Inhaled powdered dosage powder trelegy ellipta gsk treatment of chronic obstructive pulmonary disease (30 dose of inhalation)
Dosage form Box
Specifications Fluticasone Furoate, Umeclidinium, Vilanterol
Ingredient
| Composition information | Content |
| Fluticasone Furoate | 100mcg |
| Umeclidinium | 62.5mcg |
| Vilanterol | 25mcg |
Uses
Indications
Trelelegy ellipta dose powder is indicated in maintenance treatment to prevent and reduce symptoms related to chronic obstructive pulmonary disease (COPD).
Pharmacokology
ATC code: r03al08.
Pharmacological therapy group: Medications for respiratory obstruction, Adrenergic in combination with anti -cholinergic drugs include combination of three drugs with corticosteroids.
Mechanism of action
Fluticasone Furoate, Umeclidinium and Vilanterol belongs to three different groups of drugs in the order: a synthetic corticosteroid, a prolonged Muscarinic receptor antagonist (also considered as a lama or a cholinergic anti -anti -anti -beta receptor owner, prolonged, selective effect (LABA).
Fluticasone Furoate
Fluticasone Furoate is a strong anti -inflammatory corticosteroid. It is unclear the exact mechanism of Fluticasone Furoate on COPD symptoms. Corticosteroids are known to have a wide activity on many types of cells (such as eosinophilia, macrophages, lymphocytes) and intermediate substances (such as cytokin and chemokin) involved in inflammatory reactions.
umeclidinium
Umeclidinium is a long -lasting Muscarinic receptor antagonist (also considered as a cholinergic resistant). Umeclidinium has a bronchodilator effect by inhibiting the cohesion of acetylcholine with the Cholinergic Muscarinic receptors on the air of the air (Airway Smooth Muscle). Umeclidinium has the ability to play slowly at the Muscarinic M3 receptor in people on in vitro and have a prolonged effect on in vivo when it is taken directly to the lungs in preclinical models.
vilanterol
Vilanterol is a selective laba. Pharmacological effects of the Beta, -adrenergic receptor receptor owners, including Vilanterol, at least partly due to stimulating adenylate cyclase enzymes, intracellular enzymes, adenosine triphosphate (ATP) to cyclic-3 ', 5'-adenosine monophosphate (AMP). AMP concentration increases, causing bronchial smooth muscle relaxation and inhibiting the release of intermediate substances that cause immediate hypersensitivity reactions from cells, especially masters.
Heart impact
The impact of Trelegy Ellipta on the QT interval has not been evaluated in a TQT study. TQT studies with Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol does not show clinical effects related to QT intervals at clinical doses of Fluticasone Furoate, Umeclidinium and Vilanterol.
The effect of Umeclidinium/Vilanterol on QT interval was assessed in a QT study with a placebo and Moxifloxacin using Umeclidinium/Vilanterol dose of 125/25 MCG or 500/100 mcg, used once a day, for 10 days on 103 healthy volunteers. The maximum average difference in extending the QT range (corrected by the Fridericia, QTCF) method compared to the placebo after adjusting the background line is 4.3 (90% CI: 2.2; 6.4) Milijii observed after 10 minutes from Umeclidinium/Vilanterol 125/25 MCG and 8.2 (90% CI: 6.2) after 30. Umeclidinium/Vilanterol 500/100 mcg. There is no clinical related effect on the extension of the QT range (adjusted by the Fridericia method) recorded in the Umeclidinium/Vilanterol 125/25 mcg dose. Moreover, there is no clinical significant effect of Umeclidinium/Vilanterol on the heart rate when recorded on the 24 -hour holter in 281 patients using Umeclidinium/Vilanterol 125/25 mcg, 1 time/day to 12 months.
The effect of Fluticasone Furoate/Vilanterol on the QT range has been evaluated in a cross, double, multi -dose, place to control and have a positive predictive value in 85 healthy volunteers.
