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Trelegy-ellipta

Fluticasone Furoate, Umeclidinium Bromide & Vilanterol

Trelegy Ellipta

Trelegy Ellipta is a once-daily inhalation therapy approved by the FDA for adults to manage chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, and asthma. It combines three active ingredients (Fluticasone, Umeclidinium, and Vilanterol) to ease breathing by reducing inflammation and opening airways. Not a quick-relief medication, it’s unsuitable for children under 18 and comes with specific usage instructions to ensure effectiveness. Trelegy does not replace a rescue inhaler. Your results may vary. Side effects range from mild to serious, necessitating caution and regular doctor consultations. Alternatives include combination inhalers, long-acting bronchodilators, steroid inhalers, and biologic therapies, with treatment choices dependent on individual health needs and conditions.

Product Overview

Trelegy Ellipta serves as a long-term inhalation treatment for adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, as well as adult asthma. This medication combines three active components: Fluticasone (a corticosteroid), Umeclidinium (an anticholinergic), and Vilanterol (a long-acting beta2-adrenergic agonist), which work together to decrease inflammation and widen the airways, facilitating easier breathing. It is administered once daily using a specific inhaler device, available in two doses, and is not meant for sudden breathlessness or to replace a rescue inhaler. Children under 18 should not use Trelegy due to unestablished safety and effectiveness.

Trelegy’s administration involves a series of steps, from preparing the inhaler to inhaling the medication, and requires care to avoid common side effects like respiratory infections, bronchitis, and headaches. More severe reactions, although rare, can include fungal infections, pneumonia, and cardiovascular issues, highlighting the need for ongoing monitoring by a healthcare provider.

Alternatives to Trelegy Ellipta for managing COPD and asthma range from other combination inhalers like Symbicort and Advair to standalone long-acting bronchodilators and steroid inhalers, as well as oral medications and biologic therapies. These alternatives offer flexibility in treatment plans based on individual health profiles and the severity of respiratory conditions. Patients should discuss their complete health history with their doctor to ensure Trelegy Ellipta is a safe option. Regular follow-ups are crucial to manage side effects, adjust dosages as necessary, and monitor the overall effectiveness of the treatment strategy.

Uses of Trelegy Ellipta

Trelegy is taken once a day for long-term care of certain lung conditions. It is used to treat:

  • Chronic Obstructive Pulmonary Disease (COPD): This is a group of lung problems that make it hard to breathe by blocking the flow of air.
  • Chronic Bronchitis: This condition is part of COPD and causes problems with breathing due to blocked airflow.
  • Emphysema: A lung problem that leads to shortness of breath.
  • Asthma in adults: Trelegy can help manage asthma in adults.

[Important Note: Trelegy is not for sudden breathing issues and cannot take the place of a rescue inhaler. It’s also not for use in children under 18 years old, as its safety and effectiveness in this age group have not been established.]

How to Use Trelegy Ellipta?

Dosage

Trelegy Ellipta is inhaled through a special inhaler device, where “Trelegy” is the name of the medication and “Ellipta” is the inhaler used for taking it. This inhaler turns the medication into a dry powder that you breathe in.

The inhaler is loaded with a combination of three active ingredients, available in two different dose levels:

  • Fluticasone, either 100 micrograms (mcg) or 200 mcg
  • Umeclidinium, 62.5 mcg
  • Vilanterol, 25 mcg

These doses are often labeled as 100/62.5/25 mcg and 200/62.5/25 mcg to indicate the mixture of ingredients. Each inhaler provides a total of 30 doses.

Recommended Dosage of Trelegy Ellipta Inhaler

Dosage for Asthma

Trelegy Ellipta comes in two starter doses for asthma treatment:

  • One inhalation/puff of 100/62.5/25 mcg once a day, or
  • One inhalation/puff of 200/62.5/25 mcg once a day.

Which starting dose you use depends on how severe your asthma is and other important factors, like how well the treatment controls your symptoms. If the lower dose doesn’t help with your symptoms, your doctor might increase it to the higher dose.

The highest dose you can take is 200/62.5/25 mcg once a day. If this dose doesn’t control your asthma, your doctor may consider other treatment options.

