Trelegy Ellipta

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Trelegy Ellipta Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Fluticasone furoate, umeclidinium, vilanterol 100/62.5/25mcg, 200/62.5/25mcg; per inh; dry pwd for oral inhalation.

    Pharmacological Class

    Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).

    How Supplied

    Dry pwd inhaler—30 inhalations (60 blisters)

    How Supplied

    Trelegy Ellipta is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters. 

    The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs: Trelegy Ellipta 100/62.5/25 mcg 30 inhalations (60 blisters) and Trelegy Ellipta 200/62.5/25 mcg 30 inhalations (60 blisters). 

    • One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 and 25 mcg per blister, respectively).

    • A blister from each strip is used to create 1 dose. 

    Storage

    • Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. 

    • Discard Trelegy Ellipta 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable.

    Manufacturer

    GlaxoSmithKline

    Generic Availability

    NO

    Mechanism of Action

    Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Umeclidinium is a long-acting muscarinic antagonist that exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. Vilanterol is a LABA that relaxes smooth muscle and inhibits release of mediators of immediate hypersensitivity from cells.

    Trelegy Ellipta Indications

    Indications

    Maintenance treatment of COPD or asthma.

    Limitations of Use

    Not indicated for relief of acute bronchospasm.

    Trelegy Ellipta Dosage and Administration

    Adult

    COPD: 1 inh of 100/62.5/25mcg once daily (max). Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. Max 1 inh of 200/62.5/25mcg once daily. Rinse mouth after use. Consider other therapeutic regimens and additional therapeutic options if patient does not respond adequately to 200/62.5/25mcg.

    Children

    ≤17yrs: not established.

    Trelegy Ellipta Contraindications

    Contraindications

    Primary treatment of status asthmaticus or other acute episodes of COPD or asthma requiring intensive measures. Severe hypersensitivity to milk proteins.

    Trelegy Ellipta Boxed Warnings

    Not Applicable

    Trelegy Ellipta Warnings/Precautions

    Warnings/Precautions

    LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in rapidly deteriorating or potentially life-threatening episodes of COPD or asthma. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral ­treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or a severe COPD exacerbation. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children and adolescents, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension); discontinue if significant effects occur. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Moderate or severe hepatic impairment; monitor. Labor & delivery. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Serious Asthma-Related Events – Hospitalizations, Intubations, Death

    • Long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma can increase risk of asthma-related death. 

    • The increased risk of asthma-related death is considered a class effect of the LABA.

    • Available data do not suggest an increased risk of serious asthma-related events with use of LABA in fixed-dose combination with ICS compared with ICS alone in asthma patients.

    Deterioration of Disease and Acute Episodes

    • Do not initiate Trelegy Ellipta in patients with rapidly deteriorating or potentially life-threatening episodes of COPD or asthma; use in this setting is inappropriate.

    • Not for relief of acute symptoms; acute symptoms should be treated with inhaled short-acting beta2-agonist. 

    • When beginning treatment with Trelegy Ellipta, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (eg, 4 x per day) should be instructed to discontinue the regular use of these drugs. 

    Avoid Excessive Use of Trelegy Ellipta and Avoid Use with Other Long-acting Beta2-agonists

    • Do not exceed the recommended dose.

    • Clinically significant cardiovascular effects and fatalities have been reported with excessive use of inhaled sympathomimetic drugs. 

    • Patients using Trelegy Ellipta should not use another medicine containing a LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. 

    Oropharyngeal Candidiasis

    • Localized Infections of the mouth and pharynx with Candida albicans has occurred in clinical trials. Infections should be treated with appropriate local or systemic antifungal therapy while remaining on Trelegy Ellipta, though Trelegy Ellipta may need to be interrupted in some cases. 

    • Patients should rinse the mouth after inhalation of Trelegy Ellipta.

    Pneumonia

    • Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. 

    Immunosuppression and Risk of Infections  

    • Patients who are using drugs that suppress the immune system are more susceptible to infections. For patients who have not previously had chickenpox or measles or been vaccinated against these diseases, consider immunoglobulin prophylactic therapy if exposure occurs. Treatment with antivirals should be considered if chickenpox develops.