Maximum average difference (reliable limit of over 95% - 95% Upper Confidence Bound) on QTCF compared to placebo after adjusting the background line is 4.9 (7.5) Milides and 9.6 (12.2) Milids observed after 30 minutes of using Fluticasone Furoate/Vilanterol 200/25 mcg and Fluticasone Furooated/Vilanterol 800/100 MCG. It was observed that an increase in heart rate depends on the dose. Maximum average difference (reliable limit of over 95% - 95% upper confidence bound) on heart rate compared to placebo after calibrating the background line - Baseline correction is 7.8 (9.4) beat/min and 17.1 (18.7) span/minute 10 minutes after the corresponding dose of Fluticasone Furoate/Vilanterol 200/25 MCG and Fluticasone FRURELE 800/100 mcg.
There are no clinical related related effects on QTC, which is observed when considering the ECG indicators of 911 COPD patients who use Trelegy Ellipta up to 24 weeks, or 210 patients in the subgroup for up to 52 weeks.
Dynamic pharmacokinetics
When Fluticasone Furoate, Umeclidinium and Vilanterol are used in a coordinated inhaled line with a separate inhaler in healthy, pharmacokinetic subjects of each component recorded as similarly when using each active substance in the form of Fluticasone Furoate/Vilanterol (FF/VI) (Umecni), or single -ingredient treatment.
Population pharmacokinetic analysis for Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 MCG has been done using the pharmacokinetic data set combined from three phase III studies on 821 COPD patients. In these analysis, the concentration of systemic drugs (CMAX and AUCY-24 in the stable state) of Fluticasone Furoate, Umeclidinum and Vilanterol after using Fluticasone Furoate/Umeclidinum/Vilanterol in a inhaler (combination of three drugs) in the observation level after using Fluticasone Furoate/VilanterolMinum through two bottles Inhalation, combination of 2 drugs (Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol) as well as separate suction bottles (Fluticasone Furoate, Umeclidinium, and Vilanterol).
absorption
Fluticasone Furoate
After using the inhaled trelegy Ellipta in a healthy volunteer, the CMAX of Fluticasone Furoate is achieved in the 15th minute. The absolute bioavailability of Fluticasone Furoate when using Fluticasone Furoate/Vilanterol averages is 15.2%, absorbed mainly from the amount of inhaled drugs in the lungs, absorbing by drinking is negligible. After repeating the dose of inhaling Fluticasone Furoate/Vilanterol, the stable state is achieved within 6 days, accumulating up to 1.6 times.
umeclidinium
After using the inhaled Trelelegy Ellipta in a healthy volunteer, CMAX Umeclidinium is achieved in the 5th minute. The absolute bioavailability of Umeclidinium inhaled inhaled average is about 13%, with negligible oral absorption. After repeating the inhaled Umeclidinium dose, the stable state is reached for about 7 to 10 days with the accumulation of 1.5 to 2 times higher.
vilanterol
After using the inhaled Trelelegy Ellipta in a healthy volunteer, CMAX Vilanterol is achieved in the 7th minute. The absolute use of Vilanterol's absolute inhalation is about 27%, with negligible oral absorption. After repeating the dose of Fluticasone Furoate/Vilanterol inhales, the stable state is reached for about 6 days with a accumulation of 1.5 times higher.
distribution
Fluticasone Furoate
After using Fluticasone Furoate intravenously for healthy objects, the average distribution volume is 661 liters. The cohesion with protein in human plasma is> 99.6% on in vitro.
umeclidinium
After using Umeclidinium intravenously for healthy subjects, the average distribution volume is 86 liters. The average cohesion of protein in human plasma is 89% on in vitro.
vilanterol
After using venous venous venous lines for healthy subjects, the average distribution volume in a stable state is 165 liters. The average cohesion of protein in human plasma is 94% on in vitro.
transformation
Fluticasone Furoate
In vitro studies show that Fluticasone Furoate is metabolized mainly through CYP3A4 and is a substrate for P-Glycoprotein (P-GP). Fluticasone Furoate is mainly metabolized by hydrolysis of S-Fluoromethyl Carbothioate to form a significant decreased corticosteroid metabolic substance. The body exposure to the metabolites is low.
