Flovent

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fluticasone. .

Pregnancy

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 this medicine, 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 this medicine 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.

• Desmopressin

Using this medicine 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.

• Atazanavir
• Bemiparin
• Boceprevir
• Bupropion
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Dasabuvir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lumacaftor
• Nadroparin
• Nefazodone
• Nelfinavir
• Pixantrone
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

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 this medicine 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 this medicine, 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Bone problems (eg, osteoporosis) or
• Blood vessel disease (eg, Churg-Strauss syndrome) or
• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Measles or
• Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.

• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

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

This section provides information on the proper use of a number of products that contain fluticasone. It may not be specific to Flovent. Please read with care.

Inhaled fluticasone is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma 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.

Use this medicine 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 this medicine without telling your doctor. To do so may increase the chance of side effects. The full benefit of this medicine may take 1 to 2 weeks or longer to achieve.

Inhaled fluticasone comes with patient information leaflet. Read the instructions carefully before using this medicine. 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.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

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

To use the Arnuity™ Ellipta®:

• This medicine comes in foil tray. Peel back the lid to open.
• Before you use this medicine, the counter should show the number 30. The counter counts down by 1 each time you open the cover.
• Open the cover of the inhaler until you hear a clicking sound. The inhaler is now ready to use.
• Do not close the cover until you have taken your dose. If you open and close the cover without inhaling the dose, you will lose the medicine.
• Hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece.
• Close your lips around the mouthpiece. Do not cover the air holes on the side of the mouthpiece.
• Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath. Do not breathe in through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 3 to 4 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
• Hold the inhaler well away from your mouth and breathe out slowly and gently.
• You may clean the mouthpiece with a dry tissue before you close the cover.
• When the dose counter reaches "10", call your doctor or pharmacist if refill is needed. Throw away the inhaler when the dose counter is at "0".

To use the Flovent® HFA inhaler:

• When you use the inhaler for the first time, or if you have not used it for 4 weeks or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine into the air four times. (Spray the inhaler once into the air if it has not been used in 1 to 3 weeks.) The inhaler will now be ready to give the right amount of medicine when you use it.
• Shake the inhaler well for 15 seconds immediately before each use.
• Take the cap off the mouthpiece (the strap will stay attached to the actuator). Check the mouthpiece and remove any foreign objects. Make sure the canister is fully and firmly inserted into the actuator.
• Hold the mouthpiece away from your mouth and breathe out slowly and completely.
• Use the inhalation method recommended by your doctor.
  • Open-mouth method—Place the mouthpiece about 1 or 2 inches (two fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so that the spray does not hit the roof of your mouth or your tongue.
  • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue, with your lips closed tightly around it. Do not block the mouthpiece with your teeth or tongue.
• Tilt your head back a little. Start to breathe in slowly and deeply through your mouth and, at the same time, press the top of the canister one time to get one puff of the medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while inhaling. It is important to press the top of the canister and breathe in slowly at the same time so the medicine is pulled into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
• Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs. Take the mouthpiece away from your mouth and breathe out slowly.
• If your doctor has told you to inhale more than one puff of medicine at each dose, wait about 30 seconds and then gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff.
• When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.
• The inhaler has a dose counter that keeps track of how many more times you can use it before you need to open a new one. When the dose counter reaches "020", call your doctor or pharmacist if refill is needed.
• If the dose counter is not working correctly, do not use the inhaler and return it to your pharmacy or doctor. Do not change the numbers or remove the counter from the canister. .

To use the ArmonAir™ RespiClick®:

• Take the inhaler out of the pouch before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• This medicine does not require priming. Do not use it with a spacer or volume holding chamber.
• Hold the inhaler upright and open the green cap all the way until it clicks. Do not open the green cap until you are ready to take a dose of this medicine.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue. Do not block the vent above the mouthpiece with your lips or fingers.
• Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for about 10 seconds.
• Close the green cap after each inhalation. Rinse your mouth with water without swallowing after each inhalation.
• Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0, 30 days after opening the pouch.

Dosing

The dose of this medicine 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 this medicine. 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 preventing an asthma attack:
  • For inhalation dosage form (aerosol):
    • Adults and children 12 years of age and older—88 to 880 micrograms (mcg) two times a day, morning and evening.
    • Children 4 to 11 years of age—88 mcg two times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor. .
  • For inhalation dosage form (powder):
    • Adults and children 12 years of age and older—
      • Arnuity™ Ellipta®: At first, 100 micrograms (mcg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mcg per day.
      • ArmonAir™ RespiClick®: At first, 55 mcg two times a day (about 12 hours apart). Your doctor may adjust your dose as needed. Do not use this medicine more than 2 times every 24 hours.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

If you miss a dose of ArmonAir™ Respiclick®, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.

If you will be using this medicine 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.

