Breo Ellipta

Supervised by
Dr. Adham Abu Taha
Prepared by
Mohammad Al-Shouli

Trade name : Breo Ellipta

Generic name : (fluticasone furoate and vilanterol
inhalation powder)

Company: GlaxoSmithKline
Approval Status: Approved May 2013
Treatment Area: chronic obstructive pulmonary
disease

About COPD
Chronic obstructive pulmonary
disease (COPD) is a term
referring to two lung diseases
1. chronic bronchitis
2. and emphysema,
characterised by obstruction
to airflow that interferes with
normal breathing

Mechanism of Action
a combination of
1. fluticasone furoate, an inhaled corticosteroid (ICS)
2. and vilanterol, a long-acting beta2-adrenergic agonist
(LABA).

Indications
BreoEllipta is
1. the only drug specifically indicated for the long-term, oncedaily, maintenance treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema.
2. Breo Ellipta is also indicated to reduce exacerbations of
COPD in patients with a history of exacerbations.
Important Limitations of Use:
BREO ELLIPTA is NOT indicated for the relief of acute
bronchospasm or for the treatment of asthma.

WARNING: ASTHMA-RELATED DEATH

placebo-controlled, trial comparing the safety of LABA (salmeterol) with placebo, each added to usual
asthma therapy, showed an increase in asthma-related
deaths in subjects receiving salmeterol

increased risk of asthma-related death is considered a class effect of LABA, including

vilanterol, one of the active ingredients in BREO ELLIPTA.
No study adequate to determine whether the rate of asthma-related death is increased in
subjects treated with BREO ELLIPTA has been conducted.
The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established. BREO
ELLIPTA is not indicated for the treatment of asthma.

DOSAGE AND ADMINISTRATION

Breo Ellipta is supplied as a powder for inhalation.
The recommended dose is 100 mcg fluticasone
furoate /25 mcg vilanterol administered as 1
inhalation once daily by the orally inhaled route only.
After inhalation, the patient should rinse his/her mouth
with water without swallowing to help reduce the risk of
oropharyngeal candidiasis.
Breo Ellipta should be taken at the same time every
day.
Do not use more than 1 time every 24 hours.

Side Effects
may include, but are not limited to, the following:
1.
2.
3.
4.

Nasopharyngitis (common cold)

upper respiratory tract infection
headache
oral candidiasis

Pharmacokinetics
plasma concentrations was achieved after 6 days, and the

Absorption
Distribution ( after IV )
Metabolism
Elimination

fluticasone furoate

vilanterol

15.2%

27.3%

661 L
hepatic metabolism via CYP3A4
primarily in the feces 99 %
Urine 1%

165 L
hepatic metabolism via CYP3A4
Feces 30%
Urine 70%

Important safety information

1. Contraindicated in patients with severe

hypersensitivity to milk proteins or who have
demonstrated hypersensitivity to either fluticasone
furoate, vilanterol, or any of the excipients

2. Inhaled medicines can produce paradoxical

bronchospasm

DRUG INTERACTIONS
1. Strong CYP450 3A4 inhibitors (e.g., ketoconazole):
May cause systemic cardiovascular effects.
2. MAOIs and tricyclic antidepressants:
May potentiate effect of vilanterol on vascular system.
3. Beta-blockers:
May block bronchodilatory effects of beta-agonists and
produce severe bronchospasm.