umeclidinium
In vitro studies show that Umeclidinium is metabolized mainly through CYP2D6 and is a substrate for P-GP transport channel. Umeclidinium's main metabolic paths are oxidation (hydroxylation, o-dealkylation) then conjugated (glucuronid, ...), forming a series of metabolites reduced pharmacological activity or metabolites with unproven pharmacological activity. The body exposure to the metabolites is low.
vilanterol
In vitro studies show that Vilanterol is metabolized mainly through CYP3A4 and is a substrate for P-GP transport channel. The main metabolic paths are O-Dalkyl turns into a sequence of metabolites that have beta, and beta activity, significantly reduced. Descriptions of plasma metabolism after oral Vilanterol in the study marking radioactive in humans in accordance with high initial metabolism.
Systemic exposure to metabolites is low.
Medicine - Drugs
A repetitive dose study was conducted in healthy subjects using Fluticasone Furoate/Vilanterol (200/25 MCG) and Ketoconazole (400 mg, a powerful CYP3A4 inhibitor and PGP inhibitors). Use simultaneously increasing AUC (0-24) and the average CMAX of Fluticasone Furoate, 36% and 33% respectively. The increase in exposure to Fluticasone Furoate is related to a 27% reduction in the average amount of cortisol in the serum measured in 0 - 24 hours. Simultaneous use increases the average AUC (0-T) and CMAX of Vilanterol, respectively 65% and 22% respectively. The increase in exposure to Vilanterol is not related to the increase in the body's body effects on the Beta Heart or Potassium.
both Fluticasone Furoate, Umeclidinium and Vilanterol are the substrates of P-GP. A repetitive dose interactive study was conducted in healthy subjects using Umeclidinium/Vilanterol or Umecidinium, and P-GP and CYP3A4 inhibitors of Verapamil average (240 mg) showed any significant clinical effect on pharmacokinetics of Vilanterol or Umeclidinum.
The effect of poor metabolic genes of CYP2D6 on pharmacokinetics in the stable state of Umeclidinium is rated on healthy volunteers (CYP2D6 normal metabolic people and poor CYP2D6 metabolic). There is no clinical significance in the criteria of the whole body exposure to Umeclidinium (500 mcg, 8 times higher than the treatment dose) observed after repeating the daily inhaling dose for normal subjects and poor CYP2D6.
Elimination
Fluticasone Furoate
The apparent sale time of Fluticasone Furoate after inhaling Fluticasone Furoate/Vilanterol is 24 hours.
After using intravenous lines, the average selling time is 15.1 hours. Plasma clearance after intravenously 65.4 liters/hour. Excretion in urine accounts for about 2% of intravenous dose. After oral use, Fluticasone Furoate is eliminated in humans, mainly through the transformation process into metabolites and eliminated mostly through feces, with
umeclidinium
Umeclidinium's plasma sale time after taking the inhaled dose for 10 days is 19 hours, with 3% to 4% of the drug excreted in the form of unchanged urine in a stable state. Plasma clearance after intravenously use is 151 liters/hour. After intravenous lines, about 58% of the dose marked radioactive is excreted in the feces and about 22% of the dose marked radioactive is excreted in the urine. The elimination of substances related to the medication after fecal after using intravenous sugar shows that there is an excretion of drugs in the bile. After oral use, 92% of the dose marked with radiation is excreted mainly in feces. Under 1% of oral dosage (1% of radioactive activity found) is excreted in the urine, suggesting that the absorption after oral use is negligible.
vilanterol
Vilanterol's plasma waste time after taking the inhaled dose for 10 days is 11 hours. The plasma clearance of Vilanterol after using intravenous tract is 108 liters/hour. After oral vilanterol oral use is marked with radiation, 70% of the dose marks radioactive is excreted in the urine and 30% in feces. Vilanterol's main excretion path is metabolism, then excreted the metabolites into urine and feces.
Special patients
In a pharmacokinetic analysis of COPD population (n = 821), the impact of demographic variables (racial/ethnic, age, gender, weight) on pharmacokinetics of Fluticasone Furoate, Umeclidinium, and ViLanterol has been assessed. Patients with kidney failure and liver failure are assessed in separate studies.
