Prescription Required.
Product of Canada.
Shipped from Canada.
| Prescription Required. | Product of Canada. | Shipped from Canada. |
TRELEGY ELLIPTA
(Fluticasone furoate, umeclidinium and vilanterol)
What is the Trelegy Ellipta?
TRELEGY ELLIPTA is a combination of prescription corticosteroid, anticholinergic, and long-acting beta2-adrenergic agonist inhaled into the lungs to treat chronic obstructive pulmonary disease. It is manufactured as TRELEGY ELLIPTA 100/62.5/25, a combination of fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg.
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 beta2-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
People who take TRELEGY ELLIPTA have an increased risk of death from asthma-related problems. This is because it contains vilanterol, a long-acting beta2-adrenergic agonist. Therefore, it is essential to contact your healthcare provider if you experience worsening breathing while using TRELEGY ELLIPTA. You should seek urgent medical care if you have rapid worsening of your breathing, and your rescue inhaler does not help to relieve these symptoms.
TRELEGY ELLIPTA is not approved for treating asthma.
Using TRELEGY ELLIPTA increases the risk of death from asthma problems.
TRELEGY ELLIPTA is a combination of prescription corticosteroid, anticholinergic, and long-acting beta2-adrenergic agonist inhaled into the lungs to treat chronic obstructive lung disease. It is manufactured as TRELEGY ELLIPTA 100/62.5/25, a combination of fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg.
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.
TRELEGY ELLIPTA comes in a sealed foil tray. To open the tray, peel back the lid. Each inhaler can dispense 30 doses. When you open the inhaler cover, you will hear a clicking sound, and the dose counter will decrease by one. Opening the cover primes the inhaler for delivery. Do not close the cover without inhaling the medication or you will lose the prepared dose. You cannot take a double dose because the prepared dose will become unavailable once you close the cover.
To inhale the dose, slide the cover down so that you can see the mouthpiece. You will hear a click, and the counter will go down by one number. You do not need to shake this inhaler. Hold the inhaler away from your mouth and breathe out completely. Make sure that you do not breathe out into the mouthpiece. Now place the mouthpiece between your lips and take a long deep breath in through your mouth. Make sure that you do not breathe in through your nose. Also, ensure that your hands do not block the air vent on the inhaler. Hold your breath for three to four seconds after you have inhaled. When breathing in the powder, you may not taste or feel it. This does not mean that you have not received a dose. Once you have taken the required dose, close the inhaler by sliding the cover back into position.
It is important to rinse your mouth out once you have inhaled your dose. This is to prevent you from developing thrush in your mouth and throat. Make sure that you do not swallow the water.
TRELEGY ELLIPTA is contraindicated in patients with a hypersensitivity to milk proteins, fluticasone furoate, umeclidinium, or vilanterol.
TRELEGY ELLIPTA is also contraindicated in patients with status asthmaticus or patients with acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.
If you miss a dose of TRELEGY ELLIPTA, try to take it as soon as possible, then continue with the usual medication schedule. However, if you are due to take your next dose, skip the dose you missed and continue with your regular medication schedule. Under no circumstances should you take a double dose of the medication to make up for the missed dose. If you are unsure about what to do, contact your doctor or local pharmacist to obtain advice.
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
Some side effects can be severe and require medical attention. Contact your doctor immediately if you notice any of the following:
- worsening of your asthma
- difficulty breathing
- shortness of breath
- tight chest
- changes in your vision
- swelling of your face with a skin rash
- acute confusion or aggression
- development of a temperature or other signs of an infection
If you experience severe side effects, immediately contact your doctor, or go to the nearest emergency health care facility.
TRELEGY ELLIPTA should be stored away from children. It should be stored in a dry place at room temperature, away from heat and sunlight. It should be stored unopened in its foil pouch and only opened when ready for use.