fluticasone furoate and vilanterol inhalation powder

Breo Ellipta for oral inhalation is a combination of fluticasone and vilanterol and is used for treating chronic obstructive pulmonary disease (COPD). Fluticasone is a man-made steroid of the glucocorticoid family which is related to the naturally-occurring steroid hormone, cortisol or hydrocortisone, produced by the adrenal glands. Glucocorticoid steroids have potent anti- inflammatory actions. When used as an inhaler, fluticasone travels to the airways in the lung. In COPD patients, the suppression of inflammation within the airways reduces the inflammatory-stimulated spasm of the smooth muscle cells surrounding the airways that narrows the airways and makes getting air into and out of the lungs more difficult. When used in lower doses, very little fluticasone is absorbed into the body. When higher doses are used, fluticasone is absorbed and may cause side effects elsewhere in the body.

Vilanterol is a bronchodilator of the beta-2 agonist type. Beta-2 agonists are medications that stimulate beta-2 receptors on the smooth muscle cells that surround the airways, causing these muscle cells to relax and thereby opening the airways. It is similar to salmeterol (Serevent). Breo Ellipta opens the airways and increases air supply to the lungs of COPD patients. The FDA approved Breo Ellipta in May 2013.

Breo Ellipta

GENERIC AVAILABLE: no

yes

The most common side effects of Breo Ellipta are:

• headache,
• upper respiratory tract infections,
• cold symptoms, and
• oral candidiasis or thrush (a fungal infection).

Breo Ellipta also may cause bronchospasms (wheezing). Bronchospasm should be treated with a rescue inhaler.

High doses of inhaled fluticasone may decrease formation and increase breakdown of bone thereby weakening bones and promoting fractures. Higher doses of fluticasone also may cause suppression of the body's ability to make its own natural glucocorticoid in the adrenal gland. People with suppression of their own adrenal glands (which can be diagnosed by a doctor) would need increased amounts of glucocorticoids, probably by the oral or intravenous route, during periods of high physical stress when glucocorticoids are particularly important.

Inhaled steroids may cause growth suppression, weaken the immune system, and may increase the risk of glaucoma, increased eye pressure, and cataracts.

Allergic reactions, including swelling of face, throat and tongue, rash, hives, and breathing problems may occur. Use of long acting drugs like vilanterol may increase the risk of asthma-related death. Breo Ellipta should not be used for treatment of asthma.

Other important side effects of Vilanterol include:

• increased heart rate,
• blood pressure, and
• abnormal heart rhythms.

The recommended dose is one inhalation once daily by mouth. Following administration, the mouth should be rinsed thoroughly with water without swallowing to reduce risk of fungal infections.

: Ritonavir (Norvir), atazanavir (Reyataz), clarithromycin (Biaxin), indinavir (Crixivan), itraconazole (Sporanox), ketoconazole, nelfinavir (Viracept), and telithromycin (Ketek) may increase levels of fluticasone and vilanterol in the body by reducing the breakdown of fluticasone and vilanterol by liver enzymes. This may increase side effects of Breo Ellipta.

Beta blockers (for example, atenolol [Tenormin]) can block the effects of vilanterol and cause bronchospam in patients with COPD.

Combining or using Breo Ellipta within two weeks of stopping monoamine oxidase inhibitors (for example, phenelzine), tricyclic antidepressants (for example, amitriptyline [Endep, Elavil]), or other drugs that affect heart rate and rhythm, may increase risk of heart-related side effects.

It is not known if fluticasone or vilanterol are secreted in breast milk. Other medications in the same class as fluticasone or vilanterol are secreted into breast milk.

How should I keep fluticasone furoate and vilanterol inhalation stored?

Breo Ellipta should be kept at room temperature, 15 C to 30 C (59 F to 86 F) and stored in a dry place away from light.