ANORO ELLIPTA Umeclidinium Bromide / Vilanterol Trifenatate 62.5mcg / 25mcg Dry-Powder Inhalation In Capsule 30 doses
RXDRUG-DR-XY43993
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).
Dosage/Direction for Use
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is for oral inhalation only.
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be administered once daily at the same time each day.
Adults: The recommended and maximum dose is one inhalation of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) 62.5/25 micrograms once daily.
Children: Use in patients less than 18 years of age is not relevant given the indication for this product.
Elderly: No dosage adjustment is required in patients over 65 years (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Renal impairment: No dosage adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment. Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be administered once daily at the same time each day.
Adults: The recommended and maximum dose is one inhalation of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) 62.5/25 micrograms once daily.
Children: Use in patients less than 18 years of age is not relevant given the indication for this product.
Elderly: No dosage adjustment is required in patients over 65 years (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Renal impairment: No dosage adjustment is required in patients with renal impairment (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment. Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Overdosage
Symptoms: An overdose of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia) and those seen with overdose of other beta2-agonists (e.g. tremor, headache and tachycardia).
Treatment: There is no specific treatment for an overdose of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta). If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Treatment: There is no specific treatment for an overdose of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta). If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Contraindications
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is contraindicated in patients with severe milk-protein allergy.
Special Precautions
The use of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) has not been studied in patients with asthma, and is not recommended in this patient population.
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
As with other inhalation therapies, administration of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) may produce paradoxical bronchospasm that may be life-threatening. Treatment with Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be discontinued if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, maybe seen after the administration of sympathomimetic agents and muscarinic receptor antagonists, including Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta). Therefore, Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be used with caution in patients with severe cardiovascular disease.
Consistent with its antimuscarinic activity, Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) on the ability to perform tasks that require judgement, motor or cognitive skills.
Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
As with other inhalation therapies, administration of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) may produce paradoxical bronchospasm that may be life-threatening. Treatment with Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be discontinued if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, maybe seen after the administration of sympathomimetic agents and muscarinic receptor antagonists, including Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta). Therefore, Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be used with caution in patients with severe cardiovascular disease.
Consistent with its antimuscarinic activity, Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) on the ability to perform tasks that require judgement, motor or cognitive skills.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no or limited amount of data from the use of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) in pregnant women. Studies in animals have shown reproductive toxicity after inhaled administration of vilanterol (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions). Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.
Use in Lactation: It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta2-agonists are detected in human milk. A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effects of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Use in Lactation: It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta2-agonists are detected in human milk. A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effects of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Adverse Reactions
Clinical trial data: The safety profile of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta) is based on approximately 3000 patients with COPD who received doses of umeclidinium/vilanterol 62.5/25 micrograms or greater for up to one year during clinical studies. This includes approximately 1600 patients who received 62.5/25 micrograms and approximately 1300 patients who received 125/25 micrograms, both once daily.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000). (See Table 3.)
Post-marketing data: See Table 4.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000). (See Table 3.)
Post-marketing data: See Table 4.
Drug Interactions
Interaction with beta-blockers: Beta-adrenergic blockers may weaken or antagonise the effect of beta2-agonists, such as vilanterol. Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Interaction with CYP3A4 inhibitors: Vilanterol, a component of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta), is cleared by CYP3A4 mediated extensive first-pass metabolism in the gastrointestinal tract and in the liver.
Care is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole) as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions (see Pharmacology: Pharmacokinetics under Actions).
Interaction with CYP3A4 inhibitors: Vilanterol, a component of Umeclidinium bromide + Vilanterol (as trifenatate) (Anoro Ellipta), is cleared by CYP3A4 mediated extensive first-pass metabolism in the gastrointestinal tract and in the liver.
Care is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole) as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions (see Pharmacology: Pharmacokinetics under Actions).
Caution For Usage
Instruction for Use/Handling: When first using the Ellipta inhaler no need to check if it is working properly, and no need to prepare it for use in any special way. Just follow the instructions as follows.
The inhaler is packaged in a tray. Do not open the tray until the patient is ready to inhale a dose of medicine. When ready to use the inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw the packet away, don't eat or inhale it.
When taking the inhaler out of the sealed tray, it will be in the 'closed' position. Don't open it until the patient is ready to inhale a dose of medicine.
The step-by-step instructions stated as follows for the Ellipta inhaler.
Read before starting: If the patient opens and closes the cover without inhaling the medicine, the patient will lose the dose.
The lost dose will be securely held inside the inhaler, but it will no longer be available.
It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Cover: Each time opening this, it prepares one dose of medicine.
Dose counter: This shows how many doses of medicine are left in the inhaler.
Before the inhaler has been used, it shows exactly 30 doses.
It counts down by 1 each time the patients opens the cover.
When fewer than 10 doses are left, half of the dose counter shows red.
After the last dose was used, half of the dose counter shows red and the number 0 is displayed. The inhaler is now empty.
If the cover was open after this, the dose counter will change from half red to completely red.
a. Preparing a dose.
