Anoro Ellipta (Umeclidinium & Vilanterol)
Anoro Ellipta
Vilanterol Trifenatate, Umeclidinium Bromide
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ANORO ELLIPTA
(Umeclidinium and vilanterol)

What is Anoro Ellipta?

ANORO ELLIPTA is a combination of an anticholinergic and a long-acting beta2-adrenergic agonist inhaled into the lungs to treat chronic obstructive pulmonary disease. It is manufactured as ANORO ELLIPTA 62.5/25, a combination of umeclidinium 62.5 mcg, and vilanterol 25 mcg.

How Does Anoro Ellipta Work?

ANORO ELLIPTA is a combination anticholinergic and long-acting beta2-adrenergic agonist that is breathed into the lungs using an inhaler. 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.

­­WHAT ARE THE INDICATIONS FOR ANORO ELLIPTA?

ANORO ELLIPTA is indicated for the long-term treatment of chronic obstructive pulmonary disease. It works to prevent and control shortness of breath and wheezing caused by chronic obstructive pulmonary disease and is used to regain disease control. It must be used regularly (for at least two weeks) before any effect is seen.

WHAT IS THE DOSE OF ANORO ELLIPTA?

The dose of ANORO ELLIPTA for the treatment of chronic obstructive pulmonary disease is one inhalation of the umeclidinium 62.5 mcg and vilanterol 25 mcg combination, taken once a day.

Warnings & Precautions

Increased risk of asthma-related deaths

ANORO ELLIPTA contains vilanterol, a long-acting beta2-agonist. Studies have shown that these agonists increase the risk of asthma-related deaths. Data suggest that the use of long-acting beta2-agonists in pediatrics and adolescents increases the risk of hospitalization.

Acute asthmatic/chronic obstructive pulmonary disease deterioration

ANORO 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.

Risk of worsening airway obstruction

Some patients may experience a paradoxical worsening of their bronchospasm when starting ANORO ELLIPTA. Should this happen, treatment with ANORO ELLIPTA should be stopped, and an alternative therapy started.

ANORO ELLIPTA interacting with other long-acting beta2-agonists

ANORO ELLIPTA should not be used at higher doses or more often than recommended. Care should not be taken not to use ANORO ELLIPTA in conjunction with medicines containing other long-acting beta2-agonists (salmeterol, formoterol, fumarate, arformoterol tartrate, indacaterol) as this may result in an overdose.

Cardiovascular disease risk

Vilanterol may stimulate beta-adrenergic receptors in the heart and cause elevations in heart rate. 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.

Exacerbation of urinary retention

In patients with a history of urinary retention, ANORO ELLIPTA should be used with caution. Monitor patients carefully for signs of retention, including painful urination or difficulty passing urine. This risk is significantly greater in patients with bladder-neck obstruction or prostatic hyperplasia.

Glaucoma

ANORO ELLIPTA increases the risk of complications from narrow-angle glaucoma. Therefore, it should be used with caution in patients who have been or who are on treatment for glaucoma. Providers and patients should be vigilant for signs or symptoms of glaucoma. These include eye pain, eye discomfort, blurring of vision, visual halos, red eyes, corneal edema, and conjunctival congestion. If any of these signs or symptoms develop, the patient should urgently seek assistance from a healthcare provider.

Special Populations

Hepatic impairment

ANORO ELLIPTA metabolism is not significantly affected by hepatic impairment.

Renal impairment

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

Children

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

Pregnancy

ANORO ELLIPTA has not been extensively studied in pregnant women. However, some studies have shown that its use does not increase the risk of birth abnormalities.

Breastfeeding

The safety of ANORO ELLIPTA has not been tested in breastfeeding mothers. Therefore, 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 ANORO ELLIPTA for elderly patients.

Contraindications

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

ANORO ELLIPTA is contraindicated in patients with status asthmaticus or acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.

Side Effects

Common side effects of ANORO ELLIPTA include:

  • Nausea
  • Vomiting
  • Sinusitis
  • Cough
  • Sore throat
  • Headaches
  • Chest infections
  • Joint pain
  • Muscle pain
  • Tooth pain
  • Stomach pain
  • Skin bruising
  • Fast or irregular heartbeat

Less common side effects include:

  • Difficulty passing urine
  • Inability to pass urine
  • Glaucoma (eye pain, visual changes, eye redness)
  • Anaphylaxis

Drug Ineractions

Certain drugs may interact with ANORO ELLIPTA. These include:

  • Itraconazole
  • Ketoconazole
  • Voriconazole
  • Ritonavir
  • Clarithromycin
  • Conivaptan
  • Indinavir
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Saquinavir
  • Telithromycin
  • Troleandomycin
  • Monoamine oxidase inhibitors
  • Tricyclic antidepressants
  • Beta-blockers
  • Diuretics
  • Anticholinergics

Frequently Asked Questions

Those who take ANORO ELLIPTA have an increased risk of death from asthma-related problems. This is because of vilanterol, a long-acting beta2-adrenergic agonist. Therefore, it is essential to contact your healthcare provider if you experience worsening breathing while using ANORO ELLIPTA. You should seek urgent medical care if you have a rapid worsening of your breathing, and your rescue inhaler does not help to relieve these symptoms.

ANORO ELLIPTA is manufactured as a dry powder. It is presented in a light grey and red plastic inhaler that contains two blister strips filled with the powdered formulation. One of the strips contains umeclidinium 62.5 mcg. The other strip contains vilanterol 25 mcg.

The dose of ANORO ELLIPTA for the treatment of chronic obstructive pulmonary disease is one inhalation of the umeclidinium 62.5 mg/vilanterol 25 mcg combination, taken once a day.

The ANORO 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 if 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 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.

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

ANORO ELLIPTA is also contraindicated in patients with status asthmaticus or those with acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.

If you miss a dose of ANORO 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.

  • Nausea
  • Vomiting
  • Sinusitis
  • Cough
  • Sore throat
  • Headaches
  • Chest infections
  • Joint pain
  • Muscle pain
  • Tooth pain
  • Stomach pain
  • Skin bruising
  • Fast or irregular heartbeat

Less common side effects include:

  • Difficulty passing urine
  • Inability to pass urine
  • Glaucoma (eye pain, visual changes, eye redness)
  • Anaphylaxis

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.

ANORO 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.