General

Pronunciation:
floo-tik-a-sone vye-lan-ter-ol

Trade Name(s)

• Breo Ellipta

Ther. Class.

bronchodilators

Pharm. Class.

corticosteroids

adrenergics

Indications

• Maintenance treatment of COPD.
• Maintenance treatment of asthma.

Action

• Fluticasone: decreases airway inflammation
• Vilanterol: relaxes bronchial smooth muscle

Therapeutic Effect(s):

• Improved airflow and ↓ exacerbations in COPD.
• Reduction in asthma exacerbations.

Pharmacokinetics

Fluticasone

Absorption: 15.2% systemically absorbed from lungs following inhalation, minimal absorption from swallowing (swallowed drug undergoes extensive first-pass hepatic metabolism).

Distribution: Unknown.

Protein Binding: 99.6%.

Metabolism and Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme to inactive metabolites; primarily excreted in feces.

Half-life: 24 hr.

Vilanterol

Absorption: 27.3% systemically absorbed from lungs following inhalation, minimal absorption from swallowing (swallowed drugs undergo extensive first-pass hepatic metabolism).

Distribution: Unknown.

Protein Binding: 93.9%.

Metabolism and Excretion: Primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites. Primarily excreted in urine (70%), with 30% excreted in feces.

Half-life: 21.3 hr.

TIME/ACTION PROFILE (bronchodilation)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to any components or severe hypersensitivity to milk proteins;
• Acute attack of asthma or COPD (onset of action is delayed);
• Patients not receiving a long-term asthma-control medication (e.g., inhaled corticosteroid);
• Patients whose asthma is currently controlled on low- or medium-dose inhaled corticosteroid therapy.

Use Cautiously in:

• Moderate to severe hepatic impairment (↑ fluticasone levels may lead to systemic corticosteroid effects);
• Cardiovascular history (vilanterol);
• Concurrent use of beta blockers;
• Glaucoma or cataracts;
• History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis (vilanterol);
• OB:   Safety not established in pregnancy;
• Lactation:  Use while breastfeeding only if potential maternal benefit outweighs potential risk to infant;
• Pedi:  Safety and effectiveness not established in children <18 yr (COPD) or <5 yr (asthma);
• Geri:  Older adults may be more sensitive to effects.

Exercise Extreme Caution in:

Concurrent use of MAO inhibitors or tricyclic antidepressants.

Adverse Reactions/Side Effects

EENT: cataracts, glaucoma, oral candidiasis

Endo: adrenal suppression (high dose fluticasone), ↓ growth (in children) (fluticasone), hyperglycemia

F and E: hypokalemia

MS: ↓ bone mineral density (fluticasone)

Neuro: headache

Resp: nasopharyngitis, ↑ risk of pneumonia (fluticasone), upper respiratory tract infection, paradoxical bronchospasm

Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis, angioedema, and urticaria), ↑ risk of/worsening infections (fluticasone)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

• ↑ risk of corticosteroid effects or adverse cardiovascular reactions with  CYP3A4 inhibitors, including  clarithromycin,  conivaptan,  itraconazole,  ketoconazole,  lopinavir,  nefazodone,  nelfinavir, ritonavir, or  voriconazole ; concurrent use should be undertaken with extreme caution.
• Concurrent use of  beta-blockers  may ↓ effectiveness of vilanterol and ↑ risk of severe bronchospasm.
• ↑ risk of hypokalemia with concurrent use of  non-potassium-sparing diuretics.

Route/Dosage

Chronic Obstructive Pulmonary Disease

Inhaln (Adults): One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily.

Asthma

Inhaln (Adults): One inhalation of either fluticasone 100 mcg/vilanterol 25 mcg or fluticasone 200 mcg/vilanterol 25 mcg once daily (base decision on severity of asthma); not to exceed dosage of one inhalation of fluticasone 200 mcg/vilanterol 25 mcg once daily.

Inhaln (Children 12–17 yr): One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily.

Inhaln (Children 5–11 yr): One inhalation (fluticasone 50 mcg/vilanterol 25 mcg) once daily.

Availability

Powder for inhalation (contains lactose): fluticasone 50 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose, fluticasone 100 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose, fluticasone 200 mcg/vilanterol 25 mcg/inhalation in a two-strip blister per dose

Assessment

• Asses for severe milk allergies; may be allergic to fluticasone vilanterol.
• Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration. Fluticasone vilanterol is not to be used for acute symptoms or asthma. Short-acting bronchodilator should also be prescribed. If paradoxical bronchospasm (wheezing) occurs, discontinue fluticasone vilanterol immediately and use short-acting bronchodilator.
• May cause decreased bone mineral density during prolonged therapy. Monitor patients with increased risk (prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can reduce bone mass [anticonvulsants, oral corticosteroids]) for fractures.
• Monitor for signs and symptoms of hypersensitivity reactions (rash, pruritus, swelling of face and neck, dyspnea) periodically during therapy.

Lab Test Considerations:

May cause hypokalema and hyperglycemia.

Implementation

• If transferring patient from systemic corticosteroids, wean slowly after transfer to fluticasone vilanterol.
• Administer 1 inhalation once daily at the same time each day. Follow instructions in Medication Guide for use of inhaler. See medication administration techniques for administration of inhalation medications

Patient/Family Teaching

• Instruct patient in how to use inhaler, to use it once daily at the same time each day and not to stop taking medication without consulting health care professional. Advise patient to rinse mouth without swallowing to reduce risk of oropharyngeal candidiasis. Instruct patient to read  Medication Guide  prior to use of inhaler and with each Rx refill in case of changes.
• Instruct patient in need for and use of rescue inhaler. Caution patient to notify health care professional if symptoms get worse, need more inhalations than usual from rescue inhaler, decrease in lung function as described by health care professional. Increased use of short-acting agent may signal disease deterioration.
• Inform patient of increased risk of pneumonia. Advise patient to notify health care professional if fever, chills, change in sputum color, increased cough, or increase in breathing problems occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise patient to have regular eye examinations; may increase risk of cataracts and glaucoma. Instruct patient to notify health care professional immediately if signs and symptoms of glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion corneal edema) occur.
• Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

Evaluation/Desired Outcomes

• Improved airflow and ↓ exacerbations in COPD.
• Reduction in asthma exacerbations.