Arnuity Ellipta

Arnuity Ellipta is a prescription medication used to prevent symptoms of asthma in children and adults over 12 years of age. Arnuity Ellipta belongs to a class of drugs called inhaled corticosteroids. These work to prevent asthma symptoms by decreasing swelling and irritation in the airways to allow for easier breathing.

Arnuity Ellipta comes in an inhaler form and is typically used once daily.

Common side effects of Arnuity Ellipta include irritation of the nose and/or throat, headache, and inflammation of the sinuses. 

Arnuity Ellipta is a prescription medication used to control and prevent asthma in adults and children aged 12 years and older.

Arnuity Ellipta is not for use to treat sudden symptoms of an asthma attack, wheezing, cough, shortness of breath, and chest pain or tightness. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

It is not known if Arnuity Ellipta is safe and effective in children younger than 12 years.

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

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported with Arnuity Ellipta. See the “Arnuity Ellipta Precautions” section.

Common side effects of Arnuity Ellipta include the following:

• runny nose
• sore throat
• headache
• breathing problems (bronchitis)
• influenza (flu)

This is not a complete list of Arnuity Ellipta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does 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:

• albuterol
• amoxicillin
• amprenavir
• anhydrous calcium iodide
• arformoterol
• atazanavir
• bitolterol
• boceprevir
• budesonide
• cladribine
• clarithromycin
• cobicistat
• conivaptan
• dasabuvir
• delavirdine
• emtricitabine
• erythromycin
• fluticasone
• formoterol
• fosamprenavir
• glycopyrrolate
• idelalisib
• indacaterol
• indinavir
• indium oxyquinoline in-111
• insulin
• isoetharine
• isoproterenol
• itraconazole
• ketoconazole
• lapatinib
• levalbuterol
• lopinavir
• metaproterenol
• mibefradil
• mifepristone
• nefazodone
• nelfinavir
• omacetaxine
• ombitasvir
• pirbuterol
• posaconazole
• racepinephrine
• ritodrine
• ritonavir
• salmeterol
• saquinavir
• telaprevir
• telithromycin
• terbutaline
• troleandomycin
• umeclidinium
• voriconazole

This is not a complete list of Arnuity Ellipta drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Arnuity Ellipta including the following:

Fungal infections in your mouth and throat (thrush). Tell your doctor immediately if you develop any pain, redness, or white-colored coating in your mouth.

Decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea, vomiting, and low blood pressure. Decreased adrenal function can lead to death. Consult with your physician about your risk for adrenal suppression and your risk for developing it during treatment with Arnuity Ellipta.

Severe allergic reactions (anaphylaxis). Stop Arnuity Ellipta right away and get medical attention immediately if you have any of the following symptoms of a severe allergic reaction:

• swelling of the face, throat and/or tongue
• hives
• rash
• breathing problems

Decreased ability to fight infections (immunosuppression). Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection that develop while you use Arnuity Ellipta.

Slowed growth in children. There exists the possibility for slowed growth in children using medications like Arnuity Ellipta (corticosteroids). The growth rate of children using Arnuity Ellipta should be checked regularly during treatment.

Eye problems including glaucoma and cataracts. Glaucoma, increased eye blood pressure, and cataracts have been reported in patients following the long‑term use of medications like Arnuity Ellipta. Tell your doctor about any vision changes that develop while using Arnuity Ellipta. 

Increased wheezing (bronchospasm). Wheezing can develop immediately after using Arnuity Ellipta. Always have a rescue inhaler with you to treat sudden wheezing if it occurs.

Reduced bone mineral density. Changes in bone mineral density have been observed following long-term use of medications like Arnuity Ellipta. This may be a more common problem for people who already have a higher risk of developing low bone density (osteoporosis). Consult with your physician about your level of risk for developing reduced bone mineral density.

Do not take Arnuity Ellipta if you:

• are allergic to Arnuity Ellipta or to any of its ingredients 
• have a severe allergy to milk proteins
• are having an asthma attack. Arnuity Ellipta is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as albuterol, during a sudden asthma attack. 

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 Arnuity Ellipta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Arnuity Ellipta, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Arnuity Ellipta or to any of its ingredients
• take any other corticosteroids such as hydrocortisone
• have liver problems
• frequently have oral yeast infections (thrush)
• feel your asthma isn't adequately controlled
• have any adrenal gland disorders
• have osteoporosis
• have an immune system problem
• have or suspect you may have an infection of any kind
• are exposed to chickenpox or measles
• have a history of glaucoma or cataracts
• have any other medical conditions
• 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.

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Arnuity Ellipta falls into category C. There are no well-controlled studies that have been done in pregnant women. Arnuity Ellipta should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

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

It is not known if Arnuity Ellipta 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 Arnuity Ellipta.

Use Arnuity Ellipta exactly as prescribed.

• Arnuity Ellipta comes in an inhaler form and is typically used once a day. For best results, use at the same time each day. It may take up to 2 weeks for Arnuity Ellipta to reach its full effectiveness.
• Seek medical attention immediately if your asthma symptoms get worse with time.
• Arnuity Ellipta is not meant to relieve acute asthma attacks and extra doses should not be used for that purpose.

Do not use Arnuity Ellipta unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Always follow your physician's instructions on use exactly. 

Important Notes

• Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is ready to be inhaled. This is shown by a decrease in the number on the 30-dose counter.
• If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.
• 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.
• Write the “Tray opened” and “Discard” dates on the inhaler label. The “Discard” date is 6 weeks from the date you open the tray.
• Check the counter. Before the inhaler is used for the first time, the counter should show the number 30 (14 if you have a sample or institutional pack). This is the number of doses in the inhaler. Each time you open the cover, you prepare 1 dose of medicine. The counter counts down by 1 each time you open the cover.
• When you have less than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill. 
• After you have inhaled the last dose, the counter will show “0” and will be empty.

Administration:

1. Slide the cover down to expose the mouthpiece. You should hear a “click.” The counter will count down by 1 number. You do not need to shake this type of inhaler. Your inhaler is now ready to use. If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your healthcare provider or pharmacist if this happens.
2. While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.
3. Put the mouthpiece between your lips, and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece. Take 1 long, steady, deep breath in through your mouth. Do not breathe in through your nose. Do not block the air vent 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). 
4. Breathe out slowly and gently. You may not taste or feel the medicine, even when you are using the inhaler correctly. Do not take another dose from the inhaler even if you do not feel or taste the medicine.
5. Close the inhaler. You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. Routine cleaning is not required. Slide the cover up and over the mouthpiece as far as it will go.
6. Rinse your mouth. Rinse your mouth with water after you have used the inhaler and spit the water out. Do not swallow the water.

If you miss a dose of Arnuity Ellipta, take it as soon as you remember. Do not take more than one inhalation each day. Take your next dose at your usual time. Do not take two doses at one time.    

Do not stop using Arnuity Ellipta unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

Arnuity Ellipta does not relieve 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
• your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Arnuity Ellipta for to control and prevent asthma symptoms in adults and children aged 12 years and older is one inhalation (containing 100 - 200 mcg) once every 24 hours.

If you use too much Arnuity Ellipta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature
• Store in a dry place away from direct heat or sunlight
• Discard 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
• Keep this and all medicines out of the reach of children