Trelegy Ellipta

HOW DOES TRELEGY ELLIPTA WORK?

TRELEGY ELLIPTA is a combination dry powder corticosteroid, anticholinergic, and long-acting beta₂-adrenergic agonist that is breathed into the lungs using an inhaler. The steroid, fluticasone furoate, settles into the lung tissue and suppresses the chronic inflammation caused by chronic obstructive pulmonary disease. The anticholinergic, umeclidinium, blocks the action of acetylcholine on muscarinic receptors in the lung, causing the smooth muscle in the lung to relax and the bronchi to open. The long-acting beta₂-adrenergic agonist, vilanterol, stimulates the beta₂ receptors in the lung, causing prolonged dilatation of smooth muscle in the lung bronchi.

INDICATIONS

TRELEGY ELLIPTA is indicated for the long-term treatment of chronic obstructive pulmonary disease. TRELEGY ELLIPTA helps to reduce limited airflow and reduces the number of acute disease exacerbations in patients with chronic obstructive pulmonary disease. This includes patients with chronic bronchitis and/or emphysema. It is prescribed for those patients who are not achieving adequate control of their illness while taking a fixed-dose combination of only fluticasone furoate and vilanterol.

Importantly, TRELEGY ELLIPTA should not be used to relieve acute bronchospasm or to treat asthma.

DOSAGE

The dose of TRELEGY ELLIPTA for treating chronic obstructive pulmonary disease is one inhalation of the fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg combination, taken once a day.

Warnings & Precautions

Increased risk of asthma-related deaths

TRELEGY ELLIPTA contains vilanterol, a long-acting beta₂-agonist. Studies have shown that these agonists increase the risk of asthma-related deaths. However, it is unclear whether combining long-acting beta₂-agonists with steroid formulations or anticholinergics mitigates this risk. In addition, data suggest that the use of long-acting beta₂-agonists in pediatrics and adolescents increases the risk of hospitalization.

Deteriorations in chronic obstructive pulmonary disease

TRELEGY ELLIPTA should not be used in patients having a rapid deterioration or a life-threatening episode of chronic obstructive pulmonary disease. TRELEGY ELLIPTA should not be prescribed to manage acute symptoms of bronchospasm in patients with chronic obstructive pulmonary disease. Extra doses of TRELEGY ELLIPTA should not be taken to attempt the relief of acute symptoms. Instead, treat acute symptoms with inhaled, short-acting beta_2­-agonists. Where patients have been taking a short-acting beta₂-agonist regularly (approximately four times a day), its use should be stopped. Only use short-acting beta₂-agonists for the relief of acute bronchospasm.

Should there be progressive, ongoing deterioration in chronic obstructive pulmonary disease symptoms, the patient must undergo a reevaluation of their therapy. Do not increase the dose of TRELEGY ELLIPTA beyond the recommended dosing.

Interactions with other long-acting beta₂-agonists

TRELEGY ELLIPTA should not be used at higher doses than recommended for the treatment of chronic obstructive pulmonary disease. In addition, it should not be taken with other long-acting beta₂-agonists like salmeterol, formoterol, arformoterol, or indacaterol. When inappropriately used, there is a risk of significant cardiovascular complications and death.

Oral candida infection risk

TRELEGY ELLIPTA contains a steroid that may cause the development of thrush (Candida Albicans) in the mouth and throat. Patients should rinse their mouths with water after inhaling their doses to prevent this from developing. In addition, monitor patients regularly for the development of thrush.

Acute asthmatic deterioration

TRELEGY ELLIPTA should not be used for the management of acute asthmatic deterioration. It has no intrinsic bronchodilatory effects. Therefore, using it during an acute asthmatic deterioration will not help relieve any symptoms. It should also not be used in patients having an acute exacerbation of their chronic obstructive pulmonary disease.

Immunosuppression

TRELEGY ELLIPTA contains a corticosteroid that causes mild suppression of the immune system. This may worsen existing bacterial, fungal, or viral infections. For example, patients with tuberculosis, herpes simplex, measles, or chickenpox can be seriously affected.

Increased risk of pneumonia

There is an increased risk of developing pneumonia in patients using TRELEGY ELLIPTA to manage chronic obstructive pulmonary disease. Therefore, patients should be monitored for any signs and symptoms of pneumonia.

Transferring from oral steroids to TRELEGY ELLIPTA

TRELEGY ELLIPTA delivers steroid directly to the lung. As a result, there is a lower steroid concentration in the rest of the body. Therefore, when transferring from oral steroids to TRELEGY ELLIPTA, there is a risk that the body will have insufficient levels of corticosteroid available, leading to a clinical picture of adrenal insufficiency.

