Anoro Ellipta

Anoro Ellipta is an FDA-approved inhalation treatment for chronic obstructive pulmonary disease (COPD), including conditions like bronchitis and emphysema. It uses a combination of two active ingredients, umeclidinium (a long-acting anticholinergic) and vilanterol (a long-acting beta2-agonist), to help keep airways open and improve breathing. Anoro is administered once daily using a pre-filled inhaler device called Ellipta, designed for ease of use. It is not suitable for asthma treatment or as a rescue medication for bronchospasm attacks. Common side effects include muscle spasms and respiratory infections, with serious risks like paradoxical bronchospasm and heart issues.

Anoro Ellipta is an FDA-approved inhalation therapy specifically designed to manage chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medication combines two active substances: umeclidinium, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting beta2-adrenergic agonist (LABA). These components work synergistically to prevent the tightening of muscles around the airways, thus facilitating easier airflow and improving respiratory function in adults with COPD.

Anoro is provided as a powder within the Ellipta inhaler, a device pre-loaded with blister packs that release a measured dose of the medication with each inhalation. The recommended dosage is one inhalation per day, and the inhaler contains 30 doses. It is crucial to use Anoro as directed by a healthcare provider and not as a rescue therapy for sudden bronchospasm attacks, for which fast-acting inhalers should be used. Patients using Anoro may experience common side effects such as muscle spasms, upper respiratory infections, and chest pain. However, there are severe potential side effects, including paradoxical bronchospasm and cardiovascular issues such as abnormal heart rhythms and increased blood pressure.

Patients need to discuss their full medical history with their doctor to assess suitability, especially those with conditions like asthma, severe allergies, or cardiovascular problems. Moreover, Anoro interacts with various medications, which can lead to increased levels of Anoro in the blood, heightened side effects, or diminished effectiveness. It is vital for patients to inform their healthcare providers about all medications and supplements they are currently taking to avoid adverse interactions. The careful management of Anoro’s administration and adherence to prescribed guidelines ensure its effectiveness and safety in treating COPD.

Anoro Ellipta is used to:

• Help prevent blocked airways and lessen severe breathing issues in adults with COPD (chronic obstructive pulmonary disease), such as bronchitis and emphysema.

[Important Warning: It should only be used by individuals with COPD and is not suitable for treating asthma.]

Dosage

• Anoro is available as an inhaler called Ellipta. This device contains two medications: umeclidinium and vilanterol.
• The inhaler comes pre-filled with the medication, so you do not need to assemble it or load it with medication, unlike some other types of inhalers.
• Each inhalation, or puff, from the Anoro inhaler, delivers 62.5 mcg of umeclidinium and 25 mcg of vilanterol. Each inhaler provides a total of 30 puffs.

Recommended Dosage for Different Patients/Anoro

Dosage for Chronic Obstructive Pulmonary Disease

• Take one inhalation from the Anoro Ellipta inhaler once a day.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Follow your doctor’s instructions exactly when using Anoro. Always read the medication guide and prescription label thoroughly.
• Anoro Ellipta should not be used as a quick-relief medication for sudden bronchospasm attacks. For such attacks, only use a fast-acting inhaler and seek immediate medical help if your breathing problems worsen or your medications seem ineffective.
• Make sure to follow any Instructions for Use that come with your medicine. If you have any questions or do not understand the instructions, ask your doctor or pharmacist.
• The typical dosage is one inhalation daily. It’s important to take the medication at the same time each day and not to use it more than once in a 24-hour period.
• Anoro comes in a powder form and is administered using a special Ellipta inhaler that is pre-loaded with blister packs of the medicine. Each time you use the inhaler, the Ellipta device will automatically load a blister. Always follow the patient instructions provided with your inhaler.

Steps for Using Anoro Ellipta Inhaler

Step 1: Open the Inhaler Cover

• Slide the cover downwards to expose the mouthpiece until you hear a “click.” This click indicates that the inhaler is ready for use, and the dose counter will decrease by one.
• If you don’t hear the click and the counter doesn’t change, the inhaler might not release the medicine. Contact your healthcare provider or pharmacist if this occurs.
• Remember, you do not need to shake this inhaler.

