Image: TRELEGY ELLIPTA Inhaler for Asthma

Risks & Side Effects

Important Facts About TRELEGY for Asthma

Please review this safety information.

Below you can learn about the risks and side effects of TRELEGY. This, however, is not all of the safety information and does not replace talking to your healthcare provider about your medical condition or treatment.

For more information, please see the complete Prescribing Information, including Patient Information for TRELEGY, or ask your healthcare provider or pharmacist.

What is TRELEGY?

  • TRELEGY combines 3 medicines in one inhaler, an inhaled corticosteroid (ICS) medicine (fluticasone furoate), an anticholinergic medicine (umeclidinium), and a long-acting beta2-adrenergic agonist (LABA) medicine (vilanterol).
  • ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent 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.
  • TRELEGY is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
  • TRELEGY is a prescription medicine used long term (chronic) to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.
  • TRELEGY contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. TRELEGY contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

 

TRELEGY should not be used in children younger than 18 years of age. It is not known if TRELEGY is safe and effective in children younger than 18 years of age.

Do not use TRELEGY:

  • to treat sudden, severe symptoms of chronic obstructive pulmonary disease (COPD) or asthma.
  • if you have a severe allergy to milk proteins. Ask your HCP if you are not sure.
  • if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY. See the Patient Information for a complete list of ingredients in TRELEGY.

Before using TRELEGY, tell your HCP about all of your medical conditions, including if you have:

  • heart problems; high blood pressure; seizures; thyroid problems; diabetes; liver problems; weak bones (osteoporosis); an immune system problem; eye problems such as glaucoma, increased pressure in your eye, cataracts, blurred vision, or other changes in vision (TRELEGY may make your glaucoma worse).

or if you:

  • are allergic to milk proteins.
  • have prostate or bladder problems, or problems passing urine (TRELEGY may make these problems worse).
  • have any type of viral, bacterial, parasitic, or fungal infection.
  • are exposed to chickenpox or measles.
  • are pregnant or plan to become pregnant. It is not known if TRELEGY may harm your unborn baby.
  • are breastfeeding. It is not known if the medicines in TRELEGY pass into your milk and if they can harm your baby.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRELEGY and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your HCP if you take: anticholinergics (including tiotropium, ipratropium, aclidinium); atropine; other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol); antifungal or anti-HIV medicines.

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

How should I use TRELEGY?

Read the step-by-step instructions for using TRELEGY at the end of the Patient Information.

  • Do not use TRELEGY unless your HCP has taught you how to use the inhaler and you understand how to use it correctly.
  • TRELEGY comes in 2 different strengths. Your HCP prescribed the strength that is best for you.
  • Use TRELEGY exactly as your HCP tells you to use it. Do not use TRELEGY more often than prescribed.
  • Use 1 inhalation of TRELEGY 1 time each day. Use TRELEGY at the same time each day.
  • If you miss a dose of TRELEGY, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • If you take too much TRELEGY, call your HCP 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 use other medicines that contain a LABA or an anticholinergic for any reason. Ask your HCP or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
  • Do not stop using TRELEGY unless told to do so by your HCP because your symptoms might get worse. Your HCP will change your medicines as needed.
  • TRELEGY does not relieve sudden symptoms of asthma, and you should not take extra doses of TRELEGY to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your HCP to have one prescribed for you.
  • Call your HCP 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 are the possible side effects of TRELEGY?

TRELEGY can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as TRELEGY). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse chronic obstructive pulmonary disease (COPD) or asthma symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: feeling tired; lack of energy; weakness; nausea and vomiting; low blood pressure (hypotension).
  • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking TRELEGY and call your HCP right away.
  • serious allergic reactions. Call your HCP or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; breathing problems.
  • effects on heart: increased blood pressure; a fast or irregular heartbeat, awareness of heartbeat; chest pain.
  • effects on nervous system: tremor; nervousness.
  • bone thinning or weakness (osteoporosis).
  • eye problems including glaucoma, increased pressure in your eye, cataracts, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. You should have regular eye exams while using TRELEGY. 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 HCP right away before taking another dose.
  • urinary retention. People who take TRELEGY may develop new or worse urinary retention. Symptoms may include: difficulty urinating; painful urination; urinating frequently; urination in a weak stream or drips. If you have these symptoms, stop taking TRELEGY, and call your HCP right away before taking another dose.
  • changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
  • slowed growth in children.

Common side effects of TRELEGY for asthma include: runny nose and sore throat; upper respiratory tract infection; bronchitis; respiratory tract infection; inflammation of the sinuses; painful and frequent urination (signs of a urinary tract infection); flu; headache; back pain.

These are not all of the possible side effects of TRELEGY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.