    • Inhaled corticosteroids should be used with caution in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

    Transferring patients from systemic corticosteroids

    • Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically-available ICS.

    • Patients who have been previously maintained on 20mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

    • During this period of HPA suppression, patients may exhibit signs/symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.

    • In recommended doses, Trelegy Ellipta supplies less than normal physiological amounts of corticosteroid systemically and does not provide the mineralocorticoid activity that is necessary for coping with these emergencies.

    • Patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately during periods of stress or a severe asthma attack.

    • Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Trelegy Ellipta.

    • Monitor lung function, beta-agonist use, and asthma symptoms during withdrawal.

    • Observe patients for signs/symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension).

    • Transfer from systemic corticosteroids may unmask allergic conditions.

    • Some patients may experience systemically active steroid withdrawal, despite maintenance of improvement of respiratory function.

    Hypercorticism and Adrenal Suppression

    • Monitor for hypercorticism and HPA axis suppression (if occur, reduce dose gradually).

    • Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

    Paradoxical Bronchospasm 

    • Discontinue if paradoxical bronchospasm occurs; alternative therapy should be started. 

    Hypersensitivity Reactions, including Anaphylaxis 

    • Hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Trelegy Ellipta.

    • Discontinue if these reactions occur. 

    • Patients with severe milk protein allergy should not use Trelegy Ellipta.

    Cardiovascular Effects

    • Use with caution in patients with cardiovascular disorders (esp. coronary insufficiency, arrhythmias, hypertension). Consider discontinuing treatment if significant cardiovascular effects occur.

    • Beta2-agonists can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms. ECG changes have also been reported.

    Reduction in Bone Mineral Density

    • Decreases in bone mineral density have been observed with long-term administration of ICS; patients with risk factors should be monitored and treated appropriately.

    Glaucoma and Cataracts, Worsening of Narrow-Angle Glaucoma

    • Glaucoma, increased intraocular pressure, and cataracts have been reported following administration of inhaled corticosteroids, including Trelegy Ellipta. 

    • Consider referral to an ophthalmologist in those who develop ocular symptoms or use Trelegy Ellipta long term.

    Worsening of Urinary Retention

    • Use caution in patients with urinary retention. Be alert for signs and symptoms of urinary retention, esp in patients with prostatic hyperplasia or bladder-neck obstruction.

    Coexisting Conditions 

    • Use with caution in patients with convulsive disorders or thyrotoxicosis. Use with caution in patients who are unusually responsive to sympathomimetic amines.

    • Doses of the related beta2-agonist albuterol, when given intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 

    Hypokalemia and Hyperglycemia

    • Beta-agonists may produce significant hypokalemia in some patients.

    • This is usually transient and does not require supplementation.

    • Beta-agonist therapies may produce transient hyperglycemia in some patients. 

    Effect on Growth

    • Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. 

    • The safety and efficacy of Trelegy have not been established in pediatric patients 17 years of age and younger and is not indicated for use in this population.

    Pregnancy Considerations

    Risk Summary

    • There is insufficient data on the use of Trelegy Ellipta or its individual components,fluticasone furoate, umeclidinium, and vilanterol, in pregnant women.

    Clinical Considerations

    • Disease-Associated Maternal and/or Embryofetal Risk: Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. 

    • Labor or Delivery: Use only during late gestation and labor if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility.

    Nursing Mother Considerations

    Risk Summary

    • There is no available data on the presence of  fluticasone furoate, umeclidinium, or vilanterol in human milk, the effects on the breastfed child, or the effects on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Trelegy Ellipta and any potential adverse effects on the breastfed child from Trelegy Ellipta or from the underlying maternal condition. 

    Pediatric Considerations

    • The safety and effectiveness of Trelegy Ellipta in pediatric patients ≤17 years have not been established. 

    • Effects on Growth: ICS may cause a reduction in growth velocity in children and adolescents.

