Arnuity Ellipta 50mcg 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 available
FDA Approved
Aug 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Arnuity Ellipta is an inhaled medicine that contains a corticosteroid. 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 start feeling well. Establish a routine by taking the 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. 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. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. Additionally, do not use it with a spacer, and refrain from breathing 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 the 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 duration the medication remains effective after opening the foil packaging. Dispose of the inhaler after this period or when the dose counter reaches "0", whichever occurs first.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or 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 well. Establish a routine by taking the 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. 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. After taking your dose, close the inhaler.
Do not disassemble the device or wash it. Additionally, do not use it with a spacer, and refrain from breathing 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 the 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 duration the medication remains effective after opening the foil packaging. Dispose of the inhaler after this period or when the dose counter reaches "0", whichever occurs first.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or 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.
- Do not use Arnuity Ellipta for sudden asthma attacks; use your rescue inhaler 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.
- Keep the inhaler dry and clean. Do not wash the mouthpiece.
- Do not open the cover until you are ready to use a dose.
- Do not shake the inhaler.
- Follow the instructions for use provided with the inhaler carefully.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
50 mcg once daily by oral inhalation
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
asthma_maintenance:
50 mcg, 100 mcg, or 200 mcg once daily, depending on disease severity and prior treatment. Max 200 mcg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5 to 11 years: 50 mcg once daily by oral inhalation.
Adolescent:
12 years and older: 50 mcg, 100 mcg, or 200 mcg once daily by oral inhalation, depending on disease severity and prior treatment. Max 200 mcg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No dosage adjustment necessary
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
Use with caution; monitor for systemic corticosteroid effects. No specific dosage adjustment recommendations available, but systemic exposure may increase.
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 a cascade of effects including the inhibition of inflammatory cell infiltration, inhibition of mediators of inflammation (e.g., histamine, eicosanoids, leukotrienes, cytokines), and reversal of increased vascular permeability. This reduces airway hyperresponsiveness and inflammation in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 15.2% (oral inhalation, systemic bioavailability)
Tmax:
0.5 to 1 hour
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
Not available (extensive tissue distribution)
ProteinBinding:
>99% (to human plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 24 hours (terminal half-life)
Clearance:
Not available (high systemic clearance)
ExcretionRoute:
Primarily feces (approximately 90%), urine (approximately 2%)
Unchanged:
Not available (very low)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (for improvement in lung function)
PeakEffect:
Several days to 1-2 weeks (for maximal therapeutic effect)
DurationOfAction:
24 hours (due to 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 abdomen
+ 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
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
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. 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:
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 abdomen
+ 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
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
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. 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:
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, need for rescue inhaler)
- Signs of oral thrush (white patches in mouth or throat)
- Hoarseness or voice changes
- Signs of infection (fever, chills, increased mucus, change in mucus color)
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual tiredness or weakness (signs of adrenal suppression)
- Blurred vision or eye pain (potential for glaucoma/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. Be sure to describe the allergic reaction you experienced, including any 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, should not be taken with this drug. 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 vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions 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. Be sure to describe the allergic reaction you experienced, including any 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, should not be taken with this drug. 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 vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions 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
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 needs to be used more frequently, contact your doctor immediately. It may take several weeks for the full effects of this medication to become apparent.
Stopping Your Medication
If you have been taking this medication for an extended period, consult with your doctor before discontinuing its use. Your doctor may recommend a gradual tapering off of the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce 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.
Transitioning from Oral Steroids
When switching from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these.
Managing Stress and Illness
If you suffer a serious injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with these stresses. Carry a warning card with you to alert medical professionals of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this with your doctor 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 lead to weakened bones (osteoporosis). 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.
Special Considerations for Children
If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, which may be more likely to occur in younger patients. This medication may affect growth in children and teens, so regular growth checks may be necessary.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you to ensure the best possible outcome for 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 needs to be used more frequently, contact your doctor immediately. It may take several weeks for the full effects of this medication to become apparent.
Stopping Your Medication
If you have been taking this medication for an extended period, consult with your doctor before discontinuing its use. Your doctor may recommend a gradual tapering off of the medication to minimize potential side effects.
Infection Risk
You may be more susceptible to infections while taking this medication. To reduce 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.
Transitioning from Oral Steroids
When switching from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these.