Although this medicine decreases the number of asthma episodes, it may increase the chance of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and talk to your doctor or pharmacist about any questions or concerns that you have.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 2 weeks or if they become worse.
• Your short-acting inhaler does not seem to work as well as it used to and you or your child need it more often than normal (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

This medicine 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.

Do not change your dose or stop using your medicine without first asking your doctor.

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

Using too much of this medicine 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 this medicine: 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.

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

If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

This medicine 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 you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

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.

Flovent HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Important Limitation of Use

Flovent HFA is not indicated for the relief of acute bronchospasm.

Inhalation aerosol: Dark orange plastic inhaler with a peach strapcap containing a pressurized metered-dose aerosol canister containing 120 metered inhalations and fitted with a counter. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the mouthpiece.

Systemic and local corticosteroid use may result in the following:

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.

The incidence of common adverse reactions in Table 1 is based upon 2 placebo-controlled U.S. clinical trials in which 812 adult and adolescent subjects (457 females and 355 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with 2 inhalations of Flovent HFA 44 mcg Inhalation Aerosol, Flovent HFA 110 mcg Inhalation Aerosol, Flovent HFA 220 mcg Inhalation Aerosol (dosages of 88, 220, or 440 mcg twice daily), or placebo.

Table 1. Adverse Reactions with Flovent HFA with >3% Incidence and More Common than Placebo in Subjects Aged 12 Years and Older with Asthma

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with Flovent HFA and were more common than in the placebo group. Less than 2% of subjects discontinued from the trials because of adverse reactions. The average duration of exposure was 73 to 76 days in the active treatment groups compared with 60 days in the placebo group.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with Flovent HFA compared with subjects treated with placebo include the following: rhinitis, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis, diarrhea, viral gastrointestinal infections, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation, musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity, dizziness, migraines, fever, viral infections, pain, chest symptoms, viral skin infections, muscle injuries, soft tissue injuries, urinary infections.

Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to 168 subjects with asthma requiring oral corticosteroids (Trial 3). Adverse reactions not included above, but reported by more than 3 subjects in either group treated with Flovent HFA and more commonly than in the placebo group included nausea and vomiting, arthralgia and articular rheumatism, and malaise and fatigue.

In 2 long-term trials (26 and 52 weeks), the pattern of adverse reactions in subjects treated with Flovent HFA at dosages up to 440 mcg twice daily was similar to that observed in the 12-week trials. There were no new and/or unexpected adverse reactions with long-term treatment.

Pediatric Subjects Aged 4 to 11 Years

Flovent HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks. Types of adverse reactions in these pediatric subjects were generally similar to those observed in adults and adolescents.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, and Throat

Aphonia, facial and oropharyngeal edema, and throat soreness and irritation.

Endocrine and Metabolic

Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.

Eye

Cataracts.

Gastrointestinal Disorders

Dental caries and tooth discoloration.

Immune System Disorders

Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.

Infections and Infestations

Esophageal candidiasis.

Psychiatry

Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory

Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.

Skin

Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluticasone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Applies to fluticasone: inhalation aerosol powder, inhalation disk, inhalation powder

Along with its needed effects, fluticasone (the active ingredient contained in Flovent) 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 while taking fluticasone:

• White patches in the mouth and throat

• Diarrhea
• ear ache
• fever
• lower abdominal or stomach pain
• nausea
• pain on passing urine
• redness or discharge of the eye, eyelid, or lining of the eye
• shortness of breath
• sore throat
• trouble swallowing
• vaginal discharge (creamy white) and itching
• vomiting

• Blindness, blurred vision, eye pain
• bone fractures
• excess facial hair in women
• fullness or roundness of the face, neck, and trunk
• growth reduction in children or adolescents
• heart problems
• high blood pressure
• hives and skin rash
• impotence in males
• increased hunger, thirst, or urination
• lack of menstrual periods
• muscle wasting
• numbness and weakness of hands and feet
• swelling of the face, lips, or eyelids
• tightness in the chest, troubled breathing
• weakness

• Dizziness
• fast heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone:

• Darkening of skin
• fainting
• loss of appetite
• mental depression
• unusual tiredness or weakness

Some side effects of fluticasone 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:

• Cough
• general aches and pains or general feeling of illness
• greenish-yellow mucus in the nose
• headache
• hoarseness or other voice changes
• runny, sore, or stuffy nose

• Bloody mucus or unexplained nosebleeds
• eye irritation
• fainting
• headache, severe and throbbing
• irregular or painful menstrual periods
• joint pain
• mouth irritation
• muscle soreness, sprain, or strain
• sneezing
• stomach pain

• Aggression
• agitation
• bruising
• itching
• restlessness
• weight gain

• Blurred vision
• decrease in height
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• loss of voice
• pain in the back, ribs, arms or legs
• sweating
• trouble sitting still
• unexplained weight loss