Atectura Breezhaler

(Indacaterol/Mometasone Furoate)

The active ingredients in the Atectura Breezhaler inhaler are indacaterol acetate and mometasone furoate.

Indacaterol is a long-acting beta2-agonist (LABA) bronchodilator that works by relaxing the smooth muscle in your lungs and helping you breathe more deeply.

Mometasone furoate is an inhaled corticosteroid (ICS) that has anti-inflammatory properties, helping to reduce swelling in the lungs, which causes asthma symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Atectura Breezhaler. However, the following is a synopsis of the general guidelines for the use of Atectura Breezhaler:

1. The Breezhaler device employs hard capsules that are crushed within the inhaler, delivering an inhalation powder. Do not swallow the capsules.

2. To use the inhaler, start by pulling off the cap, then opening the inhaler by pushing back the mouthpiece (it will open and fold backwards).

3. Next, remove an Atectura Breezhaler capsule from the blister card by peeling back the blister paper. Do not push the capsule through the foil.

4. Insert the capsule into the receptacle (under the mouthpiece), then close the inhaler by folding the mouthpiece forward.

5. Press the two side buttons simultaneously to pierce the capsule. You should hear a noise as it is pierced. Ensure to only pierce it once.

6. Breathe out fully, away from the device, then place the mouthpiece in your mouth.

7. Breathe in quickly and deeply, then remove the mouthpiece from your mouth. You should hear a whirring noise as you breathe in.

8. Hold your breath for up to 5 seconds, then breathe out.

9. Always rinse your mouth and spit the water after using this medication.

10. Next, open the mouthpiece to check that the capsule is empty.

11. If powder is remaining, close the inhaler and repeat steps 6-10.

12. Once empty, remove the empty capsule and dispose of it.

13. Close the mouthpiece and replace the cap.

14. Always handle the capsules with dry hands, and never wash the inhaler with water.

15. Inhaling the contents of one capsule daily can help improve lung function and asthma symptoms.

The most common side effects of Atectura Breezhaler include:

• Headache.
• Sore throat.
• Cough.
• Voice hoarseness (dysphonia).
• Muscle spasms or pain.

Some individuals may experience serious side effects while using Atectura Breezhaler. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Oral candidiasis (thrush) may occur, which would present as white patches inside the mouth. This risk can be reduced by always rinsing and spitting after use.
• Suppression of the immune system may make you more likely to get infections.
• Heart problems, including fast heartbeat (tachycardia), and increased blood pressure.
• Serious life-threatening allergic reactions, which may present as skin rash, hives, swelling (angioedema) of the face, mouth, or tongue, and/ or trouble breathing.
• Adrenal insufficiency, which may present with symptoms of fatigue, weakness, nausea, vomiting, and low blood pressure. This is more common with high doses of mometasone furoate, or with recent discontinuation of a systemic corticosteroid such as prednisone.
• High blood sugar may present as increased thirst, frequent urination, dry skin, headache, blurred vision, and fatigue.
• Low potassium (hypokalemia).
• Eye problems, including cataracts or glaucoma, may present as blurry vision or eye pain.
• Slower growth in children and adolescents.

This medication also has the potential to cause paradoxical bronchospasm, an initial worsening of your asthma symptoms. This may lead you to use it more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks (wheezing, shortness of breath). Contact your physician if this occurs at any time.

These are not all of the possible side effects of Atectura Breezhaler. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Atectura Breezhaler, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Heart problems, including irregular or fast heart rate, heart palpitations, hypertension, or chest pain (angina).
• Pulmonary tuberculosis, or other chronic/ untreated bacterial, fungal, viral, or parasitic infections.
• Eye problems, including glaucoma, cataracts, or blurry vision.
• Convulsive disorders.
• Reduced bone mineral density (osteoporosis).
• Thyroid gland problems, such as thyrotoxicosis.
• Low potassium.
• Problems with your adrenal gland.
• Diabetes.
• Ketoacidosis.
• Liver problems.

Treatment of acute bronchospasm (asthma attack).

Hypersensitivity to indacaterol, mometasone furoate, or the non-medicinal ingredients in this inhaler: lactose (as monohydrate) or gelatin.

It begins working within 5 minutes, and the effects last on average 24 hours.

When Atectura Breezhaler is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Beta-blockers may reduce the efficacy of indacaterol when used together.
• Other long-acting beta-adrenergic agonists may increase the side effects of indacaterol when used together.
• Strong CYP3A4 inhibitors such as ritonavir, cobicistat, ketoconazole, and itraconazole may increase the systemic corticosteroid effects of mometasone furoate.
• Methylxanthine derivatives, corticosteroids, and non-potassium-sparing diuretics may increase the risk of hypokalemia when used with Atectura.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants should be used with caution when you are using this inhaler.

Atectura Breezhaler is a once-daily inhaler. It is provided as hard capsules containing 150 micrograms (mcg) of indacaterol and 80, 160, or 320 mcg of mometasone furoate per capsule. The capsules are provided as cartons of 30.

It should be stored at room temperature, protected from moisture and light, and away from the reach of children or pets.

It is manufactured by Novartis Pharmaceuticals.

No, there are no generic versions of this inhaler.

Barring serious side effects as listed above or under the direct advice of a physician, you should not discontinue this medication abruptly. Discontinuing an inhaled corticosteroid suddenly can cause severe acute bronchospasm.

While there are concerns of interference with uterine contractility during labour with indacaterol, it is generally considered safe for use during pregnancy. Mometasone furoate is considered probably acceptable, though other inhaled corticosteroids may be preferred.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known whether indacaterol or mometasone furoate is found in breast milk, though both are considered probably acceptable for use while breastfeeding.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.