Title: Side Effects of Trelegy Ellipta: Uses, Risks, Warnings, Interactions
Headings: Trelegy Ellipta
Trelegy Ellipta
Drug Description
What is TRELEGY ELLIPTA and how is it used?
What are the possible side effects of TRELEGY ELLIPTA?
TRELEGY ELLIPTA can cause serious side effects, including:
Common side effects of TRELEGY ELLIPTA include:
COPD:
Asthma:
DESCRIPTION
Indications & Dosage
3 pharmacies near 98837 have coupons for Trelegy Ellipta (Brand Names:Trelegy Ellipta for 60 Aerosol Powder Breath Activated)
INDICATIONS
Maintenance Treatment Of Chronic Obstructive Pulmonary Disease
Maintenance Treatment Of Asthma
Limitations Of Use
DOSAGE AND ADMINISTRATION
Dosage And Administration Overview
Recommended Dosage For Maintenance Treatment Of Chronic Obstructive Pulmonary Disease
Recommended Dosage For Maintenance Treatment Of Asthma
HOW SUPPLIED
Dosage Forms And Strengths
Storage And Handling
SLIDESHOW
Side Effects
SIDE EFFECTS
Clinical Trials Experience In Chronic Obstructive Pulmonary Disease
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)
Clinical Trials Experience In Asthma
Table 3. Adverse Reactions with TRELEGY ELLIPTA with ≥1% Incidence in Subjects with Asthma (Trial 4)
Postmarketing Experience
Drug Interactions
DRUG INTERACTIONS
Inhibitors Of Cytochrome P450 3A4
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, And QTc Prolonging Drugs
Beta-Adrenergic Receptor Blocking Agents
Non–Potassium-Sparing Diuretics
Anticholinergics
Warnings & Precautions
WARNINGS
PRECAUTIONS
Serious Asthma-Related Events – Hospitalizations, Intubations, Death
Table 1. Meta-analysis of Serious Asthma-Related Events in Subjects with Asthma Aged 12 Years and Older
Deterioration Of Disease And Acute Episodes
Avoid Excessive Use Of TRELEGY ELLIPTA And Avoid Use With Other Long-Acting Beta 2 -Agonists
Oropharyngeal Candidiasis
Pneumonia
Immunosuppression And Risk Of Infections
Transferring Patients From Systemic Corticosteroid Therapy
Hypercorticism And Adrenal Suppression
Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors
Paradoxical Bronchospasm
Hypersensitivity Reactions, Including Anaphylaxis
Cardiovascular Effects
Reduction In Bone Mineral Density
Glaucoma And Cataracts, Worsening Of Narrow-Angle Glaucoma
Worsening Of Urinary Retention
Coexisting Conditions
Hypokalemia And Hyperglycemia
Effect On Growth
Patient Counseling Information
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Use In Specific Populations
Pregnancy
Fluticasone Furoate
Umeclidinium
Lactation
Pediatric Use
Geriatric Use
Hepatic Impairment
Renal Impairment
Overdosage & Contraindications
OVERDOSE
Fluticasone Furoate
Umeclidinium
Vilanterol
CONTRAINDICATIONS
Clinical Pharmacology
CLINICAL PHARMACOLOGY
Mechanism Of Action
Pharmacodynamics
Pharmacokinetics
Excretion
Specific Populations
Figure 1. Impact of Intrinsic Factors on the Pharmacokinetics (PK) of Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) following Coadministration in COPD
Figure 2. Impact of Intrinsic Factors on the Pharmacokinetics (PK) of Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) following Coadministration in Asthmaa
Figure 3. Impact of Intrinsic Factorsa and Coadministered Drugsb on the Pharmacokinetics (PK) of Fluticasone Furoate (FF) and Vilanterol (VI) following Administration as Fluticasone Furoate/Vilanterol Combination or following Vilanterol Coadministered with Umeclidinium
Figure 4. Impact of Intrinsic Factors and Coadministered Drugs on the Systemic Exposure of Umeclidinium
Patients with Hepatic Impairment
Drug Interaction Studies
Clinical Studies
Chronic Obstructive Pulmonary Disease
Table 4. Least Squares Mean Change from Baseline in Trough FEV1 and Weighted Mean FEV1 (0-6 h) at Week 12 (Days 84/85)
Figure 5. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV1 (mL) on Day 1
Figure 6. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV1 (mL) on Day 84
Figure 7. Least Squares (LS) Mean Change from Baseline in Trough FEV1 (mL)
Table 5. Moderate and Severe Chronic Obstructive Pulmonary Disease Exacerbations (Trial 3)a
Asthma
Table 6. Least Squares Mean Change from Baseline in Trough FEV1 at Week 24
Figure 8. Least Squares Mean Change from Baseline in Trough FEV1 (mL) with TRELEGY ELLIPTA 100/62.5/25 mcg over 24 Weeks of Treatment
Figure 9. Least Squares Mean Change from Baseline in Trough FEV1 (mL) with TRELEGY ELLIPTA 200/62.5/25 mcg over 24 Weeks of Treatment
Medication Guide
PATIENT INFORMATION
What is TRELEGY ELLIPTA?
Chronic Obstructive Pulmonary Disease (COPD):
Asthma:
TRELEGY ELLIPTA should not be used in children younger than 18 years of age.
Do not use TRELEGY ELLIPTA:
Before using TRELEGY ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you:
How should I use TRELEGY ELLIPTA?
Read the step-by-step instructions for using TRELEGY ELLIPTA at the end of this Patient Information.
What are the possible side effects of TRELEGY ELLIPTA?
TRELEGY ELLIPTA can cause serious side effects, including:
Common side effects of TRELEGY ELLIPTA include:
COPD:
Asthma:
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.
What are the ingredients in TRELEGY ELLIPTA?
Instructions for Use
Read this before you start:
Your TRELEGY ELLIPTA inhaler
How to use your inhaler
Important Notes:
Check the counter. See Figure C.
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.
Step 2. Breathe out. See Figure E.
Step 3. Inhale your medicine. See Figure F.
Step 4. Breathe out slowly and gently. See Figure I.
Step 5. Close the inhaler. See Figure J.
Step 6. Rinse your mouth. See Figure K.
Important Note: When should you get a refill?
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Content: Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. What are the possible side effects of TRELEGY ELLIPTA? TRELEGY ELLIPTA can cause serious side effects, including: If you have these symptoms, call your healthcare provider right away before taking another dose. If you have these symptoms of urinary retention, stop taking TRELEGY ELLIPTA, and call your healthcare provider right away before taking another dose. fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY ELLIPTA to help reduce your chance of getting thrush. pneumonia.