) production or change in mucus color, fever, chills, increased cough, or increased breathing problems
  • Weakened immune system and increased chance of getting infections (immunosuppression)
  • Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
  • Sudden breathing problems immediately after inhaling BREZTRI. If this happens, stop taking BREZTRI and call your healthcare provider right away
  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; or breathing problems
  • Effects on your heart such as increased blood pressure, a fast or irregular heartbeat, or chest pain
  • Effects on your nervous system such as tremor or nervousness
  • Bone thinning or weakness (osteoporosis)
  • Slowed growth in children. A child’s growth should be checked regularly while using BREZTRI
  • Acute narrow-angle glaucoma and cataracts. If you have new or worsening eye or vision problems, call your healthcare provider right away before taking another dose
  • Urinary retention. If you have new or worsening symptoms or difficulty urinating, stop taking BREZTRI and call your healthcare provider right away before taking another dose
  • Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm
• Most common side effects include: upper respiratory tract infection, pneumonia, back pain, thrush in your mouth and throat, joint pain, flu, headache, high blood sugar levels, muscle spasms, cough, inflammation of the sinuses, diarrhea, hoarseness, urinary tract infection, nausea, difficulty sleeping, feeling anxious and heart palpitations