Arnuity Ellipta 200mcg 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, Inhalant; Anti-asthmatic
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Not 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 furoate. It works by reducing inflammation in your lungs, which helps to prevent asthma symptoms like wheezing, shortness of breath, and coughing. It is used once a day to help control your asthma over time, but it is not for sudden breathing problems.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. Establish a routine by taking this medication at the same time every day.
Important Administration Instructions
This medication is 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 about which one to use first.
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without taking it, the medication will be wasted and the inhaler may be damaged.
Avoid breathing out into the inhaler. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. This medication should not be used with a spacer, and you should not breathe out into the device.
To clean the mouthpiece, gently wipe it with a dry tissue or cloth. Avoid washing it or submerging it in water.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in its foil packaging until you are ready to use it. Be aware of the expiration date or the number of days this brand of medication remains effective after opening the foil. Dispose of the inhaler after this 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 correctly, follow your doctor's instructions and read all the information provided. Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. Establish a routine by taking this medication at the same time every day.
Important Administration Instructions
This medication is 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 about which one to use first.
Only prepare a dose when you are ready to take it. If you prepare a dose and then close the inhaler without taking it, the medication will be wasted and the inhaler may be damaged.
Avoid breathing out into the inhaler. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. This medication should not be used with a spacer, and you should not breathe out into the device.
To clean the mouthpiece, gently wipe it with a dry tissue or cloth. Avoid washing it or submerging it in water.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in its foil packaging until you are ready to use it. Be aware of the expiration date or the number of days this brand of medication remains effective after opening the foil. Dispose of the inhaler after this 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 every day, even if you feel well, to keep your asthma under control.
- Do not use Arnuity Ellipta for sudden asthma attacks; use your rescue inhaler (e.g., albuterol) for those.
- 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.
- Learn and practice the correct inhaler technique as demonstrated by your healthcare provider. Incorrect technique can reduce the effectiveness of the medication.
- Keep track of your asthma symptoms and peak flow readings (if applicable) and report any worsening to your doctor.
- Avoid known asthma triggers (e.g., allergens, irritants).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
100 mcg or 200 mcg once daily by oral inhalation
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
asthma:
Initial dose based on prior asthma therapy. Max dose 200 mcg once daily.
COPD:
100 mcg once daily (not indicated for COPD in US, but for asthma)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5 to 11 years: 50 mcg once daily. 12 years and older: 100 mcg or 200 mcg once daily.
Adolescent:
12 years and older: 100 mcg or 200 mcg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No specific recommendations; low systemic exposure makes dialysis unlikely to be relevant.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Use with caution; increased systemic exposure may occur. 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 of target cells, leading to the formation of a steroid-receptor complex. This complex translocates to the nucleus, where it modulates gene expression, resulting in the inhibition of inflammatory cells (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines). This action reduces airway hyperresponsiveness and inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (oral), low systemic exposure from inhalation
Tmax:
0.5-1 hour (inhalation)
FoodEffect:
Not applicable for inhaled administration.
Distribution:
Vd:
~661 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
~24 hours (terminal)
Clearance:
High systemic clearance (1270 mL/min)
ExcretionRoute:
Primarily fecal (metabolites), <1% renal
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (initial improvement)
PeakEffect:
Several days to weeks (maximal therapeutic effect)
DurationOfAction:
24 hours (allowing 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, 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 that may occur if you miss a dose or recently stopped taking this medication, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness
Other severe side effects, including:
+ 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
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 Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical attention:
Signs of a common cold
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
Reporting Side Effects
This is not an exhaustive list of possible 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 notice 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 that may occur if you miss a dose or recently stopped taking this medication, such as:
+ Feeling extremely tired, weak, or irritable
+ Trembling
+ Rapid heartbeat
+ Confusion
+ Sweating
+ Dizziness
Other severe side effects, including:
+ 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
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 Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical attention:
Signs of a common cold
Nose or throat irritation
Headache
Feeling tired or weak
Flu-like symptoms
Diarrhea
Stomach upset or vomiting
Muscle pain
Reporting Side Effects
This is not an exhaustive list of possible 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 (e.g., increased wheezing, shortness of breath, cough)
- Increased need for your rescue inhaler
- Signs of oral thrush (white patches in your mouth or throat, soreness)
- Signs of infection (fever, chills, increased mucus, change in mucus color)
- Blurred vision or eye pain (rare, may indicate glaucoma or cataracts)
- Unexplained bruising or skin thinning (rare, signs of systemic corticosteroid effects)
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing - seek immediate medical attention)
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. 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 advise you on potential interactions and help you determine which medications are safe to take with this drug.
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 vital to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all 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. 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 advise you on potential interactions and help you determine which medications are safe to take with this drug.
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 vital to:
Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all 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, as you may need to gradually taper off the medication to avoid potential side effects.
As this medication can increase your risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding 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 people 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 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 medical professionals that you may need extra steroids in these situations.
Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk, and have your eye pressure checked regularly if you are taking this medication for an extended period.
Prolonged use of this medication can also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor, and consider having a bone density test as recommended.
If you are a child or teenager taking this medication, your doctor will need to monitor you closely, as the risk of certain side effects may be higher in younger patients. This medication may also affect growth in children and teens, so regular growth checks may be necessary.
If you are pregnant, plan to become pregnant, or are 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, as you may need to gradually taper off the medication to avoid potential side effects.
As this medication can increase your risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding 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 people 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 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 medical professionals that you may need extra steroids in these situations.
Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk, and have your eye pressure checked regularly if you are taking this medication for an extended period.
Prolonged use of this medication can also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor, and consider having a bone density test as recommended.