Dosage for chronic obstructive pulmonary disease (COPD)

For COPD, the usual maintenance dose of Trelegy Ellipta is 

  • One inhalation/puff of 100/62.5/25 mcg once a day. 

[Note: This is also the highest dose recommended for COPD.]

If this dose doesn’t relieve your symptoms, your doctor might suggest using a quick-relief inhaler for sudden shortness of breath. Albuterol is one example of such a rescue inhaler.

How to Take It?

This simple guide will help you get the full benefit of your medication with ease and confidence. By following these steps, you can ensure you use your Trelegy Ellipta inhaler correctly and effectively.

Step 1: Preparing the Inhaler

  • Trelegy Ellipta is packed in a tray with a lid. Carefully peel back the lid to open it. Inside, you’ll find a small packet (desiccant) that keeps the inhaler dry. Remember, the desiccant should not be eaten or inhaled. Dispose of it safely in the trash, making sure it’s out of reach of children and pets.

Step 2: Getting the Inhaler Ready

  • Find the cover of the inhaler device and slide it down. This action will reveal the mouthpiece, and you’ll hear a clicking sound. This click means the inhaler is ready and has been primed by reducing the dose counter by one. Unlike other inhalers, you don’t need to shake Trelegy Ellipta before use.

Step 3: Preparing to Inhale

  • Before you put the inhaler in your mouth, make sure to exhale fully while keeping the inhaler away from your mouth. It’s important not to breathe out directly into the mouthpiece.

Step 4: Inhaling the Medication

  • Place the mouthpiece between your lips, ensuring a tight seal with your lips fully around its curved shape. Inhale deeply and steadily through your mouth only (not through your nose) without covering the air vent with your fingers. After inhaling, remove the inhaler from your mouth and try to hold your breath for 3 to 4 seconds or whatever is comfortable.

Step 5: Completing the Inhalation Process

  • After holding your breath, exhale slowly and gently. You might not taste or feel the medication, but that doesn’t mean it hasn’t worked. Avoid taking another dose immediately, even if you think the medicine wasn’t inhaled.

Step 6: Closing the Inhaler

  • If you feel the need, you can wipe the mouthpiece with a dry tissue. However, regularly cleaning the mouthpiece isn’t necessary. Slide the cover up to close the inhaler securely.

Step 7: Mouth Care

  • It’s good practice to rinse your mouth with water after using the inhaler. This helps remove any residue from the medication. Make sure to spit the water out and not to swallow it.

[Important Reminder: When to Refill Your Inhaler

  • You should plan to refill your inhaler when you see that you have less than 10 doses left. A red indicator on the left side of the counter will appear to remind you to get a new one.
  • Once you use the final dose, the counter will display “0,” and the inhaler will be empty.
  • Dispose of the Trelegy Ellipta inhaler 6 weeks after opening it from its foil packaging or when the dose counter reaches zero, whichever happens first.
  • Safely throw away the used inhaler in the trash, making sure it’s out of reach of children and pets.]

How Does Trelegy Ellipta Work?

Trelegy Ellipta inhaler is a medicine that has three active ingredients, each helping to make breathing easier for people with COPD by opening up the airways. Fluticasone Furoate is one of these ingredients, and it’s a type of drug known as corticosteroid. It works similarly to corticosteroid hormones that our bodies naturally produce. It helps calm down the immune system by connecting to specific spots on immune cells. This action helps stop the release of substances that cause inflammation, like histamine, leading to less swelling and making it easier for air to move through the airways, assisting patients to breathe more comfortably.

Important Safety Information of Trelegy Ellipta

Side Effects

Common side effects of Trelegy Ellipta include:

  • Upper respiratory tract infection
  • Bronchitis
  • Pneumonia
  • Back pain
  • Joint pain
  • Headache
  • Inflammation of the sinuses
  • Flu
  • Sore throat
  • Runny nose
  • Constipation
  • Taste disturbance
  • Painful and frequent urination (signs of a urinary tract infection)
  • Vomiting
  • Nausea
  • Mouth
  • Diarrhea
  • Cough
  • Throat pain
  • Hoarseness
  • Mild allergic reactions

[Note: These common side effects of Trelegy may go away within a few hours or a couple of days. Contact a medical emergency immediately in case they persist.]

