Trelegy Ellipta Side Effects Center

Last updated on RxList: 12/20/2022
Trelegy Ellipta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Trelegy Ellipta?

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder), for oral inhalation is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, and/or emphysema.

What Are Side Effects of Trelegy Ellipta?

Trelegy Ellipta may cause serious side effects including:

  • white spots on your tongue or cheeks,
  • fever,
  • chills,
  • cough,
  • increased trouble breathing,
  • increased mucus or change in color of mucus,
  • sore throat,
  • tiredness,
  • weakness,
  • nausea,
  • vomiting,
  • low blood pressure,
  • wheezing,
  • shortness of breath,
  • tightness in your chest,
  • increased blood pressure,
  • fast or irregular heartbeat,
  • chest pain,
  • feeling aware of your heartbeat,
  • curved spine at the shoulders,
  • decreased height,
  • changes in posture,
  • eye pain,
  • blurry vision,
  • seeing halos around lights,
  • red eyes,
  • tremor,
  • nervousness,
  • weakness,
  • muscle cramps,
  • skipped or extra heartbeats,
  • increased thirst,
  • increased urination,
  • blurry vision,
  • headache,
  • difficulty or painful urination,
  • hives,
  • swelling of the face, throat, and tongue, and
  • difficulty breathing

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Trelegy Ellipta include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Drugs, Substances, or Supplements Interact with Trelegy Ellipta?

The dose of Trelegy Ellipta for maintenance treatment of COPD is 1 inhalation once daily. Trelegy Ellipta may interact with ketoconazole and other azole antifungals, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, diuretics, antocholinergics, antiviral medications, conivaptan, nefazodone, and macrolide antibiotics. Tell your doctor all medications and supplements you use.

Trelegy Ellipta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Trelegy Ellipta; it is unknown how it would affect a fetus. It is unknown if Trelegy Ellipta passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder), for Oral Inhalation Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Trelegy Ellipta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • tremors, nervousness, chest pain, fast or pounding heartbeats;
  • sores or white patches in your mouth and throat, pain when swallowing;
  • wheezing, choking, or other breathing problems after using this medicine;
  • painful or difficult urination;
  • blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
  • a lung infection--fever, chills, cough with mucus, feeling short of breath;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
  • signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

  • cold or flu symptoms such as runny or stuffy nose, sinus pain, sore throat, cough, chest tightness;
  • a lung infection;
  • nausea, vomiting, constipation, diarrhea;
  • urination problems;
  • joint pain;
  • mouth sores, hoarse voice;
  • headache, back pain; or
  • mouth pain, changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Trelegy Ellipta Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Serious Asthma-Related Events - Hospitalizations, Intubations, Death [see WARNINGS AND PRECAUTIONS]
  • Oropharyngeal Candidiasis [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Pneumonia in COPD [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression and Risk of Infections [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and Adrenal Suppression [see WARNINGS AND PRECAUTIONS]
  • Paradoxical Bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
  • Reduction in Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
  • Worsening of Narrow-Angle Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Worsening of Urinary Retention [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience In Chronic Obstructive Pulmonary Disease

The safety of TRELEGY ELLIPTA in COPD is based on the safety data from two 12-week treatment trials with coadministration of umeclidinium and the fixed-dose combination of fluticasone furoate/vilanterol and a 52-week long-term trial of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-dose combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol [see Clinical Studies].

Trials 1 And 2

Two 12-week treatment trials (Trial 1 and Trial 2) evaluated the coadministration of umeclidinium + fluticasone furoate/vilanterol, the components of TRELEGY ELLIPTA, compared with placebo + fluticasone furoate/vilanterol. A total of 824 subjects with COPD across two 12-week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg or placebo + fluticasone furoate/vilanterol 100/25 mcg administered once daily (mean age: 64 years, 92% White, 66% male across all treatments) [see Clinical Studies]. The incidence of adverse reactions associated with the use of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg presented in Table 2 is based on the two 12-week trials.

