Umeclidinium Bromide/Vilanterol

Umeclidinium Bromide is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).

Vilanterol is approved for use in several combination products such as with fluticasone furoate under the tradename Breo Ellipta and in combination with Vilanterol bromide as Anoro Ellipta. Approved by the FDA in 2013, use of Breo Ellipta is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is also indicated for once-daily maintenance treatment of asthma in patients aged 18 or older with reversible obstructive airways disease. (Asthma; Chronic obstructive pulmonary disease;)

Umeclidinium Bromide is an anticholinergic that works by relaxing muscles in the airways to improve breathing.

Umeclidinium Bromide is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

Umeclidinium Bromide may also be used for purposes not listed in this medication guide.

Umeclidinium Bromide (Umeclidinium Bromide 62.5 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.

Umeclidinium Bromide should be taken at the same time every day. Do not use Umeclidinium Bromide 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.

How supplied

Dosage Forms And Strengths

Inhalation Powder. Disposable light grey and light green plastic inhaler containing a double-foil blister strip with 30 blisters containing powder intended for oral inhalation only. Each blister contains Umeclidinium Bromide 62.5 mcg. An institutional pack containing a blister strip with 7 blisters is also available.

Storage And Handling

Umeclidinium Bromide is supplied as a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 30 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-10).

Umeclidinium Bromide is also supplied in an institutional pack of a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 7 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-06).

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C). Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

Umeclidinium Bromide should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard Umeclidinium Bromide 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

GlaxoSmithKline : Research Triangle Park, NC 27709. Revised: June 2014

See also:
What is the most important information I should know about Umeclidinium Bromide?

Umeclidinium Bromide is contraindicated in patients with severe milk-protein allergy.

Hypersensitivity to the Umeclidinium Bromide bromide or to any of the excipients.

Use Umeclidinium Bromide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet with detailed instructions for use is available with Umeclidinium Bromide. Talk to your pharmacist if you have questions about this information.
• A health care provider will teach you how to use Umeclidinium Bromide at home. Be sure you understand how to use Umeclidinium Bromide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• To prepare a dose of Umeclidinium Bromide, remove the inhaler from the foil tray. Open the cover of the inhaler until you hear a click. The counter will count down by 1 number. Your inhaler is now ready to use.
• Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.
• To use a dose of Umeclidinium Bromide, hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece. Place the mouthpiece between your lips, and close your lips firmly around it. Take a long, deep breath through your mouth. Do not block the air vents of the inhaler with your fingers. Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, or as long as comfortable for you. Breathe out slowly.
• Before you close the cover, you may clean the mouthpiece with a dry tissue if needed. Slide the cover up and over the mouthpiece when you are done.
• You may not taste or feel the medicine, even when you are using the inhaler correctly. Do NOT use another dose if you do not taste or feel the medicine. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
• If you are using other inhaled medicines, wait a few minutes between using Umeclidinium Bromide and other inhalers, unless your doctor tells you otherwise.
• Do not take the device apart. Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store Umeclidinium Bromide in a dry place.
• Store Umeclidinium Bromide in the unopened foil tray until right before the first use. Throw Umeclidinium Bromide away 6 weeks after you opening the foil tray or after the dose counter reads "0," whichever comes first.
• Use Umeclidinium Bromide on a regular schedule to get the most benefit from it. Using Umeclidinium Bromide at the same time each day will help you remember to use it. Do not stop using Umeclidinium Bromide even if you feel better unless your doctor tells you to.
• If you miss a dose of Umeclidinium Bromide, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use Umeclidinium Bromide more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use Umeclidinium Bromide.

Use: Labeled Indications

Chronic obstructive pulmonary disease: Maintenance treatment of patients with COPD.

See also:
What other drugs will affect Umeclidinium Bromide?

Available clinical data has revealed no clinically relevant drug interactions.

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

Umeclidinium Bromide is a substrate of P-glycoprotein transporter (P-gp) and CYP2D6. The effect of the P-gp transporter inhibitor verapamil (240 milligrams once daily) on the steady-state pharmacokinetics of Umeclidinium Bromide was assessed in healthy volunteers. No effect of verapamil was observed on Umeclidinium Bromide C_max. An approximately 1.4-fold increase in Umeclidinium Bromide AUC was observed. Based on the magnitude of these changes, no clinically relevant interaction is expected when Umeclidinium Bromide bromide is co-administered with P-gp inhibitors.

