Breo Ellipta Facts

  • Manufacturer:GlaxoSmithKline Plc. (GSK) and Theravance, Inc.
  • Treatment For: Asthma, COPD
  • FDA Approval:May 10, 2013
  • Active Ingredients: vilanterol trifenate, fluticasone furoate
  • Inactive Ingredients: magnesium stearate, lactose monohydrate
  • Dosage: 100 mcg/ 25 mcg; 200 mcg/25 mcg     
  • Dosage Form: Inhalation powder

breo Ellipta used a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD), including emphysema and/or chronic bronchitis. It is also approved to reduce flare-ups of COPD. Asthma is when the muscles surrounding airways become swollen, tight, and irritated. Symptoms include cough, wheezing, short of breath, and chest tightness. COPD is a long-term condition that tends to slowly get worse. Symptoms include coughing up mucus, chest discomfort, and shortness of breath.

Breo contains two active ingredients:  a long-acting beta2-adrenergic agonist (LABA) known as vilanterol and an inhaled synthetic trifluorinated corticosteroid (fluticasone furoate). Vilanterol trifenate is a bronchodilator, which works to relax the muscles surrounding the smaller airways in the lungs. This makes it easier for air to move in and out of the lungs. When taken regularly, Breo helps the small airways to remain open.  Fluticasone furoate is a corticosteroid, which is simply a steroid. It is used to reduce inflammation in the small airways in the lungs, easing breathing problems. These two medicines help control breathing difficulties when taken together regularly. Breo an anti-inflammatory agent and a smooth-muscle relaxant.

FDA Approval

b reo Ellipta was approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD on May 10, 2013 and for the treatment of asthma in April 2015. The approval was based on 4 confirmatory trial enrolling 7,700 patients with moderate to severe COPD. The trials were conducted 6- and 12-months’ duration, where there were three 12-week active comparator trials, and shorter durations of dose-ranging trials. The FDA’s advisory committee had no issue recommending the drug, voting 9-4 in support for its administration in long-term maintenance and exacerbation reduction of COPD. Some panelists did raise concerns that the LABA component- vilanterol- provided great clinical benefits and also increased the risk of bone fractures (in2%) and pneumonia (in 3%), and the high dropout rate in the trials. The panelists agreed that once-daily use of Breo Ellipta may improve medication adherence, although this wasn't tested in any of the trials.

Uniqueness of Product

the Breo Ellipta powder increases airflow. In in vivo and in vitro models, fluticasone furoate blocked pro-inflammatory transcription factors (such as nuclear factor-kappa light enhancer of cells B), inhibited lung eosinophilia induced by antigens, and activated the glucocorticoid response element in sensitized rats. In in vitro tests, fluticasone furoate shows a binding similarity to the human glucocorticoid receptors, which is 1.7 times that of fluticasone propionate and 29.9 times that of dexamethasone. The functional selectivity of vilanterol was similar to salmeterol xinafoate.

Beta1-receptors are predominant in the heart whereas Beta2-receptors are adrenergic receptors predominant in bronchial smooth muscle. Beta2-receptors make up 10 to 50 percent of the total number of predominant beta-adrenergic receptors.

The pharmacological effects of beta2-adrenoceptor agonists play a major role in the stimulation of intracellular adenyl cyclase, the enzyme that acts as a catalyst in the conversion of adenosine triphosphate to cyclic adenosine monophosphate (cAMP). When the levels of cAMP increase, the bronchial muscle relax and the release of mediators of hypersensitivity from cells is inhibited.

It’s not known the mechanism by which COPD symptoms are affected by fluticasone furoate. Because the drug is a corticosteroid, it can produce various effects on many cell types (such as lymphocytes, neutrophils, eosinophil, mast cells, and macrophages) and mediators (such as eicosanoids, histamine, cytokines, and leukotriene) involved in inflammation.

