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.

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.

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.

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.