Dosing & Uses
Dosage Forms & Strengths
vilanterol/fluticasone furoate inhaled
powder for inhalation
- 25mcg/100mcg per actuation
- 25mcg/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
Indicated for long-term, once-daily, maintenance treatment of airflow obstruction with COPD, including chronic bronchitis and/or emphysema; also approved to reduce COPD exacerbations
25 mcg/100 mcg (1 actuation) inhaled PO qDay
Asthma
Indicated for maintenance treatment of asthma
1 actuation (25/100 mcg or 25/200 mcg vilanterol/ fluticasone) inhaled PO qDay
When choosing starting dose, consider patients’ disease severity, their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage, and current control of asthma symptoms and risk of future exacerbation
If asthma symptoms occur between doses, use inhaled, short-acting beta2-agonist (rescue medicine, eg, albuterol) for immediate relief
Dosage Modifications
Hepatic or renal impairment: No dosage adjustment required
Geriatric patients: No dosage adjustment required
Dosing Considerations
Limitation of use: NOT indicated for the relief of acute bronchospasm
Asthma indication
- LABAs (eg, vilanterol) increase the risk of asthma-related death
- Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients
- Therefore, when treating patients with asthma, physicians should only prescribe vilanterol/fluticasone furoate inhaled for patients not adequately controlled on a long-term asthma control medication (eg, inhaled corticosteroid), or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA
- Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue vilanterol/fluticasone furoate inhaled) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication (eg, inhaled corticosteroid)
- Do not use for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids
Dosage Forms & Strengths
vilanterol/fluticasone furoate inhaled
powder for inhalation
- 25mcg/50mcg per actuation
- 25mcg/100mcg 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
Asthma
Indicated for maintenance treatment of asthma in patients aged ≥5 years
<5 years: Safety and efficacy not established
5-11 years: 1 actuation (25/50 mcg vilanterol/fluticasone) inhaled PO qDay
12-17 years: 1 actuation (25/100 mcg vilanterol/ fluticasone) inhaled PO qDay
Dosage Modifications
Hepatic impairment
- Not studied
Renal impairment
- No dosage adjustment required
Dosing Considerations
Limitations of use: NOT indicated for the relief of acute bronchospasm
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- indacaterol, inhaled
indacaterol, inhaled, vilanterol/fluticasone furoate inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated.
- lefamulin
lefamulin will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.
Serious - Use Alternative (124)
- acebutolol
acebutolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- adagrasib
adagrasib, vilanterol/fluticasone furoate inhaled. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- alfuzosin
alfuzosin and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated
- amiodarone
amiodarone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- amisulpride
amisulpride and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- amitriptyline
amitriptyline and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
amitriptyline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - amoxapine
amoxapine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
amoxapine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - apalutamide
apalutamide will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- apomorphine
apomorphine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- arformoterol
arformoterol increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- arsenic trioxide
arsenic trioxide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- artemether/lumefantrine
artemether/lumefantrine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- asenapine
asenapine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- asenapine transdermal
asenapine transdermal and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated
- azithromycin
azithromycin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- bedaquiline
bedaquiline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- carvedilol
carvedilol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- ceritinib
ceritinib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- chloramphenicol
chloramphenicol will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- chlorpromazine
chlorpromazine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ciprofloxacin
ciprofloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- citalopram
citalopram increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- clarithromycin
clarithromycin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- clomipramine
clomipramine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
clomipramine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - clozapine
clozapine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- cobicistat
cobicistat will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- crizotinib
crizotinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- dasatinib
dasatinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- degarelix
degarelix increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- desipramine
desipramine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
desipramine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - disopyramide
disopyramide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- dofetilide
dofetilide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- dolasetron
dolasetron increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- doxepin
doxepin and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- dronedarone
dronedarone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- droperidol
droperidol increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- eribulin
eribulin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- erythromycin base
erythromycin base increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- erythromycin lactobionate
erythromycin lactobionate increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- erythromycin stearate
erythromycin stearate increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- escitalopram
escitalopram increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ezogabine
ezogabine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- fexinidazole
fexinidazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- flecainide
flecainide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- fluconazole
fluconazole increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- fluphenazine
fluphenazine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- formoterol
formoterol increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- foscarnet
foscarnet increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- gemifloxacin
gemifloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- haloperidol
haloperidol increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug.