If you are a child or teenager taking this medication, your doctor will need to monitor you closely, as the risk of certain side effects may be higher in younger patients. This medication may also affect growth in children and teens, so regular growth checks may be necessary.
If you are pregnant, plan to become pregnant, or are 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 low systemic absorption. Chronic overdose may lead to signs of hypercorticism (e.g., Cushing's syndrome, adrenal suppression), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar.
What to Do:
In case of suspected overdose, contact a poison control center immediately. For the U.S., call 1-800-222-1222. Treatment is supportive. Chronic overdose may require gradual withdrawal of the medication under medical supervision to prevent adrenal insufficiency.
Drug Interactions
Major Interactions
- Ritonavir (strong CYP3A4 inhibitor)
Moderate Interactions
- Ketoconazole (strong CYP3A4 inhibitor)
- Itraconazole (strong CYP3A4 inhibitor)
- Clarithromycin (moderate CYP3A4 inhibitor)
- Atazanavir (strong CYP3A4 inhibitor)
- Nelfinavir (strong CYP3A4 inhibitor)
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess severity of asthma.
Timing: Prior to initiation of therapy.
Asthma Control Assessment
Rationale: To evaluate baseline symptom frequency and impact on daily life.
Timing: Prior to initiation of therapy.
Routine Monitoring
Asthma Symptoms and Control
Frequency: Regularly (e.g., at each follow-up visit, patient self-monitoring)
Target: Well-controlled asthma (minimal symptoms, no exacerbations)
Action Threshold: Worsening symptoms, increased rescue inhaler use, nocturnal awakenings, or decreased peak flow readings may indicate need for dose adjustment or re-evaluation.
Pulmonary Function Tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-12 months, or as clinically indicated)
Target: Maintenance or improvement of baseline FEV1
Action Threshold: Significant decline in FEV1 may indicate worsening asthma or inadequate control.
Oral Cavity Inspection
Frequency: Regularly (e.g., at each follow-up visit)
Target: Absence of oral candidiasis
Action Threshold: Presence of white patches or soreness may indicate oral candidiasis, requiring antifungal treatment and proper rinsing technique.
Growth (Pediatric Patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity for age
Action Threshold: Growth retardation may occur with long-term use of inhaled corticosteroids; consider lowest effective dose.
Signs/Symptoms of Systemic Corticosteroid Effects
Frequency: Periodically, especially with higher doses or concomitant strong CYP3A4 inhibitors
Target: Absence of signs of adrenal suppression, Cushingoid features, bone mineral density loss, cataracts, glaucoma.
Action Threshold: Any signs warrant investigation and potential dose reduction or discontinuation.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Increased cough
- Increased need for rescue inhaler (e.g., albuterol)
- Nighttime asthma symptoms
- Oral thrush (white patches in mouth/throat)
- Hoarseness or dysphonia
- Blurred vision or eye pain (rare, for glaucoma/cataracts)
- Unexplained bruising or skin thinning (rare, systemic effects)
Special Patient Groups
Pregnancy
The decision to use Arnuity Ellipta during pregnancy should be based on a careful assessment of the benefits and risks. Uncontrolled asthma poses risks to both the mother and fetus. While animal studies have shown reproductive toxicity with high doses of fluticasone furoate, human data are limited. Due to low systemic absorption, the risk to the fetus is considered low. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show potential for teratogenicity at high doses. Clinical benefit vs. risk should be weighed.
Second Trimester:
Continued need for asthma control is important. Low systemic absorption minimizes fetal exposure.
Third Trimester:
Continued need for asthma control. Monitor for signs of adrenal suppression in neonates born to mothers receiving high doses of corticosteroids, though unlikely with inhaled fluticasone furoate.
Lactation
It is not known whether fluticasone furoate is excreted in human milk. However, other corticosteroids are excreted in human milk. Due to the low systemic absorption of fluticasone furoate following inhalation, the amount in breast milk is expected to be very low, and adverse effects on the breastfed infant are unlikely. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Arnuity Ellipta and any potential adverse effects on the breastfed infant from Arnuity Ellipta or from the underlying maternal condition.
Infant Risk:
Low risk (L2 - Safer)
Pediatric Use
Arnuity Ellipta is approved for asthma in children aged 5 years and older. Monitor growth velocity regularly in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. Use the lowest effective dose.
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. However, elderly patients may be more susceptible to systemic corticosteroid effects, so monitor closely.
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.
- Proper inhaler technique is crucial for drug delivery and efficacy. Patients should be thoroughly instructed and periodically re-evaluated on their technique.
- Rinsing the mouth with water and spitting it out after each dose helps prevent oral candidiasis (thrush).
- Patients should be advised that the full therapeutic benefit may not be achieved until several days to weeks of treatment.
- Monitor for signs of systemic corticosteroid effects, especially with higher doses or in patients concurrently taking strong CYP3A4 inhibitors.
- For pediatric patients, regular monitoring of growth is recommended.
Alternative Therapies
- Other inhaled corticosteroids (ICS): Fluticasone propionate (Flovent HFA, Flovent Diskus), Budesonide (Pulmicort Flexhaler, Pulmicort Respules), Mometasone (Asmanex HFA, Asmanex Twisthaler), Ciclesonide (Alvesco).
- ICS/LABA combinations (if asthma not controlled on ICS alone): Symbicort (budesonide/formoterol), Advair (fluticasone propionate/salmeterol), Dulera (mometasone/formoterol), Zenhale (mometasone/formoterol - Canada).
Cost & Coverage
Average Cost:
$200 - $350 per 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.