Anoro Ellipta (umeclidinium and vilanterol)

Anoro Ellipta is a combination anticholinergic/long-acting beta2-adrenergic agonist (anticholinergic/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

• Anoro Ellipta is only approved for use in chronic obstructive pulmonary disease (COPD).
• Anoro Ellipta is NOT approved for use in asthma.
• Anoro Ellipta combines an anticholinergic, umeclidinium, and a LABA medicine, vilanterol.
• Anticholinergic and LABA medicines 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 to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Anoro Ellipta is used long term as 1 inhalation, 1 time each day, to improve symptoms of COPD for better breathing.
• Anoro Ellipta is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
• Anoro Ellipta is not for the treatment of asthma. It is not known if Anoro Ellipta is safe and effective in people with asthma.
• Anoro Ellipta should not be used in children. It is not known if Anoro Ellipta is safe and effective in children.

What are the side effects of Anoro Ellipta?

WARNING

Asthma-Related Death

Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. Data from a large placebo-controlled US trial comparing the safety of another LABA (salmeterol) with a placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA.

The safety and efficacy of Anoro Ellipta in patients with asthma have not been established. Anoro Ellipta is not indicated for the treatment of asthma.

Anoro Ellipta can cause serious side effects, including:

• changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Anoro Ellipta and call your healthcare provider right away.
• serious allergic reactions.

Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

• rash
• hives
• swelling of your face, mouth, and tongue
• breathing problems
• effects on heart
• increased blood pressure
• a fast or irregular heartbeat, awareness of heartbeat
• chest pain
• effects on the nervous system
• tremor
• nervousness
• new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated.

Symptoms of acute narrow-angle glaucoma may include:

• eye pain or discomfort
• nausea or vomiting
• blurred vision
• seeing halos or bright colors around lights
• red eyes

If you have these symptoms, call your healthcare provider right away before taking another dose.

People who take Anoro Ellipta may develop new or worse urinary retention. Symptoms of urinary retention may include:

• difficulty urinating
• painful urination
• urinating frequently
• urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking Anoro Ellipta and call your healthcare provider right away before taking another dose.

Common side effects of Anoro Ellipta include:

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

What is the dosage of Anoro Ellipta?

• Anoro Ellipta (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.
• Anoro Ellipta should be used at the same time every day. Do not use Anoro Ellipta more than 1 time every 24 hours.
• No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.

What drugs interact with Anoro Ellipta?

Inhibitors of Cytochrome P450 3A4

Vilanterol, a component of Anoro Ellipta, is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases systemic exposure to vilanterol. 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).

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

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 or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-adrenergic Receptor Blocking Agents

Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

Non-Potassium-Sparing Diuretics

The electrocardiographic changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as vilanterol, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Anoro Ellipta with non-potassium-sparing diuretics.

Anticholinergics

There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of Anoro Ellipta with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

Is Anoro Ellipta safe to use while pregnant or breastfeeding?

Before using Anoro Ellipta, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or planning to become pregnant. It is not known if Anoro Ellipta may harm your unborn baby.
• are breastfeeding. It is not known if the medicines in Anoro Ellipta pass into your milk and if they can harm your baby.

Summary

Anoro Ellipta (umeclidinium and vilanterol) is an inhalation powder drug product for delivery of a combination of umeclidinium (an anticholinergic) and vilanterol (a LABA) to patients by oral inhalation for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Do not take Anoro Ellipta if you have asthma.