Race
There is no clinical difference that requires dose adjustment in COPD patients based on racial factors recorded on body absorption with Fluticasone Furoate, Umeclidinium or Vilanterol.
In East Asian patients with COPD (Japanese patients and patients with East Asia (East Asian Heritage) (N = 113) when using Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcG, AUCSS estimates of Fluticasone Furoate average higher than 30% higher than whites. There is no clinical effect on the effect of eliminating cortisol in serum or through the urine for 24 hours.
Elderly
There is no clinical related effect on the adjustment of the dose based on the age recorded in COPD patients.
kidney failure
Trelegy Ellipta has not been evaluated in kidney failures. However, studies have been conducted with Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol.
A clinical pharmacological study of Fluticasone Furoate/Vilanterol has shown that severe kidney failure (creatinine clearance A study on severe kidney failures using Umeclidinium/Vilanterol did not see evidence of an increase in body exposure to Umeclidinium or Vilanterol (CMAX and AUC). Studies in Vitro's plasma proteins between severe kidney failure and healthy volunteers have been performed and have no clinical evidence of clinical clinical cohesion to be observed.
The effect of blood decomposition has not been studied.
Hepatic failure
Trelegy Ellipta has not been evaluated in liver failure objects. However, studies have been conducted with Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol.
After repeating Fluticasone Furoate/Vilanterol for 7 days, there is an increase in the body exposure to Fluticasone Furoate (up to 3 times when evaluating the AUC index (0-24) in the subjects of the liver (Child-Pugh a, B or C) comparison with healthy objects. There are no clinical effects on serum cortisols that are recorded in the objects of mild-pug a). Increasing body exposure to Fluticasone Furoate (Fluticasone Furoate/Vilanterol 200/25 mcg) in medium-sized objects (Child-Pugh B) is related to an average reduction of an average of about 34% of serum cortisol compared to healthy people. In severe liver failure (Child-Pugh C), the dose of Fluticasone Furoate/Vilanterol 100/12.5 mcg does not have a decrease in serum cortisol (serum cortisol increases by 10%). For patients with medium or severe liver failure, the maximum dose is 100/62.5/25 mcg.
After repeating Fluticasone Furoate/Vilanterol for 7 days, there is no significant increase in the body exposure with Vilanterol (CMAX and AUC) in mild, medium or heavy liver failure objects (Child-Pugh A, B or C).
There are no clinical relevant effects of Fluticasone Furoate/Vilanterol combination on the body effects of beta-adrenergic (Heart rate or serum potassium) in patients with mild or medium liver failure (Vilanterol 25 mcg) or patients with severe liver impairment (Vilanterol 12.5 mcg) compared to healthy people.
There is no evidence of an increase in systemic exposure to Umeclidinium or Vilanterol (CMAX and AUC) in medium -sized liver failure objects, and there is no evidence in vitro in terms of protein cohesion that is transformed between medium -degree liver failures and healthy volunteers.
umeclidinium has not been evaluated on serious liver failure objects.
Other patient characteristics
There is no clinical difference that needs to adjust the dose based on the impact of gender, weight or body mass index (BMI) recorded in COPD patients.
Poor CYP2D6 metabolic objects show no evidence of clinical impact on the multi -phenotype of the GIP2D6 gene system on the body exposure to Umeclidinium.
Before taking Inhaled powdered dosage powder trelegy ellipta gsk treatment of chronic obstructive pulmonary disease (30 dose of inhalation)
How to use
Trelegy Ellipta is only used to inhale. Trelelegy Ellipta should be used once a day, at the same time fixed in the morning or evening.
After inhaling, patients should rinse with water and not swallow.
After opening the aluminum tray, using the drug for a period of 01 month.
Write the day of inhaled tools should be removed on the space of the inhaler label. The date of elimination should be recorded as soon as the inhaler is removed from the tray.
Dosage
Adults
The recommended and maximum dose is a trelegy Ellipta 100/62.5/25 mcg, 1 time/day.
Children and teenagers
Based on the instructions of the product, the use for patients under 18 years of age is inappropriate.
Elderly
No dose adjustment in patients over 65 years old.
kidney failure
No dose adjustments in patients with renal failure.
