Asmanex HFA

The active ingredient in Asmanex HFA is mometasone furoate, an inhaled corticosteroid. Inhaled corticosteroids work by targeting swelling in the lungs, treating the symptoms of asthma, and improving overall lung function.

This inhaler is not intended for sudden breathing problems and will not replace your rescue inhaler/ bronchodilator (albuterol).

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 the Asmanex HFA inhaler. However, the following is a synopsis of the general guidelines for the use of Asmanex HFA:

1. To assemble the HFA inhaler, insert the metal canister into the blue plastic actuator. Check the back of the plastic actuator to ensure you can see the counter on the canister through the window.

2. To open the HFA inhaler, remove the pink plastic cap by squeezing the sides of the cap and pulling it straight out.

3. Before using the inhaler for the first time, prime it by shaking it for 5 seconds and spraying it into the air away from your face. Repeat four times before first use, twice if you haven’t used the inhaler for 4 weeks or more, or dropped it.

4. To use, shake the inhaler well for five seconds, and breathe out through your mouth.

5. Put the mouthpiece in your mouth and close your lips around it.

6. Push the top of the canister down while breathing in slowly and deeply through your mouth.

7. Hold your breath for as long as is comfortable, try for at least 10 seconds, then breathe out slowly.

8. Wait about 30 seconds, then repeat steps 4-7 if needed for another dose.

9. Always rinse your mouth (swish and spit) after using this inhaler, and replace the mouthpiece for storage.

10. You should clean the mouthpiece of your HFA inhaler once a week, after your evening dose, to prevent medicine build-up. To do so, remove the cap and use a dry cotton swab to wipe the small circular opening. Then use a clean, dry tissue to wipe the inside of the mouthpiece, and let it air-dry overnight.

11. Watch the dose counter, and refill your prescription when it reads 020. When the counter reads 000, there are no doses left, and you should dispose of the inhaler. Do not use the inhaler past the written expiration date.

The most common side effects of Asmanex HFA include:

• Allergy, flu, or cold symptoms, including sneezing, an itchy nose, and watery or itchy eyes.
• Inflammation of the sinuses.
• Headache.
• Bronchitis.

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

• Fungal infections of the mouth/ throat (thrush), which may present as white patches on the roof of your mouth - to avoid/ reduce this risk, always rinse your mouth after using this inhaler, and spit out the water (don’t swallow).
• Higher chance of infections, which may present with symptoms of cough, fever, chills, body aches, sore throat, and increased breathing problems.
• Suppression of the immune system. While taking this drug, you should avoid contact with anyone who has been exposed to or is currently diagnosed with measles or chickenpox.
• Adrenal gland insufficiency, which may present with symptoms of fatigue, weakness, nausea, vomiting, and low blood pressure.
• Serious allergic reactions, which may present as rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.
• Increased wheezing (bronchospasm) after using the inhaler.
• Lower bone mineral density is especially a problem for those with osteoporosis.
• Eye problems such as increased intraocular pressure, glaucoma, cataracts, or blurred vision - to manage this risk, you should have regular eye exams while using this medication.
• Slowed growth in pediatric or adolescent populations.

This medication also has the potential to cause an initial worsening of your asthma symptoms, requiring you to use your rescue inhaler more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks. Contact your physician if this occurs at any time.

These are not all of the possible side effects of Asmanex HFA. 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 Asmanex HFA, 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 whether you have:

• Existing tuberculosis, fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex infections. Mometasone may worsen these conditions.
• Existing adrenal insufficiency.
• Weak bones (osteoporosis).
• Medical conditions affecting the immune system.
• Eye conditions such as glaucoma or cataracts.

• Treatment of a sudden or severe asthma attack (rescue use).
• Allergy or hypersensitivity to mometasone furoate.

The maximum benefits of Asmanex HFA are seen after 2 weeks of regular use. You will not feel a significant difference immediately after using this inhaler.

When Asmanex HFA 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:

• Strong CYP3A4 inhibitors, such as azole antifungals (ketoconazole, posaconazole, voriconazole), antibiotics (clarithromycin), and antivirals (ritonavir), may increase the levels of the drug and induce heart-related side effects.
• Prednisone, or other oral corticosteroids, should not be used at the same time as this inhaler, as this increases the risk of impaired adrenal function.

Brand name Asmanex HFA is available as an inhalation aerosol containing 50, 100, or 200 mcg of mometasone furoate per actuation.

Asmanex HFA should be stored at room temperature in a dry location, out of reach of children or pets.

Asmanex HFA is manufactured by Organon & Co.

No, there is no generic version of Asmanex HFA currently available.

This medication should not be discontinued abruptly, as you will have an increased risk of asthma symptoms. If, after a two-week trial, you feel this medication is not effective or you are experiencing significant side effects, talk with your physician to discuss next steps for managing your condition.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a growing fetus.

Regarding mometasone furoate, it is reported to be compatible with pregnancy, and experts suggest that there is a minimal risk of exposure to a growing fetus when the parent uses inhaled fluticasone. There were also no reports of effects of pre-term labour, low birth weight, or malformations.

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.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a nursing infant.

There is no human data on the exposure of mometasone furoate to a nursing infant, but the properties of the drug suggest it poses minimal risk.

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.