Step 2: Exhale Fully

• Hold the inhaler away from your mouth and breathe out completely. Ensure you do not exhale into the mouthpiece.

Step 3: Inhale the Medicine

• Place the mouthpiece between your lips and seal your lips tightly around it, fitting them over the mouthpiece’s curved shape.
• Take a deep, steady breath in only through your mouth (not your nose).
• Keep your fingers away from the air vent.
• After inhaling, remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, or as long as is comfortable.

Step 4: Breathe Out Slowly

• Exhale slowly and gently after inhaling the medicine. It’s common not to taste or feel the medicine, but this does not mean it hasn’t worked. Do not take an extra dose even if you don’t feel or taste anything.

Step 5: Close the Inhaler

• If needed, clean the mouthpiece with a dry tissue before closing the cover. Regular cleaning isn’t necessary.
• Slide the cover upwards over the mouthpiece until it is fully closed.

Important Note: Refill Reminder

• Start planning for a refill when your inhaler shows fewer than 10 doses left. You will notice the left half of the dose counter turn red, serving as a reminder to order a new inhaler.
• Once you use the final dose, the counter will display “0,” and the inhaler will be empty.
• Safely dispose of the used inhaler in your household trash. Ensure it is kept out of reach of children and pets.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Chronic obstructive pulmonary disease (COPD) includes several lung conditions that gradually worsen over time. Most people with COPD have chronic bronchitis, emphysema, or both. Chronic bronchitis leads to inflammation in the airways, causing them to get clogged with mucus. Emphysema damages the tiny air sacs (alveoli) in your lungs. Both conditions make it difficult to breathe in oxygen and breathe out carbon dioxide.

Umeclidinium is one of the active ingredients in Anoro and belongs to a class of medications known as long-acting anticholinergics (LAMA). LAMAs work by blocking acetylcholine, a chemical in your body that causes certain muscles, such as those in the lungs, to tighten. By blocking this action, Umeclidinium helps keep the airways relaxed and open, improving airflow in and out of the lungs. Vilanterol is the other active ingredient in Anoro. It is a long-acting beta2-agonist (LABA). Vilanterol works by binding to specific receptors in the lung muscles, causing them to relax. This relaxation helps to open up the airways, making it easier for you to breathe.

Common side effects of Anoro may include:

• Muscle spasms
• Upper respiratory infections, such as the common cold or sinus infections
• Constipation
• Chest pain
• Pain in your arms or legs
• Diarrhea
• Neck pain

Serious side effects of Anoro may include the following:

• Heart problem signs may include:
  • Abnormal heart rhythm
  • Chest pain
  • Increased blood pressure
  • Fast heart rate
• Worsening or new eye problems, with narrow-angle glaucoma signs, may include:
  • Increased pressure in your eyes
  • Blurry vision
  • Seeing halos
  • Pain in your eyes
• Worsening or new urinary problem signs may include:
  • Trouble urinating, with having urinary retention
  • Pain when you urinate
  • Urinating more often than normal
  • Urinating a small amount
• Hypokalemia (low potassium levels), which may cause muscle or heart problems signs may include:
  • Abnormal heart rhythm
  • Muscle weakness
  • Heart palpitations
  • Muscle spasms (cramps)
• Worsening of COPD with exacerbations (flare-ups) signs may include:
  • Wheezing more than usual
  • Coughing up more mucus than usual
  • Trouble breathing
  • Shortness of breath, even when you’re at rest
  • Cough
  • Fatigue (lack of energy)
• High blood sugar levels, which can be dangerous for diabetic patients signs, may include:
  • Excessive thirst
  • Fatigue (lack of energy)
  • Urinating more often at night
  • Urinating more often than normal
• A paradoxical bronchospasm is when your airways unexpectedly tighten instead of relaxing as intended by the medication. Symptoms may include:
  • Trouble breathing that doesn’t get better even after you use an inhaler
  • Cough
• Severe allergic reaction

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

• Anoro Ellipta should only be used by individuals diagnosed with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.
• It’s important to note that Anoro Ellipta is not a rescue medication. It doesn’t act quickly enough to relieve sudden bronchospasm attacks. If you notice that your COPD symptoms are not being controlled as effectively as before, inform your doctor.
• While vilanterol may increase the risk of death in people with asthma, its effect on individuals with COPD is not yet known. If you find that your breathing difficulties persist or worsen rapidly, seek medical attention promptly.
• Remember, Anoro Ellipta is not suitable for treating sudden bronchospasm attacks. For such situations, only use a fast-acting inhaler.
• If your breathing problems persist or worsen suddenly, seek immediate medical assistance.

