Anoro Ellipta was approved by the FDA on December 18th, 2013 as the first once-a-day, LONG-TERM MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, INCLUDING BRONCHITIS AND EMPHYSEMA. ANORO ELLIPTA IS A COMBINATION OF AN INHALED ANTICHOLINERGIC AND A LONG-ACTING BETA2-ADRENERGIC AGONIST THAT RELAXES THE MUSCLES AROUND THE AIRWAYS TO ALLOW MORE AIR TO FLOW IN AND OUT OF THE LUNGS. ANORO ELLIPTA IS AVAILABLE AS AN INHALATION POWDER CONTAINING 62. 5MCG UMECLIDINIUM AND 25MCG OF VILANTEROL.
ANORO ELLIPTA IS EXPECTED TO BE AVAILABLE THE FIRST QUARTER OF 2014.
Warnings/Precautions THE DRUG CARRIES A BOXED WARNING THAT LABAS INCREASE THE RISK OF ASTHMA-RELATED DEATH.
THE SAFETY AND EFFICACY OF ANORO ELLIPTA IN PATIENTS WITH ASTHMA HAVE NOT BEEN ESTABLISHED, AND IT IS NOT APPROVED FOR THE TREATMENT OF ASTHMA. ANORO ELLIPTA SHOULD NOT BE USED AS A RESCUE THERAPY TO TREAT SUDDEN BREATHING PROBLEMS (ACUTE BRONCHOSPASM). Contraindications – HYPERSENSITIVITY TO UMECLIDINUM, VILANTEROL, OR ANY COMPONENT OF THE FORMULATION. – THOSE WITH A HYPERSENSITIVITY TO MILK PROTEINS. – PATIENTS WHO CURRENTLY TAKE INDACATEROL
Black Box Warnings LONG-ACTING BETA2-ADRENERGIC AGONISTS (LABAS), SUCH AS VILANTEROL, INCREASE THE RISK FOR ASTHMA-RELATED DEATH A PLACEBO-CONTROLLED TRIAL WITH ANOTHER LABA (SALMETEROL) SHOWED AN INCREASE IN ASTHMA-RELATED DEATHS;
THIS FINDING IS CONSIDERED A CLASS EFFECT OF ALL LABA, INCLUDING VILANTEROL SAFETY AND EFFICACY NOT ESTABLISHED IN PATIENTS WITH ASTHMA; NOT APPROVED FOR TREATMENT OF ASTHMA.
Adverse Effects (1-10%) – PHARYNGITIS – DIARRHEA – PAIN IN EXTREMITY – NECK PAIN – CHEST PAIN – SINUSITIS Pregnancy Category ANORO ELLIPTA HAS A PREGNANCY CATEGORY OF “C”, AND SINCE THE DRUG IS A BETA-AGONIST, THERE IS POTENTIAL TO AFFECT UTERINE CONTRACTILITY IF ADMINISTERED DURING LABOR. IT IS UNKNOWN WHETHER THE DRUG IS DISTRIBUTED IN HUMAN BREAST MILK. Pharmacology ELIMINATION – HALF-LIFE:
11 HOURS EXCRETION – UMECLIDINIUM (IV): 58% FECES; 22% URINE – UMECLIDINIUM (PO): 92% FECES; <1% URINE – VILANTEROL (PO): 30% FECES; 70% URINE AWP – NONE AVAILABLE – SIMILAR DRUGS INCLUDE: OSPIRIVA (TIOTROPIUM BROMIDE INHALATION POWDER) 30-DAY SUPPLY: $261. 99 OATROVENT (IPRATROPIUM BROMIDE INHALATION AEROSOL) ONE 12. 9G INHALER: