RYBREVANT FASPRO™ Receives FDA Approval for First-Line EGFR-Mutated NSCLC
December 26, 2025
Brand Name :
Breo Ellipta
Synonyms :
Class :
Corticosteroids, Beta2 Agonists
Dosage Forms & Strengths
vilanterol/fluticasone furoate
powder for inhalation
25mcg/100mcg (actuation)- vilanterol/fluticasone furoate
25mg/200mcg (actuation)- vilanterol/fluticasone furoate
Initial dose:
1 inhalation 100mcg/25mcg or 200mcg/25mcg (fluticasone furoate/vilanterol) once daily
Maximum dose: 1 inhalation 200mcg/ 25mcg (fluticasone furoate/vilanterol) once daily
Safety and efficacy not established
Adverse drug reactions:
Frequency Defined
1-10%
Nasopharyngitis
Sinusitis
Headache
<1%
Oral Candidiasis
Post-Marketing Reports
Angina pectoris
cardiac arrhythmias
QT prolongation
elevated blood pressure
Pregnancy warnings:
Pregnancy Category: N/A
Lactation: unknown if distributed into breast milk, avoid
Pregnancy Categories:
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.
Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient Information Leaflet
Generic Name: Fluticasone furoate and vilanterol
Why do we use Fluticasone furoate and vilanterol?
Fluticasone furoate and vilanterol is an Beta2 Agonists, Corticosteroids, and it is used to treat COPD and severe Asthma.