Wait to open the cover until ready to take the dose.
Do not shake the inhaler.
Slide the cover fully down until hearing a "click".
The medicine is now ready to be inhaled.
The dose counter counts down by 1 to confirm.
If the dose counter does not count down as hearing the "click", the inhaler will not deliver medicine. Take it back to the pharmacist for advice.
Do not shake the inhaler at any time.
b. Inhaling the medication.
While holding the inhaler away from the mouth, breathe out as far as is comfortable. Don't breathe out into the inhaler.
Put the mouthpiece between the lips, and close the lips firmly around it. Don't block the air vent with fingers.
The lips fit over the contoured shape of the mouthpiece for inhaling. Don't block the air vent with fingers.
Take one long, steady, deep breath in. Hold this breath for as long as possible (at least 3-4 seconds).
Remove the inhaler from the mouth.
Breathe out slowly and gently.
The patient may not be able to taste or feel the medicine, even when the patient is using the inhaler correctly.
c. Close the inhaler.
In cleaning the mouthpiece, use a dry tissue, before closing the cover.
Slide the cover upwards as far as it will go, to cover the mouthpiece.
The inhaler is packaged in a tray. Do not open the tray until the patient is ready to inhale a dose of medicine. When ready to use the inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw the packet away, don't eat or inhale it.
When taking the inhaler out of the sealed tray, it will be in the 'closed' position. Don't open it until the patient is ready to inhale a dose of medicine.
The step-by-step instructions stated as follows for the Ellipta inhaler.
Read before starting: If the patient opens and closes the cover without inhaling the medicine, the patient will lose the dose.
The lost dose will be securely held inside the inhaler, but it will no longer be available.
It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Cover: Each time opening this, it prepares one dose of medicine.
Dose counter: This shows how many doses of medicine are left in the inhaler.
Before the inhaler has been used, it shows exactly 30 doses.
It counts down by 1 each time the patients opens the cover.
When fewer than 10 doses are left, half of the dose counter shows red.
After the last dose was used, half of the dose counter shows red and the number 0 is displayed. The inhaler is now empty.
If the cover was open after this, the dose counter will change from half red to completely red.
a. Preparing a dose.
Wait to open the cover until ready to take the dose.
Do not shake the inhaler.
Slide the cover fully down until hearing a "click".
The medicine is now ready to be inhaled.
The dose counter counts down by 1 to confirm.
If the dose counter does not count down as hearing the "click", the inhaler will not deliver medicine. Take it back to the pharmacist for advice.
Do not shake the inhaler at any time.
b. Inhaling the medication.
While holding the inhaler away from the mouth, breathe out as far as is comfortable. Don't breathe out into the inhaler.
Put the mouthpiece between the lips, and close the lips firmly around it. Don't block the air vent with fingers.
The lips fit over the contoured shape of the mouthpiece for inhaling. Don't block the air vent with fingers.
Take one long, steady, deep breath in. Hold this breath for as long as possible (at least 3-4 seconds).
Remove the inhaler from the mouth.
Breathe out slowly and gently.
The patient may not be able to taste or feel the medicine, even when the patient is using the inhaler correctly.
c. Close the inhaler.
In cleaning the mouthpiece, use a dry tissue, before closing the cover.
Slide the cover upwards as far as it will go, to cover the mouthpiece.
Storage
Store at temperatures not exceeding 30°C.
If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Following removal from the tray, the product may be stored for a maximum period of 6 weeks.
Write the date the inhaler should be discarded on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Following removal from the tray, the product may be stored for a maximum period of 6 weeks.
Write the date the inhaler should be discarded on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA). Following inhalation both compounds act locally on airways to produce bronchodilation by separate mechanisms.
Umeclidinium: Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes. Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic acetylcholine receptors on airway smooth muscle. It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Umeclidinium: Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes. Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic acetylcholine receptors on airway smooth muscle. It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Pharmacokinetics: When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately (see Metabolism as follows and Interactions). For pharmacokinetic purposes each component can therefore be considered separately.
Absorption: Umeclidinium: Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes. The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption. Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Absorption: Umeclidinium: Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes. The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption. Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Toxicology: Pre-clinical Safety Data: In nonclinical studies with umeclidinium and vilanterol, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta2-agonists respectively and/or local irritancy.
Administration of umeclidinium and vilanterol in combination did not result in any new toxicity. The following statements reflect studies conducted on the individual components.
Administration of umeclidinium and vilanterol in combination did not result in any new toxicity. The following statements reflect studies conducted on the individual components.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Anoro Ellipta
Full Details
Dosage Strength
62.5mcg / 25mcg
Drug Ingredients
- Umeclidinium Bromide
- Vilanterol Trifenatate
Drug Packaging
Dry-Powder Inhalation In Capsule 30 doses
Generic Name
Umeclidinium Bromide / Vilanterol
Dosage Form
Dry-Powder Inhalation In Capsule
Registration Number
DR-XY43993
Drug Classification
Prescription Drug (RX)
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