Suppression of the adrenal system

TRELEGY ELLIPTA results in lower levels of steroids in the rest of the body than when taking oral steroids. However, this lower dose may still be enough to suppress the body’s production of corticosteroids from the adrenal glands. This may lead to adrenal insufficiency during periods of severe stress, where additional corticosteroid is needed, or when TRELEGY ELLIPTA is suddenly stopped.

Bone mineral density reductions

Patients taking TRELEGY ELLIPTA are at risk of reducing their bone density due to the long-term effect of the inhaled steroid. This may increase the risk of developing bone fractures.

Paradoxical bronchospasm

TRELEGY ELLIPTA may paradoxically trigger bronchospasm. If this happens, immediately treat the patient with an inhaled short-acting bronchodilator. Then, stop TELEGY ELLIPTA and start different therapy.

Glaucoma and cataracts

The long-term use of inhaled steroids can cause an increase in eye pressure (glaucoma). It also increases the long-term risk of developing cataracts.

Eosinophilia and Churg-Strauss Syndrome

Rarely long-term inhaled corticosteroids can cause an increase of eosinophils in the body that presents with clinical features consistent with a Churg-Strauss Syndrome vasculitis.

Cardiovascular disease risk

Vilanterol may stimulate beta-adrenergic receptors in the heart and cause elevations in heart rate, blood pressure, and may induce heart arrhythmias. In patients with heart disease, this may exacerbate their symptoms.

Co-morbid conditions

TRELEGY ELLIPTA should be used with care in patients with a history of seizures, diabetes mellitus, ketoacidosis, or thyrotoxicosis. Patients should also be monitored for the development of hyperglycemia and hypokalemia.

Worsening urinary retention

TRELEGY ELLIPTA contains an anticholinergic. This increases the risk of urinary retention. Monitor patients carefully for retention symptoms like difficulty passing urine and painful urination.

SPECIAL POPULATIONS

Hepatic impairment

The blood levels of fluticasone furoate may increase in patients with moderate or severe hepatic impairment. Patients should be monitored for systemic side effects of corticosteroids.

Renal impairment

There are no significant increases in the blood levels of fluticasone furoate, vilanterol, or umeclidinium in patients with severe renal dysfunction. No dose adjustments are therefore required in this population.

Children

TRELEGY ELLIPTA has not been tested in persons under 18 years. As a result, its use is not recommended in this age group.

Pregnancy

TRELEGY ELLIPTA has not been extensively studied in pregnant women. Therefore, there are insufficient data to clearly understand the risks of using TRELEGY ELLIPTA in this population. TRELEGY ELLIPTA should only be used at the end of pregnancy or during labor if the possible benefits of using the drug outweigh the potential risks of inhibiting the contraction of the uterus.

Breastfeeding

The safety of TRELEGY ELLIPTA has not been tested in breastfeeding mothers. It is not known whether TRELEGY ELLIPTA is secreted in breastmilk. When using TRELEGY ELLIPTA, the risk to the infant should be weighed up against the benefit for the mother. This should be discussed with a doctor.

Use in the elderly

Data suggest that no dosage adjustments are required when prescribing TRELEGY ELLIPTA for elderly patients.

Contraindications

TRELEGY ELLIPTA is contraindicated in patients with a hypersensitivity to milk proteins, fluticasone furoate, umeclidinium, or vilanterol.

TRELEGY ELLIPTA is contraindicated in patients with status asthmaticus, asthma, or acute exacerbations of chronic obstructive pulmonary disease who may require intensive management measures.

Side Effects

Common side effects of TRELEGY ELLIPTA include:

• Thrush in the mouth and throat (Candida albicans)
• Sinusitis
• Headaches
• Back pain
• Fever
• Chest infection
• Changes in voice
• Changes in taste
• Difficulty sleeping
• Nausea, vomiting, and diarrhea
• Cough
• Mouth and throat pain

Less common side effects include:

• Pneumonia
• Bronchitis
• Suppression of the immune system
• Reduction in bone density
• Glaucoma and cataracts
• Systemic eosinophilia
• Churg-Strauss syndrome
• Anaphylaxis
• Sudden breathing problems after inhaling the medication
• Effects on the heart, like increased blood pressure, chest pain, or a fast heartbeat
• Tremors or shakes
• Inability to pass urine, or pain when trying to pass urine
• Development of high blood sugar levels and low levels of potassium

Drug Interactions

Certain drugs may interact with TRELEGY ELLIPTA. These include:

• Antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• Antiretrovirals (e.g., ritonavir, atazanavir, indinavir)
• Antibiotics (e.g., clarithromycin, telithromycin)
• Antidepressants (e.g., nefazodone)
• Other long-acting beta₂-agonists
• Loop diuretics
• Beta-blockers
• Monoamine oxidase inhibitors
• Tricyclic antidepressants
• Anticholinergics

Frequently Asked Questions