TRELEGY ELLIPTA by GlaxoSmithKline



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Indications & Usage

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.

 

INDICATIONS AND USAGE

 

TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for:

  • ·         the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
  • ·         the maintenance treatment of asthma in patients aged 18 years and older.

Limitations of use: Not indicated for relief of acute bronchospasm.

 

 


Please see full Prescribing Information, including Patient Information, for TRELEGY.

Dosage & Administration

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.

 

DOSAGE AND ADMINISTRATION

 

·        For oral inhalation only.

·        Maintenance treatment of COPD: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg once daily administered by oral inhalation.

·        Maintenance treatment of asthma: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg once daily administered by oral inhalation.

 

 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Dosage Forms & Strengths

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.

 

DOSAGE FORMS AND STRENGTHS

 

Inhalation powder: 2 foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate 100 or 200 mcg per blister and the other contains umeclidinium/vilanterol 62.5/25 mcg per blister.



Please see full Prescribing Information, including Patient Information, for TRELEGY.

Contraindications

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.


CONTRAINDICATIONS

 

·        Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.

·        Severe hypersensitivity to milk proteins or any ingredients.


 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Warnings & Precautions

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.

 

WARNINGS AND PRECAUTIONS

 

·        LABA monotherapy increases the risk of serious asthma-related events.

·        Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.

·        Do not use in combination with additional therapy containing a LABA because of risk of overdose.

·        Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.

·        Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.

·        Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

·        Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA.

·        Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue TRELEGY ELLIPTA slowly.

·        If paradoxical bronchospasm occurs, discontinue TRELEGY ELLIPTA and institute alternative therapy.

·        Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

·        Assess for decrease in bone mineral density initially and periodically thereafter.

·        Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY ELLIPTA long term.

·        Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

·        Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

·        Be alert to hypokalemia and hyperglycemia.

 

  

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Adverse Reactions

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.


ADVERSE REACTIONS

 

·        COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

·        Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.

 

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Drug Interactions

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.


DRUG INTERACTIONS

 

·        Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects.

·        Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system.

·        Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.

·        Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.

·        Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of TRELEGY ELLIPTA with other anticholinergic-containing drugs.


 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Use in Specific Populations

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full Prescribing Information for TRELEGY ELLIPTA.


USE IN SPECIFIC POPULATIONS

 

Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects.

 

 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

Patient Counseling Information

PATIENT COUNSELING INFORMATION

 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

 

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. [See Warnings and Precautions (5.1).]

 

Not for Acute Symptoms

 

Inform patients that TRELEGY ELLIPTA is not meant to relieve acute symptoms of COPD or asthma and extra doses should not be used for that purpose. Advise patients to treat acute 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
  •         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. [See Warnings and Precautions (5.2).]

 

Do Not Use Additional Long-acting Beta2-agonists

 

Instruct patients not to use other LABA for COPD and asthma. [See Warnings and Precautions (5.3).]

 

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 (i.e., 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. [See Warnings and Precautions (5.4).]

 

Pneumonia

 

Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia. [See Warnings and Precautions (5.5).]

 

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. [See Warnings and Precautions (5.6).]

 

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. [See Warnings and Precautions (5.8).]

 

Paradoxical Bronchospasm

 

As with other inhaled medicines, TRELEGY ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue TRELEGY ELLIPTA and contact their healthcare provider right away. [See Warnings and Precautions (5.10).]

 

Hypersensitivity Reactions, including Anaphylaxis

 

Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of TRELEGY ELLIPTA. Instruct patients to discontinue TRELEGY ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use TRELEGY ELLIPTA. [See Warnings and Precautions (5.11).]

 

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. [See Warnings and Precautions (5.13).]

 

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.

 

Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions (5.14).]

 

Worsening of Urinary Retention

 

Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions (5.15).]

 

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. Instruct patients to consult a health care practitioner immediately should any of these signs and symptoms develop. [See Warnings and Precautions (5.12).]

 

 

Please see full Prescribing Information, including Patient Information, for TRELEGY.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For US Healthcare Professionals only.

TRELEGY ELLIPTA was developed in collaboration with 

Trademarks are owned or licensed by the GSK group of companies.

©2021 GSK or licensor.

FVUWCNT200107 January 2021

Produced in USA.

Please see full Prescribing Information, including Patient Information, for TRELEGY.

INDICATIONS AND IMPORTANT SAFETY INFORMATION 

Indications

·       COPD: TRELEGY 100/62.5/25 mcg is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

·       Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

Important Safety Information

CONTRAINDICATIONS

TRELEGY is contraindicated in the following:

  • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required. 
  • Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.

WARNINGS AND PRECAUTIONS

  • Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. TRELEGY is not indicated for use in pediatric patients aged 17 years and younger.
  • TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
  • TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.
  • Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap.
  • A more serious or even fatal course of chickenpox or measles may occur in susceptible patients using corticosteroids. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
  • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. If such changes occur, reduce the dose of TRELEGY slowly and consider other treatments for management of COPD or asthma symptoms.
  • Caution should be exercised when considering the coadministration of TRELEGY with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Decreases in bone mineral density have been observed with long‐term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating TRELEGY and periodically thereafter.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of ICS or inhaled anticholinergics. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY long term.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Be alert to hypokalemia and hyperglycemia.
  • Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.

ADVERSE REACTIONS: TRELEGY 100/62.5/25 MCG FOR COPD

  • In subjects with COPD, the most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with UMEC + FF/VI, the components of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).
  • Additional adverse reactions (≥1% incidence) reported in subjects with COPD taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

ADVERSE REACTIONS: TRELEGY FOR ASTHMA

  • In subjects with asthma, the most common adverse reactions (≥2% incidence with TRELEGY) reported in a 24-week to 52-week clinical trial with:

-       TRELEGY 100/62.5/25 mcg (or FF/VI 100/25 mcg) were: pharyngitis/nasopharyngitis, 17% (16%); headache, 9% (7%); upper respiratory tract infection/viral upper respiratory tract infection, 5% (7%); respiratory tract infection/viral respiratory tract infection, 4% (4%); bronchitis, 4% (3%); influenza, 4% (3%); back pain, 3% (4%); sinusitis/acute sinusitis, 2% (3%); rhinitis, 2% (3%).

-       TRELEGY 200/62.5/25 mcg (or FF/VI 200/25 mcg) were: pharyngitis/nasopharyngitis, 15% (16%); upper respiratory tract infection/viral upper respiratory tract infection, 7% (6%); headache, 5% (6%); bronchitis, 5% (5%); sinusitis/acute sinusitis, 3% (2%); respiratory tract infection/viral respiratory tract infection, 3% (2%); back pain, 2% (1%); urinary tract infection, 2% (<1%).

DRUG INTERACTIONS

  • TRELEGY 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 they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

USE IN SPECIFIC POPULATIONS

  • TRELEGY is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.
  • Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

 

Please see full Prescribing Information, including Patient Information, for TRELEGY.