- ibutilide
ibutilide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- idelalisib
idelalisib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- iloperidone
iloperidone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- imipramine
imipramine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- indapamide
indapamide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- isocarboxazid
isocarboxazid and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- isradipine
isradipine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ivosidenib
ivosidenib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
- labetalol
labetalol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- lapatinib
lapatinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- levofloxacin
levofloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- lonafarnib
lonafarnib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- lopinavir
lopinavir increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- macimorelin
macimorelin and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- maprotiline
maprotiline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- mefloquine
mefloquine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- methadone
methadone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- mifepristone
mifepristone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
mifepristone will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. - mobocertinib
mobocertinib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- moxifloxacin
moxifloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- nadolol
nadolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- nilotinib
nilotinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- nortriptyline
nortriptyline and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
nortriptyline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - octreotide
octreotide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ofloxacin
ofloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- olanzapine
olanzapine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ondansetron
ondansetron increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- paliperidone
paliperidone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- pasireotide
pasireotide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- pazopanib
pazopanib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- penbutolol
penbutolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- pentamidine
pentamidine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- perphenazine
perphenazine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- phenelzine
phenelzine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- pimozide
pimozide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- pindolol
pindolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- posaconazole
posaconazole increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- procainamide
procainamide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- propafenone
propafenone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- propranolol
propranolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic synergism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- protriptyline
protriptyline and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
protriptyline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - quetiapine
quetiapine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- quinidine
quinidine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- quinine
quinine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ranolazine
ranolazine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- rasagiline
rasagiline and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- ribociclib
ribociclib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rilpivirine
rilpivirine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- risperidone
risperidone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- romidepsin
romidepsin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- saquinavir
saquinavir increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- selegiline
selegiline and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- selegiline transdermal
selegiline transdermal and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- sertraline
sertraline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- solifenacin
solifenacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- sorafenib
sorafenib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- sotalol
sotalol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
sotalol increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - sunitinib
sunitinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- tacrolimus
tacrolimus increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- telavancin
telavancin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- thioridazine
thioridazine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- thiothixene
thiothixene increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- timolol
timolol, vilanterol/fluticasone furoate inhaled. pharmacodynamic antagonism. Avoid or Use Alternate Drug. If a beta-blocker must be used in patients with COPD taking a beta-agonist, consider using a beta-blocker that is beta-1 selective .
- toremifene
toremifene increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- tranylcypromine
tranylcypromine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
- trimipramine
trimipramine and vilanterol/fluticasone furoate inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Exercise extreme caution if vilanterol coadministered with MAOIs or TCAs, or within 2 weeks of discontinuation of these drugs; adrenergic agonist effects on the cardiovascular system may be potentiated
trimipramine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. - tucatinib
tucatinib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- vandetanib
vandetanib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vardenafil
vardenafil increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vemurafenib
vemurafenib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- voriconazole
voriconazole increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- ziprasidone
ziprasidone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
Monitor Closely (67)
- aripiprazole
aripiprazole and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- artemether
artemether and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- atazanavir
atazanavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- atomoxetine
atomoxetine and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- bumetanide
vilanterol/fluticasone furoate inhaled and bumetanide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- ceritinib
ceritinib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- chloroquine
chloroquine increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Use Caution/Monitor.
- chlorothiazide
vilanterol/fluticasone furoate inhaled and chlorothiazide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- chlorthalidone
vilanterol/fluticasone furoate inhaled and chlorthalidone both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- clarithromycin
clarithromycin will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- conivaptan
conivaptan will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- dabrafenib
dabrafenib will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- darunavir
darunavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- deutetrabenazine
deutetrabenazine and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- donepezil
donepezil and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- efavirenz
efavirenz will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid or Use Alternate Drug.
efavirenz and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor. - elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- encorafenib
encorafenib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- entrectinib
entrectinib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- ethacrynic acid
vilanterol/fluticasone furoate inhaled and ethacrynic acid both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- fedratinib
fedratinib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fingolimod
fingolimod and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- fluoxetine
fluoxetine and vilanterol/fluticasone furoate inhaled both increase QTc interval. Modify Therapy/Monitor Closely. Fluoxetine prolongs the QT interval; the prescribing information for fluoxetine recommends avoiding concurrent use of other drugs that may prolong the QT interval; risk may be increased with higher doses and/or when associated with hypokalemia; drugs that prolong the QTc interval may potentiate the effects of beta2 agonists on the cardiovascular system
- fosamprenavir
fosamprenavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- fosphenytoin
fosphenytoin will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid or Use Alternate Drug.
- furosemide
vilanterol/fluticasone furoate inhaled and furosemide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- gepirone
gepirone and vilanterol/fluticasone furoate inhaled both increase QTc interval. Modify Therapy/Monitor Closely.
