A starting dose of one inhalation of Relvar Ellipta 92/22 micrograms once daily should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta 2-agonist. If patients are inadequately controlled on Relvar Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control. Do not use ANORO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. If you take too much ANORO ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. Diabetes. Using Trelegy Ellipta can raise your blood sugar levels. If you have diabetes, this could worsen your condition. Your doctor may recommend monitoring your blood sugar levels more closely while you’re using Trelegy Ellipta.

Fluticasone furoate was not teratogenic in rats or rabbits, but delayed development in rats and caused abortion in rabbits at maternally toxic doses. There were no effects on development in rats at exposures approximately 3-times greater than those at the maximum recommended human dose, based on AUC. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ANORO ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. The effects of age on the pharmacokinetics of fluticasone furoate and vilanterol were determined in phase III studies in COPD and asthma. There was no evidence for age (12-84) to affect the pharmacokinetics of fluticasone furoate and vilanterol in subjects with asthma.

What are the risks associated with Relvar Ellipta?

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Relvar Ellipta 184/22 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta 2-agonist. Trelegy Ellipta contains three active drugs.* Each works a little differently to manage symptoms of COPD and asthma: Some people experience asthma symptoms throughout the day. Certain activities can also trigger asthma symptoms or make symptoms worse. Trelegy Ellipta is used every day to help manage symptoms. Oral corticosteroids can cause weight gain, especially if they’re taken long term. One example of this type of drug is prednisone (Rayos). ANORO ELLIPTA does not relieve sudden symptoms of COPD and you should not take extra doses of ANORO ELLIPTA to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.The clinical efficacy of umeclidinium bromide administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373). Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm. If your symptoms feel life threatening, call 911 (or your local emergency number) or get immediate medical help. Here’s a short list of some of the mild side effects that Trelegy Ellipta can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Trelegy Ellipta’s prescribing information. feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)

A 24 week randomised, double-blind placebo controlled study (FFA112059) evaluated the safety and efficacy of FF 92 micrograms once daily [n= 114] and FP 250 micrograms twice daily [n=114] versus placebo [n=115] in adult and adolescent patients with persistent asthma. All subjects had to have been on a stable dose of an ICS for at least 4 weeks prior to visit 1 (screening visit) and the use of LABAs was not permitted within 4 weeks of visit 1. The primary efficacy endpoint was change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV 1 at the end of the treatment period. Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary. At the 24-week time point FF and FP increased trough FEV 1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo. FF and FP both increased the percentage of 24 hour rescue free periods by 14.8% (95% CI 6.9, 22.7, p<0.001) and 17.9% (95% CI 10.0, 25.7, p<0.001) respectively versus placebo. The inhaler should be held away from the mouth breathing out as far as is comfortable. But not breathing out into the inhaler. serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; swelling of your face, mouth, and tongue; hives; breathing problems. Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was no significant increase in systemic exposure to vilanterol (C max and AUC) in subjects with mild, moderate, or severe hepatic impairment (Child-Pugh A, B or C). There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).Will I need to use Trelegy Ellipta long term? It’s possible. You’ll use Trelegy Ellipta long term if you and your doctor agree that it’s safe and effective for you. A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate non-inferiority (using a margin of -100 mL for trough FEV 1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504). Subjects randomised to once-daily FF/VI maintained lung function comparable with those randomised to twice-daily salmeterol/FP [difference in trough FEV 1 of +19 mL (95% CI: -11, 49)]. urinary retention. People who take ANORO ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include: difficulty urinating; painful urination; urinating frequently; urination in a weak stream or drips. If you have these symptoms of urinary retention, stop taking ANORO ELLIPTA and call your healthcare provider right away before taking another dose. effects on heart: increased blood pressure; chest pain; a fast or irregular heartbeat, awareness of heartbeat.

Do not use ANORO to treat sudden symptoms of COPD. Always have a rescue inhaler with you to treat sudden symptoms. To lower your risk of thrush, rinse your mouth with water and spit the water out (without swallowing) after each dose of Trelegy Ellipta. In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at week 12 was not demonstrated for umeclidinium bromide (1.0 units, p=0.05). A statistically significant improvement compared with placebo in the TDI focal score at week 24 was demonstrated for umeclidinium bromide (1.0 units, p<0.001) in the 24-week study. If you have trouble breathing after using Trelegy Ellipta, use your rescue inhaler right away. Albuterol ( ProAir HFA, Proventil-HFA) is a common example of a rescue inhaler. Your doctor will explain how you should use your Trelegy Ellipta inhaler. They’ll also explain how much to use and how often. You’ll typically take one inhalation each day, at about the same time each day.

But some research has shown that heavy drinking can worsen your lung function over time. If you drink alcohol and you have chronic obstructive pulmonary disease (COPD) or asthma, it’s best to avoid drinking large amounts. Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids. This list does not contain all types of drugs that may interact with Trelegy Ellipta. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with the use of Trelegy Ellipta. Before you start treatment with Trelegy Ellipta, your doctor will evaluate your risk of side effects, including raised blood pressure.