Arnuity Ellipta 100mcg Oral Inh14
It is used to treat asthma.Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
Drug Class
Corticosteroid, Inhalant; Anti-inflammatory
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Apr 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Arnuity Ellipta is an inhaled medication used once daily to help prevent asthma attacks and improve breathing by reducing inflammation in the lungs. It is a maintenance medicine and should not be used for sudden breathing problems.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling better. Establish a routine by taking the medication at the same time every day.
Important Administration Instructions
Use the medication for inhalation only.
After each use, rinse your mouth with water and spit it out - do not swallow the rinse water.
If you are using multiple inhaled medications, consult your doctor about which one to use first.
Only prepare a dose when you are ready to take it. Preparing a dose and then closing the inhaler without taking it can waste the medication and potentially damage the device.
Avoid breathing out into the inhaler.
Close the inhaler after each use.
Do not disassemble the device or wash it.
Do not use the inhaler with a spacer.
Avoid breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing or submerging it in water.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms.
Keep the medication in its foil packaging until you are ready to use it. Be aware of the expiration date or the duration the medication remains effective after opening the foil.
Dispose of the inhaler after the specified time period or when the dose counter reaches "0", whichever occurs first.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling better. Establish a routine by taking the medication at the same time every day.
Important Administration Instructions
Use the medication for inhalation only.
After each use, rinse your mouth with water and spit it out - do not swallow the rinse water.
If you are using multiple inhaled medications, consult your doctor about which one to use first.
Only prepare a dose when you are ready to take it. Preparing a dose and then closing the inhaler without taking it can waste the medication and potentially damage the device.
Avoid breathing out into the inhaler.
Close the inhaler after each use.
Do not disassemble the device or wash it.
Do not use the inhaler with a spacer.
Avoid breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing or submerging it in water.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms.
Keep the medication in its foil packaging until you are ready to use it. Be aware of the expiration date or the duration the medication remains effective after opening the foil.
Dispose of the inhaler after the specified time period or when the dose counter reaches "0", whichever occurs first.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Use regularly as prescribed, even when feeling well, to maintain asthma control.
- Do not stop using Arnuity Ellipta suddenly without consulting your doctor.
- Rinse your mouth with water and spit it out after each use to help prevent oral thrush (a fungal infection in the mouth). Do not swallow the rinse water.
- Always have a rescue inhaler (e.g., albuterol) available for sudden breathing problems.
- Maintain good oral hygiene.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
100 mcg once daily
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
asthma:
100 mcg or 200 mcg once daily
COPD:
100 mcg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5-11 years: 50 mcg once daily for asthma. Not established for COPD.
Adolescent:
12 years and older: 100 mcg or 200 mcg once daily for asthma. Not established for COPD.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No specific considerations; low systemic exposure
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
Monitor for systemic corticosteroid effects; use with caution
Pharmacology
Mechanism of Action
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., cytokines, chemokines, eicosanoids) and suppressing the migration and activity of inflammatory cells (e.g., eosinophils, mast cells, lymphocytes, macrophages). This action reduces airway hyperresponsiveness and inflammation in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (oral), ~15% (inhaled, systemic)
Tmax:
0.5-1 hour
FoodEffect:
Not applicable for inhaled administration
Distribution:
Vd:
Approximately 661 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 24 hours (terminal half-life)
Clearance:
High systemic clearance (approximately 65.4 L/hr)
ExcretionRoute:
Primarily fecal (as metabolites), minimal renal excretion
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Within 24 hours
PeakEffect:
1-2 weeks of regular use
DurationOfAction:
24 hours (allowing once-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Symptoms of withdrawal, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness (if you miss a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or mouth sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Breathing Problems: A Life-Threatening Emergency
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Signs of a common cold
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Symptoms of withdrawal, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness (if you miss a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or mouth sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Breathing Problems: A Life-Threatening Emergency
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Signs of a common cold
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma symptoms or increased need for your rescue inhaler
- Signs of oral thrush (white patches in your mouth or throat)
- Signs of infection (fever, chills, body aches, increased mucus, changes in mucus color)
- Signs of an allergic reaction (rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing)
- Vision changes (e.g., blurred vision, eye pain)
- Unexplained weight gain, muscle weakness, or fatigue (signs of systemic corticosteroid effects)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance on potential interactions.
It is important to note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.
To ensure your safety, it is vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions with your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug and should not be taken concurrently. Your doctor or pharmacist can provide guidance on potential interactions.
It is important to note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.
To ensure your safety, it is vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions with your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Condition
If you experience any worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately. It may take several weeks to feel the full effects of this medication.
Stopping Treatment
If you have been taking this medication for an extended period, consult with your doctor before stopping. Your doctor may recommend gradually tapering off the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce this risk, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and avoid exposure to chickenpox and measles if you have not had these illnesses before. If you are exposed to chickenpox or measles, notify your doctor promptly.
