Arnuity Ellipta 100mcg Oral Inh 30
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, Inhaled
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Aug 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Arnuity Ellipta is an inhaled medicine that contains a corticosteroid called fluticasone. It works by reducing inflammation in your lungs, which helps to prevent asthma symptoms like wheezing and shortness of breath. It is used daily to control asthma and is not 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 feel well. 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, but do not swallow the rinse water. Instead, spit it out.
If you are using multiple inhaled medications, consult your doctor to determine 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 inhaler.
Avoid breathing out into the inhaler. Close the inhaler after each use.
Do not disassemble the device or wash it. Additionally, do not use it with a spacer, and refrain from breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing it or submerging it in water.
Storage and Disposal
Store the medication at room temperature in a dry location, 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 feel well. 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, but do not swallow the rinse water. Instead, spit it out.
If you are using multiple inhaled medications, consult your doctor to determine 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 inhaler.
Avoid breathing out into the inhaler. Close the inhaler after each use.
Do not disassemble the device or wash it. Additionally, do not use it with a spacer, and refrain from breathing out into the device.
Cleaning and Maintenance
Clean the mouthpiece by gently wiping it with a dry tissue or cloth. Avoid washing it or submerging it in water.
Storage and Disposal
Store the medication at room temperature in a dry location, 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 Arnuity Ellipta regularly, once a day, at the same time each day, even if you feel well. It is a maintenance medication, not a rescue inhaler.
- Do not use Arnuity Ellipta for sudden asthma attacks; use your rescue inhaler (e.g., albuterol) for acute symptoms.
- Rinse your mouth with water and spit it out after each dose to help prevent oral thrush (a fungal infection in the mouth). Do not swallow the water.
- Do not stop using Arnuity Ellipta suddenly without talking to your doctor, as this can lead to withdrawal symptoms or worsening asthma.
- Keep track of your asthma symptoms and peak flow readings (if applicable) and report any worsening to your doctor.
- Avoid exposure to asthma triggers (e.g., allergens, irritants, smoke).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
100 mcg once daily
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
asthma_maintenance:
100 mcg once daily; may increase to 200 mcg once daily if needed for severe asthma.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5 to 11 years: 50 mcg once daily. If inadequate control, may increase to 100 mcg once daily.
Adolescent:
12 years and older: 100 mcg once daily; may increase to 200 mcg once daily if needed for severe asthma.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; systemic exposure is low.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; increased systemic exposure possible. Monitor for corticosteroid effects.
Pharmacology
Mechanism of Action
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It binds to glucocorticoid receptors in the cytoplasm, leading to a cascade of effects including the inhibition of inflammatory cell migration and activity, reduction of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines), and suppression of airway hyperresponsiveness. This action reduces inflammation in the airways, thereby improving asthma symptoms and lung function.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 15.2% (oral inhalation, systemic)
Tmax:
0.5 to 1 hour
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
661 L (high)
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited (due to high protein binding and rapid metabolism)
Elimination:
HalfLife:
Approximately 24 hours (terminal half-life)
Clearance:
58.7 L/hr (systemic)
ExcretionRoute:
Primarily fecal (approximately 90% of orally administered dose), <1% renal
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (initial improvement)
PeakEffect:
Several days to 1-2 weeks (maximal therapeutic effect)
DurationOfAction:
24 hours (allows once-daily dosing)
Safety & Warnings
Side Effects
Urgent 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Feeling extremely tired, weak, or irritable; trembling; rapid heartbeat, confusion, sweating, or dizziness (especially if you've missed a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Respiratory 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 Possible 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 discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea, upset stomach, or vomiting
* Muscle pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Feeling extremely tired, weak, or irritable; trembling; rapid heartbeat, confusion, sweating, or dizziness (especially if you've missed a dose or recently stopped taking this medication)
Flushing
Redness or white patches in the mouth or throat
Mouth irritation or sores
Bone or joint pain
Changes in vision
Changes in voice
Difficulty speaking
Respiratory 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 Possible 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 discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Common cold symptoms
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea, upset stomach, or vomiting
* Muscle pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 (e.g., increased wheezing, shortness of breath, cough, or need for rescue inhaler)
- Signs of oral thrush (white patches in the mouth or throat)
- Signs of infection (e.g., fever, chills, body aches, increased mucus, change in mucus color)
- Symptoms of adrenal insufficiency (e.g., severe tiredness, weakness, nausea, vomiting, dizziness, low blood pressure) if stopping the medication suddenly after prolonged high-dose use.
- Vision changes (e.g., blurred vision, eye pain) which could indicate glaucoma or cataracts.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a milk allergy.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat HIV, infections, depression, and other conditions should not be taken with this medication. Your doctor or pharmacist can advise you on potential interactions.
Please 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 crucial to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a milk allergy.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain drugs used to treat HIV, infections, depression, and other conditions should not be taken with this medication. Your doctor or pharmacist can advise you on potential interactions.
Please 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 crucial to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of using your rescue inhaler, contact your doctor immediately.
You may not notice the full effects of this medication for several weeks. If you have been taking this medication for an extended period, consult with your doctor before stopping treatment, as you may need to gradually taper off the medication to avoid potential side effects.
While taking this medication, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. If you have not previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.
When transitioning from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Monitor for symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these signs.
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 indicating that you may need extra steroids in these situations.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and have your eye pressure checked regularly if you are taking this medication for an extended period.
Prolonged use of this medication may also lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Follow your doctor's recommendations for bone density testing.