Serious side effects of Trelegy Ellipta Inhaler include:

  • Fungal infection in your mouth or throat (thrush). After using Trelegy, swish water around in your mouth and spit it out without swallowing. This helps lower the risk of developing thrush.
  • People with COPD are more likely to catch pneumonia. If you see any of these signs, don’t hesitate to get in touch with your healthcare provider:
    • Change in amount or color of mucus
    • Increased cough
    • Chills
    • Increased breathing problems
    • Fever
  • Weakened immune system (It increases the risk of getting infections)
  • Reduced adrenal function (This can occur when you switch from oral corticosteroids to inhaled corticosteroids.)
  • Sudden breathing problems immediately after inhaling Trelegy
  • Serious allergic reactions
  • Adverse effects on heart
  • Effects on the nervous system and symptoms may include:
    • Nervousness
    • Tremor
  • Osteoporosis (bone thinning or weakness)
  • Eye problems
  • New or worse urinary retention
  • Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
  • Slowed growth in children

[Note: These serious side effects are rare, but If you notice any of these, stop taking Trelegy and call your healthcare provider immediately.]

Warnings

Trelegy Ellipta might not be suitable for everyone. It’s essential to have a detailed conversation with your doctor about your health history before starting it. Here are some important things to consider:

  • Bladder or Prostate Issues: If you have trouble peeing or other problems with your bladder or prostate, Trelegy Ellipta could make these problems worse. Make sure your doctor knows about these issues to decide if this medication is okay for you. Symptoms of bladder or prostate issues may include: 
    • Painful, difficult, or frequent urination
    • Urination in a weak stream or drips
  • Diabetes: Trelegy Ellipta can increase your blood sugar levels. If you have diabetes, this might make your condition harder to manage. Your doctor might suggest keeping an extra close eye on your blood sugar while you’re taking this medication.
  • Eye Problems: Tell your doctor if you have eye conditions like glaucoma or cataracts before using Trelegy Ellipta, as it could make these problems more serious. Your doctor will help you figure out if this medication is safe for you. The eye problems include:
    • Glaucoma
    • Cataracts
    • Increased pressure in your eye
    • Worsening of narrow-angle glaucoma
    • Blurred vision
    • Other changes in vision

[Note: Regular eye check-ups are important when taking Trelegy. If not treated promptly, a serious eye condition called acute narrow-angle glaucoma can lead to permanent vision loss. If you experience this, contact your doctor right away.]

  • Heart Conditions: Although rare, Trelegy Ellipta can lead to heart issues. If you already have heart disease or high blood pressure, this medication might not be the best choice, as it could worsen your condition or even lead to serious heart problems. Talk to your doctor if you notice any of these symptoms, including:
    • Increased blood pressure
    • Awareness of heartbeat
    • A fast or irregular heartbeat
    • Chest pain
  • Weakened Immune System: If your immune system is not as strong as it should be, Trelegy Ellipta may not be the best option, as it could increase your risk of getting infections. Your doctor will assess if this medication is safe for you and might keep a closer watch for infections if you start taking it.
  • Liver Issues: Trelegy Ellipta might be harder for your body to process if you have liver problems, increasing the chance of side effects. People with mild to moderate liver issues might still be able to use it, but if you have severe liver problems, you and your doctor might need to think about other treatment options. Discuss your liver health with your doctor to decide if this medication is right for you.
  • Osteoporosis: If you have osteoporosis, taking Trelegy Ellipta could make your condition worse. Your doctor will determine if it’s safe for you to use this medication and may monitor your bone health more closely during treatment.

It’s crucial to discuss your complete health history with your doctor before starting Trelegy Ellipta. This includes any current or past issues with your bladder, prostate, diabetes, eyes, heart, immune system, liver, or bones. Your doctor will consider all these factors to ensure that Trelegy Ellipta is a safe and effective treatment option for you.

