What is PERFOROMIST^® (formoterol fumarate) Inhalation Solution?

• PERFOROMIST Inhalation Solution is a long-acting beta₂-adrenergic agonist (LABA) used to control the symptoms of COPD in adults with COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
• PERFOROMIST Inhalation Solution is only for use with a nebulizer.
• LABA medicines such as PERFOROMIST Inhalation Solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
• PERFOROMIST Inhalation Solution is for long-term use and should be taken 2 times each day, to improve the symptoms of COPD for better breathing.
• PERFOROMIST Inhalation Solution is not used to treat sudden symptoms of COPD.
• PERFOROMIST is not for the treatment of asthma. It is not known if PERFOROMIST Inhalation Solution is safe and effective in people with asthma.
• PERFOROMIST Inhalation Solution should not be used in children. It is not known if PERFOROMIST Inhalation Solution is safe and effective in children.

Do not use PERFOROMIST Inhalation Solution if you have asthma.

Tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have diabetes
• have seizures
• have thyroid problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if the medicine formoterol in PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.
• are breastfeeding or plan to breastfeed. It is not known if the medicine formoterol in PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain other medicines may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use PERFOROMIST Inhalation Solution?
Read the step-by-step instructions for using PERFOROMIST Inhalation Solution at the end of this Patient Information leaflet.

• Use PERFOROMIST Inhalation Solution exactly as prescribed. Do not use more than 2 vials of PERFOROMIST Inhalation Solution a day.
• Do not mix other medicines with PERFOROMIST Inhalation Solution in your nebulizer machine.
• While you are using PERFOROMIST Inhalation Solution 2 times each day:
  • do not use other medicines that contain a long-acting beta₂-agonist (LABA) for any reason.
  • do not use your short-acting beta₂-agonist medicine on regular basis (four times a day).
• PERFOROMIST Inhalation Solution does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
• Do not use PERFOROMIST Inhalation Solution:
  • more often than prescribed,
  • more medicine than prescribed for you, or
  • with other LABA medicines

Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with PERFOROMIST Inhalation Solution, you need to use your rescue medicine more often than usual, or your rescue medicine does not work as well for you to relieve your symptoms.

PERFOROMIST Inhalation Solution can cause serious side effects, including:

• people with asthma who take long-acting beta₂-adrenergic agonist (LABA) medicines, such as PERFOROMIST Inhalation Solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
  • Call your healthcare provider if breathing problems worsen over time while using PERFOROMIST Inhalation Solution. You may need a different treatment.
  • Get emergency medical care if:
    • breathing problems worsen quickly
    • you use your rescue inhaler medicine, but it does not relieve your breathing problems
• COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of PERFOROMIST Inhalation Solution, instead call your healthcare provider.
• using too much of a LABA medicine may cause:
  • chest pain
  • increased blood pressure
  • fast and irregular heartbeat
  • headache
  • tremor
  • nervousness
• sudden shortness of breath immediately after use of PERFOROMIST Inhalation Solution. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, call your healthcare provider or go to nearest hospital emergency room right away.
• effects on your heart, including fast or irregular heartbeat, chest pain or increased blood pressure.
• changes in laboratory levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
• 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.

Common side effects of PERFOROMIST Inhalation Solution include:

• headache
• tremor
• nervousness
• dry mouth
• muscle cramps
• nausea
• vomiting
• diarrhea
• dizziness
• tiredness
• trouble sleeping

Tell your healthcare provider if you get any side effect that bothers you or that does not go away.
These are not all the possible side effects of PERFOROMIST Inhalation Solution. For more information, ask your healthcare provider or pharmacist for more information.

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 and Patient Information.

For additional information, please contact us at 800-395-3376