Table 2: Adverse Reactions with Umeclidinium + Fluticasone Furoate/Vilanterol with ≥1% Incidence and More Common than Placebo + Fluticasone Furoate/Vilanterol in Subjects with COPD (Trials 1 and 2)

Adverse Reaction Umec + FF/VI
(n = 412) %
Placebo + FF/VI
(n = 412) %
Nervous system disorders
Headache 4 3
Dysgeusia 2 <1
Musculoskeletal and connective tissue disorders
Back pain 4 2
Respiratory, thoracic, and mediastinal disorders
Cough 1 <1
Oropharyngeal pain 1 0
Gastrointestinal disorders
Diarrhea 2 <1
Infections and infestations
Gastroenteritis 1 0
Umec = Umeclidinium, FF/VI = Fluticasone Furoate/Vilanterol.

Trial 3 - Long-term Safety Data

A 52-week trial (Trial 3) evaluated the long-term safety of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-dose combinations of fluticasone furoate/vilanterol 100/25 mcg and umeclidinium/vilanterol 62.5/25 mcg. A total of 10,355 subjects with COPD with a history of moderate or severe exacerbations within the prior 12 months were randomized (2:2:1) to receive TRELEGY ELLIPTA 100/62.5/25 mcg, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily in a double-blind clinical trial (mean age: 65 years, 77% White, 66% male across all treatments) [see Clinical Studies].

The incidence of adverse reactions in the long-term trial were consistent with those in Trials 1 and 2. However, in addition to the adverse reactions shown in Table 2, adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg (n = 4,151) for up to 52 weeks also included upper respiratory tract infection, pneumonia [see WARNINGS AND PRECAUTIONS], bronchitis, oral candidiasis [see WARNINGS AND PRECAUTIONS], arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

Clinical Trials Experience In Asthma

The safety of TRELEGY ELLIPTA in asthma is based on a randomized, double-blind, parallel-group, active-controlled trial of 24 to 52 weeks' duration (Trial 4) that enrolled 2,436 adult subjects inadequately controlled on their current treatment of combination therapy (ICS plus a LABA) [see Clinical Studies]. In the overall population, 62% were female and 80% were White; mean age was 53 years. The incidence of adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg is shown in Table 3. Adverse reactions observed for the groups treated with TRELEGY ELLIPTA were similar to those observed for the fluticasone furoate/vilanterol arms.

Table 3: Adverse Reactions with TRELEGY ELLIPTA with ≥1% Incidence in Subjects with Asthma (Trial 4)

Adverse Reaction TRELEGY ELLIPTA 200/62.5/25 mcg
(n = 408) %
TRELEGY ELLIPTA 100/62.5/25 mcg
(n =406) %
FF/VI 200/25 mcg
(n = 406) %
FF/VI 100/25 mcg
(n = 407) %
Infections and infestations
Pharyngiti s/nasopharyngiti s 15 17 16 16
Upper respiratory tract 7 5 6 7
infection/viral upper respiratory tract infection
Bronchitis 5 4 5 3
Respiratory tract infection/viral respiratory tract infection 3 4 2 4
Sinusitis/acute sinusitis 3 2 2 3
Urinary tract infection 2 <1 <1 1
Rhinitis 1 2 2 3
Influenza 1 4 2 3
Pneumonia <1 1 2 2
Nervous system disorders
Headache 5 9 6 7
Musculoskeletal and connective tissue disorders
Back pain 2 3 1 4
Respiratory, thoracic, and mediastinal disorders
Dysphonia 1 1 2 1
Oropharyngeal pain 1 1 <1 <1
Cough 1 <1 1 1
FF/VI = Fluticasone Furoate/Vilanterol.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of TRELEGY ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to TRELEGY ELLIPTA or a combination of these factors.

Eye Disorders

Blurred vision, eye pain, glaucoma.

Immune System Disorders

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Renal And Urinary Disorders

Dysuria, urinary retention.

DRUG INTERACTIONS

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 [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

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 [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Trelegy Ellipta (Fluticasone Furoate Inhalation Powder)

© Trelegy Ellipta Patient Information is supplied by Cerner Multum, Inc. and Trelegy Ellipta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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