Precautions

Trelegy contains Vilanterol, a type of drug known as a long-acting beta2-adrenergic agonist (LABA). When LABA drugs are used on their own, they can increase the risk of hospital visits and death due to asthma issues. However, Trelegy also includes an inhaled corticosteroid (ICS) and an anticholinergic drug. Using an ICS and LABA together does not significantly raise the risk of these problems. 

Allergic Reactions: Some individuals might experience an allergic reaction to Trelegy Ellipta. Although this was not observed during clinical studies, there have been reports after the medication was approved for use. If you have a mild allergic reaction, you might notice:

  • A skin rash
  • Itchiness
  • Flushing, which means your skin may feel warm, look red, or appear darker for a short time

Although rare, some people can have a severe allergic reaction. Signs of this include:

  • Swelling beneath the skin, often seen in areas like the eyelids, hands, lips, or feet
  • Swelling of the mouth, tongue, or throat, which could make it hard to breathe

If you believe you’re having an allergic reaction to Trelegy Ellipta, contact your doctor immediately. In cases where you think it’s an emergency, don’t hesitate to call 911 or your local emergency services.

Pregnancy and Breast-feeding: If you are pregnant, breast-feeding, or thinking about becoming pregnant, it is not clear if Trelegy Ellipta is safe for you to use. It is important to consult your doctor. Your doctor can advise you on the most suitable treatment for COPD or asthma during this time. They can also guide you on safe options for feeding your baby if necessary.

Other Important Precautions

Do Not Use for Immediate Relief: Trelegy is not meant for quick relief of breathing issues. Always have a rescue inhaler with you for sudden symptoms.

Age Restrictions: Children under 18 years should not use Trelegy, as its safety and effectiveness in this age group have not been established.

Allergies: Do not take Trelegy if you are severely allergic to milk proteins or any component of the medication. If you’re unsure, consult your healthcare provider.

Usage Frequency: Only use Trelegy as often as your doctor prescribes. Do not use it more frequently. 

[Note: If your breathing issues worsen, if you find yourself needing your rescue inhaler more often, or if your rescue inhaler is not as effective, contact your healthcare provider or seek medical care immediately.]

Missed Dose

  • Remember, you should not take more than one dose (one inhalation) in a single day; as soon as you possibly can, take your missed dose.
  • However, if it’s nearly time for your next dose, don’t take the missed one. Just take the next dose at the regular time or schedule.

[Note: Always adhere to the guidelines given by your doctor to use your medication safely and effectively.]

Overdose 

You should only use Trelegy Ellipta as prescribed by your doctor. Taking too much can cause serious health issues. Symptoms of taking too much include feeling chest pain, having a fast heartbeat, and feeling shaky or finding it hard to breathe.

[Note: If you think you have taken too much Trelegy Ellipta, contact your doctor immediately. Call your local emergency number or 911 directly for severe symptoms, or go straight to the nearest emergency room.]

Storage

  • Keep the Trelegy Ellipta at a normal room temperature, between 68°F to 77°F (20°C to 25°C).
  • Store in a dry area, away from direct heat and sunlight.
  • Keep the device in its original packaging until you’re ready to use it.
  • Dispose of Trelegy Ellipta properly in the garbage 6 weeks after opening the packaging or when the usage counter shows “0”, whichever occurs first.
  • Remember to note the date you first opened the packaging on the inhaler’s label for reference.

[Note: Ask your pharmacist or doctor if you have any questions related to storing or disposing of this medication, and follow instructions strictly.]

Trelegy Ellipta Interactions

If you’re considering different options for managing your respiratory condition, like chronic obstructive pulmonary disease (COPD) or asthma, it’s good to know that there are alternatives to Trelegy Ellipta. Each medication has its own way of helping you breathe better, and your doctor can guide you on which one is best suited to your health needs. Here’s a simplified overview of some alternatives:

Combination Inhalers Similar to Trelegy Ellipta: There are other inhalers that combine different types of medicine to help control symptoms. For example:

  • Symbicort (contains budesonide and formoterol)
  • Advair (contains Fluticasone and salmeterol) 

They offer both a steroid and a long-acting beta-agonist, similar to Trelegy Ellipta.