Managing Stress and Illness
If you suffer a serious injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with these stresses. Carry a warning card with you to alert medical professionals of this potential need.
Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this with your doctor 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 lead to weakened bones (osteoporosis). 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.
Special Considerations for Children
If you are a child or teenager taking this medication, your doctor will closely monitor you for potential side effects, which may be more likely to occur in younger patients. This medication may affect growth in children and teens, so regular growth checks may be necessary.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you to ensure the best possible outcome for 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, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive. Gradual withdrawal of the drug may be necessary if chronic overdose has led to adrenal suppression.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat-containing products): 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): May increase systemic exposure to fluticasone furoate, but to a lesser extent than strong inhibitors. Monitor for systemic corticosteroid effects.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy
Growth (in pediatric patients)
Rationale: Inhaled corticosteroids may cause a reduction in growth velocity.
Timing: Prior to initiation of therapy
Ocular examination (for patients with history of glaucoma/cataracts)
Rationale: Corticosteroids can increase intraocular pressure or cause cataracts.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma symptoms and control
Frequency: Regularly (e.g., at each follow-up visit)
Target: Well-controlled asthma (minimal symptoms, no exacerbations)
Action Threshold: Increased symptoms, increased rescue inhaler use, decreased peak flow readings
Adverse effects (e.g., oral candidiasis, dysphonia, systemic corticosteroid effects)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Absence or minimal adverse effects
Action Threshold: Development of new or worsening adverse effects
Growth (in pediatric patients)
Frequency: Periodically (e.g., every 3-6 months)
Target: Normal growth velocity for age
Action Threshold: Significant reduction in growth velocity
Bone Mineral Density (BMD)
Frequency: Periodically, especially in patients with risk factors for decreased BMD
Target: Stable BMD
Action Threshold: Significant decrease in BMD
Symptom Monitoring
- Wheezing
- Shortness of breath
- Cough
- Chest tightness
- Need for rescue inhaler (e.g., albuterol)
- Oral thrush (white patches in mouth/throat)
- Hoarseness/dysphonia
- Sore throat
- Blurred vision (potential cataracts/glaucoma)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy. The benefits of maintaining asthma control outweigh the potential risks. Inhaled corticosteroids have low systemic absorption, minimizing fetal exposure. Use during pregnancy should be individualized based on the patient's asthma control.
Trimester-Specific Risks:
First Trimester:
Low risk; uncontrolled asthma poses greater risks to mother and fetus.
Second Trimester:
Low risk; continued use to maintain asthma control.
Third Trimester:
Low risk; continued use to maintain asthma control.
Lactation
Considered compatible with breastfeeding. Fluticasone furoate is minimally transferred into breast milk due to its high protein binding and low systemic bioavailability. Monitor breastfed infant for any adverse effects, though unlikely.
Infant Risk:
Low risk
Pediatric Use
Approved for children 5 years and older. Monitor growth velocity regularly, as inhaled corticosteroids may cause a small reduction in growth velocity. The lowest effective dose should be used.
Geriatric Use
No dosage adjustment is necessary based on age. Efficacy and safety profiles are similar to younger adults. Monitor for potential systemic corticosteroid effects, especially in those with comorbidities or on other medications.
Clinical Information
Clinical Pearls
- Arnuity Ellipta is a maintenance medication for asthma and should be used daily, not for acute asthma attacks.
- Patients should be instructed on the correct use of the Ellipta inhaler device, including the importance of a quick, deep inhalation.
- Rinsing the mouth and spitting after each dose is crucial to minimize the risk of oral candidiasis (thrush).
- Adherence to once-daily dosing is important for optimal asthma control.
- Patients transitioning from oral corticosteroids to Arnuity Ellipta should be carefully monitored for signs of adrenal insufficiency.
- Regular follow-up with a healthcare provider is essential to assess asthma control and monitor for adverse effects.
Alternative Therapies
- Other inhaled corticosteroids (e.g., fluticasone propionate, budesonide, mometasone, ciclesonide, beclomethasone)
- Long-acting beta-agonists (LABAs) - often used in combination with ICS for better control (e.g., Advair, Breo, Symbicort, Dulera)
- Leukotriene receptor antagonists (e.g., montelukast)
- Mast cell stabilizers (e.g., cromolyn)
- Immunomodulators (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma
Cost & Coverage
Average Cost:
$200 - $300 per 30 doses
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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.