Vilanterol-Fluticasone Furoate Inhaled

Vilanterol/Fluticasone Furoate Inhaled is a combination prescription medication used for treating the symptoms of chronic obstructive pulmonary disease and asthma.

• Vilanterol/Fluticasone Furoate Inhaled is available under the following different brand names: Breo Ellipta

Adult dosage

Powder for inhalation

• 25mcg/100mcg per actuation
• 25mg/200mcg per actuation
• Ellipta inhaler contains 2 double-foil blister strips, 1 containing fluticasone furoate and the other strip contains vilanterol; after the inhaler is activated, the powder within both blisters is exposed and ready for dispersion

Chronic Obstructive Pulmonary Disease

Adult  dosage

• 25 mcg/100 mcg (1 actuation) inhaled orally every day

Asthma

Adult dosage

• Use prescribe strength (25 mcg/100 mcg or 25 mcg/200 mcg per actuation) once daily via oral inhalation

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Vilanterol/Fluticasone Furoate Inhaled include:

• upper respiratory tract infection,
• runny nose,
• sore throat,
• headache,
• oral candidiasis (thrush in the mouth or throat),
• back pain,
• pneumonia,
• bronchitis,
• sinus infection,
• cough,
• mouth pain,
• joint pain,
• influenza
• sore throat, and
• fever.

Serious side effects of Vilanterol/Fluticasone Furoate Inhaled include:

• decreasing effectiveness,
• need for more inhalations than usual,
• significant decrease in lung function,
• increase in mucus (sputum) production,
• change in mucus color,
• fever,
• chills,
• increased cough,
• increased breathing problems,
• feeling tired,
• lack of energy,
• weakness,
• nausea,
• vomiting,
• low blood pressure,
• tremor,
• nervousness,
• rash,
• hives
• swelling of the face, mouth or tongue,
• breathing problems,
• chest pain,
• increased blood pressure, and
• fast or irregular heartbeat.

Rare side effects of Vilanterol/Fluticasone Furoate Inhaled include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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.

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.

• Vilanterol/Fluticasone Furoate Inhaled has severe interactions with the following drugs:
  • indacaterol, inhaled
  • lefamulin
• Vilanterol/Fluticasone Furoate Inhaled has serious interactions with at least 123 other drugs.
• Vilanterol/Fluticasone Furoate Inhaled has moderate interactions with at least 62 other drugs.
• Vilanterol/Fluticasone Furoate Inhaled 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 the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care 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 COPD or asthma where intensive measures are required
• Hypersensitivity to drug, any components/excipients, or milk proteins

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Risk of LABAs used as monotherapy
  • Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death
  • Data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patient
  • These findings are considered a class effect of LABA monotherapy
  • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
• Not for treatment of acute episodes
• Increasing use of inhaled, short-acting beta2-agonists (ie, rescue inhalers) is a marker of deteriorating disease and acute episodes; reevaluate the patient immediately
• Do not initiate during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy acute bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist LABAs increase asthma-related death
• Do not use in combination with another medication containing a LABA because of risk for overdose
• Risk of localized infections of nose, mouth, and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk
• Caution with underlying cardiovascular disease because of beta-adrenergic stimulation
• Risk of paradoxical bronchospasm, which may be life-threatening; discontinue and treat immediately with inhaled SABA
• Decreases bone mineral density following long-term administration of corticosteroids; bone fractures reported with inhaled corticosteroid use; assess upon initiation and periodically thereafter
• Corticosteroids increase risk of pneumonia; monitor for S/S of pneumonia and lung infections
• Corticosteroids increase risk of cataracts, glaucoma, and increased IOP; consider referral to an ophthalmologist in patients who develop ocular symptoms or use drug long term
• Excessive use (or at regular dose in susceptible individuals) may result in hypercorticism and suppress HPA function; monitor closely, especially postoperatively or during periods of stress
• Corticosteroids increase risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
• Risk for more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure to corticosteroids
• Particular care is needed to transfer patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before/after; taper patient slowly from systemic corticosteroids
• Risk of hypokalemia and hyperglycemia
• Caution with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis; increases in blood glucose levels reported; this should be considered in patients with a history of, or with risk factors for, diabetes mellitus
• Close monitoring for glaucoma and cataracts is warranted
• Angioedema, rash, or urticaria may occur after administration

Pregnancy and Lactation

• Disease-associated maternal and/or embryofetal risk; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal outcomes such as pre-eclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma
• Labor and Delivery: There are no human studies evaluating effects during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom benefits clearly outweigh risks
• Lactation
  • There is no information available on presence of fluticasone furoate or vilanterol in human milk; effects on breastfed child, or effects on milk production; low concentrations of other inhaled corticosteroids have been detected in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from fluticasone furoate or vilanterol or from underlying maternal condition