Special Considerations
When transitioning from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.
In the event of a severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert healthcare providers of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor to discuss this risk, and have your eye pressure checked regularly if you are taking this medication long-term.
Bone Health
Long-term use of this medication may also increase your risk of developing osteoporosis (weak bones). Discuss your individual risk with your doctor, and follow their recommendations for bone density testing.
Pediatric Use
If you are a parent or caregiver of a child taking this medication, be aware that the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and regular growth checks may be necessary. Consult with your child's doctor to discuss these potential risks.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of this medication for both you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Condition
If you experience any worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more frequently, contact your doctor immediately. It may take several weeks to feel the full effects of this medication.
Stopping Treatment
If you have been taking this medication for an extended period, consult with your doctor before stopping. Your doctor may recommend gradually tapering off the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce this risk, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and avoid exposure to chickenpox and measles if you have not had these illnesses before. If you are exposed to chickenpox or measles, notify your doctor promptly.
Special Considerations
When transitioning from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects, including weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.
In the event of a severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert healthcare providers of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor to discuss this risk, and have your eye pressure checked regularly if you are taking this medication long-term.
Bone Health
Long-term use of this medication may also increase your risk of developing osteoporosis (weak bones). Discuss your individual risk with your doctor, and follow their recommendations for bone density testing.
Pediatric Use
If you are a parent or caregiver of a child taking this medication, be aware that the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and regular growth checks may be necessary. Consult with your child's doctor to discuss these potential risks.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to low systemic absorption.
- Chronic overdose may lead to signs of hypercorticism (e.g., Cushing's syndrome, adrenal suppression), including fatigue, weakness, nausea, vomiting, and hypotension.
What to Do:
Call 1-800-222-1222 (Poison Control) or seek immediate medical attention. Treatment is supportive. Gradual withdrawal of the medication may be necessary if chronic overdose has led to adrenal suppression.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil)
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1, FVC)
Rationale: To assess baseline lung function and disease severity.
Timing: Prior to initiation of therapy.
Ophthalmic examination
Rationale: Long-term inhaled corticosteroid use may increase risk of glaucoma or cataracts.
Timing: Prior to initiation, especially for patients with pre-existing conditions or risk factors.
Routine Monitoring
Asthma symptom control (e.g., frequency of rescue inhaler use, nocturnal awakenings, activity limitation)
Frequency: At each follow-up visit (e.g., every 1-3 months initially, then every 3-12 months)
Target: Well-controlled asthma symptoms
Action Threshold: Worsening symptoms, increased rescue inhaler use, or exacerbations.
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Improvement towards patient's personal best or predicted values
Action Threshold: Lack of improvement or worsening FEV1.
Growth monitoring (pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity
Action Threshold: Growth retardation.
Signs/symptoms of oral candidiasis (thrush)
Frequency: At each visit
Target: Absence of oral thrush
Action Threshold: Presence of white patches in mouth/throat.
Symptom Monitoring
- Worsening asthma symptoms
- Increased need for rescue inhaler
- Signs of oral candidiasis (white patches in mouth/throat)
- Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, muscle weakness)
- Vision changes
- Signs of infection (fever, chills, increased mucus)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy when asthma control is needed. Uncontrolled asthma poses greater risks to both mother and fetus than the potential risks associated with inhaled corticosteroids. Use the lowest effective dose.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk due to low systemic absorption.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Low systemic absorption suggests minimal transfer into breast milk. Considered compatible with breastfeeding. Monitor infant for adverse effects.
Infant Risk:
Low
Pediatric Use
Approved for asthma in children 5 years and older. Monitor growth velocity regularly. Risk of adrenal suppression and growth retardation, though generally low with recommended doses.
Geriatric Use
No specific dose adjustment needed. Monitor for age-related comorbidities and potential for increased susceptibility to systemic corticosteroid effects (e.g., osteoporosis, cataracts, glaucoma).
Clinical Information
Clinical Pearls
- Arnuity Ellipta is a once-daily inhaled corticosteroid, which can improve patient adherence compared to twice-daily regimens.
- It is a maintenance medication and should never be used for acute bronchospasm; patients must have a fast-acting rescue inhaler available.
- Proper inhaler technique is critical for effective drug delivery. Patients should be thoroughly instructed and periodically re-evaluated on their technique.
- Advise patients to rinse their mouth with water and spit after each use to minimize the risk of oral candidiasis (thrush).
- Patients should be educated not to stop the medication abruptly, as this can lead to worsening asthma symptoms or, in rare cases, adrenal insufficiency if systemic absorption has occurred.
Alternative Therapies
- Other inhaled corticosteroids (ICS) such as fluticasone propionate (Flovent), budesonide (Pulmicort), mometasone (Asmanex), ciclesonide (Alvesco), beclomethasone (Qvar).
Cost & Coverage
Average Cost:
Variable, check current pricing per 14 or 30 dose inhaler
Insurance Coverage:
Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.