INCRUSE ELLIPTA Inhaler

INCRUSE helps people with COPD breathe better for a full 24 hours. Your results may vary.

Talk to your doctor to see if INCRUSE is right for you.

ABOUT INCRUSE

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. INCRUSE is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

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.

INCRUSE is an anticholinergic medicine (also known as a LAMA).

Anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent COPD symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

LAMA=long-acting muscarinic antagonist

FREQUENTLY ASKED QUESTIONS

  • How should I use INCRUSE?

    Read the step-by-step instructions for using INCRUSE at the end of the Patient Information for INCRUSE. You can also ask your healthcare provider or pharmacist for more information.

  • Who should not use INCRUSE?

    Do not use INCRUSE if you:

    • have a severe allergy to milk proteins or to umeclidinium or any of the ingredients in INCRUSE. Ask your healthcare provider if you are not sure.
  • What should I tell my healthcare provider before using INCRUSE?

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

    • have heart problems.
    • have eye problems such as glaucoma. INCRUSE may make your glaucoma worse.
    • have prostate or bladder problems, or problems passing urine. INCRUSE may make these problems worse.
    • are allergic to any of the ingredients in INCRUSE, any other medicines, or food products. See “What are the ingredients in INCRUSE?” below for a complete list of ingredients. Ask your healthcare provider if you are not sure.
    • are pregnant or plan to become pregnant. It is not known if INCRUSE may harm your unborn baby.
    • are breastfeeding. It is not known if the medicine in INCRUSE passes into your 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. INCRUSE and certain other medicines may interact with each other. This may cause serious side effects.

    Especially tell your healthcare provider if you take anticholinergics (including tiotropium, ipratropium, aclidinium) or atropine.

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

  • What are the possible side effects with INCRUSE?

    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 doctor 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 the 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. 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 doctor 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 doctor 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
    • fast or irregular heartbeat

    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 FDA at 1-800-FDA-1088.

  • What is the approved use for INCRUSE?

    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.

  • What is COPD?

    COPD is a condition that makes it hard to breathe. When you breathe, air travels through tubes in your lungs, also called airways, to millions of tiny air sacs. In a healthy lung, air easily moves in through the airways and fills the air sacs, and then is quickly released back out. For someone with COPD, it’s much tougher for air to move through the airways and into the air sacs and back out. A doctor may be able to diagnose COPD through a test called spirometry, which measures how much air you can breathe into your lungs and how quickly you can release it. Other tests or chest x-rays may help your doctor with diagnosing COPD. These breathing difficulties tend to worsen over time.

    There are several potential causes of COPD
    Cigarette smoking is the most common cause of COPD. Most people who have COPD smoke or used to smoke. It’s possible to have COPD even if you have never smoked. Secondhand cigarette smoke can also be a cause of COPD. There are several other potential causes of COPD, including:

    • Dust
    • Chemical fumes at work and at home
    • Outdoor air pollution
    • Indoor air quality
    • Respiratory infections
    • Genetic factors

    How does COPD disrupt airflow?
    COPD disrupts the airflow in and out of your lungs and reduces your lung function. Some of the reasons are:

    • Airways and air sacs lose elasticity.
    • The walls separating the air sacs become permanently damaged.
    • The walls of the airways become thick and inflamed.
    • The airways make more mucus than usual, which can clog them.

    There are different types of COPD
    COPD can include emphysema, chronic bronchitis, or both. Either emphysema or chronic bronchitis may reduce lung function, resulting in COPD symptoms that can make it difficult to breathe.

    • Emphysema is a disease that damages the air sacs and may damage the small airways in the lungs. This significantly reduces your ability to expel the normal amount of air from the lungs. This causes shortness of breath and prevents the lungs from delivering oxygen into the blood.
    • Chronic bronchitis involves increased cough and mucus production caused by inflammation of the airways. Bronchitis is considered chronic (or long term) if you cough and produce excess mucus most days for several months during 2 years in a row.
  • What are the symptoms of COPD?

    Reduced lung function due to COPD can result in 1 or more of these COPD symptoms:

    • Shortness of Breath
      When you have to work harder to breathe and find it hard to catch your breath.
    • Cough
      Coughing can occur at any time of the day or night.
    • Wheezing
      Air is trying to flow through a narrow airway. You may hear a slight whistling or squeaky sound coming from your chest.
    • Chest Tightness
      Feeling like something heavy is sitting on your chest, restricting your breathing.

    COPD is a progressive disease. Over time, most people with COPD develop many of these symptoms. COPD is a chronic disease, but your symptoms may vary from day to day.

    Keep in mind that COPD symptoms develop slowly. At times, they may get worse. Certain COPD symptoms, like shortness of breath, affect each individual differently. That’s why it’s important to talk to your healthcare provider if you notice a change in any of the symptoms listed above.

  • Does INCRUSE treat sudden symptoms of COPD?

    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.

  • What are the ingredients in INCRUSE?

    Active ingredients: umeclidinium

    Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

  • When should I take INCRUSE?

    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.

  • What if I miss a dose of INCRUSE?

    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.

  • What if I take too much INCRUSE?

    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.

  • Should I stop taking INCRUSE if my symptoms get better?

    Do not stop using INCRUSE, 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.

  • Will I taste or feel my dose of INCRUSE after inhalation?

    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.

  • How do I store INCRUSE?

    • 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 tray, and only open when ready for use.
    • Safely throw away INCRUSE in the trash 6 weeks after you open the 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.
  • Are there coupons or savings offers available for INCRUSE?

    No, there are no coupons or savings offers available for INCRUSE.

  • What is the St. George’s Respiratory Questionnaire?

    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.

  • Where can I learn more about COPD?

    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.