Long-Acting Bronchodilators Alone: If your doctor thinks a simpler approach might work, they might suggest a long-acting bronchodilator by itself. Medications like Spiriva (tiotropium) focus on relaxing your airways to make breathing easier without the addition of steroids.

Steroid Inhalers: In some cases, using a steroid inhaler alone, such as Flovent (Fluticasone), can help reduce inflammation in your airways, making it easier to breathe.

Short-Acting Inhalers (Rescue Inhalers): While not a direct alternative for daily management like Trelegy Ellipta, rescue inhalers such as Albuterol are crucial for sudden symptoms and flare-ups. They work quickly to open your airways.

Oral Medications: Some people might need or prefer an oral medication. Drugs like Theophylline slowly relax and open the airways in your lungs, making breathing easier over time.

Biologic Therapies: For certain types of asthma, biologic therapies that target specific parts of your immune system can be effective. These are usually given by injection and include medications like Xolair (omalizumab).

Alcohol: There’s no direct issue with having alcohol while using Trelegy Ellipta. However, studies suggest that heavy drinking can harm your lungs over time. If you drink alcohol and suffer from chronic obstructive pulmonary disease (COPD) or asthma, it’s wise to limit how much you drink. If you’re unsure about the safe amount of alcohol for you while on Trelegy Ellipta, it’s important to consult your doctor.

[Note: Remember, it’s important to discuss all your options with your healthcare provider. They can consider your medical history, current health status, and lifestyle to recommend the best treatment plan for you.]

Trelegy Ellipta Alternatives

There are other medicines that can help with your health issues. Some might suit you better than Trelegy Ellipta. If you’re open to exploring different options, have a discussion with your doctor. They can share information about other medicines that might be effective for you.

Note that some medicines we mention might be recommended for uses that are not officially approved. This means a drug approved for one health problem is sometimes used to treat another.

Alternative Medications for COPD and Asthma

Combination medications that can be used in the treatment of COPD and Asthma include:

Other Alternatives Medications for COPD

Other Alternatives that may be used to treat COPD include:

  • Oral medications, such as:
    • Daliresp (roflumilast)
    • Theochron (Theophylline)

Other Alternative Medications for Asthma

Other medications that may be used to treat asthma include:

  • Leukotriene modifiers, such as:
  • Oral medications, such as:
    • Theo-24 (Theophylline)

[Important Note: Trelegy Ellipta, along with the other medications mentioned, is designed for ongoing treatment to control symptoms of COPD. These medications are not suitable for immediate relief during sudden breathing difficulties caused by COPD. For quick relief during such episodes, you should use a rescue inhaler.]

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Frequently Asked Questions

How many doses are there per Trelegy Ellipta inhaler?

Each Trelegy Ellipta inhaler contains 30 doses. If you use it once a day, as recommended, the inhaler will last for 30 days. Taking your medication daily is essential for managing your symptoms over time. Your pharmacist will guide you on how to properly use the inhaler and track the remaining doses, ensuring you don’t run out of your medication.

How long does it take for Trelegy to work?

Trelegy Ellipta is a medication designed for long-term management rather than immediate relief. Initially, you might not sense any improvement, but it gradually helps ease breathing difficulties. Typically, it could take several weeks before you start noticing its benefits. Besides improving your breathing, Trelegy is also effective in preventing the worsening of symptoms associated with COPD (chronic obstructive pulmonary disease) or asthma over time.

What time of day is best to take Trelegy Ellipta?

You can take Trelegy Ellipta whenever it’s most convenient for you, but it’s important to use it at the same time every day. This consistent schedule helps control your symptoms around the clock. Remember, Trelegy Ellipta isn’t meant for quick relief during sudden breathing problems or wheezing. For more information you can contact your healthcare provider or pharmacist to know what works best for you.

What happens if you use Trelegy twice in one day?

If you accidentally use Trelegy twice in one day, don’t worry about taking your next dose sooner than usual. Instead, stick to your regular schedule and skip the extra dose you would have taken. It’s important not to double up on doses. If you’ve taken too much Trelegy and notice symptoms like worsening trouble breathing, chest pain, a faster heartbeat, or feeling shaky, you should immediately contact your healthcare provider or visit the nearest emergency room for assistance.

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