If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, as the risk may be higher in younger patients. This medication may affect growth in children and teens, and regular growth checks may be necessary. Discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to you and your baby.
You may not notice the full effects of this medication for several weeks. If you have been taking this medication for an extended period, consult with your doctor before stopping treatment, as you may need to gradually taper off the medication to avoid potential side effects.
While taking this medication, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. If you have not previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor promptly.
When transitioning from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Monitor for symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these signs.
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 indicating that you may need extra steroids in these situations.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and have your eye pressure checked regularly if you are taking this medication for an extended period.
Prolonged use of this medication may also lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at higher risk for osteoporosis or if you have any questions. Follow your doctor's recommendations for bone density testing.
If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, as the risk may be higher in younger patients. This medication may affect growth in children and teens, and regular growth checks may be necessary. Discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to the low systemic absorption of inhaled fluticasone furoate.
- Chronic overdose or excessive use may lead to signs of hypercorticism (e.g., Cushing's syndrome) and adrenal suppression (e.g., fatigue, weight loss, nausea, vomiting).
What to Do:
In case of suspected overdose, seek medical attention. Management is supportive. For chronic overdose, gradual reduction of the dose may be necessary under medical supervision to avoid adrenal crisis. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat, clarithromycin, itraconazole, telithromycin, nefazodone): May significantly increase systemic exposure to fluticasone furoate, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression).
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice): May increase systemic exposure to a lesser extent, but caution is still advised.
Monitoring
Baseline Monitoring
Asthma symptom control
Rationale: To establish baseline disease severity and response to therapy.
Timing: Prior to initiation of therapy
Pulmonary function tests (e.g., FEV1)
Rationale: To assess baseline lung function and monitor therapeutic efficacy.
Timing: Prior to initiation of therapy
Growth (in pediatric patients)
Rationale: To establish baseline growth velocity, as inhaled corticosteroids can affect growth.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma symptom control (e.g., frequency of symptoms, rescue inhaler use)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Minimal symptoms, infrequent rescue inhaler use
Action Threshold: Worsening symptoms, increased rescue inhaler use, nocturnal awakenings
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Improved or stable lung function
Action Threshold: Decline in FEV1 or lack of improvement
Oral cavity inspection (for candidiasis)
Frequency: Regularly (e.g., at each follow-up visit)
Target: No signs of oral thrush
Action Threshold: Presence of white patches in mouth/throat
Growth velocity (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity for age
Action Threshold: Significant decrease in growth velocity
Signs of systemic corticosteroid effects (e.g., adrenal suppression, bone mineral density, ocular effects)
Frequency: Periodically, especially with high doses or long-term use
Target: Absence of systemic effects
Action Threshold: Symptoms of Cushing's, bone pain, vision changes
Symptom Monitoring
- Worsening asthma symptoms (e.g., increased shortness of breath, wheezing, cough)
- Increased need for rescue inhaler (e.g., albuterol)
- Oral candidiasis (white patches in mouth or throat)
- Signs of infection (e.g., fever, chills, increased sputum)
- Adrenal insufficiency symptoms (e.g., fatigue, nausea, vomiting, dizziness) if abruptly discontinued after prolonged high-dose use
- Vision changes (e.g., blurred vision, glaucoma, cataracts) with long-term use
Special Patient Groups
Pregnancy
Generally considered low risk. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma poses a greater risk to both mother and fetus than inhaled corticosteroids.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally low systemic exposure suggests low risk.
Second Trimester:
No specific increased risks identified.
Third Trimester:
No specific increased risks identified.
Lactation
Low systemic exposure of fluticasone furoate in the mother suggests that the amount excreted in breast milk would be negligible. Considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a small reduction in growth. The lowest effective dose should be used. Approved for asthma in patients 5 years and older.
Geriatric Use
No dosage adjustment is required based on age. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Clinical Information
Clinical Pearls
- Arnuity Ellipta is a once-daily inhaled corticosteroid for maintenance treatment of asthma; it is NOT a rescue inhaler for acute bronchospasm.
- Patients should be instructed on proper inhaler technique and to rinse their mouth with water and spit after each dose to minimize the risk of oral candidiasis.
- Regular follow-up is crucial to assess asthma control, monitor for adverse effects, and ensure proper technique.
- Systemic effects are rare at recommended doses but can occur, especially with higher doses or in sensitive individuals. Monitor for signs of adrenal suppression or bone density changes with long-term use.
- Counsel patients on the importance of adherence, even when feeling well, to maintain asthma control.
Alternative Therapies
- Other inhaled corticosteroids (ICS): Fluticasone propionate (Flovent HFA/Diskus), Budesonide (Pulmicort Flexhaler/Respules), Mometasone (Asmanex Twisthaler), Beclomethasone (Qvar RediHaler), Ciclesonide (Alvesco).
- ICS/LABA combinations (if asthma is not well-controlled on ICS alone): Fluticasone/salmeterol (Advair Diskus/HFA), Budesonide/formoterol (Symbicort), Mometasone/formoterol (Dulera), Fluticasone furoate/vilanterol (Breo Ellipta - for COPD and asthma).
- Leukotriene receptor antagonists (e.g., montelukast)
- Long-acting beta-agonists (LABA) - NOT as monotherapy for asthma.
- Oral corticosteroids (for severe exacerbations or refractory asthma, short-term use).
Cost & Coverage
Average Cost:
$200 - $300 per 30 doses (1 inhaler)
Insurance Coverage:
Tier 2 or Tier 3 (Preferred Brand 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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.