BREO ELLIPTA Dosage & Rx Info | Uses, Side Effects

Breo Ellipta Generic Name & Formulations

Legal Class

General Description

Fluticasone furoate, vilanterol 50/25mcg, 100/25mcg, 200/25mcg; per inh; dry pwd for oral inh.

Pharmacological Class

Corticosteroid + long-acting beta-2 agonist (LABA).

How Supplied

Dry pwd inhaler—30 inh

Manufacturer

GlaxoSmithKline

Generic Availability

Mechanism of Action

Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known. Corticosteroids have been shown to have a wide range of actions on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. The pharmacologic effects of beta₂-adrenoceptor agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of ATP to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Breo Ellipta Indications

Indications

Maintenance treatment of COPD in adults. Maintenance treatment of asthma in patients aged ≥5yrs.

Limitations of Use

Not for relief of acute bronchospasm.

Breo Ellipta Dosage and Administration

Adult

≥18yrs: COPD: 1 inh of 100/25mcg once daily (max). Asthma: initially 1 inh of 100/25mcg or 200/25mcg once daily, based on disease severity and previous asthma therapy; max 1 inh of 200/25mcg once daily. Rinse mouth after use.

Children

<18yrs (COPD) or <5yrs (asthma): not established. Asthma (5–11yrs): 1 inh of 50/25mcg once daily (max); (12–17yrs): 1 inh of 100/25mcg once daily (max). Rinse mouth after use.

Breo Ellipta Contraindications

Contraindications

Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. Severe hypersensitivity to milk proteins.

Breo Ellipta Boxed Warnings

Not Applicable

Breo Ellipta Warnings/Precautions

Warnings/Precautions

Increased risk of asthma-related events (death, hospitalizations, intubations) with LABA monotherapy (without ICS). Do not initiate in rapidly or acutely deteriorating COPD or asthma. Not for use with other long-acting β₂-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β₂-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress, a severe COPD exacerbation, or a severe asthma attack. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Moderate or severe hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Labor & delivery. Pregnancy. Nursing mothers.

Breo Ellipta Pharmacokinetics

Absorption

Peak plasma concentrations are reached within 0.5–1 hour (fluticasone); within 10 minutes (vilanterol).

Absolute bioavailability: 15.2% (fluticasone); 27.3% (vilanterol).

Distribution

Volume of distribution at steady state: 661 L (fluticasone); 165 L (vilanterol).

Plasma protein bound: >99% (fluticasone); 94% (vilanterol).

Metabolism

Hepatic (CYP3A4).

Elimination

Fluticasone: fecal. Vilanterol: renal (70%), fecal (30%).

Half-life: 24 hours (fluticasone); 21.3 hours (vilanterol).

Breo Ellipta Interactions

Interactions

Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole), during or within 2 weeks of discontinuing MAOIs, tricyclic antidepressants, or drugs known to prolong QT interval (increased cardiac effects), β-blockers (consider cardioselective), K⁺-depleting diuretics.

Breo Ellipta Adverse Reactions

Adverse Reactions

Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, pyrexia, dysphonia; hypersensitivity reactions.

Breo Ellipta Clinical Trials

See Literature

Breo Ellipta Note