Breo Dosage and Administration

breo is a powdered inhaler containing a white dry powder mixture of micronized vilanterol trifenate and micronized fluticasone furoate. The starting dose of vilanterol-fluticasone for patients 18 years or older depends of the severity of the condition. The recommended dose of Breo Ellipta for patients with COPD and asthma is 100 mcg of fluticasone furoate and 25 mcg of vilanterol once daily as one oral inhalation. Conversely, the doctor may recommend one inhalation 200 mg fluticasone furoate and 25 mcg of vilanterol, which is the higher strength Breo inhaler. The starting dosage for patients with asthma is based on the severity of the condition. For patients previously treated with mid-to-high dose of treatment containing a corticosteroid, Breo Ellipta 200/25 mcg should be considered.

Conversely, Breo 100/25 should be considered for patients previously treated with low-to-mid dose of treatment containing corticosteroid. Breo Ellipta 200/25 may provide additional improvement in asthma control for patients who do not adequately respond to the drug. A doctor will assess your condition at regular intervals so as to ensure that the patient is getting the dose most suitable for the severity of their asthma.  The higher strength Breo dose is not suitable for the treatment of COPD. 

Breo should be taken at the same time every day and after inhalation, patients are advised to rinse their mouth without swallowing in order to reduce the risk of fungal infection in the mouth or throat (oropharyngeal candidiasis). No dosage adjustments are needed for patients with renal or hepatic impairment or geriatric patients. The dose of medication that a person needs may vary based on the body weight, other medication taken, and other medical conditions. If your doctor recommends a dose that’s different from the one stated here, you should not change how you’re taking the medication without medical advice. Use Breo for as long as your doctor recommends and don’t stop without consulting your doctor, even if you feel better.

Breo Ellipta should not be used as a rescue therapy to relieve acute bronchospasm episodes.  

Side Effects Possible with Breo

along with its needed effects, a medication may cause an unwanted response when taken in normal doses. Side effects can be temporary or permanent, mild or severe. Although not all of the side effects listed below are experienced by everyone who takes Breo Ellipta, if they do occur, they may need immediate medical attention. It’s important to discuss the risks and benefits of Breo with your physician.

Common side effects include:

  • back pain
  • cough
  • fever
  • anxiety
  • flu
  • chills
  • dizziness
  • headache
  • sneezing
  • nausea
  • muscle spasms
  • voice changes and hoarseness
  • difficulty with breathing
  • tremor
  • weakness
  • thrush
  • rash
  • hives
  • runny, itchy, or blocked nose
  • sudden lack of energy
  • chest discomfort

Contact your doctor as soon as possible if you experience any of the following side effects:

  • increased blood pressure
  • signs of decreased adrenal function (e.g. low blood pressure, vomiting, nausea, tiredness, or weakness)
  • signs of pneumonia (such as shortness of breath, chills, cough, fever)
  • signs of electrolyte imbalance (e.g., weakness, muscle pain or cramps, irregular heartbeat)
  • sinus or throat infection
  • bone pains or fractures (osteoporosis)
  • joint pain
  • shakiness in the arms, hands, legs, or feet
  • irregular or increased heartbeat
  • flu-like symptoms (e.g. fever, sore throat, sudden lack of energy, fever) that includes pins and needles sensation, rash, breathing problems, worsening breathing problems
  • symptoms of cataracts (e.g., eye pain, blurry vision, clouding in the eye)
  • signs of too much corticosteroid (sweating, dry skin, thinning skin, rapid weight gain, muscle weakness)
  • symptoms of high blood sugar (e.g. increased thirst, poor wound healing, fruity breath odor, infections, unexplained weight loss, frequent urination)
  • symptoms of thrush or oral candidiasis (raised, sore patches in the mouth)
  • symptoms of worsening COPS (e.g. chest discomfort, shortness of breath, coughing up mucus)
  • symptoms of glaucoma or increased pressure in the eye (e.g. seeing halos of bright colors around lights, eye pain or discomfort, blurred vision, red eyes)
  • allergic reaction such as swelling on the face or throat
  • wheezing or sudden shortness of breath immediately after using Breo