    Geriatric Considerations

    • No adjustment of the dosage of Trelegy Ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. 

    Hepatic Impairment Considerations

    • Trelegy Ellipta has not been studied in patients with hepatic impairment. 

    • Use caution in patients with moderate or severe hepatic impairment.

    • Monitor for corticosteroid-related side effects.

    Trelegy Ellipta Pharmacokinetics

    Absorption

    Fluticasone Furoate: 

    • Cmax occurred within 0.5 to 1 hour following inhalation.

    • Absolute bioavailability: 15.2%.

    • Steady state was achieved within 6 days with up to 2.6-fold accumulation.

    Umeclidinium:

    • Cmax occurred at 5 to 15 minutes.

    • Steady state was achieved within 14 days with up to 1.8-fold accumulation.

    Vilanterol:

    • Cmax occurred at 5 to 15 minutes.

    • Steady state was achieved within 14 days with up to 1.7-fold accumulation.

    Distribution

    Fluticasone Furoate: 

    • Mean volume of distribution: 661 L.

    • >99% plasma protein bound.

    Umeclidinium:

    • Mean volume of distribution: 86 L.

    • 89% plasma protein bound.

    Vilanterol:

    • Mean volume of distribution: 165 L.

    • 94% plasma protein bound.

    Metabolism

    Fluticasone Furoate: 

    • Hepatic (CYP3A4).

    Umeclidinium:

    • Primarily metabolized by CYP2D6 and is a substrate for the P-gp transporter. 

    • Primary metabolic routes are oxidative followed by conjugation.

    Vilanterol:

    • Primarily metabolized by CYP3A4 and is a substrate for the P-gp transporter.

    Elimination

    Fluticasone Furoate: 

    • Half-life: 24 hours.

    • Fecal (101%), renal (~1%).

    Umeclidinium:

    • Half-life: 11 hours.

    • Fecal (92%), renal (<1%).

    Vilanterol:

    • Half-life: 11 hours.

    • Renal (70%), fecal (30%).

    Trelegy Ellipta Interactions

    Interactions

    Not for use with other drugs containing LABAs. Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole), MAOIs, tricyclic antidepressants, drugs known to prolong the QT interval or within 2 weeks of discontinuing such agents (increased cardiac effects), K+-depleting diuretics (eg, loop or thiazides). Antagonized by β-blockers; if needed, consider cardioselective agents. Additive effects when concomitant other anticholinergic-containing drugs; avoid.

    Trelegy Ellipta Adverse Reactions

    Adverse Reactions

    Upper RTI, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, UTI, diarrhea, gastroenteritis, oropharyngeal pain, cough, dysphonia; hypersensitivity reactions. Asthma: also nasopharyngitis, viral upper RTI, RTI/viral RTI, acute sinusitis.

    Trelegy Ellipta Clinical Trials

    Clinical Trials

    Chronic Obstructive Pulmonary Disease

    Clinical Trials 1 (NCT01957163) and 2 (NCT02119286)

    • Trials 1 and 2 were multicenter, randomized, double-blind, parallel-group, 12-week treatment trials in which patients were coadministered umeclidinium 62.5mcg + fluticasone furoate/vilanterol 100mcg/25mcg. 

    • The primary endpoint was the change from baseline in trough FEV1 at Day 85. In both trials, umeclidinium + fluticasone furoate/vilanterol showed a statistically significant increase vs placebo + fluticasone furoate/vilanterol.

    • In Trial 1 (n=206), the difference from placebo in trough FEV1 was 124mL (95% CI: 93, 154).  In Trial 2 (n=206), the difference from placebo in trough FEV1 was 122mL (95% CI: 91, 152). Secondary endpoints showed similar results for the weighted mean FEV1 (0–6 hours postdose) on Day 84.

    • In both trials, patients treated with umeclidinium + fluticasone furoate/vilanterol on average used less rescue medication vs patients treated with placebo + fluticasone furoate/vilanterol over Weeks 1 to 12.

