Flucticasone Furoate/ Vilanterol - Corticosteroids
Drug Name:Flucticasone Furoate/ Vilanterol - Corticosteroids
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole):
Use with caution.
May cause systemic corticosteroid and cardiovascular effects.
Monoamine oxidase inhibitors and tricyclic antidepressants:
Use with extreme caution. May potentiate effect of vilanterol
on vascular system.
Beta-blockers: Use with caution. May block bronchodilatory effects
of beta-agonists and produce severe bronchospasm.
.
Diuretics: Use with caution. Electrocardiographic changes
and/or hypokalemia associated with non.potassium-sparing
diuretics may worsen with concomitant beta-agonists.
Indication:
BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder)
FOR ORAL INHALATION USE Initial U.S. Approval: 2013
WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.
Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the
active ingredients in BREO ELLIPTA, increase the risk of asthma-related death.
A placebo-controlled trial with another LABA (salmeterol) showed an increase
in asthma-related deaths in subjects receiving salmeterol.
This finding with salmeterol is considered a class effect of all LABA, including
vilanterol.
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.
Drug Name- Breo Ellipta
Active Ingredient - Flucticasone Furoarate and Vilanterol
BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS),
and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for long-term,
once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations
in patients with chronic obstructive pulmonary disease (COPD). (1)
Important limitations: Not indicated for relief of acute bronchospasm or for treatmen
of asthma.
Approved by FDA on 10-5-2013 (Ref- FDA Approved List- 2013)
Adverse Reaction:
Most common adverse reactions (incidence .3%) are
nasopharyngitis, upper respiratory tract infection, headache,
and oral candidiasis.
Contra-Indications:
CONTRAINDICATIONS
Severe hypersensitivity to milk proteins or any ingredients.
WARNINGS AND PRECAUTIONS
LABA increase the risk of asthma-related death.
Do not initiate in acutely deteriorating COPD or to treat acute symptoms.
Do not use in combination with an additional medicine containing 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 without swallowing after inhalation
to help reduce the risk.
Increased risk of pneumonia in patients with COPD taking BREO ELLIPTA.
Monitor patients for signs and symptoms of pneumonia.
.
Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial,
viral, or parasitic infection; 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.
.
Close monitoring for glaucoma and cataracts is warranted.
.
Use with caution in patients with convulsive disorders, thyrotoxicosis,
diabetes mellitus, and ketoacidosis.
.
Be alert to hypokalemia and hyperglycemia.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
BREO ELLIPTA is a combination of fluticasone furoate, an inhaled
corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic
agonist (LABA), indicated for long-term, once-daily, maintenance treatment
of airflow obstruction and for reducing exacerbations in patients with chronic
obstructive pulmonary disease (COPD).
Important limitations: Not indicated for relief of acute bronchospasm or for
treatment of asthma.
DOSAGE AND ADMINISTRATION
For oral inhalation only.
Maintenance treatment of COPD:
1 inhalation of BREO ELLIPTA 100 mcg/25 mcg once daily.
DOSAGE FORMS AND STRENGTHS
Inhalation Powder. Inhaler containing 2 double-foil blister strips of powder
formulation for oral inhalation. One strip contains fluticasone furoate
100 mcg per blister and the other contains vilanterol 25 mcg per blister.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide
and Instructions for Use).
1. Asthma-Related Death
Patients should be informed that LABA, such as vilanterol, one of the active
ingredients in BREO ELLIPTA, increase the risk of asthma-related death.
BREO ELLIPTA is not indicated for the treatment of asthma.
2. Not for Acute Symptoms
BREO ELLIPTA is not meant to relieve acute symptoms of COPD and extra
doses should not be used for that purpose. Acute symptoms should be treated
with a rescue inhaler such as albuterol.
The physician should provide the patient with such medicine and instruct the
patient in how it should be used.
3.Patients should be instructed to notify their physicians immediately if they
experience any of the following:
Symptoms get worse
Need for more inhalations than usual of their rescue inhaler
Significant decrease in lung function as outlined by the physician
Patients should not stop therapy with BREO ELLIPTA without
physician/provider guidance since symptoms may recur after discontinuation.
4. Do Not Use Additional Long-Acting Beta2-Agonists
When patients are prescribed BREO ELLIPTA, other medicines containing
a LABA should not be used.