Hepatic failure
Be careful when taking medication for patients with liver failure due to the risk of unwanted effects related to corticosteroids.
For patients with moderate or severe liver failure, the maximum dose is a dose of trelegy ellipta 100/62.5/25 mcg.
Specific dose depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?
Overdose
There is no data on overdose of Trelegy Ellipta from clinical trials.
Signs and symptoms
Overdose of Trelegy Ellipta can cause signs, symptoms or unwanted effects due to the pharmacological impact of each separate ingredient of the drug.
Handling
There is no specific treatment when overdose of Trelegy Ellipta. If overdose occurs, patients should be supported with appropriate supervision when needed.
Selected beta blockers on the heart should only be considered when the overdose effects caused by Vilanterol seriously affected clinically and does not respond to supportive treatment measures. Selected beta blockers on the heart should be used carefully for patients with a history of bronchospasm.
The next control measures should be clinically indicated or recommended by the National Poison Control Center, if any.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using the trelegy Ellipta GSK dosage powder, the unwanted effects (ADR) such as:
Infections and parasites:
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Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Trelegy Ellipta drug is contraindicated in the following cases:
Caution when using
plays
Trelegy Ellipta should not be used to treat the COPD acute acute drama but need to be treated with short -acting bronchodilators.
Increasing the use of bronchodilators short -acting to reduce symptoms shows that the disease control is deteriorating and the patient should go to the doctor to check.
Patients should not stop treating with Trelegy Ellipta without a doctor's supervision due to symptoms that may recur after stopping the drug.
paradoxical bronchospasm
As well as other inhaled sugars, paradoxical bronchospasm can occur accompanied by an increase in the medication immediately and may threaten the patient's life. Trelegy ellipta should be stopped immediately, patients should be evaluated and used for replacement therapies if needed.
Heart effects
Heart effects, for example, arrhythmia such as atrial fibrillation and tachycardia, can be seen after using Muscarinic receptor drugs or sympathetic nerve stimulants, including Umeclidinium or Vilanterol. Therefore, Trelegy Ellipta should be used carefully for patients with unstable or life -threatening cardiovascular disease.
Patients with liver failure
Patients with severe to severe hepatic and severe liver failure are treated with Trelegy Ellipta 100/62.5/25 mcg, so they are monitored with adverse body reactions related to corticosteroids.
Corticosteroid's body effects
Systemic effects may occur with any inhaled corticosteroids, especially when taking high doses for a long time. These effects occur much less than oral corticosteroids. The systemic effects may include: Inhibiting the hypothalamus - pituitary - adrenal gland, reducing the mineral density of bones, cataracts, increasing glaucoma and dark retinopathy (Central Serous Choriorinopathy (CSCR).
As well as all drugs containing corticosteroids, trelegy ellipta should be used carefully in patients with tuberculosis, or patients with chronic or untreated bacterial infections.
Muscarinic resistance
Due to the anti -Muscarinic activity of the drug, Trelegy Ellipta should be used carefully for patients with glaucoma or urinary retention.
pneumonia
Similar to the known common effect of inhaled corticosteroids, pneumonia (including pneumonia leading to hospitalization) has been observed in COPD patients using Trelegy Ellipta.
In some cases, pneumonia deaths have been reported when using drugs containing Fluticasone Furoate - inhaled corticoids, including Trelegy Ellipta. The doctor should continue to be alert for the progression of pneumonia in COPD patients, because of the clinical characteristics of pneumonia, which is fitted with the signs of the COPD play.
Risk factors for pneumonia in COPD patients using inhaled corticosteroid drugs include smokers, but the disease
History of pneumonia, patients with low body mass index and patients with severe COPD. These factors need to be considered when prescribing Trelegy Ellipta and need to re -evaluate the treatment when pneumonia occurs.
excipients
If the doctor announces that you have tolerated disorders with some types of sugar, contact your doctor before using this medication.
Trelegy Ellipta contains lactose, should not use this drug for patients with rare genetic disorders in galactose tolerance such as lactase deficiency, glucose absorption disorders - Galactose.
