APPROVED USES:

Asthma: BREYNA is for the treatment of asthma in adults and children 6 years and older.

BREYNA is not for adults and children with asthma who are well‐controlled with an asthma-control medicine such as an inhaled corticosteroid (ICS).

BREYNA is for adults and children with asthma who need both an ICS and a long-acting beta₂-adrenergic agonist (LABA).

COPD: COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both. BREYNA 160/4.5 mcg is used long-term in adults to improve symptoms of chronic obstructive pulmonary disease (COPD), for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

BREYNA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

IMPORTANT SAFETY INFORMATION

• BREYNA combines an ICS, budesonide and a LABA medicine, formoterol. LABA medicines, such as formoterol, 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 BREYNA for sudden severe symptoms of COPD or asthma or if you are allergic to any of the ingredients in BREYNA
• Before you use BREYNA, tell your healthcare provider about all of your medical conditions, including if you have heart conditions or high blood pressure, and all the medicines you may be taking. Some patients taking BREYNA may experience increased blood pressure, heart rate, or change in heart rhythm
• Do not use BREYNA more often than prescribed. BREYNA should be taken as 2 puffs 2 times each day
• While taking BREYNA, do not use another medicine containing a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines
• Call your healthcare provider or get medical care right away if:
  • Your breathing problems worsen
  • You need to use your rescue inhaler more often than usual or your rescue inhaler doesn’t work as well at relieving symptoms
• BREYNA may cause serious side effects, including:
  • Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache or nervousness
  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREYNA to help reduce your chance of getting thrush
  • Pneumonia and other lower respiratory tract infections. People with COPD may have a higher chance of pneumonia and other lung infections. ICS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus production or change in color, fever, increased cough, chills, or increased breathing problems
  • Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as: fever, body aches, feeling tired, vomiting, pain, chills, or nausea
  • Adrenal insufficiency. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
  • Increased wheezing right after taking BREYNA. Always have a rescue inhaler with you to treat sudden wheezing
  • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction
  • Lower bone mineral density can happen in people who have a high chance for low bone mineral density (osteoporosis)
  • Slowed growth in children. A child’s growth should be checked regularly while using BREYNA
  • Eye problems including glaucoma and cataracts. You should have regular eye exams while using BREYNA
  • Swelling of blood vessels. This can happen in people with asthma. Tell your healthcare provider right away if you have: a feeling of pins and needles or numbness of arms or legs, rash, flu like symptoms, or pain and swelling of the sinuses
  • Decreases in blood potassium levels (hypokalemia)
  • Increases in blood sugar levels (hyperglycemia)

• The most common side effects of BREYNA include:
  • Asthma: throat irritation, headache, upper respiratory tract infection, throat pain, sinusitis, flu, back pain, nasal congestion, stomach discomfort, vomiting, and thrush in the mouth and throat
  • COPD: throat irritation, thrush in the mouth and throat, bronchitis, sinusitis, and upper respiratory tract infection

This summary does not include all the information about BREYNA and is not meant to take the place of a discussion with your healthcare provider about your treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for Full Prescribing Information.