Boxed Warning

Black Box Warnings: Risk of Asthma-Related Death with Long-Acting Beta2-Adrenergic Agonists (LABAs): Long-acting beta2-adrenergic agonists, such as vilanterol, are associated with an increased risk of asthma-related deaths. Comparative studies with another LABA, salmeterol, and a placebo (an inactive substance) have shown a higher number of asthma-related deaths. This risk is believed to apply to all LABAs, including vilanterol. It has not been proven safe or effective for treating asthma and is not approved for this use.

Before starting Anoro, discuss your medical history with your doctor to determine if it is suitable for you. Anoro may not be appropriate if you have certain health conditions, such as:

• Asthma: Do not use Anoro as a sole treatment for asthma. It must be used in combination with an inhaled corticosteroid to safely manage asthma. Using Anoro alone increases the risk of asthma-related death. If you have asthma, consult your doctor to see if Anoro is a safe option for you.
• Severe Allergic Reactions: Avoid taking Anoro if you have previously experienced a severe allergic reaction to any of its ingredients. The primary components of Anoro are umeclidinium and vilanterol. If you are unsure whether you have had a severe allergic reaction to Anoro or its ingredients, it is important to discuss this with your doctor.
• Milk Protein Allergy: The powder form of Anoro contains milk proteins. If you are allergic to milk proteins, you should not use Anoro.
• Heart Issues: Anoro may lead to or worsen heart-related issues, such as high blood pressure, accelerated heartbeat, and irregular heart rhythms. If you have existing heart conditions, using Anoro could exacerbate these problems. It’s crucial to discuss the safety of using Anoro with your doctor if you have heart concerns.
• Convulsive Disorders: Anoro has the potential to aggravate seizure disorders. If you suffer from seizures, consult your doctor to determine if Anoro is a suitable treatment option for you.
• Urinary Problems: Anoro can cause or intensify urinary retention, which is difficulty urinating. This is especially important for individuals with a history of urinary or prostate issues. Ensure to discuss with your doctor about the safety of using Anoro in your specific health condition.
• Thyroid Disorder: Anoro may increase thyroid hormone levels. If you have hyperthyroidism (an overactive thyroid), it is important to consult with your doctor to determine if Anoro is a suitable medication for your condition.
• Narrow-angle Glaucoma: Anoro has the potential to cause or worsen narrow-angle glaucoma, a condition involving increased pressure within the eye. If you have a history of glaucoma, discuss with your doctor whether Anoro is safe for you to use.

Other Important Precautions

• Alcohol Use: While there are no documented interactions between Anoro Ellipta and alcohol, studies suggest that heavy alcohol consumption may deteriorate lung function over time. If you have COPD (Chronic Obstructive Pulmonary Disease) and consume alcohol, it is advisable to limit your intake. For personalized advice regarding alcohol consumption during your treatment with Anoro Ellipta, please consult your doctor or pharmacist.
• Safety During Pregnancy: The safety of using Anoro Ellipta during pregnancy is not clearly established. It may affect uterine contractions, making it unsuitable for use during late pregnancy or labor unless the benefits of managing COPD symptoms outweigh the potential risks. If you are pregnant or planning to become pregnant, it is crucial to discuss with your doctor before initiating treatment with Anoro Ellipta to fully understand the risks and benefits.
• Safety While Breastfeeding: The safety of Anoro Ellipta during breastfeeding has not been established. If you are currently breastfeeding or plan to breastfeed, it’s important to discuss the potential risks and benefits of using Anoro Ellipta with your doctor before starting this medication.