These are not all the possible side effects of Breo. Some people may experience other side effects not listed above. While most of these side effects don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Drug Interactions

A total of 807 drugs are known to interact with Breo:

  • 19 minor drug interactions
  • 723 moderate drug interactions, and
  • 65 major interactions

Caution should be taken when prescribing Breo with strong CYP3A4 inhibitors and long-term treatments with ketoconazole (Nizoral). Breo may interact with the following drugs:

  • aspirin
  • albuterol
  • clarithromycin (Biaxin, AbbVie)
  • ritonavir (Norvir, AbbVie)
  • lopinavir/ritonavir (Kaletra, AbbVie)
  • itraconazole (Sporanox, PriCara/Janssen)
  • nefazodone (Serzone, Bristol-Myers Squibb)
  • saquinavir (Invirase, Genentech)
  • nelfinavir (Viracept, Pfizer)
  • indinavir (Crixivan, Merck)
  • telithromycin (Ketek, Sanofi)
  • furosemide (Lo-Aqua, Diaqua-2, Lasix)
  • voriconazole (Vfend, Pfizer)
  • conivaptan (Vaprisol, Astellas)
  • metronidazole (Flagyl)
  • voriconazole (Vfend)
  • diuretics (water pills; e.g., triamterene, hydrochlorothiazide, furosemide)
  • beta-blockers such as nadolol (Corgard), atenolol (Tenormin), propranolol (Inderal), metoprolol (Lopressor, Toprol XL), and labetalol (Normodyne)
  • tramadol (Zydol, Ryzolt, Tramadol Hydrochloride ER, Ultram, Tramal, Rybix ODT, Ultram ODT Tramedo, Tramahexal SR, Ultram ER, Larapam SR, Zamadol, Tramal SR, GenRx Tramadol, ConZip, Tramahexal, Zydol XL)
  • troleandomycin (TAO)
  • diabetes medications (e.g., glyburide, glipizide, insulin, chlorpropamide, rosiglitazone, metformin)
  • other long-acting beta2-agonists (e.g., indacaterol, formoterol, salmeterol)
  • macrolide antibiotics (e.g., erythromycin, clarithromycin)
  • monoamine oxidase inhibitors (MAOIs; e.g., rasagiline, phenelzine, moclobemide, tranylcypromine, selegiline)
  • protein kinase inhibitors (e.g., sunitinib, pazopanib, lapatinib,)
  • tricyclic antidepressants (e.g., desipramine, amitriptyline, trimipramine, clomipramine)
  • antipsychotics (e.g., haloperidol, clozapine, olanzapine, chlorpromazine, risperidone, quetiapine,)

Drug interactions may change how the medication works and may also increase the risk for life-threatening side effects. For instance, medications such as azole antifungals, HIV protease inhibitors, boceprevir, among others can affect the removal of fluticasone from the body, which may consequently affect how fluticasone functions. Interactions may also result in increased cardiovascular and systemic corticosteroid adverse effects. A class of medicines known as “beta-blockers” used to treat a heart condition or high blood pressure should be avoided because they block the pulmonary effect of vilanterol and may also produce severe bronchospasm in patients with asthma or COPD.

Not all possible drug interactions are listed above. Patients are advised to keep a list of all products they use (including herbal products and prescription/non-prescription drugs) and share it with their doctor. In addition, one should not start, change, or stop the dosage of any medicine without the approval of a doctor.

Warnings and Precautions

  • Deterioration of Disease 

Breo should not be administered to patients during potentially threatening or rapidly deteriorating episodes of asthma or COPD. There’s no study for Breo in individuals with acutely deteriorating asthma or COPD but initiation of an inhaled short-acting beta2-agonist in this setting is not appropriate. When prescribing Breo, physicians should prescribe a short-acting beta2-agonist and provide instructions on how it should be used.

