Fluticasone Furoate Inhalation Powder

Fluticasone Furoate is a prescription medication used for the treatment of Asthma. 

• Fluticasone Furoate is available under various brand names: Arnuity Ellipta

Common side effects of Fluticasone Furoate include:

• dry or irritated throat,
• hoarseness, and
• cough

Serious side effects of Fluticasone Furoate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• white patches in the mouth or the tongue,
• fever,
• chills,
• persistent sore throat,
• mood changes,
• depression,
• mood swings,
• agitation,
• vision problems,
• increased thirst or urination,
• easy bruising or bleeding,
• bone pain, and
• severe wheezing

Rare side effects of Fluticasone Furoate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Powder for inhalation

• 50 mcg/actuation
• 100 mcg/actuation
• 200 mcg/actuation

Asthma

Adult dosage

• 1 inhalation orally every day; not to exceed 1 inhalation every 24 hours
• Starting dose is based on asthma severity
• Recommended starting dose: 100 mcg/day
• May increase to 200 mcg/day after 2 weeks if patient does not respond to 100 mcg/day
• Not to exceed 200 mcg every day

Pediatric dosage

• Aged below 5 years: Safety and efficacy not established
• Aged between 5-11 years: 50 mcg inhaled orally every day
• Aged above 12 years: Same as adult dosage

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fluticasone Furoate has severe interactions with no other drugs.
• Fluticasone Furoate has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • fexinidazole
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tucatinib
• Fluticasone Furoate has moderate interactions with at least 45 other drugs.
• Fluticasone Furoate has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
• Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone Furoate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone Furoate?”

Cautions

• Localized infections of the mouth and pharynx with Candida albicans reported with inhaled corticosteroids; treat with appropriate local or systemic (e.g., oral) antifungal therapy while treatment continues; at times therapy may need to be interrupted
• Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or even fatal course of chickenpox or measles in susceptible patients; use caution because of potential for worsening of these infections; if exposed to chickenpox, prophylaxis with varicella-zoster immune globulin or pooled IV immunoglobulin may be indicated; if a patient is exposed to measles, prophylaxis with pooled IM immunoglobulin (IG) may be indicated
• Caution when withdrawing from systemic corticosteroids and transferring to inhaled corticosteroids; taper systemic corticosteroids gradually and monitor for symptoms of HPA axis suppression and adrenal insufficiency; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy
• Therapy not to be regarded as bronchodilator and not indicated for rapid relief of bronchospasm; instruct patient to contact physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during course of treatment; during such episodes, patients may require therapy with oral corticosteroids
• If patient is exposed to chickenpox, may administer prophylaxis with varicella-zoster immune globulin (VZIG); if a patient is exposed to measles, may administer prophylaxis with pooled intramuscular immunoglobulin (IG) (See respective package inserts for complete VZIG and IG prescribing information); if chickenpox develops, treatment with antiviral agents may be considered; use with caution, if at all, in patients with active or quiescent tuberculosis infections of respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
• Anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported; patients with severe milk protein allergy should not use product
• Decreases in bone mineral density (BMD) reported with long-term administration of products containing ICS; clinical significance of small changes in BMD with regard to longterm consequences such as fracture is unknown; monitor and treat patients with established standards of care patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids)
• Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth of pediatric patients receiving ICS routinely (eg. via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, titrate each patient’s dosage to lowest dosage that effectively controls his/her symptoms
• Paradoxical bronchospasm may occur with immediate increase in wheezing after dosing; if bronchospasm occurs following dosing treat immediately with an inhaled, short-acting bronchodilator; discontinued therapy immediately; and institute alternative therapy
• CYP3A4 substrate; strong CYP3A4 inhibitors may increase fluticasone systemic exposure
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids
• Epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing; monitor patients periodically for signs of adverse effects on nasal mucosa; avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma
• Eosinophilic conditions
  • In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions; some patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy; these events, have been associated (not always) with reduction and/or withdrawal of oral corticosteroid therapy following introduction of fluticasone propionate
  • Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting; physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients; a causal relationship between fluticasone propionate and these underlying conditions not established
  • Transferring patients from systemic corticosteroid therapy
  • Particular care needed for patients transferred from systemically active corticosteroids to ICS; deaths due to adrenal insufficiency during and after transfer from systemic corticosteroids to less systemically available ICS
  • After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function
  • During periods of stress or a severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction; patients should carry warning card indicating possible need for supplementary systemic steroids in such emergencies
  • Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ICS; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with ICS
  • Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids
  • Patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension
  • Transfer of patients from systemic corticosteroid therapy to ICS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions)
  • Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects; if effects occur, ICS dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered.

Pregnancy & Lactation

• Insufficient data on use in pregnant women
• Clinical considerations
  • In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
  • Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
• Lactation
  • No information is available on the presence of Fluticasone Furoate in human milk, the effects on the breastfed child, or the effects on milk production
  • Low concentrations of other inhaled corticosteroids have been detected in human milk
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from Fluticasone Furoate or from the underlying maternal condition