    • Health-related quality of life was assessed using the SGRQ.  Responder rate was defined as a decrease in score from baseline ≥4 at Day 84.  Trial 1: 40% for umeclidinium + fluticasone furoate/vilanterol vs 35% for placebo + fluticasone furoate/vilanterol (odds ratio 1.2, 95% CI: 0.8, 1.8).  Trial 2: 35% vs 21% (odds ratio 2.0, 95% CI: 1.3, 3.1).

    Clinical Trial 3 (NCT02164513)

    • Trial 3 was a randomized, multicenter, double-blind, parallel-group, 52-week treatment trial that compared the efficacy of Trelegy Ellipta with the fixed-dose combinations of fluticasone furoate/vilanterol 100mcg/25mcg and umeclidinium/vilanterol 62.5mcg/25mcg.

    • Lung function: Treatment with Trelegy Ellipta showed a statistically significant improvement in lung function (mean change from baseline trough FEV1 at Week 52) vs fluticasone furoate/vilanterol and umeclidinium/vilanterol.  Mean change from baseline in trough (predose) FEV1 at Week 52 was 97mL for Trelegy Ellipta vs fluticasone furoate/vilanterol (95% CI: 85, 109; P <.001) and 54mL for Trelegy Ellipta vs umeclidinium/vilanterol (95% CI: 39, 69; P <.001).

    • Exacerbations: The primary endpoint was the annual rate of on-treatment moderate and severe exacerbations. Treatment with Trelegy Ellipta statistically significantly reduced the on-treatment annual rate of moderate/ severe exacerbations by 15% vs fluticasone furoate/ vilanterol and by 25% vs umeclidinium/vilanterol. 

      • Treatment with Trelegy Ellipta statistically significantly decreased the risk of a moderate/severe exacerbation as measured by time to 1st exacerbation vs fluticasone furoate/vilanterol (14.8%; 95% CI: 9.3, 19.9; P <.001) and umeclidinium/vilanterol (16.0%; 95% CI: 9.4, 22.1; P <.001).

      • Treatment with Trelegy Ellipta reduced the on-treatment annual rate of severe exacerbations by 13% vs fluticasone furoate/vilanterol (95% CI: -1, 24; P =.064) (not statistically significant).  Treatment with Trelegy Ellipta statistically significantly reduced the on-treatment annual rate of severe exacerbations by 34% compared with umeclidinium/vilanterol (95% CI: 22, 44; P <.001).

     

    Asthma

    • Approval was based on a randomized, double-blind, active-controlled, parallel group confirmatory trial (NCT02924688) that evaluated the efficacy and safety of Trelegy Ellipta in 2436 adult patients with asthma inadequately controlled on their current treatments of combination therapy (inhaled corticosteroid [ICS] plus a LABA).  

    • Patients with an Asthma Control Questionnaire (ACQ-6) score ≥1.5 on current treatment of ICS plus LABA entered a 3-week run-in period with fluticasone propionate/salmeterol 250/50mcg twice daily. After the 3-week run-in period, patients who remained inadequately controlled (ACQ-6 ≥1.5) were transferred to fluticasone furoate/vilanterol 100/25mcg once daily for a 2- week stabilization period.

    • After the 5-week run-in/stabilization period, eligible patients were randomized to receive 1 of the following treatments once daily:  Trelegy Ellipta 100/62.5/25mcg (n=406); Trelegy Ellipta 200/62.5/25mcg (n=408); Fluticasone furoate/umeclidinium/vilanterol 100/31.25/25mcg (n=405); Fluticasone furoate/umeclidinium/vilanterol 200/31.25/25mcg (n=404);  Fluticasone furoate/vilanterol (FF/VI) 100/25mcg (n=407);  FF/VI 200/25mcg (n=406). 

    • At screening: Mean prebronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 58.5%.  Mean percent reversibility was 29.9%.  Mean absolute reversibility: 484mL  Mean ACQ-6 score: 2.5.  During the 5-week run-in/stabilization period  Trough FEV1 improvement of 287mL.  Mean ACQ-6 score decreased by 0.6. 

