Fluticasone furoate, umeclidinium, and vilanterol

Fluticasone, umeclidinium, and vilanterol is a prescription medication used to treat chronic obstructive pulmonary disease (COPD), a group of diseases that includes chronic bronchitis and emphysema. 

It is a single product containing 3 medications: fluticasone, vilanterol, and umeclidinium. Fluticasone is a steroid that reduces swelling in the airways. Vilanterol is a long-acting beta agonist (LABA) that works by relaxing the airway, making it easier to breathe. Umeclidinium is an inhaled anticholinergic that stops the muscles around the airways from tightening, making it easier to breathe.

This medication comes as an inhalation powder to inhale by mouth using a special inhaler. It is inhaled once daily, at the same time each day.

Common side effects of fluticasone, umeclidinium, and vilanterol include headache, back pain, and taste disturbance.

Fluticasone, umeclidinium, and vilanterol is a prescription medication used to treat chronic obstructive pulmonary disease (COPD). This medication is used improve symptoms of COPD for better breathing and is also approved to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Fluticasone furoate, umeclidinium, and vilanterol may be found in some form under the following brand names:

• Trelegy Ellipta

Serious side effects have been reported with fluticasone, umeclidinium, and vilanterol. See the “Fluticasone, umeclidinium, and vilanterol Precautions” section.

Common side effects of fluticasone, umeclidinium, and vilanterol include the following:

• fungal infection in the mouth called thrush
• headache
• back pain
• taste disturbance
• nausea, vomiting, and diarrhea
• cough
• mouth or throat pain

This is not a complete list of fluticasone, umeclidinium, and vilanterol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), and rasagiline (Azilect)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), and propranolol (Inderal)
• certain diuretics that do not spare potassium such as furosemide and hydrochlorothiazide.
• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

This is not a complete list of fluticasone, umeclidinium, and vilanterol drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fluticasone, umeclidinium, and vilanterol including the following:

• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol, when given alone, have an increased risk of asthma-related problems such as hospitalizations, intubations, and death. When LABA medications, such as vilanterol, are given with a steroid, the studies do not show a significant increase in the risk of serious asthma-related events The safety and efficacy of this medication in patients with asthma have not been established. This medication is not approved for the treatment of asthma. It is not known if LABA medicines, such as vilanterol, increase the risk of death in people with COPD. 
• Pneumonia. People with COPD have a higher chance of getting pneumonia. This medication can increase the chance of getting pneumonia. Call your doctor if you have any symptoms of pneumonia including increased mucus production, change in mucus color, fever, chills, increased cough, and increased breathing issues.
• Weakened immune system and increased risk of infections. If you experience any of the following symptoms, call your doctor immediately including fever, chills, sore throat, ongoing cough and congestion, or other signs of infection.
• Breathing problems suddenly immediately after inhaling fluticasone, umeclidinium, and vilanterol. If you have sudden breathing problems after taking fluticasone, umeclidinium, and vilanterol, contact your healthcare provider.
• Hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, rash or hives
• Effects on your heart such as increased blood pressure, a fast and/or irregular heartbeat, or chest pain. Tell your doctor if you have any heart problems as extra precaution will need to be taken.
• Effects on your nervous system such as tremor or nervousness.
• Thrush (fungal infection) in mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water without swallowing after using at fluticasone, umeclidinium, and vilanterol to help prevent thrush in your mouth and throat.
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as fluticasone/vilanterol). When your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency including feeling tired, lack of energy, weakness, nausea, vomiting, or low blood pressure.
• Bone thinning or weakness (osteoporosis)
• Eye problems including glaucoma and cataracts. You should have regular eye exams while using fluticasone, umeclidinium, and vilanterol. 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, seeing halos or bright colors around lights, nausea or vomiting, red eyes, blurred vision. If you have these symptoms, call your healthcare provider right away.   
• Urinary retention. People who take umeclidinium/vilanterol may develop new or worse urinary retention. Symptoms of urinary retention may include difficulty urinating, painful urination, urinating frequently, and urination in a weak stream or drips 

Fluticasone, umeclidinium, and vilanterol should not be used in children. It is not known if fluticasone, umeclidinium, and vilanterol is safe and effective in children.

Do not take fluticasone, umeclidinium, and vilanterol if you:

• are allergic to fluticasone, umeclidinium, and vilanterol or to any of its ingredients
• are allergic to milk proteins or any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluticasone, umeclidinium, and vilanterol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking fluticasone, umeclidinium, and vilanterol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fluticasone, umeclidinium, and vilanterol or to any of its ingredients
• are allergic to milk proteins or to any of its ingredients
• have high blood pressure
• have seizures
• have heart problems
• have thyroid problems
• have diabetes
• have liver problems
• have weak bones or osteoporosis
• have any immune system problems
• have eye problems such as glaucoma or cataracts
• have prostate or bladder problems
• have any infections
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticholinergics (including tiotropium, ipratropium, aclidinium) 
• atropine 
• other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol) 
• antifungal or anti-HIV medicines. 

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with fluticasone, umeclidinium, and vilanterol. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if fluticasone, umeclidinium, and vilanterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fluticasone, umeclidinium, and vilanterol.

Use fluticasone, umeclidinium, and vilanterol only if your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

Use fluticasone, umeclidinium, and vilanterol exactly as prescribed. Do not use fluticasone, umeclidinium, and vilanterol more often than prescribed.

This medication is used once a day: Use 1 inhalation of 1 time each day. Use this medication at the same time each day.

Rinse mouth out with water after each fluticasone, umeclidinium, and vilanterol use to prevent thrush.

If you miss a dose of fluticasone, umeclidinium, and vilanterol, 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 one time.

Do not stop using fluticasone, umeclidinium, and vilanterol unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

Fluticasone, umeclidinium, and vilanterol does not relieve sudden symptoms. This medication does not relieve sudden symptoms of COPD and you should not take extra doses of to relieve these sudden symptoms

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.

Call your healthcare provider or get medical care right away if:

• your breathing problems get worse
• you need to use your rescue inhaler more often than usual
• your rescue inhaler does not work as well to relieve your symptoms
• you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row
• you use 1 whole canister of your rescue inhaler in 8 weeks

The recommended dose for the treatment of COPD is 1 inhalation 1 time each day, at the same time each day.

If you take too much fluticasone, umeclidinium, and vilanterol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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