ASMANEX® HFA (mometasone furoate) Inhalation Aerosol 50 mcg, 100 mcg, 200 mcg & ASMANEX® TWISTHALER® (mometasone furoate inhalation powder) 110 mcg, 220 mcg

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.
Do not take ASMANEX TWISTHALER if you have an allergy to milk proteins. Ask your doctor if you are not sure. ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone.
ASMANEX 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 to help prevent thrush.
Avoid coming in contact with measles, chickenpox virus, tuberculosis, or any other infections before or while using ASMANEX. 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, 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 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 should be reduced slowly.
Patients who use inhaled steroids, including ASMANEX, 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, 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 may increase the risk of some eye problems such as cataracts, glaucoma, increased intraocular pressure, blurred vision, and visual disturbance. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
The most common side effects with ASMANEX TWISTHALER include: headache, nasal allergy symptoms, sore throat, upper respiratory infection, sinus infection, fungal infections in the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.
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 as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This site is intended only for residents of the United States, its territories, and Puerto Rico.

US-XAF-110016 10/21

Selected 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. Continue reading >
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. Continue reading >
Do not take ASMANEX TWISTHALER if you have an allergy to milk proteins. Ask your doctor if you are not sure. ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone.
ASMANEX 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 to help prevent thrush.
Avoid coming in contact with measles, chickenpox virus, tuberculosis, or any other infections before or while using ASMANEX. 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, 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 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 should be reduced slowly.
Patients who use inhaled steroids, including ASMANEX, 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, 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 may increase the risk of some eye problems such as cataracts, glaucoma, increased intraocular pressure, blurred vision, and visual disturbance. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
The most common side effects with ASMANEX TWISTHALER include: headache, nasal allergy symptoms, sore throat, upper respiratory infection, sinus infection, fungal infections in the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.
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 as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This site is intended only for residents of the United States, its territories, and Puerto Rico.

US-XAF-110016 10/21

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