Using drugs for women during pregnancy and lactation
fertility
There is no data on the impact of Trelegy Ellipta on human fertility. Animal studies show that there is no influence on the fertility of males and females.
pregnancy
There is no enough data on the use of Trelegy Ellipta in pregnant women. Animal studies show that toxicity on reproductive organs occurs after using beta, or corticosteroids.
Trelegy Ellipta should only be used during pregnancy if the benefit to the mother outperforms any risk that may occur with the fetus.
breastfeeding
It is unknown whether Fluticasone Furoate, Umeclidinium, Vilanterol or their metabolic products are excreted through breast milk. However, corticosteroids, Muscarinic antagonists and beta -owners have been discovered in breast milk. The risk for infants/breastfed babies cannot be excluded.
Consider stopping breastfeeding or stopping Trelegy Ellipta based on the benefit of breastfeeding for babies and treatment benefits for the mother.
The effect of the drug on driving and operating machinery
has no research to assess the effects of Trelegy Ellipta on the ability to perform activities that require judgment, exercise or cognitive skills.
The adverse effects on these activities have not been predicted based on the pharmacological properties of Fluticasone Furoate, Umeclidinium or Vilanterol, at clinical doses.
Drug interaction
almost no clinical interactions are caused by Fluticasone Furoate, Umeclidinium or Vilanterol at clinical doses because after inhaling the drug concentration achieved in low plasma.
Interaction with beta blockers
Beta - adrenergic blockers can weaken or antagonistic effects of beta2 - adrenergic agreeders, for example, vilanterol. If you have to prescribe beta blockers, you should consider using selective beta blockers on the heart; However, be careful when used simultaneously with selective and non -selective beta blockers.
Interaction with CYP3A4 inhibitors
Fluticasone Furoate and Vilanterol, both of Trelegy Ellipta, are quickly excreted by the initial initial transformation through the intermediary by the CYP3A4 enzyme in the liver.
Be careful when used in combination with strong CYP3A4 inhibitors (such as ketoconazole, ritonavir) due to the ability to increase the body exposure to both Fluticasone Furoate and Vilanterol, leading to an increased risk of unwanted effects.
Interaction with CYP2D6/polymorphic inhibitors
Umeclidinium is a substrate of Cytochrome P450 2D6 (CYP2D6). Mobile pharmacokinetics in the stable state of Umeclidinium are evaluated on healthy volunteers deficiency CYP2D6 (poor metabolism).
Do not record the impact on Umeclidinium's AUC and CMAX CMAX at an 8 times higher dose of treatment. Umeclidinium's AUC increased by 1.3 times at a dose higher than 16 times and did not affect Umecidinium's cmax.
Based on the level of these changes, clinical related drug interactions are expected to occur when Fluticasone Furoate/Umeclidinium/Vilanterol is used in combination with CYP2D6 inhibitors or when used in patients with CYP2D6 genetic deficiencies (poor metabolism).Interaction with p - glycoprotein inhibitors
Fluticasone Furoate, Umeclidinium and Vilanterol are substrates of P-Glycoprotein (P-GP).
The impact of P-GP inhibitors in Verapamil average (240 mg once a day) on pharmacokinetic pharmacokinetics in a stable state of Umeclidinium and Vilanterol is assessed in healthy volunteers. Do not record the effects of Verapamil on Umeclidinium and Vilanterol's CMAX. Umeclidinium's AUC increased by 1.4 times and did not affect the AUC of Vilanterol. Based on the level of these changes, clinical interactions are expected not to occur when Fluticasone Furoate/Umeclidinium/Vilanterol is used in combination with P-GP inhibitors. Clinical pharmacy studies with specific P-GP inhibitors and Fluticasone Furoate are not done.
Prolonged Muscarinic anti -antacids and Beta2 - Adrenergic owners are elongated.
Concomitance Trelegy Ellipta with long -lasting Muscarinic drugs or Beta - adrenergic -acting owners who have not been researched and are not recommended because they have the potential to cause unwanted effects.
Cavalry
Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Store no more than 30 ° C. If stored in the refrigerator, take out the medicine to stay at the room temperature for at least 1 hour before use.
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