ANORO ELLIPTA*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Umecilidinium and Vilaterol Inhalation powder - mg,
Umecilidinium and Vilaterol Inhalation powder - mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Air flow obstruction in patients with chronic obstructive pulmonary disease (COPD)
List Of Drugs:
- Umeclidinium and Vilanterol - Bronchodilators
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole):
Use with caution. May cause cardiovascular effects.
Monoamine oxidase inhibitors and tricyclic antidepressants:
Use with extreme caution. May potentiate effect of vilanterol
on cardiovascular system.
Beta-blockers: Use with caution. May block bronchodilatory effects
of beta-agonists and produce severe bronchospasm.
Diuretics: Use with caution. Electrocardiographic changes and/or
hypokalemia associated with non–potassium-sparing diuretics
may worsen with concomitant beta-agonists.
Anticholinergics: May interact additively with concomitantly used
anticholinergic medications. Avoid administration of ANORO ELLIPTA
with other anticholinergic-containing drugs.
Indication:
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder),
for oral inhalation
Initial U.S. Approval: 2013
WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.
Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase
the risk of asthma-related death.
A placebo-controlled trial with another LABA (salmeterol) showed an increase
in asthma-related deaths. This finding with salmeterol is considered a
class effect of all LABA. (5.1)
The safety and efficacy of ANORO ELLIPTA in patients with asthma have
not been established. ANORO ELLIPTA is not indicated for the treatment
of asthma. (5.1)
Drug Name- Anoro Ellipta
Active Ingredient - Unmeclidinium and Vilanterol Inhalation
Once daily long term maintenance of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD)
Indication-
Long term maintenance of airflow obstruction in patients with
chronic obstructive disease (COPD)
Approved by FDA on 18-12--2013 (Ref- FDA approved List- 2013)
Adverse Reaction:
Most common adverse reactions (incidence greater than or equal to 1%
and more common than placebo) are
pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea,
pain in extremity, muscle spasms, neck pain, and chest pain.
Contra-Indications:
CONTRAINDICATIONS
Severe hypersensitivity to milk proteins or any ingredients.
WARNINGS AND PRECAUTIONS
LABA increase the risk of asthma-related death.
Do not initiate in acutely deteriorating COPD or to treat acute symptoms.
Do not use in combination with an additional medicine containing a LABA
because of risk of overdose.
If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and
institute alternative therapy.
Use with caution in patients with cardiovascular disorders because
of beta-adrenergic stimulation.
Use with caution in patients with convulsive disorders, thyrotoxicosis,
diabetes mellitus, and ketoacidosis.
Worsening of narrow-angle glaucoma may occur. Use with caution in patients
with narrow-angle glaucoma and instruct patients to contact a physician
immediately if symptoms occur.
Worsening of urinary retention may occur. Use with caution in patients
with prostatic hyperplasia or bladder-neck obstruction and instruct patients
to contact a physician immediately if symptoms occur.
Be alert to hypokalemia and hyperglycemia.
Dosages/ Overdosage Etc:
Indication-
Long term maintenance of airflow obstruction in patients with
chronic obstructive disease (COPD)
INDICATIONS AND USAGE
ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic,
and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated
for the long-term, once-daily, maintenance treatment of airflow obstruction
in patients with chronic obstructive pulmonary disease (COPD).
Important limitations: Not indicated for relief of acute bronchospasm
or for the treatment of asthma.
DOSAGE AND ADMINISTRATION
For oral inhalation only.
Maintenance treatment of COPD: 1 inhalation of ANORO ELLIPTA once daily. (2)
DOSAGE FORMS AND STRENGTHS
Inhalation Powder. Inhaler containing 2 foil blister strips of powder
formulation for oral inhalation. One strip contains umeclidinium
62.5 mcg per blister and the other contains vilanterol 25 mcg per blister.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and
Instructions for Use).
Asthma-Related Death
Inform patients that LABA, such as vilanterol, one of the active ingredients in
ANORO ELLIPTA, increase the risk of asthma-related death.
ANORO ELLIPTA is not indicated for the treatment of asthma.
