FREQUENTLY ASKED QUESTIONS

Once-daily INCRUSE is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

COPD is a condition that makes it hard to breathe, and worsens over time. COPD includes chronic bronchitis, emphysema, or both.

  • Chronic bronchitis is increased cough and mucus production caused by inflammation of the airways. Bronchitis is considered chronic (or long term) if a person coughs and produces excess mucus most days for several months during 2 years in a row.
  • Emphysema is a disease that damages the air sacs and may damage the small airways in the lungs.

No. INCRUSE is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Use 1 inhalation of INCRUSE 1 time each day. Use INCRUSE at the same time each day. Use INCRUSE exactly as your healthcare provider tells you to use it. Do not use INCRUSE more often than prescribed.

If you miss a dose of INCRUSE, take it as soon as you remember. Do not take more than 1 inhalation each day. Take your next dose at your usual time. Do not take 2 doses at one time.

If you take too much INCRUSE, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

Do not stop using INCRUSE ELLIPTA, even if you are feeling better, unless your healthcare provider tells you to. Talk to your healthcare provider right away if you stop using INCRUSE ELLIPTA.

Common side effects of INCRUSE include:

  • upper respiratory tract infection
  • stuffy or runny nose
  • cough
  • mouth and throat pain
  • joint pain
  • change in taste
  • muscle pain
  • tooth pain
  • stomach pain
  • bruising or dark areas of skin
  • fast or irregular heartbeat

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of INCRUSE.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Store INCRUSE at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.

Store INCRUSE in the unopened foil tray and only open when ready for use.

Safely throw away INCRUSE in the trash 6 weeks after you open the foil tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.

Keep INCRUSE and all medicines out of the reach of children.

You may not taste or feel the medicine, even when you are using the inhaler correctly. Do not take another dose from the inhaler, even if you do not feel or taste the medicine.

In 2 clinical studies, patients took a disease-specific questionnaire, called the St. George’s Respiratory Questionnaire. They answered questions about their symptoms, activity, and impact of disease. More patients taking INCRUSE had an improvement in total score on the questionnaire compared with patients taking an inactive treatment, called placebo; however, your results may vary.

There are many organizations that help patients living with COPD and their caregivers. The following list provides information on some of those organizations.

American Lung Association

The American Lung Association website offers information about lung health education and research, as well as programs and services for people living with conditions such as COPD.

COPD Foundation

A not-for-profit organization created in 2004, the COPD Foundation supports research, education, and advocacy programs. Its website offers an online community for patients and caregivers affected by COPD, as well as information on the disease and a calendar of relevant events.

National Emphysema Foundation

The National Emphysema Foundation website provides regularly updated news and information on research and treatments related to emphysema and COPD. Its archives include articles on prevention, living with COPD, and healthy habits.

US COPD Coalition

A nonprofit organization that brings together patient foundations and organizations, health professional organizations, individuals, and government agencies who work together in a unified manner to promote the interests of individuals affected by COPD. Every day, the US COPD Coalition works toward its vision of a COPD-free United States.

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IMPORTANT SAFETY INFORMATION FOR INCRUSE

  • Do not use INCRUSE to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use INCRUSE if you have a severe allergy to milk proteins or any of the ingredients in INCRUSE. Ask your healthcare provider if you are not sure.
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IMPORTANT SAFETY
INFORMATION FOR INCRUSE

  • Do not use INCRUSE to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use INCRUSE if you have a severe allergy to milk proteins or any of the ingredients in INCRUSE. Ask your healthcare provider if you are not sure.
  • Do not use INCRUSE more often than prescribed.
  • Do not take INCRUSE with other medicines that contain an anticholinergic for any reason. Tell your healthcare provider about all the medicines you take and about all of your medical conditions. Especially tell your healthcare provider if you take anticholinergics including tiotropium, ipratropium, aclidinium, or atropine.
  • Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems.
  • INCRUSE can cause serious side effects, including:
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking INCRUSE and call your healthcare provider right away.
    • serious allergic reactions (anaphylaxis). Stop taking INCRUSE and call your healthcare provider or go to the nearest emergency room right away if you get any of the following symptoms of a serious allergic reaction: rash; hives; severe itching; swelling of your face, lips, mouth, or tongue; breathing problems.
    • new or worsening eye problems including acute narrow-angle glaucoma. You should have regular eye exams while using INCRUSE ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: eye pain or discomfort; nausea or vomiting; blurred vision; seeing halos or bright colors around lights; red eyes. If you have these symptoms, call your healthcare provider right away before taking another dose.
    • urinary retention. People who take INCRUSE may develop new or worse urinary retention. Symptoms of urinary retention may include: difficulty urinating; painful urination; urinating frequently; urination in a weak stream or drips. If you have these symptoms of urinary retention, stop taking INCRUSE, and call your healthcare provider right away before taking another dose.
  • Common side effects of INCRUSE include upper respiratory tract infection, stuffy or runny nose, cough, mouth and throat pain, joint pain, change in taste, muscle pain, tooth pain, stomach pain, bruising or dark areas of skin, and fast or irregular heartbeat.
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.