A patient’s condition may worsen over a few hours, several days or longer. If the short-acting beta2-agonist is not as effective as it should be or Breo no longer controls the symptoms associated with bronchoconstriction, or the patient needs more inhalations than usual, these may be signs that the disease is deteriorating. In such a case, there’s need for immediate reevaluation of the patient and the COPD regimen. Increasing the daily dose of Breo Ellipta 100/25 in the case of COPD is not suitable.

If there’s need to increase of inhaled short-acting beta2-agonist, that’s a sign of deteriorating asthma. In such a setting, an immediate reevaluation of the patient is required along reassessment of the treatment regimen, considering the possible need for initiating systemic corticosteroids, adding additional ICS, or replacing the current strength of Breo with a higher strength.

  • Pneumonia

In clinical trials, an increased incidence of pneumonia was observed in patients with COPD receiving the Breo 100/25 dose. Also, there was an increase in cases of pneumonia resulting in hospitalization and some were fatal. The symptoms of COPD exacerbations overlap with clinical features of pulmonary infections and for this reason, doctors should remain vigilant for the possible development of pneumonia.

In 3,255 subjects with COPD who had an exacerbation of COPD, there was a higher incidence of pneumonia in those receiving 200 mcg/25 mcg or 100 mcg/25 mcg than in subjects receiving 25 mcg vilanterol. Also, there were no fatal cases of pneumonia in subjects taking Breo Ellipta 50 mcg/25 mcg. There were 7 pneumonia-related fatalities in patients taking Breo 200/25 and in 1 subject receiving Breo 100/25.

  • Immunosuppression

Individuals taking immunosuppressive drugs are more susceptible to infections when compared to healthy persons. Measles and chickenpox, for instance, can have severe or fatal effects in individuals using corticosteroids. Physicians should be cautious to avoid exposure. The risk of developing a disseminated infection caused by the route, dose, and duration of corticosteroids is not known. If a patient is exposed to prophylaxis and chickenpox with pooled immune globulin may be indicated. Inhaled corticosteroids should be cautiously used if the patient is in quiescent or active tuberculosis infections of the respiratory tract; bacterial, systemic, parasitic, or viral infection; or ocular herpes simplex.

  • Reduced Bone Density

Long-term administration of inhaled corticosteroids has been linked to result in decreased bone density (BMD). Patients with major risk factors such as family history of osteoporosis, tobacco use, poor nutrition, prolonged immobilization, advanced age and prolonged use of drugs known to reduce bone mass should be treated and monitored with established standards of care.

And since individuals with COPD usually have multiple risk factors for reduced bone density, an assessment is recommended before and after Breo Ellipta is used. Conversely, if Breo Ellipta is still considered as beneficial for the COPD therapy but there’s a significant reduction of bone mineral density, a medication to prevent or treat osteoporosis should be considered. In a 12-month clinical trial in 3,255 individuals with COPD, 2% of patients receiving Breo Ellipta 200/25, 100/25, and 50/25 had bone fractures compared with less than 1% of individuals receiving 25 mcg vilanterol alone.

  • Cardiovascular Effects

Like other beta2-agonists, vilanterol can produce significant cardiovascular effects. This can be marked by an increase in systolic or diastolic blood pressure, pulse rate, as well as cardiac arrhythmias such as extrasystoles and supraventricular tachycardia. Breo Ellipta may need to be discontinued if such effects occur. Furthermore, beta-agonists produce electrocardiographic changes such as the prolongation of the corrected QTc interval, flattening of the T wave, and ST-segment depression. Large doses or excessive use of Breo Ellipta has been associated with prolongation of the QTc interval, which can result in ventricular arrhythmias. As such, caution should be taken if patients have cardiovascular disorders, particularly cardiac arrhythmias, coronary insufficiency, and hypertension.

  • Ocular Problems

Patients with COPD receiving inhaled corticosteroids for a long-term are at risk of cataracts, glaucoma, and increased intraocular pressure. Close monitoring is warranted in patients with a history of ocular changes or a change in vision.

