Trelegy Ellipta 200/62.5/25 mcg Inhalation 30 Doses

• TRELEGY contains vilanterol, a long-acting beta2-adrenergic agonist (LABA). When LABA medicines such as vilanterol are used alone, they may increase the risk of hospitalization and death related to asthma. TRELEGY contains an inhaled corticosteroid (ICS), an anticholinergic, and a LABA. When an ICS and LABA are used together, this increased risk has not been shown to be significant.
• TRELEGY is not a rescue inhaler. It should not be used to treat sudden breathing difficulties or acute asthma symptoms. Always keep your prescribed rescue inhaler available for sudden symptoms.
• TRELEGY is not recommended for children under 18 years of age, as its safety and effectiveness in this age group have not been established.
• Do not use TRELEGY if you have a severe allergy to milk proteins or are allergic to any of its ingredients. Consult your healthcare provider if you are unsure about your allergies.
• Use TRELEGY only at the prescribed dose. Do not use it more frequently than recommended.
• Do not use TRELEGY together with other medicines containing a LABA or anticholinergic, regardless of the reason for use. Inform your healthcare provider about all medicines, supplements, and medical conditions.
• Seek medical attention promptly if your breathing problems worsen, you need your rescue inhaler more frequently than usual, or your rescue inhaler is no longer providing adequate relief.

Serious Side Effects

TRELEGY may cause serious adverse effects, including:

Oral Thrush

An inhaled corticosteroid may cause a fungal infection of the mouth or throat known as thrush. After using TRELEGY, rinse your mouth thoroughly with water and spit it out without swallowing to help reduce the risk.

Pneumonia

People with COPD already have an increased risk of pneumonia, and TRELEGY may further increase this risk. Contact your healthcare provider if you develop:

• Changes in the amount or color of mucus
• Fever
• Chills
• Increased coughing
• Worsening breathing difficulties

Weakened Immune System

Inhaled corticosteroids may weaken the immune response and increase susceptibility to certain infections.

Reduced Adrenal Function

Reduced adrenal function may occur, particularly when oral corticosteroids are stopped and treatment with inhaled corticosteroids is started. Medical supervision is important during this transition.

Paradoxical Bronchospasm

TRELEGY may rarely cause sudden worsening of breathing immediately after inhalation. If this occurs, stop using TRELEGY and seek medical attention immediately.

Serious Allergic Reactions

Serious allergic reactions may occur. Seek emergency medical care if you develop:

• Skin rash
• Hives
• Swelling of the face, mouth, or tongue
• Difficulty breathing

Cardiovascular Effects

TRELEGY may cause cardiovascular effects such as:

• Increased blood pressure
• Rapid or irregular heartbeat
• Awareness of heartbeat or palpitations
• Chest pain

Nervous System Effects

Possible effects include:

• Tremor
• Nervousness

Bone Effects

Long-term corticosteroid use may contribute to bone thinning or weakening (osteoporosis).

Eye Problems

TRELEGY may cause or worsen certain eye problems, including:

• Glaucoma
• Increased pressure inside the eye
• Cataracts
• Blurred vision
• Worsening of narrow-angle glaucoma
• Other changes in vision

Regular eye examinations may be recommended during treatment.

Acute narrow-angle glaucoma is a medical emergency and can result in permanent vision loss if not treated promptly. Seek immediate medical attention if you experience:

• Eye pain or discomfort
• Nausea or vomiting
• Blurred vision
• Seeing halos or bright colors around lights
• Red eyes

Do not take another dose until you have consulted your healthcare provider.

Urinary Retention

TRELEGY may cause new or worsening urinary retention. Symptoms can include:

• Difficulty urinating
• Painful urination
• Frequent urination
• Weak urine stream
• Dribbling after urination

If these symptoms occur, stop using TRELEGY and contact your healthcare provider immediately.

Changes in Blood Tests

TRELEGY may cause changes in certain laboratory values, including:

• Increased blood glucose (hyperglycemia)
• Reduced blood potassium levels (hypokalemia)

Effects on Growth

Inhaled corticosteroids may slow growth in children.

Common Side Effects in COPD

Common adverse effects reported with TRELEGY 100/62.5/25 mcg in patients with COPD include:

• Upper respiratory tract infection
• Pneumonia
• Bronchitis
• Oral or throat thrush
• Headache
• Back pain
• Joint pain
• Influenza
• Sinus inflammation
• Runny nose
• Sore throat
• Changes in taste
• Constipation
• Painful or frequent urination associated with urinary tract infection
• Nausea
• Vomiting
• Diarrhea
• Mouth and throat pain
• Cough
• Hoarseness

Rinsing the mouth with water and spitting it out after inhalation may help reduce the risk of oral thrush.

Common Side Effects in Asthma

Common side effects reported with TRELEGY in patients with asthma include:

• Runny nose
• Sore throat
• Upper respiratory tract infection
• Bronchitis
• Respiratory tract infection
• Sinus inflammation
• Painful or frequent urination associated with urinary tract infection
• Influenza
• Headache
• Back pain

Important Reminder

TRELEGY should be used exactly as prescribed by a healthcare professional. It is a maintenance inhaler and not intended for immediate relief of sudden breathing problems. Keep your prescribed rescue inhaler available for acute symptoms and seek medical attention if your breathing suddenly worsens.

Wait to open the cover until you are ready to take a dose. If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held inside the inhaler, but it will no longer be available to be inhaled. Don’t worry—it’s not possible to accidentally take an extra dose in 1 inhalation.

Note: Before the inhaler is used for the first time, the dose counter will start at 30 (or 14 if you’re using a sample). You may see "60" mentioned on your prescription printouts. This refers to the blisters inside the inhaler, not the number of doses. The 3 medicines in TRELEGY are packaged into 2 strips that each contain 30 blisters. When you open the inhaler (and hear the click), the contents of 1 blister from each of the 2 strips combine to form 1 dose of TRELEGY.

Make sure to ask your doctor or pharmacist for more information.

STEP 1

Open the cover of the inhaler

• Slide the cover down to expose the mouthpiece. You should hear a “click” and the counter will count down by 1 number. Your inhaler is now ready to use—you do not need to shake the inhaler.
• If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your healthcare provider or pharmacist if this happens.

STEP 2

Breathe out

• While holding the inhaler away from your mouth, breathe out fully.
• Do not breathe out into the mouthpiece.

STEP 3

Inhale the medicine

• Put the mouthpiece between your lips and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece.
• Take one long, steady, deep breath in through your mouth. Do not breathe in through your nose.
• Make sure not to block the air vent with your fingers.
• Remove the inhaler from your mouth and hold your breath for about 3-4 seconds (or as long as is comfortable for you).

STEP 4

Breathe out slowly and gently

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

STEP 5

Close the inhaler

• Routine cleaning is not required. If needed, you can clean the mouthpiece with a dry tissue before you close the cover.
• Slide the cover up and over the mouthpiece as far as it will go.

STEP 6

Rinse your mouth

• Rinse your mouth with water and spit the water out.
• Do not swallow the water.

IMPORTANT NOTE

When should you get a refill?

• Once there are fewer than 10 doses left in your inhaler, the left half of the dose counter will show red as a reminder to get a refill.
• After you have inhaled the last dose, the counter will show “0” and will be empty.
• Make sure to throw the empty inhaler away in your household trash, out of reach of children and pets.