• Severe Hypersensitivity Reactions: Anoro should not be used by individuals who have experienced severe allergic reactions to any of its components, including umeclidinium, vilanterol, any other excipients in the formulation, or milk proteins.
• Asthma Treatment: Vilanterol, one of the active ingredients in Anoro, should not be used as a standalone treatment for asthma. It is contraindicated unless it is combined with an inhaled corticosteroid.

• If you miss a dose of Anoro, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and proceed with your regular dosing schedule.
• Do not take more than one dose (one puff) of Anoro per day. Taking additional doses can lead to an increased risk of serious side effects.
• Consider setting medication reminders to help ensure you do not miss your doses.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Taking more than the recommended amount of Anoro can result in serious health issues. Symptoms of Overdose:

• Rapid heartbeat
• Nausea
• Severe heart issues, including heart attacks
• Chest pain
• Seizures
• Elevated blood pressure
• Headaches
• Blurred vision
• Dry mouth and throat
• Constipation

Immediate Actions: If you suspect an overdose, contact your doctor immediately. You can also reach out to the American Association of Poison Control Centers by phone or use their online tool for guidance. In cases of severe symptoms, call 911 or head to the nearest emergency room without delay.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

• Store Anoro at room temperature, between 68°F and 77°F (20°C to 25°C), and keep it in its original packaging until you start using it.
• After opening Anoro, protect the device from direct heat and light.
• Do not store the medication in damp or wet areas, such as bathrooms, to prevent damage.
• Anoro remains usable for up to six weeks after its initial opening.
• Dispose of Anoro six weeks after you first open it, regardless of the remaining amount.
• If you have unused Anoro, safely dispose of it to avoid accidental ingestion by others, including children and pets, and to prevent environmental harm.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Anoro may interact with various medications, supplements, and certain foods, each potentially affecting how the drug functions. Some interactions could lessen Anoro’s effectiveness, while others may intensify side effects or make them more severe.

Interaction with Other Medications

Below are some medications known to interact with Anoro. However, this list does not cover all possible drug interactions. Before starting Anoro, it’s important to discuss with your doctor and pharmacist all medications you are currently taking, including prescription, over-the-counter drugs, and any vitamins, herbs, and supplements. Sharing this comprehensive information helps avoid potential interactions. If you have any questions about how other drugs might interact with Anoro, consult your doctor or pharmacist for guidance.

Interaction with Certain Antibacterial and Antifungal Drugs: Taking Anoro alongside certain antibacterial or antifungal drugs can raise the levels of Anoro in your body. This increase occurs because some antibacterial and antifungal medications can block the breakdown (metabolism) of Anoro, leading to higher concentrations in your system. Elevated levels of Anoro may lead to serious side effects. Examples of antibacterial drugs that can increase Anoro levels:

• Telithromycin
• Clarithromycin

Examples of antifungal drugs that can increase Anoro levels:

• Omnel (itraconazole)
• Vfend (voriconazole)
• Extina (ketoconazole)
• Sporanox (itraconazole)
• Tolsura (itraconazole)
• Nizoral (ketoconazole)
• Xolegel (ketoconazole)

If you are prescribed any of these antibacterial or antifungal drugs while taking Anoro, your doctor may opt to monitor you more closely for any adverse effects.

Interaction with Certain Antiviral Drugs: Taking Anoro with specific antiviral medications used for treating HIV or hepatitis can lead to increased levels of Anoro in your body, heightening the risk of side effects. Examples of antiviral drugs that can raise Anoro levels if used concurrently include:

• Invirase (saquinavir)
• Crixivan (indinavir)
• Norvir (ritonavir)
• Lopinavir

Many antiviral medications are available as combination therapies, which include more than one drug. It’s important to review your medications to determine if any contain the drugs listed above. If you are prescribed one of these antivirals while on Anoro, your doctor might closely monitor you for any adverse effects.

Interactions with Specific Antidepressants: If you take Anoro alongside certain antidepressants, it could raise your chances of experiencing irregular heartbeats (heart rates that are either too quick, too slow, or not steady). These irregular heartbeats could potentially lead to severe heart issues, including heart attacks. Two particular types of antidepressants can cause these irregular heartbeats when taken with Anoro. These antidepressants are known as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs).