The effect of lack of CYP2D6 poor metaboliser genotype on the steady-state pharmacokinetics of Umeclidinium Bromide was assessed in healthy volunteers (CYP2D6 normal metabolisers and CYP2D6 poor metabolisers). No clinically meaningful difference in systemic exposure to Umeclidinium Bromide (500 micrograms) was observed following repeat daily inhaled dosing to normal and CYP2D6 poor metaboliser subjects.

See also:
What are the possible side effects of Umeclidinium Bromide?

The following adverse reactions are described in greater detail in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the 8 clinical trials conducted to support initial approval of Umeclidinium Bromide, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of Umeclidinium Bromide at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received Umeclidinium Bromide for up to 24 weeks, of which 487 subjects received the recommended dose of Umeclidinium Bromide 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received Umeclidinium Bromide 125 mcg for up to 52 weeks.

The incidence of adverse reactions associated with Umeclidinium Bromide in Table 1 is based upon 2 placebo-controlled efficacy trials: one 12-week trial and one 24-week trial.

Other adverse reactions with Umeclidinium Bromide observed with an incidence less than 1% but more common than placebo included atrial fibrillation.

In a long-term safety trial, 336 subjects (n = 227 Umeclidinium Bromide 125 mcg, n = 109 placebo) were treated for up to 52 weeks with Umeclidinium Bromide 125 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the efficacy trials described above. Adverse reactions that occurred with a frequency greater than or equal to 1% in subjects receiving Umeclidinium Bromide 125 mcg that exceeded that in placebo in this trial were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo.

The safety and efficacy of Umeclidinium Bromide in combination with an inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) were also evaluated in four 12‑week clinical trials. A total of 1,637 subjects with COPD across four 12-week, randomized, double-blind clinical trials received at least 1 dose of Umeclidinium Bromide (62.5 mcg) or placebo administered once daily in addition to background ICS/LABA (mean age: 64 years, 88% white, 65% male across all treatments). Two trials (Trials 1 and 2) evaluated Umeclidinium Bromide in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg administered once daily, and 2 trials (Trials 3 and 4) evaluated Umeclidinium Bromide administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily. Adverse reactions that occured with Umeclidinium Bromide in combination with an ICS/LABA were similar to those reported with Umeclidinium Bromide as monotherapy. In addition to the Umeclidinium Bromide monotherapy adverse reactions reported above, adverse reactions occurring with Umeclidinium Bromide in combination with an ICS/LABA, at an incidence of greater than or equal to 1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia.

Umeclidinium Bromide is a long-acting muscarinic antagonist (LAMA) used as maintenance treatment for symptoms of chronic obstructive pulmonary disease (COPD). It is available as a once-daily inhalation monotherapy or as a fixed-dose combination product with the long-acting beta2-agonist vilanterol. COPD is a progressive obstructive lung disease characterized by shortness of breath, cough, sputum production, and chronically poor airflow with a forced expiratory volume in 1 second (FEV1) of less than 80%. By blocking the M3 muscarinic receptor which is highly expressed in airway smooth muscle of the lungs, Umeclidinium Bromide inhibits the binding of acetylcholine and thereby opens up the airways by preventing bronchoconstriction. Its use has been shown to provide clinically significant, sustained improvements in lung function.

Vilanterol is a selective long-acting beta2-adrenergic agonist (LABA) with inherent 24-hour activity for once daily treatment of COPD and asthma. Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increases in cyclic AMP are associated with relaxation of bronchial smooth muscle and inhibition of release of hypersensitivity mediators from mast cells in the lungs. Vilanterol is approved for use in several combination products such as with fluticasone furoate under the tradename Breo Ellipta and in combination with Vilanterol bromide as Anoro Ellipta. Approved by the FDA in 2013, use of Breo Ellipta is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is also indicated for once-daily maintenance treatment of asthma in patients aged 18 or older with reversible obstructive airways disease.