Not for Acute Symptoms
Inform patients that ANORO ELLIPTA is not meant to relieve acute symptoms
of COPD and extra doses should not be used for that purpose. Advise patients
to treat acute symptoms with an inhaled, short-acting beta2-agonist such
as albuterol. Provide patients with such medicine and instruct them in how
it should be used.
Instruct patients to seek medical attention immediately if they experience
any of the following:
Decreasing effectiveness of inhaled, short-acting beta2-agonists
Need for more inhalations than usual of inhaled, short-acting beta2-agonists
Significant decrease in lung function as outlined by the physician
Tell patients they should not stop therapy with ANORO ELLIPTA without
physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-Acting Beta2-Agonists
Instruct patients not to use other medicines containing a LABA. Patients should not
use more than the recommended once-daily dose of ANORO ELLIPTA.
Instruct patients who have been taking inhaled, short-acting beta2-agonists
on a regular basis to discontinue the regular use of these products and use
them only for the symptomatic relief of acute symptoms.
Paradoxical Bronchospasm
As with other inhaled medicines, ANORO ELLIPTA can cause paradoxical
bronchospasm. If paradoxical bronchospasm occurs, instruct patients to
discontinue ANORO ELLIPTA and contact their healthcare provider right away.
Risks Associated with Beta-Agonist Therapy
Inform patients of adverse effects associated with beta2-agonists, such as
palpitations, chest pain, rapid heart rate, tremor, or nervousness.
Worsening of Narrow-Angle Glaucoma
Instruct patients to be alert for signs and symptoms of acute narrow-angle
glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored
images in association with red eyes from conjunctival congestion
and corneal edema). Instruct patients to consult a physician immediately
if any of these signs or symptoms develops.
Worsening of Urinary Retention
Instruct patients to be alert for signs and symptoms of urinary retention
(e.g., difficulty passing urine, painful urination). Instruct patients to consult
a physician immediately if any of these signs or symptoms develops.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
ANORO ELLIPTA contains both umeclidinium and vilanterol.
The mechanisms of action described below for the individual components
apply to ANORO ELLIPTA. These drugs represent 2 different classes of
medications (an anticholinergic and a LABA) that have different effects on
clinical and physiological indices
2 Pharmacokinetics
Linear pharmacokinetics was observed for umeclidinium (62.5 to 500 mcg) and
vilanterol (25 to 100 mcg).
Absorption
Umeclidinium: Umeclidinium plasma levels may not predict therapeutic effect.
Following inhaled administration of umeclidinium in healthy subjects,
Cmax occurred at 5 to 15 minutes. Umeclidinium is mostly absorbed from the lung
after inhaled doses with minimum contribution from oral absorption.
Following repeat dosing of inhaled ANORO ELLIPTA, steady state was achieved
within 14 days with up to 1.8-fold accumulation.
Vilanterol: Vilanterol plasma levels may not predict therapeutic effect.
Following inhaled administration of vilanterol in healthy subjects,
Cmax occurred at 5 to 15 minutes. Vilanterol is mostly absorbed from the lung
after inhaled doses with negligible contribution from oral absorption.
Following repeat dosing of inhaled ANORO ELLIPTA, steady state was achieved
within 14 days with up to 1.7-fold accumulation
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Teratogenic Effects
Pregnancy Category C. There are no adequate and well-controlled trials of
ANORO ELLIPTA or its individual components, umeclidinium and vilanterol,
in pregnant women. Because animal reproduction studies are not always
predictive of human response,
ANORO ELLIPTA should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Women should be advised to contact their physicians if they become pregnant
while taking ANORO
2. Nursing Mothers
ANORO ELLIPTA It is not known whether ANORO ELLIPTA is excreted in human
breast milk. Because many drugs are excreted in human milk, caution should
be exercised when ANORO ELLIPTA is administered to a nursing woman.
3.Pediatric Use
ANORO ELLIPTA is not indicated for use in children. The safety and efficacy in
pediatric patients have not been established.
4. Geriatric Use
Based on available data, no adjustment of the dosage of ANORO ELLIPTA in
geriatric patients is necessary, but greater sensitivity in some older individuals
cannot be ruled out.
Clinical
