Anoro Ellipta inhalation powder 22mcg + 55mcg/dose, inhaler 30 doses

Composition

1 dose/cell:

Strip with vilanterol:

– vilanterol triphenatate micronized 40 mcg (equivalent to 25 mcg of vilanterol)

auxiliary substances:

magnesium stearate 125 mcg;

lactose monohydrate up to 12.5 mg

Umeclidinium strip:

– umeclidinium bromide micronized 74.2 mcg (equivalent to 62.5 mcg of umeclidinium)

auxiliary substances:

magnesium stearate 75 mcg;

lactose monohydrate up to 12.5 mg

Pharmacological action

Anoro Ellipta® is a combination of a long-acting inhaled muscarinic cholinergic antagonist and a long-acting inhaled beta-2-adrenomimetic.

After oral inhalation, both compounds have a local effect on the respiratory tract, causing bronchodilation due to different mechanisms of action.

Vilanterol belongs to the class of selective long-acting beta-2-adrenergic receptor agonists (beta-2-agonists).

The pharmacological effects of beta-2-adrenergic agonists, including vilanterol, are at least partially related to the stimulation of intracellular adenylate cyclase, an enzyme that catalyzes the conversion of ATP to cAMP.

An increase in the level of cAMP leads to relaxation of the smooth muscles of the bronchi and inhibition of the release of mediators of immediate hypersensitivity reactions from cells (primarily from mast cells).

Umeclidinium is a long-acting muscarinic receptor antagonist (also called an anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist that acts on muscarinic cholinergic receptors of various subtypes.

Umeclidinium has a bronchodilator effect by competitively inhibiting the binding of acetylcholine to muscarinic acetylcholine receptors in the airway smooth muscle. In preclinical studies in in vitro models, this compound showed slow reversibility of action on human muscarinic receptors of the M3 subtype, and in vivo models demonstrated the duration of drug exposure after use directly into the lungs.

Pharmacodynamic effects.

In two placebo-controlled clinical efficacy studies, an increase in forced expiratory volume in the first second (FEV 1) was observed after the first dose of a combination of vilanterol and umeclidinium on the first day.

This indicator increased by 0.11 and 0.13 liters 15 minutes after the use of the drug at a dosage of 22+55 mcg/dose and 22+113 mcg/dose, respectively, compared with the same indicator with placebo (in both cases, the effect of the combination of vilanterol and umeclidinium on the duration of the QT interval was evaluated in a placebo and moxifloxacin-controlled study. 103 healthy volunteers used a combination of vilanterol and umeclidinium for 10 days once a day at a dosage of 22+113 or 88+452 mcg / dose.

After repeated use of this drug, there was no clinically significant effect on the duration of the QT interval (corrected by the Frederick method).

In addition, there was no clinically significant effect of the combination of vilanterol and umeclidinium on heart rate during 24-hour Holter ECG monitoring in 108 patients with COPD who received this drug for 6 months (53 of them received the drug at a dosage of 22+55 mcg/dose and 55-at a dosage of 22+113 mcg / dose 1 time per day), as well as in 226 patients who received the drug at a dosage of 22+113 mcg/dose 1 time per day for 12 months.

Indications

Supportive bronchodilator therapy aimed at alleviating the symptoms of chronic obstructive pulmonary disease.

Contraindications

: children under 18 years of age. and severe allergic reactions to milk protein or hypersensitivity to active substances or any other component included in the preparation, in the anamnesis;With caution: after the use of sympathomimetics and muscarinic receptor antagonists, including the drug Anoro Ellipta®, adverse reactions such as arrhythmia (for example, atrial fibrillation and tachycardia) may occur from the cardiovascular system. 4

In this regard, patients with severe forms of cardiovascular diseases should be prescribed Anoro Ellipta® with caution.

Given the antimuscarinic activity of this drug, it should be used with caution in patients with angle-closure glaucoma or urinary retention.

Side effects

From the heart: infrequently — atrial fibrillation, tachycardia. Respiratory, thoracic and mediastinal disorders: often-cough. From the gastrointestinal tract: often-constipation, dry mouth.

The safety profile of the combination of vilanterol and umeclidinium is based on data from clinical trials involving 2,454 patients with COPD who received at least one dose of the combination of vilanterol and umeclidinium during the study.

All patients received the drug once a day; of these,1,124 received the drug at a dosage of 22 + 55 mcg / dose and 1330 — 22 + 113 mcg / dose.

The adverse reactions listed below are listed according to the lesion of organs and organ systems and frequency of occurrence. The frequency of occurrence is determined as follows: very common (≥1/10); common (≥1/100) and Infectious and parasitic diseases: often-pharyngitis.

Interaction

Beta-blockers can weaken the effects of beta-2 agonists or act as antagonists of drugs of this group, including vilanterol.

Concomitant use of non-selective and selective beta-blockers should be avoided, unless there is a good reason for their combined use.

Vilanterol, a component of Anoro Ellipta®, is rapidly metabolized mainly in the gastrointestinal tract and liver by the cytochrome P450 isoenzyme CYP3A4.

Caution should be exercised when concomitantly prescribing the drug with strong inhibitors of the CYP3A4 isoenzyme (for example, ketoconazole), since there is a possibility of increasing the systemic exposure of vilanterol, which in turn can lead to an increased risk of adverse reactions (see “Pharmacokinetics”).

