Umeclidinium bromide/vilanterol

What is Umeclidinium bromide/vilanterol?

• Umeclidinium bromide/vilanterol (ANORO ELLIPTA) is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) used to treat people with chronic obstructive pulmonary disease (COPD).

What are the uses of this medicine?

• ANORO ELLIPTA combines 2 medicines in one inhaler, an anticholinergic medicine (umeclidinium) and a long‑acting beta2-adrenergic agonist (LABA) medicine (vilanterol).
• Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
• ANORO ELLIPTA is a prescription medicine used long term (chronic) to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
• ANORO ELLIPTA is used as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Limitations of use:

• ANORO ELLIPTA is not used to treat sudden symptoms of COPD.
• ANORO ELLIPTA is not for the treatment of asthma. It is not known if ANORO ELLIPTA is safe and effective in people with asthma.

How does this medicine work?

ANORO ELLIPTA contains both umeclidinium and vilanterol.

Umeclidinium

• Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5.
• In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation.
• The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.

Vilanterol

• Vilanterol is a LABA.
• In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol.
• The pharmacologic effects of beta2-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP).
• Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
• with asthma. ANORO ELLIPTA is not indicated for the treatment of asthma.

What drug interactions can this medicine cause?

• Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole).
• Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval.
• Beta-blockers must be used with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.
• Caution is advised in the coadministration of ANORO ELLIPTA with non–potassium-sparing diuretics.
• Avoid coadministration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage:

• ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.
• No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.

Administration

• Use ANORO ELLIPTA exactly as prescribed. Do not use ANORO ELLIPTA more often than prescribed.
• Use 1 inhalation of ANORO ELLIPTA 1 time each day. Use ANORO ELLIPTA at the same time each day.
• If you miss a dose of ANORO ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• If you take too much ANORO ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
• Do not stop using ANORO ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• ANORO ELLIPTA does not relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation powder: Inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains umeclidinium 62.5 mcg per blister and the other contains vilanterol 25 mcg per blister.

This medicine is available in fallowing brand namesː

• ANORO ELLIPTA

What side effects can this medication cause?

The most common side effects of this medicine include:

• sore throat
• common cold symptoms
• pain in your arms or legs
• chest pain
• sinus infection
• constipation
• muscle spasms
• lower respiratory infection
• diarrhea
• neck pain

ANORO ELLIPTA can cause serious side effects, including:

• serious problems in people with asthma
• sudden breathing problems immediately after inhaling your medicine
• serious allergic reactions
• effects on heart
• effects on nervous system
• new or worsened eye problems including acute narrow-angle glaucoma
• urinary retention
• changes in laboratory blood levels

What special precautions should I follow?

• LABA as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of serious asthma-related events.
• Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms.
• Do not use in combination with an additional medicine containing a LABA because of risk of overdose.
• If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy.
• Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
• Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.
• Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.
• Be alert to hypokalemia and hyperglycemia.

What to do in case of emergency/overdose?

Umeclidinium

• High doses of umeclidinium may lead to anticholinergic signs and symptoms.

Vilanterol

• Signs and symptoms of beta-adrenergic stimulation (e.g., angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).
• Cardiac arrest and even death may be associated with an overdose of vilanterol.

Management of overdosage:

• Treatment of overdosage consists of discontinuation of ANORO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy.
• The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm.
• Cardiac monitoring is recommended in cases of overdosage.

Can this medicine be used in pregnancy?

• There are insufficient data on the use of ANORO ELLIPTA or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• ANORO ELLIPTA is not indicated for use in children. The safety and efficacy in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: umeclidinium, vilanterol
• Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

Who manufactures and distributes this medicine?

• Trademarks are owned by or licensed to the GSK group of companies.
• ANORO ELLIPTA was developed in collaboration with Innoviva.
• GlaxoSmithKline, Research Triangle Park

What should I know about storage and disposal of this medication?

• Store ANORO ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C).
• Store ANORO ELLIPTA in a dry place away from heat and sunlight.
• Store ANORO ELLIPTA in the unopened tray and only open when ready for use.
• Safely throw away ANORO ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.
• Keep ANORO ELLIPTA and all medicines out of the reach of children.

• Dailymed label info on Umeclidinium bromide/vilanterol
• FDA Umeclidinium bromide/vilanterol

Umeclidinium bromide/vilanterol Resources
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