Fluticasone furoate/vilanterol trifenatate

What is Fluticasone furoate and vilanterol trifenatate?

• Fluticasone furoate and vilanterol trifenatate (BREO ELLIPTA) is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA), used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

What are the uses of this medicine?

• This medicine is used for Chronic Obstructive Pulmonary Disease(COPD) and asthma and as follows:

• BREO ELLIPTA combines an inhaled corticosteroid (ICS) medicine, fluticasone furoate, and a long-acting beta2-adrenergic agonist (LABA) medicine, vilanterol.
• ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• 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.

COPD:

• BREO ELLIPTA 100/25 is a prescription medicine used to treat COPD.
• COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
• BREO ELLIPTA 100/25 is used long term as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Limitation of Use

• BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.

Asthma:

• BREO ELLIPTA is a prescription medicine used as 1 inhalation 1 time each day to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.
• BREO ELLIPTA contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO ELLIPTA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Limitation of Use

• BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.

How does this medicine work?

• Since BREO ELLIPTA contains both fluticasone furoate and vilanterol, the mechanisms of action described below for the individual components apply to BREO ELLIPTA.

Fluticasone Furoate

• Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.
• The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known.
• Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy.

Vilanterol Vilanterol is a LABA.

• The pharmacologic effects of beta2-adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP).
• Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• to treat sudden, severe symptoms of asthma or COPD.
• have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• allergic to fluticasone furoate, vilanterol, or any of the ingredients in BREO ELLIPTA. See the end of this Patient Information for a complete list of ingredients in BREO ELLIPTA.

What drug interactions can this medicine cause?

• Caution should be exercised when considering the coadministration of BREO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole).
• Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval.
• Caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics(such as loop or thiazide diuretics).
• Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, a component of BREO ELLIPTA, but may also produce severe bronchospasm in patients with COPD or asthma.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: Chronic Obstructive Pulmonary Disease

• BREO ELLIPTA 100/25 should be administered as 1 inhalation once daily. The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 100/25 once daily, the only strength indicated for the treatment of COPD.

Asthma

• The recommended starting dosage is BREO ELLIPTA 100/25 or BREO ELLIPTA 200/25 administered as 1 inhalation once daily.
• The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 200/25 once daily.
• For patients who do not respond adequately to BREO ELLIPTA 100/25, increasing the dose to BREO ELLIPTA 200/25 may provide additional improvement in asthma control.

Administration

• Do not use BREO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• BREO ELLIPTA comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
• Use BREO ELLIPTA exactly as your healthcare provider tells you to use it. Do not use BREO ELLIPTA more often than prescribed.
• Use 1 inhalation of BREO ELLIPTA 1 time each day. Use BREO ELLIPTA at the same time each day.
• If you miss a dose of BREO ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• If you take too much BREO 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.
• Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• Do not stop using BREO ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• BREO ELLIPTA does not relieve sudden symptoms of asthma or COPD and you should not take extra doses of BREO 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.
• Call your healthcare provider or get medical care right away if:
• your breathing problems get worse.
• you need to use your rescue inhaler more often than usual.
• your rescue inhaler does not work as well to relieve your symptoms.
• your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation powder: Inhaler containing 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 vilanterol 25 mcg per blister.

This medicine is available in fallowing brand namesː

• BREO ELLIPTA

What side effects can this medication cause?

The most common side effects of this medicine include:

COPD:

• runny nose and sore throat
• upper respiratory tract infection
• headache
• thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• back pain
• pneumonia
• bronchitis
• inflammation of the sinuses
• cough
• mouth and throat pain
• joint pain
• increased blood pressure
• flu
• fever

Asthma:

• runny nose and sore throat
• thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• headache
• flu
• respiratory tract infection
• bronchitis
• inflammation of the sinuses
• mouth and throat pain
• hoarseness and voice changes
• cough

BREO ELLIPTA can cause serious side effects, including:

• fungal infection in your mouth or throat (thrush)
• pneumonia
• weakened immune system and increased chance of getting infections (immunosuppression)
• reduced adrenal function (adrenal insufficiency)
• sudden breathing problems immediately after inhaling your medicine
• serious allergic reactions
• effects on heart
• effects on nervous system
• bone thinning or weakness (osteoporosis)
• eye problems
• high levels of blood sugar (hyperglycemia)
• changes in laboratory blood levels
• slowed growth in children

What special precautions should I follow?

• 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 an additional medicine 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 BREO ELLIPTA.
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue BREO ELLIPTA slowly.
• If paradoxical bronchospasm occurs, discontinue BREO 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. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREO ELLIPTA long term.
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
• Increased blood glucose levels have been reported. Also, be alert to hypokalemia.

What to do in case of emergency/overdose?

• No human overdosage data has been reported for BREO ELLIPTA.

Symptoms of overdosage may include: Fluticasone Furoate:

• hypercorticism may occur

Vilanterol The expected signs and symptoms with overdosage of vilanterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).

Management of Overdose

• Treatment of overdosage consists of discontinuation of BREO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy.
• The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm.
• Cardiac monitoring is recommended in cases of overdosage.

Can this medicine be used in pregnancy?

• There are insufficient data on the use of BREO ELLIPTA, fluticasone furoate, or vilanterol in pregnant women.

Can this medicine be used in children?

• BREO ELLIPTA 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.

What are the active and inactive ingredients in this medicine?

• Active ingredients: fluticasone furoate, vilanterol trifenatate
• Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

Who manufactures and distributes this medicine?

• Trademarks are owned by or licensed to the GSK group of companies.
• BREO ELLIPTA was developed in collaboration with Innoviva.
• GlaxoSmithKline, Research Triangle Park

What should I know about storage and disposal of this medication?

• Store BREO ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
• Store BREO ELLIPTA in the unopened tray and only open when ready for use.
• Safely throw away BREO ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.
• Keep BREO ELLIPTA and all medicines out of the reach of children.

• Dailymed label info on Fluticasone furoate/vilanterol trifenatate
• FDA Fluticasone furoate/vilanterol trifenatate

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