Incruse Ellipta

Incruse Ellipta
(umeclidinium)

What is Incruse Ellipta (umeclidinium)?

Incruse Ellipta is prescribed for the ongoing treatment of chronic obstructive pulmonary disease (COPD). Incruse Ellipta is a maintenance medication used to control and decrease symptoms of COPD.

Incruse Ellipta belongs to the drug class anticholinergics, also known as long-acting muscarinic antagonists (LAMA). They work by enlarging and relaxing the airways in your lungs, making breathing easier.

What are the Indications for Incruse Ellipta?

Chronic obstructive pulmonary disease (COPD) is a group of diseases including emphysema and chronic bronchitis. COPD causes your airway to tighten, which worsens over time, making it hard for you to breathe.

Chronic bronchitis is a condition that develops over time where the airway becomes inflamed. This inflammation can lead to breathing difficulties. Symptoms may decrease but will never go away completely.

Emphysema is a condition that develops over time, damaging tissues in your lungs resulting in breathing difficulties. There is no cure for Emphysema; however, treatments such as Incruse Ellipta may help manage symptoms.

Incruse Ellipta is not recommended:

• For the treatment of asthma
• To relieve sudden breathing problems.
• To replace a rescue inhaler.
• For patients younger than 18 years old

How is Incruse Ellipta used?

Incruse Ellipta should be used as prescribed by your doctor. Incruse Ellipta is a powder that comes in a preloaded foil blister pack of 30. The blister pack is administered through a disposable inhalation device distinguished by light grey and light green colors.

The inhalation device has a counter that will keep track of how many doses are left in it after you’ve used it. Throw away the inhalation device when you’ve completed the last of the 30 doses, and the counter reads “0” or if it has been more than six weeks since you’ve opened the tray.

Storage

Incruse Ellipta should be stored at room temperature, away from heat, moisture, and light.

Keep out of reach of children.

Instructions

Follow the illustrated patient information that came in the box with your device step by step.

Do not remove the cover of the inhalation device until you are ready to take your dose. Each time you remove and open the cover, the inhalation device will be ready to be used and inhaled. If you do not inhale the dose and you close the inhalation device, you will lose the dose. This dose will be held in a different compartment of the inhaler that is not accessible.

Before using the inhalation device, write the first use date on the inhalation device so that you know when to discard it. To prepare and take your dose:

• Open the foil tray.
• Push the cover down until you hear a clicking sound.
• Turn away from the inhalation device and breathe out, not into the inhalation device.
• Then place the mouthpiece between your lips, and close your mouth around the mouthpiece, being careful not to block the air vent.
• Take a deep breath through your mouth and remove the mouthpiece.
• Hold your breath for as long as you can, preferably 3-4 seconds, then breathe out slowly. It’s important to note that you may not feel or taste the medication. This does not mean you are using it incorrectly, and you should not take another dose.
• If needed, clean the mouthpiece with a dry tissue and close the inhalation device.
• Rinse your mouth out afterward to prevent developing infections in your mouth and throat.

Dosage

The recommended dosage is to take one inhalation (puff) once daily by mouth. The dose should be taken at the same time every day. Do not take more than one inhalation as prescribed within a 24 hour period.

If you experience an acute symptom or flare-up of COPD, do not take another dose of Incruse Ellipta. Follow the care plan your doctor has outlined using a rescue inhaler. Contact your doctor if you have any questions or do not have a rescue inhaler.

SIDE EFFECTS

It’s important to understand that although Incruse Ellipta is FDA approved, it comes with side effects that may or may not affect you.

Before starting Incruse Ellipta, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Incruse Ellipta, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Cough
• Joint or muscle pain
• Mouth or tooth pain
• Stomach pain
• Constipation
• Cold symptoms such as a runny nose or sore throat
• Irregular heartbeat
• Change in tastebuds
• Bruising of the skin
• Upper respiratory infection

Serious Side Effects

Severe adverse reactions while taking Incruse Ellipta are not common but can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Immediate breathing problems such as an asthma attack right after using Incruse Ellipta.
• Severe allergic reaction; hives, rash, severe itching, and swelling in the face, tongue, mouth, or lips.
• Urinary problems; frequent urination, painful urination, difficulty or weak stream or urination.
• Worsening eye problems, eye pain or discomfort, blurred vision, or seeing halos around bright lights.

 The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

WARNINGS & PRECAUTIONS

Before using Incruse Ellipta, tell your doctor or pharmacist:

• If you are allergic to any medications.
• If you are allergic to milk proteins or any ingredients in Incruse Ellipta.
• If you have prostate problems. Incruse Ellipta may worsen your condition.
• If you have glaucoma.
• If you have urinary problems.
• If you are pregnant or breastfeeding.
• If you have heart disease.

Milk Protein Allergy

Using Incruse Ellipta with a milk protein allergy may cause a severe allergic reaction. Occurrences of severe allergic reactions in patients with a milk protein allergy have been reported. Incruse Ellipta is not recommended for patients with a milk protein allergy.

Narrow-Angle Glaucoma

Using Incruse Ellipta may worsen existing eye problems, or you may develop new eye problems such as narrow-angle glaucoma. Schedule regular exams with your eye doctor. Narrow-angle glaucoma can cause blindness in the affected eye. Symptoms may include eye discomfort or pain, blurred vision, nausea and vomiting, red eyes, and seeing halos around bright lights.

Paradoxical Bronchospasm

Using Incruse Ellipta may cause paradoxical bronchospasm, which is rapid wheezing or airway constriction that occurs right after inhaling the inhalation device. Symptoms may include wheezing, trouble breathing, chest tightness, or coughing.

Urinary Retention

Using Incruse Ellipta may worsen existing urinary problems, or you may develop new urinary problems. Symptoms may include urinating frequently, difficulty urinating, painful or weak stream during urination.

Pediatric

Incruse Ellipta is not recommended for patients under 18 years of age. It has not been established if Incruse Ellipta is safe or effective for pediatric patients.

Pregnant or Breast Feeding

There is insufficient data to support whether Incruse Ellipta may cause harm to an unborn child or if the medication will pass through to breastmilk. Consult with your doctor to determine whether you should take Incruse Ellipta.

Renal Impairment

There are no significant increases in Cmax or AUC in patients with severe renal impairment. No dose adjustments are needed.

Hepatic Impairment

There are no significant increases in Cmax or AUC in patients with moderate hepatic impairment. Studies have not been completed for patients with severe hepatic impairment.

INTERACTIONS & CONTRAINDICATIONS

Before using Incruse Ellipta, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Anticholinergics

Incruse Ellipta should not be taken with another anticholinergic medication. Taking more than one anticholinergic medication may increase your chance of adverse side effects.

FREQUENTLY ASKED QUESTIONS