Asmanex HFA Corticosteroid Inhaler

ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 5 years of age and older. ASMANEX HFA is not used to treat sudden severe symptoms of asthma. ASMANEX HFA should not be used as a rescue inhaler.

Important Safety Information

• Do not use ASMANEX to treat sudden, severe symptoms of asthma. ASMANEX is not a rescue inhaler and should not be used to provide relief from a sudden asthma attack. Serious side effects of ASMANEX may include worsening asthma or sudden asthma symptoms. Use a rescue inhaler (an inhaled short-acting bronchodilator, such as albuterol) to relieve symptoms of a sudden asthma attack.
• ASMANEX HFA is not for patients who have a hypersensitivity (including allergic reactions) to mometasone.
• ASMANEX HFA can cause serious allergic reactions. Call your health care provider or get emergency medical care if you develop any symptoms of a serious allergic reaction, including rash, swelling of the face, mouth and tongue, or breathing problems.
• Patients who use inhaled steroid medicines for asthma may develop thrush, a yeast infection in the mouth and throat. Rinse your mouth with water and, without swallowing, spit out the contents after each dose (2 puffs) of ASMANEX HFA to help prevent thrush.
• Avoid coming in contact with measles, chickenpox virus, tuberculosis, or any other infections before or while using ASMANEX HFA. Contact your health care provider immediately if you or your child has been exposed.
• If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX HFA, you should be followed closely by your health care provider, and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
• It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal glands cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX HFA is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider, as the dosage of ASMANEX HFA should be reduced slowly.
• Patients who use inhaled steroids, including ASMANEX HFA, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.
• Inhaled steroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms.
• ASMANEX HFA may increase the risk of some eye problems such as glaucoma, cataracts, and blurred vision. Patients should have regular eye exams while using ASMANEX HFA.
• The most common side effects of ASMANEX HFA include: inflammation of the nose and throat, headache, inflammation of the sinuses, bronchitis, and flu infection.
• Use ASMANEX HFA as directed by your health care provider. If your asthma symptoms do not improve after using ASMANEX HFA regularly for 1 to 2 weeks, contact your health care provider.

ASMANEX HFA can cause serious side effects, including:

• Thrush in your mouth and throat. You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose (2 puffs) of ASMANEX HFA, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
• Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as:
  • fever
  • feeling tired
  • body aches
  • vomiting
  • pain
  • nausea
  • chills
• Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX HFA than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:
  • feeling tired or exhausted (fatigue)
  • lack of energy
  • low blood pressure (hypotension)
  • weakness
  • nausea and vomiting
  • dizziness or feeling faint
• Increased wheezing right after taking ASMANEX HFA. Always have a rescue inhaler with you to treat sudden wheezing.
• Serious allergic reactions. Stop taking ASMANEX HFA and call your health care provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling, including swelling of the face, mouth, and tongue
  • breathing problems
• Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
• Slowed growth in children. A child’s growth should be checked often.
• Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using ASMANEX HFA.

The most common side effects reported while using ASMANEX HFA include:

• inflammation of the nose and throat (nasopharyngitis)
• headache
• flu infection (influenza)
• inflammation of the sinuses (sinusitis)
• bronchitis

Other side effects: Worsening asthma or sudden asthma symptoms have been reported with the use of inhaled mometasone furoate. Tell your health care provider about any side effect that bothers you or that does not go away. These are not all the side effects with ASMANEX HFA. Ask your health care provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.