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TRELEGY ELLIPTA is a brand name for Umeclidinium, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol) is a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA). COPD TRELEGY ELLIPTA 100/62.5/25 mcg is indicated in adult patients who are not adequately treated by a…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations COPD and Asthma • As with other inhaled drugs containing beta2-adrenergic agents, TRELEGY ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA or LAMA, as an overdose may result.
• When beginning treatment with TRELEGY ELLIPTA, patients who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular basis should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking TRELEGY ELLIPTA.
• TRELEGY ELLIPTA should not be used to treat acute symptoms of COPD or asthma. , salbutamol) to relieve acute symptoms such as shortness of breath and advised to have this available for use at all times. • Patients should be made aware that for optimum benefit, TRELEGY ELLIPTA must be used regularly, even when asymptomatic.
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. Asthma • Patients with asthma should be regularly reassessed by a healthcare professional so that the strength of TRELEGY ELLIPTA they are receiving remains optimal and is only changed on medical advice.
• Healthcare professionals should only prescribe TRELEGY ELLIPTA for patients not adequately controlled on long-term asthma control treatment with a medium or high dose inhaled corticosteroid and a LABA. • The starting dose of TRELEGY ELLIPTA should be based on the patients' previous asthma therapy including the inhaled corticosteroid dosage.
• If a previously effective dose of TRELEGY ELLIPTA fails to provide adequate control of asthma symptoms, patients should seek medical advice as this indicates worsening of their underlying condition. 5/25 mcg once daily. 5/25 mcg is not indicated for the treatment of COPD.
5/25 mcg once daily. 5/25 mcg should be considered for patients who require a low to mid dose of inhaled corticosteroid in combination with a LAMA and a LABA. 5/25 mcg should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a LAMA and a LABA.
5/25 mcg once daily, which may provide improvement in asthma control. 5/25 mcg once daily. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). Pediatrics TRELEGY ELLIPTA should not be used in patients under 18 years of age.
and 10 CLINICAL PHARMACOLOGY). If such effects occur, TRELEGY ELLIPTA may need to be discontinued. Driving and Operating Machinery There have been no studies investigating the effect of TRELEGY ELLIPTA on the ability to perform tasks that require judgment, motor or cognitive skills.
The occurrence of headache or blurred vision may influence the ability to drive or to use machinery. Trelegy Ellipta, fluticasone/umeclidinium/vilanterol Page 12 of 63 Ear/Nose/Throat Localized infections of the mouth and pharynx with Candida albicans, which are associated with the use of inhaled glucocorticosteroids, have occurred in patients treated with TRELEGY ELLIPTA during clinical studies.
Patients should therefore be advised to rinse their mouth with water (without swallowing) after inhalation of TRELEGY ELLIPTA to reduce the risk of oropharyngeal candidiasis. , oral) antifungal therapy while treatment with TRELEGY ELLIPTA continues.
4 Drug-Drug Interactions). Endocrine and Metabolism Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur with inhaled corticosteroids than with oral corticosteroids.
Possible systemic effects include:
Cushing’s syndrome, Cushingoid features, hypothalamic-pituitary-adrenal (HPA) axis suppression, growth retardation in children and adolescents (in asthma), a decrease in bone mineral density (BMD), cataracts, glaucoma, and central serous chorioretinopathy.
2 Pharmacodynamics). 4 Drug-Drug Interactions). It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects.
In light of the possibility of systemic absorption of inhaled corticosteroids, patients treated with TRELEGY ELLIPTA should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
, General). 5/25 mcg are indicated for the long-term, once-daily, maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a maintenance combination of a medium or high dose of an ICS and a LABA (see 14 CLINICAL TRIALS).
TRELEGY ELLIPTA is not indicated for the relief of acute bronchospasm (see 7 WARNINGS AND PRECAUTIONS, General). 1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of TRELEGY ELLIPTA in pediatric patients below 18 years of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics ( 65 years of age): No dosage adjustment is required in patients 65 years of age and older. 2 CONTRAINDICATIONS TRELEGY ELLIPTA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. TRELEGY ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions).
1 Dosing Considerations COPD and Asthma • As with other inhaled drugs containing beta2-adrenergic agents, TRELEGY ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA or LAMA, as an overdose may result.
• When beginning treatment with TRELEGY ELLIPTA, patients who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular basis should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking TRELEGY ELLIPTA.
• TRELEGY ELLIPTA should not be used to treat acute symptoms of COPD or asthma. , salbutamol) to relieve acute symptoms such as shortness of breath and advised to have this available for use at all times. • Patients should be made aware that for optimum benefit, TRELEGY ELLIPTA must be used regularly, even when asymptomatic.
TRELEGY ELLIPTA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
TRELEGY ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions). Trelegy Ellipta, fluticasone/umeclidinium/vilanterol Page 5 of 63
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5/25 mcg. Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration TRELEGY ELLIPTA is for oral inhalation only. TRELEGY ELLIPTA should be administered as a single dose once-daily at the same time of the day each day.
After inhalation, patients should rinse their mouth with water (without swallowing). Do not use TRELEGY ELLIPTA more than once every 24 hours. 5 Missed Dose If a dose is missed, the patient should be instructed to take the next dose when it is due.
The patient should be instructed not to take an extra dose.
If such effects occur, appropriate therapy should be considered.
Systemic Steroid Replacement by Inhaled Steroid:
Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
After withdrawal from systemic corticosteroids, a number of months are required for recovery of HPA function. Patients who have been previously maintained on 20 mg or more 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 and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.
Although TRELEGY ELLIPTA may control COPD or asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amount of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.
During periods of stress, a severe asthma attack, or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids immediately and to contact their physicians for further instruction.
These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress, a severe asthma attack, or severe COPD exacerbation. Trelegy Ellipta, fluticasone/umeclidinium/vilanterol Page 13 of 63 Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to TRELEGY ELLIPTA.
Lung function (mean forced expiratory volume in 1 second [FEV1]), beta-agonist use, and COPD or asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.
, rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). , joint and/or muscular pain, lassitude, depression), despite maintenance or even improvement of respiratory function.
Reduction in Bone Mineral Density:
Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. , anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care.
Since patients with COPD often have […]
, chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. Asthma • Patients with asthma should be regularly reassessed by a healthcare professional so that the strength of TRELEGY ELLIPTA they are receiving remains optimal and is only changed on medical advice.
• Healthcare professionals should only prescribe TRELEGY ELLIPTA for patients not adequately controlled on long-term asthma control treatment with a medium or high dose inhaled corticosteroid and a LABA. • The starting dose of TRELEGY ELLIPTA should be based on the patients' previous asthma therapy including the inhaled corticosteroid dosage.
• If a previously effective dose of TRELEGY ELLIPTA fails to provide adequate control of asthma symptoms, patients should seek medical advice as this indicates worsening of their underlying condition. 5/25 mcg once daily. 5/25 mcg is not indicated for the treatment of COPD.
5/25 mcg once daily. 5/25 mcg should be considered for patients who require a low to mid dose of inhaled corticosteroid in combination with a LAMA and a LABA. 5/25 mcg should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a LAMA and a LABA.
5/25 mcg once daily, which may provide improvement in asthma control. 5/25 mcg once daily. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). Pediatrics TRELEGY ELLIPTA should not be used in patients under 18 years of age.
5/25 mcg. Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration TRELEGY ELLIPTA is for oral inhalation only. TRELEGY ELLIPTA should be administered as a single dose once-daily at the same time of the day each day.
After inhalation, patients should rinse their mouth with water (without swallowing). Do not use TRELEGY ELLIPTA more than once every 24 hours. 5 […]