  • Hypersensitivity

The administration of Breo Ellipta may elicit hypersensitive reactions. Patients with severe milk protein allergy may get anaphylactic reactions after inhalation of other powder products containing lactose. As such, Breo should not be recommended for patients with severe milk protein allergy.

  • Paradoxical Bronchospasm

Breo Ellipta, as with other inhaled products, can result in paradoxical bronchospasm, which may be fatal. Patients should use inhaled short-acting bronchodilator if they get bronchospasm. Also, the use of Breo Ellipta should be immediately stopped and an alternative treatment used.

  • Adrenal Suppression and Hyperadrenocorticism

Inhaled fluticasone furoate can be systemically active as it’s absorbed into the circulation system. The effects of the recommended therapeutic dose of Breo are observed on the HPA axis, but exceeding dosage or taking the drug with a strong cytochrome inhibitor may cause HPA dysfunction. And since sensitive patients face a risk of significant absorption of inhaled corticosteroids, patients receiving Breo Ellipta should be closely monitored to see is there are systemic corticosteroid effects such as adrenal suppression and hyperadrenocorticism. Breo Ellipta dosage should be reduced slowly if these effects occur with accepted systemic corticosteroids reduction procedures, and other alternative therapies for COPD symptoms should be considered.

  • Oral Candidiasis

Like with other inhaled corticosteroids, the use of fluticasone furoate/vilanterol may result in localized infections of the mouth and throat. While the treatment of Breo Ellipta continues, Candida albicans should be treated with appropriate anti-fungal therapy. In some cases, it might be necessary for inhaler therapy to be interrupted. Patients are advised to rinse their mouth after inhalation to reduce the risk of oral candidiasis.

  • Hyperglycemia and Hypokalemia

Breo Ellipta may produce hypokalemia, which may result in adverse cardiovascular effects. Beta-adrenergic agonists may lead to a decrease in potassium and may produce transient hyperglycemia in some patients.

Contraindications

the use of Breo Ellipta is contraindicated in demonstrated hypersensitivity to vilanterol, fluticasone furoate, or any of the excipients, severe hypersensitivity to milk proteins as well as in the primary treatment of acute episodes of asthma or COPD where intensive measures are required.

Breo Ellipta Black Box Warning

data from large placebo-controlled trials in asthmatic patients suggested that LABAs may increase the risk of asthma-related deaths. However, it is not known whether LABAs increase the rate of death in patients with COPD. In a trial comparing salmeterol (another LABA) with placebo, asthma-related deaths increased with each usual asthma therapy. The finding is a class effect of LABAs, vilanterol included. However, a review of four large clinical safety trials by the FDA indicates that the use of long-acting beta-agonists for the treatment of asthma in combination with inhaled corticosteroids doesn’t lead to more serious asthma-related side effects that when inhaled corticosteroids are administered exclusively.

In December 2018, the boxed warning about asthma-related deaths was removed from the Breo Ellipta label and other medicines that contain both LABA and ICS. Trials that led to this decision showed that when used with ICS, LABAs did not significantly increase the risk of hospitalizations, the need to insert an intubation, or asthma-related deaths, when compared to the use of ICS alone. The FDA stated that the risk of asthma-related deaths was associated with the use of LABAs to treat asthma without incorporating ICS to treat lung inflammation. Even so, a Warning and Precaution section will be retained on the Breo Ellipta label to warn patients of the risks of asthma-related deaths.

Finding Help for a Breo Lawsuit Near Me

if you took Breo Ellipta and suffered serious infections, cancer, intestinal perforations, tuberculosis, or any other serious side effect, you may be entitled to compensation. Consumer Alert Now helps connect individuals from all over the United States with seasoned attorneys. We are committed to keeping people safe from potentially harmful drugs and support people in pursuit of due justice for their injuries, damages, suffering, and deadly side effects of prescription medications. We work with leaders in the mass tort field to ensure that affected individuals get the help and justice they deserve. All our services are free and you don’t have to be a member to get help. Call us today at (800) 511-0747or fill out the free case review form to get connected to the appropriate legal professional.