5.Risks Associated With Corticosteroid Therapy
Local Effects: Patients should be advised that localized infections
with Candida albicans occurred in the mouth and pharynx in some patients.
If oropharyngeal candidiasis develops, it should be treated with appropriate
local or systemic (i.e., oral) antifungal therapy while still continuing therapy
with BREO ELLIPTA, but at times therapy with BREO ELLIPTA may need to
be temporarily interrupted under close medical supervision.
Rinsing the mouth without swallowing after inhalation is advised to help
reduce the risk of thrush.
6.Pneumonia:
Patients with COPD who have received BREO ELLIPTA have a higher risk
of pneumonia and should be instructed to contact their healthcare providers
if they develop symptoms of pneumonia (e.g., fever, chills, change in
sputum color, increase in breathing problems).
7.Immunosuppression:
Patients who are on immunosuppressant doses of corticosteroids should
be warned to avoid exposure to chickenpox or measles and, if exposed,
to consult their physicians without delay.
Patients should be informed of potential worsening of existing tuberculosis,
fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.
8.Hypercorticism and Adrenal Suppression:
Patients should be advised that BREO ELLIPTA may cause systemic
corticosteroid effects of hypercorticism and adrenal suppression.
Additionally, patients should be instructed that deaths due to adrenal
insufficiency have occurred during and after transfer from systemic
corticosteroids.
9.Reduction in Bone Mineral Density:
Patients who are at an increased risk for decreased BMD should be
advised that the use of corticosteroids may pose an additional risk.
10.Ocular Effects:
Long-term use of inhaled corticosteroids may increase the risk of
some eye problems (cataracts or glaucoma); regular eye examinations
should be considered.
11. Risks Associated With Beta-Agonist Therapy
Patients should be informed of adverse effects associated with beta2-agonists,
such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
12. Hypersensitivity Reactions, Including Anaphylaxis
Advise patients that hypersensitivity reactions (e.g., anaphylaxis,
angioedema, rash, urticaria) may occur after administration of
BREO ELLIPTA.
Instruct patients to discontinue BREO ELLIPTA if such reactions occur.
There have been reports of anaphylactic reactions in patients with
severe milk protein allergy after inhalation of other powder medications
containing lactose; therefore, patients with severe milk protein allergy
should not use BREO ELLIPTA.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
BREO ELLIPTA: Since BREO ELLIPTA contains both fluticasone furoate and
vilanterol, the mechanisms of action described below for the individual
components apply to BREO ELLIPTA.
These drugs represent 2 different classes of medications
(a synthetic corticosteroid and a LABA) that have different effects on
clinical and physiological indices.
Fluticasone Furoate: Fluticasone furoate is a synthetic trifluorinated corticosteroid
with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit
a binding affinity for the human glucocorticoid receptor that is approximately
29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate.
The clinical relevance of these in vitro findings is unknown.
The precise mechanism through which fluticasone furoate affects COPD symptoms
is not known.
2. Pharmacokinetics
Linear pharmacokinetics was observed for fluticasone furoate (200 to 800 mcg)
and vilanterol (25 to 100 mcg). On repeated once-daily inhalation administration,
steady state of fluticasone furoate and vilanterol plasma concentrations
was achieved after 6 days, and the accumulation was up to 2.6-fold for
fluticasone furoate and 2.4-fold for vilanterol as compared with single dose.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled
trials with BREO ELLIPTA in pregnant women.
Because animal studies are not always predictive of human response,
BREO ELLIPTA should be used during pregnancy only if the potential benef
justifies the potential risk to the fetus
Women should be advised to contact their physicians if they become pregnant
while taking BREO ELLIPTA.
2. Nursing Mothers
It is not known whether fluticasone furoate or vilanterol are excreted in human
breast milk. However, other corticosteroids and beta2-agonists have been
detected in human milk. Since there are no data from controlled trials on the
use of BREO ELLIPTA by nursing mothers, caution should be exercised when
it is administered to a nursing woman.
3. Pediatric Use
BREO ELLIPTA is not indicated for use in children. The safety and efficacy
in pediatric patients have not been established.
4. Geriatric Use
Based on available data, no adjustment of the dosage of BREO ELLIPTA
in geriatric patients is necessary, but greater sensitivity in some older
individuals cannot be ruled out.