How to take, course of use and dosage

By inhalation. The drug Anoro Ellipta® should be used daily at the same time 1 time a day. Recommended dose of Anoro Ellipta: one inhalation of 22+55 mcg / dose 1 time per day. It was found that in some patients, the use of Anoro Ellipta® at a dosage of 22+113 mcg/dose once a day has an additional advantage in terms of the effect on lung function and the frequency of use of emergency medications. The maximum dose is one inhalation of Anoro Ellipta® at a dosage of 22+113 mcg / dose 1 time per day. Special patient groups. Children. This drug is not used for the treatment of patients under 18 years of age, taking into account the indications for its appointment.

Elderly patients.

Patients over 65 years of age do not need to adjust the dose (see “Pharmacokinetics”).

Impaired renal function.

In patients with impaired renal function, no dose adjustment is required (see “Pharmacokinetics”).

Impaired liver function.

No dose adjustment is required in patients with mild or moderate hepatic impairment.

Studies on the use of a combination of vilanterol and umeclidinium in patients with severe hepatic impairment have not been conducted (see “Pharmacokinetics”).

Recommendations for use:

When using the Ellipta® inhaler for the first time, there is no need to check its correct operation or prepare the inhaler for special use. You should consistently follow the recommendations for use listed below. The Ellipta ® inhaler is packaged in a container containing a moisture-absorbing silica gel bag that is not intended for food or inhalation. This bag should be disposed of. After removing the inhaler from the container, its lid is in the closed position. Do not open it until you are ready to take the drug. Instructions for using the Ellipta®Inhaler:

When opening and closing the lid of the Ellipta ® inhaler without taking medication, one dose is lost. This dose remains sealed inside the inhaler, but it will not be available for use. It is not possible to accidentally get a large dose or a double dose in one inhalation. One dose of the drug is ready for inhalation after each opening of the lid.

The dose counter shows how many doses of the drug are left in the inhaler. Before you start using the inhaler, the dose counter shows the number 30. Each time the lid is opened, the number of doses decreases by 1. When there are less than 10 doses left, half of the counter turns red. After the last dose of the drug is consumed, half of the counter is highlighted in red, and the counter shows the number 0. This means that the inhaler is empty. When you open the lid afterwards, the dose counter will turn completely red.

Dose preparation:

Do not open the lid until you are ready to take the drug. Do not shake the inhaler. 1. Slide the lid down until it clicks into place. 2. The dose of the drug is ready for inhalation, and in confirmation of this, the counter reduces the number of doses by one. 3. If the counter does not reduce the number of doses after clicking, the inhaler is not ready to deliver the dose of the drug. In this case, you should contact us by phone or at the address specified in the “Contact us for additional information”subsection. 4. Do not shake the inhaler. Inhalation of a medicinal product: 1. While holding the inhaler at a certain distance from the mouth, exhale as deeply as possible. Do not exhale into the inhaler.2. Place the mouthpiece between your lips and wrap it tightly around your lips. Do not cover the air vent with your fingers. The lips should exactly follow the shape of the mouthpiece of the inhaler. 3. Take one deep, long, even breath. Hold your breath as long as possible (at least 3-4 seconds).4. Remove the inhaler from your mouth. 5. Exhale slowly and calmly.

If the inhaler is used correctly, the patient may not be able to taste or feel the intake of the drug.

Closing the inhaler:

If it is necessary to clean the mouthpiece, use a dry paper towel before closing the lid. Lift the lid all the way up until the mouthpiece is completely closed.

Overdose

Treatment: in case of overdose, symptomatic therapy is required and, if necessary, the patient is monitored accordingly. Further management of patients in case of overdose should be carried out in accordance with clinical indications.

In clinical studies, no overdose data were obtained for the combination of vilanterol and umeclidinium.

Symptoms: it is possible to develop symptoms and signs due to the action of individual components of the drug, including known adverse reactions that develop when exposed to muscarinic receptor antagonists (for example, dry mouth, accommodation disorders and tachycardia) and signs observed with an overdose of other beta-2 agonists (for example, tremor, headache and tachycardia).

Special instructions

Anoro Ellipta® is intended for use as a maintenance therapy for COPD. Do not use this medicine for the relief of acute symptoms, i. e. as an emergency treatment for an acute episode of bronchospasm. A short-acting bronchodilator should be used to relieve acute symptoms. An increase in the frequency of using short-acting bronchodilators to relieve symptoms indicates a deterioration in disease control, in which case the patient needs to consult a doctor.

Studies on the use of Anoro Ellipta® in patients with bronchial asthma have not been conducted, so the use of this drug for therapy in this group of patients is not recommended.

As with other types of inhalation therapy, the use of Anoro Ellipta® can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, treatment with the drug should be discontinued, and alternative therapy may be prescribed if necessary.

Anoro Ellipta® is intended for the maintenance treatment of patients with COPD. Due to the fact that the general population of COPD is significantly dominated by patients over the age of 40 years, when prescribing the drug to patients under 40 years of age, spirometric confirmation of the diagnosis of COPD is required.

Influence on the ability to drive vehicles and work with mechanisms. Studies on the effect of the drug Anoro Ellipta® on the ability to drive vehicles and work with mechanisms have not been conducted.

Form of production

ANORO ELLIPTA powder for inhalation dosed.

Active ingredient

Vilanterol, Umeclidinium bromide

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation

Purpose

For adults as directed by your doctor

Indications

Chronic obstructive pulmonary disease, Bronchial asthma