Arnuity Ellipta

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Arnuity Ellipta (Fluticasone-furoate-inh). If you are concerned about side effects, discuss the risks and benefits of Arnuity Ellipta (Fluticasone-furoate-inh) with your doctor.

The following side effects have been reported by at least 1% of people taking Arnuity Ellipta (Fluticasone-furoate-inh). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• cough
• Diarrhea
• headache
• hoarseness, voice change
• sore mouth and tongue
• stomach pain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms (e.g., Fever, chills, sore throat, muscle ache)
• Osteoporosis or bone fractures
• signs of respiratory tract infection (e.g., fever or chills, shortness of breath, prolonged dizziness, headache, weight loss, tightness in chest, difficulty breathing, or wheezing)
• signs of too much corticosteroid (e.g., round face, rapid weight gain, increased sweating, thinning of skin, muscle weakness)
• signs of thrush (e.g., white patches in mouth and throat, sore throat)
• slowed growth (adolescents)
• symptoms of decreased adrenal function (e.g., tiredness, weakness, nausea, vomiting, decreased blood pressure)
• symptoms of Glaucoma or Cataracts (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• worsening asthma symptoms

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• skin rash or Hives

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Arnuity Ellipta (Fluticasone-furoate-inh).

Arnuity Ellipta (Fluticasone-furoate-inh) consists of an inhaler with a plastic light grey body, dose counter, and orange mouthpiece cover. The inhaler encompasses a foil strip with blisters containing 100 µg or 200 µg fluticasone furoate.

100 µg 
Each blister contains 100 µg of micronized fluticasone furoate. Nonmedicinal ingredients: lactose monohydrate.

200 µg
Each blister contains 200 µg of micronized fluticasone furoate. Nonmedicinal ingredients: lactose monohydrate.

Do not take Arnuity Ellipta (Fluticasone-furoate-inh) if you:

• are allergic to fluticasone or any ingredients of the medication
• are allergic to milk or lactose
• are having an asthma attack with sudden shortness of breath or wheezing

Do not give Arnuity Ellipta (Fluticasone-furoate-inh) to children less than 12 years of age. 

There may be an interaction between fluticasone furoate and any of the following:

• Aldesleukin
• amphotericin B
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baricitinib
• BCG
• Bicalutamide
• Cobicistat
• conivaptan
• Deferasirox
• Denosumab
• Diltiazem
• Dronedarone
• echinacea
• Fingolimod
• grapefruit juice
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• hyaluronidase
• Ivacaftor
• Leflunomide
• loop diuretics (e.g., bumetanide, Furosemide)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Natalizumab
• nefazodone
• Nivolumab
• Pimecrolimus
• certain protein kinase inhibitors (e.g., Crizotinib, Dasatinib, Idelalisib, imatinib)
• Stiripentol
• Tacrolimus
• thiazide diuretics (water pills; e.g., Hydrochlorothiazide, Indapamide, Metolazone)
• Tofacitinib
• Trastuzumab
• vaccines
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Arnuity Ellipta (Fluticasone-furoate-inh). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Arnuity Ellipta (Fluticasone-furoate-inh).

Infection: Arnuity Ellipta (Fluticasone-furoate-inh), like other corticosteroids, may prevent you from noticing the early signs of a serious infection. Try to limit the amount of time you spend around others who have recently had infections such as Chickenpox or Measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice.

Glaucoma: Arnuity Ellipta (Fluticasone-furoate-inh) may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how Arnuity Ellipta (Fluticasone-furoate-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arnuity Ellipta (Fluticasone-furoate-inh), and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking Arnuity Ellipta (Fluticasone-furoate-inh).

Liver function: Liver disease or reduced liver function may cause fluticasone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Arnuity Ellipta (Fluticasone-furoate-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arnuity Ellipta (Fluticasone-furoate-inh), and whether any special monitoring is needed.

Non-responsive asthma: Contact your doctor immediately if you experience episodes of asthma that are not responsive to bronchodilators (such as salbutamol or terbutaline) while using Arnuity Ellipta (Fluticasone-furoate-inh). During such episodes, further treatment may be needed.

Oral hygiene: Adequate oral hygiene is very important in minimizing the overgrowth of microorganisms such as Candidiasis (thrush). Make sure you rinse your mouth with water after using the inhaler. If you do get a thrush infection, you may require treatment with antifungal therapy or you may have to stop using fluticasone, depending on the seriousness of the infection.

Stopping Arnuity Ellipta (Fluticasone-furoate-inh): Do not stop Arnuity Ellipta (Fluticasone-furoate-inh) suddenly, as this may result in withdrawal symptoms such as stomach discomfort or pain, or worsening of asthma. Your doctor will tell you how to gradually lower the dose over a period of time in order to stop Arnuity Ellipta (Fluticasone-furoate-inh) properly.

Wheezing: Arnuity Ellipta (Fluticasone-furoate-inh) may cause the airways to spasm immediately after using the inhaler. If this happens, use your rescue inhaler as soon as possible to relieve the symptoms, then call your doctor as soon as possible.

Worsening of asthma: If you find you need to use your bronchodilators more often (e.g., salbutamol) to control asthma symptoms it may be an indication that your asthma is worsening. Worsening asthma can potentially become life-threatening. Your fluticasone dose may need to be increased. Talk to your doctor or pharmacist to learn more about how to properly monitor for symptoms of worsening asthma.

Pregnancy: Arnuity Ellipta (Fluticasone-furoate-inh) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Arnuity Ellipta (Fluticasone-furoate-inh), contact your doctor immediately.

Breast-feeding: It is not known if fluticasone passes into breast milk. If you are a breast-feeding mother and are taking Arnuity Ellipta (Fluticasone-furoate-inh), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Arnuity Ellipta (Fluticasone-furoate-inh) have not been established for children less than 12 years of age. Adolescents may experience slowing of growth while using Arnuity Ellipta (Fluticasone-furoate-inh). Your doctor will monitor for this. Talk to your doctor if you have any concerns.