- Breo Ellipta
- Maintenance treatment of patients with COPD; combination of a corticosteroid (fluticasone) and a long-acting beta agonist (LABA, vilanterol).
- As concomitant therapy for the treatment of asthma and the prevention of bronchospasm in patients who are currently taking but are inadequately controlled on a long-term asthma-control medication (e.g., inhaled corticosteroid).
- Fluticasone–decreases airway inflammation
- Vilanterol–relaxes bronchial smooth muscle
Improved airflow and ↓ exacerbations in COPD.
Absorption: Fluticasone–15.2% systemically absorbed from lungs following inhalation, minimal absorption from swallowing; vilanterol–27.3% systemically absorbed from lungs following inhalation, minimal absorption from swallowing. Swallowed drugs undergo extensive first-pass hepatic metabolism
Protein Binding: Fluticasone–99.6%, vilanterol–93.9%
Metabolism and Excretion: Both fluticasone and vilaterol are metabolized by CYP3A4, with some conversion to agents with less pharmacolgic activity. Fluticasone–Parent drug and metabolites are exreted primarily in feces, 1–2% is excreted in urine; vilanterol–parent drug and metaolites are 70% excreted in urine, 30% in feces.
Half-life: Fluticasone–24 hr, vilanterol–21.3 hr
TIME/ACTION PROFILE (bronchodilation)
|Fluticasone/vilanterol (inhaln)||within 1 hr||1–2 hr||24 hr|
- 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 (close monitoring recommended);
- History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis (vilanterol);
- Geri: May be more sensitive to effects;
- OB: Use only if potential maternal benefit justifies risk to the fetus (hypoadrenalism may occur in infant);
- Lactation: Use cautiously if breastfeeding (some corticosteroids enter milk);
- Pedi: Safety and effectiveness not established.
Exercise Extreme Caution in:
Concurrent use of MAOIs or tricyclic antidepressants (vilanterol).
Adverse Reactions/Side Effects
Resp: ASTHMA-RELATED DEATH (VILANTEROL), nasopharyngitis, ↑ risk of pneumonia (fluticasone), upper respiratory tract infection, paradoxical bronchospasm
GI: oral candidiasis
Endo: ↓ growth (in children) (fluticasone), hyperglycemia, adrenal suppression (high dose fluticasone), impaired adrenal function (during taper from systemic corticosteroids)
F and E: hypokalemia
MS: ↓ bone mineral density (fluticasone)
Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA, ↑ risk of/worsening infections (fluticasone)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- ↑ risk of corticosteroid effects or adverse cardiovascular reactions with CYP3A4 inhibitors, including clarithromcin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir,ritonavir, saquinavir, troleandomycin 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 on non-potassium-sparing diuretics (vilanterol).
Careful monitoring during transfer from systemic corticosteroids is required
Inhaln:(Adults)One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily.
Inhaln:(Adults)Receiving low-to-mid-dose corticosteroids–One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily; may be ↑ to one inhalation (fluticasone 200 mcg/vilanterol 25 mcg) once daily if additional control needed; Receiving mid-to-high-dose corticosteroids–One inhalation (fluticasone 200 mcg/vilanterol 25 mcg) once daily.
Powders for inhalation (each dose unit contains 2 double-foil blister strips, in a self-contained inhaler system): fluticasone 100 mcg/vilanterol 25 mcg/inhalation (contains lactose), fluticasone 200 mcg/vilanterol 25 mcg/inhalation (contains lactose)
- 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, post-menopausal 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, pruritis, swelling of face and neck, dyspnea) periodically during therapy.
Lab Test Considerations:
May cause hypokalema and hyperglycemia.
- Ineffective airway clearance (Indications)
- 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
- 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 female patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
Improved airflow and ↓ exacerbations in COPD.
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