Trelegy Ellipta (Page 10 of 10)
16 HOW SUPPLIED/STORAGE AND HANDLING
TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack).
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. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
NDC 0173-0887-10 TRELEGY ELLIPTA 100/62.5/25 mcg 30 inhalations (60 blisters)
NDC 0173-0887-14 TRELEGY ELLIPTA 100/62.5/25 mcg 14 inhalations (28 blisters), institutional pack
NDC 0173-0893-10 TRELEGY ELLIPTA 200/62.5/25 mcg 30 inhalations (60 blisters)
NDC 0173-0893-14 TRELEGY ELLIPTA 200/62.5/25 mcg 14 inhalations (28 blisters), institutional pack
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.
TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. 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. Do not attempt to take the inhaler apart.
17 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:
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- Decreasing effectiveness of inhaled, short-acting beta2 -agonists
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- Need for more inhalations than usual of inhaled, short-acting beta2 -agonists
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- 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).]
Trademarks are owned by or licensed to the GSK group of companies.
GlaxoSmithKline
Durham, NC 27701
©2023 GSK group of companies or its licensor.
TRL:9PI
PATIENT INFORMATION TRELEGY ELLIPTA (TREL-e-ge e-LIP-ta) (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) for oral inhalation use | ||
What is TRELEGY ELLIPTA?
TRELEGY ELLIPTA should not be used in children younger than 18 years of age. It is not known if TRELEGY ELLIPTA is safe and effective in children younger than 18 years of age. | ||
Do not use TRELEGY ELLIPTA:
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Before using TRELEGY ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRELEGY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. | ||
How should I use TRELEGY ELLIPTA? Read the step-by-step instructions for using TRELEGY ELLIPTA at the end of this Patient Information.
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What are the possible side effects of TRELEGY ELLIPTA? TRELEGY ELLIPTA can cause serious side effects, including:
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Common side effects of TRELEGY ELLIPTA include: COPD: | ||
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Asthma: | ||
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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. | ||
How should I store TRELEGY ELLIPTA?
Keep TRELEGY ELLIPTA and all medicines out of the reach of children. | ||
General information about the safe and effective use of TRELEGY ELLIPTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TRELEGY ELLIPTA for a condition for which it was not prescribed. Do not give TRELEGY ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TRELEGY ELLIPTA that is written for health professionals. | ||
What are the ingredients in TRELEGY ELLIPTA? Active ingredients: fluticasone furoate, umeclidinium, vilanterol Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate For more information about TRELEGY ELLIPTA, call 1-888-825-5249 or visit our website at www.trelegy.com. Trademarks are owned by or licensed to the GSK group of companies. GlaxoSmithKline, Durham, NC 27701 ©2022 GSK group of companies or its licensor. TRL:7PIL |
- This Patient Information has been approved by the U.S. Food and Drug Administration Revised: December 2022
INSTRUCTIONS FOR USE TRELEGY ELLIPTA (TREL-e-ge e-LIP-ta) (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) for oral inhalation use | |
Read this before you start:
Your TRELEGY ELLIPTA inhaler How to use your inhaler
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Important Notes:
Check the counter. See Figure C. | |
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Prepare your dose: Wait to open the cover until you are ready to take your dose. | |
Step 1. Open the cover of the inhaler. See Figure D.
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Step 2. Breathe out. See Figure E.
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Step 3. Inhale your medicine. See Figure F.
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Step 4. Breathe out slowly and gently. See Figure I.
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Figure J | Step 5. Close the inhaler. See Figure J.
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Figure K | Step 6. Rinse your mouth. See Figure K.
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Important Note: When should you get a refill? | |
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For more information about TRELEGY ELLIPTA or how to use your inhaler, call 1-888-825-5249 or visit our website at www.trelegy.com. Trademarks are owned by or licensed to the GSK group of companies. GlaxoSmithKline, Durham, NC 27701 ©2022 GSK group of companies or its licensor. TRL:4IFU |
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: December 2022
PRINCIPAL DISPLAY PANEL
NDC 0173-0887-10
TRELEGY ELLIPTA
(fluticasone furoate, umeclidinium, and vilanterol inhalation powder)
100 mcg/62.5 mcg/25 mcg
Rx Only
FOR ORAL INHALATION ONLY
TRELEGY ELLIPTA contains 2 foils strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 62.5 mcg of umeclidinium, 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
GSK
Made in UK
©2023 GSK group of companies or its licensor.
PRINCIPAL DISPLAY PANEL
NDC 0173-0893-10
TRELEGY ELLIPTA
(fluticasone furoate, umeclidinium, and vilanterol inhalation powder)
200 mcg/62.5 mcg/25 mcg
Rx Only
FOR ORAL INHALATION ONLY
TRELEGY ELLIPTA contains 2 foils strips of 30 blisters each. Each blister on one strip contains 200 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 62.5 mcg of umeclidinium, 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
GSK
Made in UK
©2023 GSK group of companies or its licensor.
TRELEGY ELLIPTA fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder | |||||||||||||||||||||||||||||||||||||||||||||
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TRELEGY ELLIPTA fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder | |||||||||||||||||||||||||||||||||||||||||||||
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Labeler — GlaxoSmithKline LLC (167380711) |
Revised: 06/2023 GlaxoSmithKline LLC
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