- gilteritinib
gilteritinib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- hydrochlorothiazide
vilanterol/fluticasone furoate inhaled and hydrochlorothiazide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- imatinib
imatinib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- indapamide
vilanterol/fluticasone furoate inhaled and indapamide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- indinavir
indinavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- isoniazid
isoniazid will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- istradefylline
istradefylline will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- itraconazole
itraconazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
itraconazole and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor. - ketoconazole
ketoconazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- lenacapavir
lenacapavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- levoketoconazole
levoketoconazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- lopinavir
lopinavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- methyclothiazide
vilanterol/fluticasone furoate inhaled and methyclothiazide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- metolazone
vilanterol/fluticasone furoate inhaled and metolazone both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- mitotane
mitotane will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use Alternate Drug or monitor and adjust dose of combination drug as necessary
- nefazodone
nefazodone will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- nelfinavir
nelfinavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- nicardipine
nicardipine will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- olodaterol inhaled
vilanterol/fluticasone furoate inhaled and olodaterol inhaled both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Caution with coadministration of adrenergic drugs by any route because of additive sympathetic effects
- osimertinib
osimertinib and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- ozanimod
ozanimod and vilanterol/fluticasone furoate inhaled both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- phenobarbital
phenobarbital will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- phenytoin
phenytoin will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- posaconazole
posaconazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- primidone
primidone will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- quinidine
quinidine will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- quizartinib
quizartinib, vilanterol/fluticasone furoate inhaled. Either increases effects of the other by QTc interval. Modify Therapy/Monitor Closely. Monitor patients more frequently with ECG if coadministered with QT prolonging drugs.
- ribociclib
ribociclib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Use Caution/Monitor.
- ritonavir
ritonavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- rucaparib
rucaparib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
saquinavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- selpercatinib
selpercatinib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Use Caution/Monitor.
- solriamfetol
vilanterol/fluticasone furoate inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- stiripentol
stiripentol, vilanterol/fluticasone furoate inhaled. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- tazemetostat
tazemetostat will decrease the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tipranavir
tipranavir will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- torsemide
vilanterol/fluticasone furoate inhaled and torsemide both decrease serum potassium. Modify Therapy/Monitor Closely. Beta-agonists may acutely worsen ECG changes and/or hypokalemia resulting from non-potassium-sparing diuretics
- valbenazine
valbenazine and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.
- voriconazole
voriconazole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Fluticasone furoate and vilanterol are both CYP3A4 substrates; coadministration with potent CYP3A4 inhibitors may increase systemic exposure
- vorinostat
vorinostat increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Use Caution/Monitor. Exercise caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
Minor (4)
- acetazolamide
acetazolamide will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of vilanterol/fluticasone furoate inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
1-10%
Nasopharyngitis (9%)
Upper respiratory infection (7%)
Headache (7%)
Oropharyngeal candidiasis (5%)
Postmarketing reports
Anxiety
Tremors
Palpitations, tachycardia
Anaphylaxis, angioedema, rash, urticaria
Muscle spasms
Tremor
Nervousness
Paradoxical bronchospasm
Hyperglycemia
Warnings
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
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
Increased use of inhaled, short-acting pulmonary beta2-agonists (ie, rescue inhalers) is a marker of deteriorating disease and acute episodes; reevaluate 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 Candidal infections; must rinse mouth after inhalation to reduce risk; monitor patients periodically; when infection develops, treat with appropriate local or systemic (eg, oral) antifungal therapy while treatment inhaler therapy continues; in some cases, therapy may need to be interrupted
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
Orally inhaled corticosteroids may reduce growth velocity when administered to pediatric patients; monitor growth routinely (eg, via stadiometry); titrate dose to lowest dosage that effectively controls symptoms to minimize systemic effects
An increase in the incidence of pneumonia observed in patients with COPD receiving therapy and increase resulting in hospitalization; in some incidences these pneumonia events were fatal; healthcare providers should remain vigilant for possible development of pneumonia in patients with COPD as clinical features of pneumonia and exacerbations frequently overlap
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 in those unusually responsive to sympathomimetic amines; increases in blood glucose levels reported; this should be considered in patients with a history of, or with risk factors for, diabetes mellitus; when administered IV, doses of related beta2- adrenoceptor agonist albuterol, reported to aggravate preexisting diabetes mellitus and ketoacidosis
Angioedema, rash, or urticaria may occur after administration
Pregnancy & Lactation
Pregnancy
Insufficient data on effects of individual components, fluticasone furoate and vilanterol, in pregnant women to inform a drug-associated risk
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
- Use during late gestation and labor only if potential benefit justifies potential for risks related to beta-agonists interfering with uterine contractility
Animal data
- Animal reproduction study, fluticasone furoate and vilanterol administered by inhalation alone or in combination to pregnant rats during period of organogenesis produced no fetal structural abnormalities
