Fluticasone, umeclidinium, and vilanterol Inhalation

Fluticasone, umeclidinium, and vilanterol combination is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is used long term to improve breathing problems and to reduce the number of COPD flare-ups (worsening of your COPD symptoms for several days). fluticasone, umeclidinium, and vilanterol will not relieve a COPD attack that has already started.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause COPD symptoms.

Inhaled umeclidinium and vilanterol are long-acting bronchodilators. These are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

fluticasone, umeclidinium, and vilanterol is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone, umeclidinium, and vilanterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone, umeclidinium, and vilanterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of fluticasone, umeclidinium, and vilanterol combination is not recommended in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone, umeclidinium, and vilanterol combination in the elderly. However, elderly patients are more sensitive to the effects of fluticasone, umeclidinium, and vilanterol than younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone, umeclidinium, and vilanterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fluticasone, umeclidinium, and vilanterol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Desmopressin
• Dronedarone
• Fluconazole
• Ketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using fluticasone, umeclidinium, and vilanterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Atazanavir
• Bemiparin
• Boceprevir
• Buprenorphine
• Bupropion
• Buserelin
• Butriptyline
• Ceritinib
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Dabrafenib
• Darunavir
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Donepezil
• Dothiepin
• Doxepin
• Efavirenz
• Escitalopram
• Foscarnet
• Glycopyrrolate
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Idelalisib
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Iprindole
• Itraconazole
• Ivabradine
• Ketoconazole
• Leuprolide
• Levofloxacin
• Lofepramine
• Lopinavir
• Lumacaftor
• Macimorelin
• Melitracen
• Methadone
• Metronidazole
• Nadroparin
• Nafarelin
• Nefazodone
• Nelfinavir
• Nilotinib
• Nortriptyline
• Opipramol
• Panobinostat
• Pasireotide
• Pimavanserin
• Pitolisant
• Pixantrone
• Posaconazole
• Propizepine
• Protriptyline
• Quetiapine
• Ribociclib
• Ritonavir
• Saquinavir
• Secretin Human
• Sertraline
• Sotalol
• Sulpiride
• Tacrolimus
• Telaprevir
• Telithromycin
• Tianeptine
• Tiotropium
• Tipranavir
• Trimipramine
• Triptorelin
• Troleandomycin
• Vemurafenib
• Vinflunine
• Voriconazole
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fluticasone, umeclidinium, and vilanterol with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use fluticasone, umeclidinium, and vilanterol, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of fluticasone, umeclidinium, and vilanterol. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to milk proteins, severe or
• Asthma or
• Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.

• Bladder blockage or
• Cataracts, history of or
• Diabetes or
• Enlarged prostate or
• Glaucoma, history of or
• Heart or blood vessel disease (eg, coronary insufficiency) or
• Heart rhythm problems (eg, arrhythmia, prolonged QT interval) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Osteoporosis, family history of or
• Problems passing urine or
• Seizures or
• Thyrotoxicosis (excess thyroid hormone in the body)—Use with caution. May make these conditions worse.

• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Inhaled fluticasone, umeclidinium, and vilanterol combination is used to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve a COPD attack that has already started. For relief of an COPD attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled fluticasone, umeclidinium, and vilanterol combination is used with a special inhaler that comes with a Medication Guide and patient instructions. Read the directions carefully before using fluticasone, umeclidinium, and vilanterol. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use fluticasone, umeclidinium, and vilanterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using fluticasone, umeclidinium, and vilanterol without telling your doctor. To do so may increase the chance of side effects.

Use fluticasone, umeclidinium, and vilanterol at the same time each day.

Do not stop using fluticasone, umeclidinium, and vilanterol or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the inhaler:

• fluticasone, umeclidinium, and vilanterol comes in a foil tray. Peel back the lid to open the tray.
• Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. Do not close the cover until you have taken the medicine. If you open and close the inhaler without inhaling the dose, you will lose the medicine.
• Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.
• Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath for 3 or 4 seconds or for as long as you can before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red to remind you to refill your prescription.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Dosing

The dose of fluticasone, umeclidinium, and vilanterol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fluticasone, umeclidinium, and vilanterol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For COPD:
    • Adults—One inhalation once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of fluticasone, umeclidinium, and vilanterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take more than 1 inhalation per day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away fluticasone, umeclidinium, and vilanterol 6 weeks after it was opened or when the counter reads "0."

If you will be using fluticasone, umeclidinium, and vilanterol for a long time, it is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor about other medicines you are using for COPD. Follow your doctor's instructions on how you should take your medicine.

fluticasone, umeclidinium, and vilanterol should not be used if you are having a COPD attack, or if symptoms of a COPD attack has already started. Your doctor will prescribe another medicine for you to use in case of an acute attack. If the other medicine does not work as well, tell your doctor right away.

fluticasone, umeclidinium, and vilanterol may increase the chance of asthma-related problems. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

fluticasone, umeclidinium, and vilanterol should not be used together with similar inhaled medicines such as arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Onbrez®), or salmeterol (Serevent®).

Your doctor may want you to carry a medical identification (ID) card stating that you are using fluticasone, umeclidinium, and vilanterol. The card will say that you may need additional medicine during an emergency, a severe COPD attack or other illness, or unusual stress.

fluticasone, umeclidinium, and vilanterol may weaken your immune system and increase your risk for infections. Tell your doctor about any immune system problems or infections, including tuberculosis or herpes infection in your eye. Tell your doctor right away if you have been exposed to chickenpox or measles.

fluticasone, umeclidinium, and vilanterol may cause a fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

fluticasone, umeclidinium, and vilanterol may increase your risk of having pneumonia. Call your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of fluticasone, umeclidinium, and vilanterol or using it for a long time may cause may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using fluticasone, umeclidinium, and vilanterol: darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, loss of appetite, mental depression, muscle pain or weakness, nausea, skin rash, unusual tiredness or weakness, or vomiting.

fluticasone, umeclidinium, and vilanterol may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, or shortness of breath after using fluticasone, umeclidinium, and vilanterol.

If you or your child develop a skin rash, hives, or any allergic reaction (including anaphylaxis) to fluticasone, umeclidinium, and vilanterol, check with your doctor right away.

fluticasone, umeclidinium, and vilanterol may increase your risk for heart and blood vessel problems, including changes in heart rhythm. Check with your doctor right away if you have dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or fast or irregular heartbeats.

fluticasone, umeclidinium, and vilanterol may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

fluticasone, umeclidinium, and vilanterol may affect blood sugar and potassium levels. If you have heart disease or diabetes and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough
• diarrhea
• loss of appetite
• nausea
• pain in the nose and mouth
• stomach pain
• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• change in taste
• headache
• loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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