Asmanex Twisthaler

(Mometasone Furoate)

The active ingredient in Asmanex Twisthaler 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).

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

1. Remove the device from the foil pouch, and write the date on the cap. Do not use the device 45 days past this date.

2. Holding the device upright, twist off the cover in a counterclockwise direction.

3. Holding it horizontally with the mouthpiece aimed towards your face, breathe out away from the device. Make sure your fingers do not cover the ventilation holes.

4. Seal your lips around the mouthpiece, and breathe in fast and deep.

5. Hold your breath for 10 seconds, then breathe out away from the inhaler.

6. Dry the mouthpiece with a clean tissue.

7. To close the device, twist the cap on until you hear a click.

8. If you need another inhalation, repeat steps 1-5.

9. Always rinse your mouth with water and spit after using an inhaled corticosteroid.

10. Keep an eye on the dose counter on the side of the device, which lets you know the doses left.

The most common side effects of Asmanex Twisthaler include:

• Allergy or flu symptoms, including sneezing, an itchy nose, and watery or itchy eyes.
• Headache.
• Sore throat.
• Bronchitis.

Some individuals may experience serious side effects while using Asmanex Twisthaler. 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, 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 Twisthaler. 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 Twisthaler, 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 or milk proteins (contained in the Twisthaler device).

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

When Asmanex Twisthaler 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 steroids, should not be used at the same time as this inhaler, as this increases the risk of impaired adrenal function.

It is available as a powder for inhalation containing 200 mcg of mometasone furoate per actuation.

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

Asmanex Twisthaler is manufactured by Schering Corporation.

No, there is no generic version of Asmanex Twisthaler 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.