- The highest fluticasone furoate and vilanterol doses in this study were approximately 5 and 40 times maximum recommended human daily inhalation doses (MRHDID) of 200 and 25 mcg, respectively
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Vilanterol: Long-acting selective beta2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells
Fluticasone furoate (FF): Long-acting inhaled trifluorinated corticosteroid with potent anti-inflammatory activity; inhibits multiple cell types (eg, mast cells, eosinophils, basophils, lymphocytes, macrophages, neutrophils) and mediator production or secretion (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in the asthmatic response
Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate
Absorption
Bioavailability: 27.3% (vilanterol); 15.2% (FF)
Peak plasma time: 10 minutes (vilanterol); 0.5-1 hr (FF)
AUC: 46% lower in patients with COPD compared with healthy individuals
Distribution
Following IV administration of each component
Protein bound: 93.9% (vilanterol); 99.6% (FF)
Vd: 165 L (vilanterol); 661 L (FF)
Metabolism
Vilanterol is mainly metabolized, principally via CYP3A4, to a range of metabolites with significantly reduced beta1- and beta2-agonist activity
Fluticasone furoate is cleared from systemic circulation principally by hepatic metabolism via CYP3A4 to metabolites with significantly reduced corticosteroid activity
Elimination
Half-life: 21.3 hr (vilanterol); 24 hr (FF)
Excretion
- Pharmacokinetic studies following oral and IV administration
- Vilanterol and metabolites: 30% feces; 70% urine
- Fluticasone furoate and metabolites: 90-100% feces; 1-2% urine
Administration
Instructions
After inhalation, rinse mouth with water and expectorate to help reduce risk of oropharyngeal candidiasis
Take at same time each day
Do not exceed 1 administration/24 hr
More frequent administration or a greater number of inhalations (>1 inhalation daily) of the prescribed strength is not recommended as some patients are more likely to experience adverse effects with higher doses
Patients should not use an additional long-acting beta agonist (LABA) for any reason
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Breo Ellipta inhalation - | 200-25 mcg/dose aerosol |  | |
| Breo Ellipta inhalation - | 100-25 mcg/dose aerosol |  | |
| Breo Ellipta inhalation - | 200-25 mcg/dose aerosol |  | |
| Breo Ellipta inhalation - | 100-25 mcg/dose aerosol |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fluticasone furoate-vilanterol for inhalation
FLUTICASONE/VILANTEROL POWDER INHALER - ORAL INHALATION
(floo-TIK-a-sone/vye-LAN-ter-ol)
COMMON BRAND NAME(S): Breo Ellipta
USES: This medication is used to prevent and decrease symptoms (wheezing and trouble breathing) caused by asthma and ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). This inhaler contains 2 medications: fluticasone and vilanterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. Vilanterol belongs to a class of drugs known as long-acting beta agonists. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.When used alone, long-acting beta agonists (like vilanterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. For asthma treatment, this product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment.Before using this medication, it is important to learn how to use it properly. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.Inhale this medication by mouth as directed by your doctor, usually once daily. Do not use more than 1 inhalation daily. If you open and close the cover without inhaling this medication, you will lose the dose. If this happens, you should load a new dose and inhale it.If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use it as needed for sudden shortness of breath. Contact your doctor for details.If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose, use this medication more often, or stop using it without talking to your doctor. Also, do not use other long-acting beta agonists while using this medication.If this medication stops working well, or you need to use your quick-relief inhaler more often than usual (4 or more puffs daily or use of more than 1 inhaler every 8 weeks), get medical help right away. It may be a sign of worsening asthma or COPD, which is a serious condition.Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.If you are regularly taking corticosteroids by mouth (such as prednisone), continue to follow your doctor's instructions on taking them. Do not stop taking them. Your doctor may want you to reduce your dose gradually.It may take several weeks or longer before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Precautions section.Headache, dry/irritated throat, hoarseness, runny nose, and coughing may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: white patches in your mouth or on your tongue, weakness, puffy face, unusual weight gain, slow wound healing, thinning skin, bone pain, menstrual period changes, mental/mood changes (such as depression, nervousness, mood swings, agitation), easy bruising/bleeding, increased thirst/urination, vision problems, muscle cramps, shaking (tremor), signs of infection (such as sore throat that doesn't go away, fever, chills, cough).Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, chest pain.Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing, use your quick-relief inhaler and get medical help right away.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to fluticasone or vilanterol; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (such as cataracts, glaucoma), heart problems (such as angina, irregular heartbeat), any recent infection, liver problems, overactive thyroid (hyperthyroidism), seizures.Fluticasone/vilanterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using fluticasone/vilanterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluticasone/vilanterol safely.If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Fluticasone/vilanterol can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child's height can be checked.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include some azole antifungals (such as ketoconazole), HIV protease inhibitors (such as lopinavir), ritonavir, among others.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast heartbeat, shaking (tremor).
NOTES: Do not share this medication with others.Lab and/or medical tests (such as cortisol levels, lung function, eye exam, bone density tests) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen asthma and other breathing problems.Because the flu virus can worsen breathing problems, ask your doctor or pharmacist whether you should have an annual flu shot.In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not remove the inhaler from its original foil package until ready to use. Discard the inhaler 6 weeks after you remove it from the original foil package or when the counter reads "0," whichever is sooner.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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