Trelegy Ellipta (fluticasone furoate)

What is Trelegy Ellipta and how is it used?

• Trelegy Ellipta 100/62.5/25 mcg is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma in patients aged 18 years and older.
• Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm.
• Trelegy Ellipta combines 3 medicines in 1 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 Ellipta can cause serious side effects, including:

If you have these symptoms, call your healthcare provider right away before taking another dose.

If you have these symptoms of urinary retention, stop taking Trelegy Ellipta, and call your healthcare provider right away before taking another dose.

• fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Trelegy Ellipta to help reduce your chance of getting thrush.
• pneumonia. People with COPD have a higher chance of getting pneumonia. Trelegy Ellipta may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
  • increase in mucus (sputum) production
  • change in mucus color
  • fever
  • chills
  • increased cough
  • increased breathing problems
• 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 Ellipta). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse 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 Ellipta and call your healthcare provider 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 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 Ellipta.

  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
• urinary retention. People who take Trelegy Ellipta 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
• 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 Ellipta include:

COPD:

• upper respiratory tract infection
• pneumonia
• bronchitis
• thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
• headache
• back pain
• joint pain
• flu
• inflammation of the sinuses
• runny nose and sore throat
• taste disturbance
• constipation
• painful and frequent urination (signs of a urinary tract infection)
• nausea, vomiting, and diarrhea
• mouth and throat pain
• cough
• hoarseness

Asthma:

• 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 the possible side effects of Trelegy Ellipta.

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

Dosage And Administration Overview

• Administer 1 actuation of Trelegy Ellipta once daily by oral inhalation.
• After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
• Trelegy Ellipta should be used at the same time every day. Do not use Trelegy Ellipta more than 1 time every 24 hours.
• No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.

Recommended Dosage For Maintenance Treatment Of Chronic Obstructive Pulmonary Disease

• The recommended dosage of Trelegy Ellipta for maintenance treatment of COPD is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) once daily by oral inhalation. Trelegy Ellipta 100/62.5/25 mcg is the only strength indicated for the treatment of COPD.
• If shortness of breath occurs in the period between doses, an inhaled, short-acting beta₂-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Recommended Dosage For Maintenance Treatment Of Asthma

• The recommended starting dosage of Trelegy Ellipta for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 200/62.5/25 mcg) once daily, by oral inhalation.
• When choosing the starting dosage strength of Trelegy Ellipta, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation.
• The maximum recommended dosage is 1 inhalation of Trelegy Ellipta 200/62.5/25 mcg once daily.
• For patients who do not respond adequately to Trelegy Ellipta 100/62.5/25 mcg once daily, increasing the dose to Trelegy Ellipta 200/62.5/25 mcg once daily may provide additional improvement in asthma control. For patients who do not respond adequately to Trelegy Ellipta 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options.
• If asthma symptoms arise in the period between doses, an inhaled, short-acting beta₂-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Inhibitors Of Cytochrome P450 3A4

• Fluticasone furoate and vilanterol are substrates of CYP3A4.
• Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol.
• Caution should be exercised when considering the coadministration of Trelegy Ellipta with ketoconazole and other known strong CYP3A4 inhibitors.

Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, And QTc Prolonging Drugs

• Vilanterol, like other beta₂-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents.
• Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-Adrenergic Receptor Blocking Agents

• Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD or asthma. Therefore, patients with COPD or asthma should not normally be treated with beta-blockers.
• However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

Non-Potassium-Sparing Diuretics

• The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.
• Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.

Anticholinergics

• There is potential for an additive interaction with concomitantly used anticholinergic medicines.
• Therefore, avoid coadministration of Trelegy Ellipta with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

• There are insufficient data on the use of Trelegy Ellipta or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug-associated risk.
• There is no information available on the presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; the effects on the breastfed child; or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trelegy Ellipta and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium, or vilanterol or from the underlying maternal condition.