Incruse Ellipta

Generic Name: umeclidinium inhalation powder
Date of Approval: April 30, 2014
Company: GlaxoSmithKline

Treatment for: Chronic Obstructive Pulmonary Disease

FDA Approves Incruse Ellipta

The U.S. Food and Drug Administration (FDA) has approved Incruse Ellipta (umeclidinium), an anticholinergic bronchodilator for the long-term, once-daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Umeclidinium belongs to the class of drugs called long-acting muscarinic antagonists (LAMAs), which also includes tiotropium (Spiriva) and aclidinium (Tudorza Pressair).

Incruse Ellipta is for maintenance treatment only and should not be used to relieve acute symptoms of COPD. It should be used regulary once a day, every day. Patients should always contact their healthcare provider if their symptoms become worse, or if they require more inhalations than usual of their rescue inhaler.

Incruse Ellipta should not be used in patients who have a severe hypersensitivity to milk proteins. The most common side effects of treatment include nasopharyngitis, upper respiratory tract infections, cough, and arthralgia. Less common side effects included atrial fibrillation. Patients should also be aware of a condition called paradoxical bronchospasm, which is the worsening of symptoms immediately after inhaling the medicine. Patients with narrow-angle glaucoma, and urinary retention may experience worsening of their condition.

Patient Information

Read this Patient Information before you receive this medicine and each time you receive treatment. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Slideshow: Flashback: FDA Drug Approvals 2013

What is Incruse Ellipta?

Incruse Ellipta is an anticholinergic bronchodilator which works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.

It is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a chronic lung disease that includes chronic bronchitis, emphysema, or both.

This medicine is used long term, one inhalation daily. It should not be used in children.

Important information

Incruse Ellipta is for oral inhalation via a special inhaler. The powder should not be swallowed.

Before using this medicine, tell your healthcare provider if you have narrow-angle glaucoma, or an enlarged prostate or bladder obstruction.

Incruse Ellipta is used for the prevention of bronchospasm attacks, and will not work fast enough to treat an attack that has already begun. You must always use a faster acting rescue inhaler (short-acting bronchodilator) to treat a sudden bronchospasm attack. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Who should not use Incruse Ellipta?

Do not use this medicine if you:

  • have a severe allergy to milk proteins
  • are allergic to umeclidinium or any of the ingredients

Before using Incruse Ellipta

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

  • have heart problems
  • have eye problems such as glaucoma
  • have prostate or bladder problems, or problems passing urine
  • are allergic to any of the ingredients, or any other medicines, or food products
  • have any other medical conditions
  • are pregnant or planning to become pregnant as it is not known if this medicine may harm your unborn baby. FDA pregnancy category C.
  • are breastfeeding as it is not known if the active ingredient passes into breastmilk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Umeclidinium 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)
  • atropine

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

How should I use Incruse Ellipta?

Read the step-by-step instructions included in the package. Do not use the inhaler unless your healthcare provider has taught you how to use it, and you understand how to use it correctly.

  • Use exactly as your healthcare provider tells you to use it.
  • Do not more often than prescribed.
  • Use one inhalation once a day at the same time.
  • If you miss a dose, take it as soon as you remember. Do not take more than one inhalation each day. Take your next dose at your usual time. Do not take two doses at one time.
  • Do not use other medicines that contain an anticholinergic for any reason.
  • Do not stop using this medicine unless you are told to do so by your healthcare provider because your symptoms might get worse.
  • Incruse Ellipta does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse
    • you need to use your rescue inhaler more often than usual
    • your rescue inhaler does not work as well to relieve your symptoms

    What happens if I overdose?

    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.

    Incruse Ellipta side effects

    Serious side effects, include:

    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, you should stop using this medicine and and call your doctor right away.
    • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of the face, mouth, and tongue
    • breathing problems
  • new or worsened eye problems including acute narrow-angle glaucoma. Symptoms may include:
    • eye pain or discomfort
    • nausea or vomiting
    • blurred vision
    • seeing halos or bright colors around lights
    • red eyes
  • urinary retention. Symptoms may include:
    • difficulty urinating
    • painful urination
    • urinating frequently
    • urination in a weak stream or drips

Common side effects include:

  • upper respiratory infection
  • stuffy or runny nose
  • cough
  • sore throat
  • joint pain
  • 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. This is not a complete list of side effects. Ask your healthcare provider or pharmacist if you need more information.

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

How do I store Incruse Ellipta?

  • Store 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 in the unopened foil tray and only open when ready for use.
  • Safely throw away Incruse Ellipta in the trash six 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 all medicines out of the reach of children.

General information about Incruse Ellipta

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition that you have. It may harm them.

If you would like more information about this medicine, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals.

What are the ingredients in Incruse Ellipta?

Active ingredients: umeclidinium

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

about all medicines you use now and any medicine you start or stop using.

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