    • At randomization: Majority (93%) remained not well controlled (mean ACQ-6 score of 1.9). Mean prebronchodilator percent predicted FEV1 was 68.2%.

    • The primary endpoint was the change from baseline in trough forced expiratory volume in 1 second (FEV1) at 24 weeks. 

    • Least squares mean change from baseline in trough FEV1 at week 24: 

      • Trelegy Ellipta 100/62.5/25mcg vs FF/VI 100/25mcg difference: 110mL (95% CI, 66-153mL; P <.001).  

      • Trelegy Ellipta 200/62.5/25mcg vs FF/VI 200/25mcg difference: 92mL (95% CI, 49-135mL; P <.001).  

    • Change from baseline in FEV1 at 3 hours postdose was supportive of the primary end point with improvements for Trelegy Ellipta:  

      • Trelegy Ellipta 100/62.5/25mcg vs FF/VI 100/25mcg (111mL, 95% CI, 67-155mL).  

      • Trelegy Ellipta 200/62.5/25mcg vs FF/VI 200/25mcg (118mL, 95% CI, 74-162mL).

    • Mean annualized rate of asthma exacerbations:  

      • Pooled analysis: 0.31 for Trelegy Ellipta vs 0.31 for FF/VI.  

      • Unpooled analysis: 0.41 for Trelegy Ellipta 100/62.5/25mcg and 0.23 for Trelegy Ellipta 200/62.5/25mcg vs 0.38 for FF/VI 100/25mcg and 0.26 for FF/VI 200/25mcg.  

    • Asthma Control Questionnaire (ACQ)-7 responder rate at week 24:  

      • Pooled analysis: 63% for Trelegy Ellipta vs 55% for FF/VI  

      • Unpooled analysis: 62% for Trelegy Ellipta 100/62.5/25mcg vs 52% for FF/VI 100/25mcg (OR 1.59; 95% CI, 1.18-2.13); 64% for Trelegy Ellipta 200/62.5/25mcg vs 58% for FF/VI 200/25mcg (OR 1.28; 95% CI, 0.95-1.72).

    Trelegy Ellipta Note

    Not Applicable

    Trelegy Ellipta Patient Counseling

    Patient Counseling

    Serious Asthma-Related Events

    • Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with Trelegy Ellipta, there is not a significant increase in the risk of these events. 

    Not for Acute Symptoms

    • Inform patients that Trelegy Ellipta is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, short-acting beta2-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.

    • Instruct patients to seek medical attention immediately if they experience any of the following: decreasing effectiveness of inhaled, short-acting beta2-agonists; need for more inhalations than usual of inhaled, short-acting beta2-agonists; or significant decrease in lung function as outlined by the physician.

    • Tell patients they should not stop therapy with Trelegy Ellipta without physician/provider guidance since symptoms may recur after discontinuation.

    Do Not Use Additional Long-acting Beta2-agonists

    • Instruct patients not to use other LABA for asthma.

    Oropharyngeal Candidiasis

    • Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (ie, oral) antifungal therapy while still continuing therapy with Trelegy Ellipta, but at times therapy with Trelegy Ellipta may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.

    Pneumonia

    • Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia.

    Immunosuppression and Risk of Infections

    • Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

    Hypercorticism and Adrenal Suppression

    • Advise patients that Trelegy Ellipta may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to Trelegy Ellipta.

    Paradoxical Bronchospasm

    • Discontinue Trelegy Ellipta if paradoxical bronchospasm occurs..

    Hypersensitivity Reactions, including Anaphylaxis

    • Advise patients that immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Trelegy Ellipta. 

    • Reports of anaphylactic reactions in patients with severe milk protein allergy have occurred. Patients with severe milk protein allergy should not use Trelegy Ellipta.

    • Patients should discontinue Trelegy Ellipta if such reactions occur. 

    Reduction in Bone Mineral Density

    • Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. 

    Glaucoma and Cataracts

    • Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.

    Worsening of Urinary Retention

    • Consult a physician if any signs or symptoms of urinary retention develop.

    Risks Associated with Beta-agonist Therapy

    • Inform patients of adverse effects associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.

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