Breo Ellipta 200-25mcg Oral Inh(30)

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators and suppressing immune responses. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, or a rapid heartbeat
Shakiness or tremors
Feeling nervous or excitable
Bone pain
Changes in vision, eye pain, or severe eye irritation
Mouth irritation or mouth sores
Redness or white patches in the mouth or throat
Feeling extremely tired or weak

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache
Runny nose
Nose or throat irritation
Common cold symptoms
Flu-like symptoms
Voice changes
Back pain
Joint pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you are experiencing to ensure safe treatment.

Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Blood Sugar Control
If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to rise. Discuss with your doctor how to manage your blood sugar levels effectively. Monitor your breathing problems closely, and contact your doctor immediately if they worsen, if your rescue inhaler is less effective, or if you need to use it more frequently.

Dosage and Administration
Do not exceed the recommended dose or use this medication more often than prescribed. Overdose can be fatal. Consult your doctor if you have any concerns.

Transitioning from Oral Steroids
When switching from an oral steroid to another 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. If you experience any of these symptoms, contact your doctor immediately.

Stressful Situations
In cases of severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card indicating that you may need extra steroids in such situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this risk with your doctor and schedule regular eye exams as recommended.

Bone Health
Long-term use of this medication may also lead to osteoporosis (weak bones). Consult your doctor to determine if you are at higher risk or have any questions. Have a bone density test as advised by your doctor.

Infection Risk
You may be more susceptible to infections while taking this medication. Practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu.

Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, contact your doctor immediately.

Growth and Development in Children and Teens
This medication may affect growth in some cases. Children and teens may require regular growth checks. Discuss this risk with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

COPD Patients
If you have Chronic Obstructive Pulmonary Disease (COPD), you are at a higher risk of developing pneumonia, which can be severe or even fatal. This medication may increase this risk, and you may be more likely to require hospitalization for pneumonia. Discuss this risk with your doctor.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Acute bronchospasm or status asthmaticus

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, atazanavir, indinavir, nelfinavir, saquinavir, telithromycin): May significantly increase systemic exposure to fluticasone furoate and vilanterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.
• Beta-blockers (especially non-selective): May block the bronchodilatory effect of vilanterol and cause severe bronchospasm in patients with asthma or COPD.

• Diuretics (non-potassium sparing): May potentiate hypokalemia associated with beta-agonists.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of vilanterol on the cardiovascular system.
• Other sympathomimetics: May potentiate adverse cardiovascular effects.

• Not specifically identified as minor, but general caution with drugs affecting QT interval.

• Worsening shortness of breath
• Increased cough or wheezing
• Increased need for rescue inhaler (e.g., albuterol)
• Chest pain or palpitations
• Blurred vision or eye pain
• Oral thrush (white patches in mouth/throat)
• Hoarseness or dysphonia
• Signs of infection (fever, increased sputum production, change in sputum color)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown reproductive toxicity.

Caution should be exercised when Breo Ellipta is administered to a nursing mother. It is unknown whether fluticasone furoate or vilanterol are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Breo Ellipta and any potential adverse effects on the breastfed infant from Breo Ellipta or from the underlying maternal condition.

Not approved for children under 12 years of age for asthma. For asthma, approved for patients 12 years and older (100/25 mcg dose). Not approved for pediatric patients with COPD. ICS can cause growth suppression in children; monitor growth velocity.

No dosage adjustment is required based on age. Efficacy and safety profiles are generally similar to younger adults, but older patients may be more susceptible to cardiovascular effects of LABAs or systemic effects of ICS.

• Breo Ellipta is a maintenance medication and should be used consistently once daily, not as a rescue inhaler for acute symptoms.
• Patients should be instructed on proper inhaler technique and to rinse their mouth after each use to minimize the risk of oral candidiasis.
• Due to the LABA component, Breo Ellipta carries a Black Box Warning regarding increased risk of asthma-related death, particularly when used as monotherapy in asthma. It should only be used in asthma as part of a combination therapy with an ICS.
• Monitor for systemic corticosteroid effects (e.g., adrenal suppression, bone mineral density changes, ocular effects) especially with long-term use or higher doses.
• Caution with strong CYP3A4 inhibitors due to increased systemic exposure to both components.
• Patients should be advised to report any worsening of symptoms or increased use of their rescue inhaler immediately.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone)
• Long-acting Beta2-Adrenergic Agonists (LABA) monotherapy (e.g., salmeterol, formoterol, indacaterol, olodaterol) - generally not recommended for asthma without ICS
• Long-acting Muscarinic Antagonists (LAMA) monotherapy (e.g., tiotropium, umeclidinium, glycopyrronium)
• Oral corticosteroids (for severe exacerbations)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast - for severe COPD)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.