Interactions with Monoamine Oxidase Inhibitors: If you take Anoro along with a monoamine oxidase inhibitor (MAOI) or stop taking an MAOI and start Anoro within two weeks, it could lead to irregular heartbeats. Here are some examples of MAOIs: 

• Emsam (selegiline)
• Marplan (isocarboxazid)
• Zelapar (selegiline)
• Nardil (phenelzine)

Interaction with tricyclic antidepressants: Taking Anoro with a TCA or within two weeks of stopping a TCA can cause abnormal heart rhythms. Examples of TCA’s include:

• Norpramin (desipramine)
• Tofranil (imipramine)
• Amitriptyline
• Pamelor (nortriptyline)

If you need to take an antidepressant with Anoro, talk with your doctor about which options are safe for you.

Interaction with Certain Blood Pressure or Heart Rate Medications: Taking Anoro alongside certain medications for blood pressure or heart rate, specifically beta-blockers, may reduce Anoro’s effectiveness. Additionally, these drugs can cause the muscles in your airways to tighten, potentially making breathing more difficult. Examples of beta-blockers include:

• Coreg (carvedilol)
• Toprol XL, Lopressor (metoprolol)
• Tenormin (atenolol)
• Innopran XL, Inderal (propranolol)

Anoro should generally not be taken with a beta-blocker unless it is necessary, such as during a heart attack, due to these potential complications.

Interaction with Certain Urinary Incontinence Medications: Anoro contains umeclidinium, an anticholinergic drug, which is also commonly used to treat urinary incontinence (loss of bladder control). When Anoro is taken with other anticholinergic drugs, there is an increased risk of serious side effects. Examples of anticholinergics that could heighten your risk of side effects when taken with Anoro include:

• Ditropan XL (oxybutynin)
• Enablex (darifenacin)
• Toviaz (fesoterodine)
• VESIcare (solifenacin)
• Detrol (tolterodine)

If you need to use Anoro along with another anticholinergic drug, your doctor may closely monitor you for side effects. They might also consider alternative treatments for your COPD or urinary incontinence.

Interaction with Certain Diuretics: Taking Anoro with specific diuretics, commonly known as water pills, can increase your risk of developing hypokalemia (low potassium levels). Hypokalemia can lead to abnormal heart rhythms (heartbeats that are too slow, too fast, or uneven) and other muscle problems. Examples of diuretics that can lower potassium levels when taken with Anoro include:

• Demadex (torsemide)
• Microzide (hydrochlorothiazide)
• Chlorthalidone
• Lasix (furosemide)

Many diuretics are also available as combination medications that contain more than one drug. It’s important to review your medications to determine if any include the drugs listed above. If you are prescribed a diuretic while taking Anoro, your doctor may monitor your potassium levels more closely to manage this risk.

[Note: This isn’t a complete list, and there could be other drugs that interact with Anoro. Make sure to tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

• Stiolto Respimat (olodaterol / tiotropium)
• Bevespi Aerosphere (formoterol/glycopyrrolate)
• Anoro Ellipta (Vilanterol / Umeclidinium)
• Advair Diskus (salmeterol / Fluticasone)
• Symbicort (formoterol / budesonide)
• Dulera (formoterol/ mometasone)
• Atrovent HFA (ipratropium)
• Breo Ellipta (Vilanterol / Fluticasone)
• Tudorza Pressair (aclidinium)
• Lonhala Magnair (glycopyrrolate)
• Seebri Neohaler (glycopyrrolate)
• Spiriva (tiotropium)
• Daliresp (roflumilast)
• Incruse Ellipta (Umeclidinium)
• Theochron (Theophylline)
• Perforomist (formoterol)
• Foradil (formoterol)
• Serevent (salmeterol)
• Serevent (salmeterol)
• Striverdi (olodaterol)
• Arcapta (indacaterol)
• Flovent HFA (Fluticasone)
• Theo-24 (Theophylline)
• Asmanex Twisthaler (mometasone)
• Alvesco (ciclesonide)
• Pulmicort Flexhaler (budesonide)
• Singulair (montelukast)
• Qvar RediHaler (beclomethasone)
• Zyflo (zileuton)
• Accolate (zafirlukast)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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