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of the United States, its territories,
and Puerto Rico.
What is DULERA?
DULERA is an inhaled medicine used to control and prevent asthma symptoms such as wheezing in people 12 and older.
DULERA is not a rescue inhaler and should not be used as a treatment for sudden asthma symptoms.
DULERA is not for people who are well controlled on a long-term asthma control medicine like a low to medium dose of an inhaled corticosteroid medicine, or who only need a rescue inhaler once in a while.
What are the 2 medicines in DULERA?
DULERA is an FDA-approved inhaler that combines 2 medicines that treat asthma. DULERA contains an inhaled corticosteroid called mometasone furoate and a long acting
beta2-agonist medicine (LABA) called formoterol fumarate.
There are 2 main ways that asthma affects your lungs—DULERA helps treat them both.
One medicine in DULERA helps to decrease the swelling (inflammation) in the lungs that can cause asthma symptoms. The other medicine in DULERA helps to relax the muscles in the airways. This helps to prevent symptoms like wheezing and shortness of breath that can happen when asthma makes the airways close up (constriction).
In a clinical research study over 6 months†…
People 12 years of age and older using DULERA experienced:
- Significant improvement in lung function
- Reduced use of a rescue inhaler to treat sudden symptoms
- Fewer wake-ups at night to use a rescue inhaler
† The study involved people whose asthma was not under control while using medium dose inhaled corticosteroids. Results may vary.
70% had no flare-ups∗
Over the 6-month clinical research study, 70% of the people taking DULERA 100 mcg/5 mcg did not have an asthma
* Flare-up defined as an important reduction in lung function that may last 2 or more consecutive days, emergency treatment, hospitalization, or treatment with certain additional asthma medications.
Selected Important Safety Information About DULERA
-
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
- Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
- Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.
-
DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
Selected Important Safety Information About DULERA
-
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
- Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
- Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.
-
DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness and seizures. Tell your doctor about medicines you take and about all of your medical conditions.
-
People taking DULERA may experience
- Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
- Thrush (yeast infection) in the mouth and throat.
- A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
- Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
- Increase in wheezing right after taking DULERA.
- 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.
- Eye problems including glaucoma and cataracts. You should have regular eye exams while using DULERA.
- Decrease in blood potassium and increase in blood sugar levels.
- If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider's instructions to avoid serious health risks when you stop using oral corticosteroids.
- The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
Selected Important Safety Information About DULERA
When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
- Do not use DULERA more often than prescribed. Do not
take DULERA with other medicines that contain a
LABA for any reason, as using too much LABA may cause
chest pain, increase or
decrease in blood pressure,
fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness and seizures. Tell your doctor about medicines you take and about
all of your medical conditions.
Selected Important Safety Information About DULERA
-
People taking DULERA may experience
Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
- Thrush (yeast infection) in the mouth and throat.
A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
Increase in wheezing right after taking DULERA.
Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
Eye problems including glaucoma and cataracts. You should have regular eye exams while using DULERA.
Decrease in blood potassium and increase in blood sugar levels.
Selected Important Safety Information About DULERA
If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider's instructions to avoid serious health risks when you stop using oral corticosteroids.
- The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
Selected Important Safety Information About DULERA
-
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.
DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
Selected Important Safety Information About DULERA
When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness and seizures. Tell your doctor about medicines you take and about all of your medical conditions.
Selected Important Safety Information About DULERA
-
People taking DULERA may experience
Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
Thrush (yeast infection) in the mouth and throat.
A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
Increase in wheezing right after taking DULERA.
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.
Eye problems including glaucoma and cataracts. You should have regular eye exams while using DULERA.
Decrease in blood potassium and increase in blood sugar levels.
Selected Important Safety Information About DULERA
When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness and seizures. Tell your doctor about medicines you take and about all of your medical conditions.
Selected Important Safety Information About DULERA
If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider's instructions to avoid serious health risks when you stop using oral corticosteroids.
The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
Selected Important Safety Information About DULERA
-
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
- Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
- Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.
-
>DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
What is DULERA?
DULERA is an inhaled medicine used to control and prevent asthma symptoms such as wheezing in people 12 and older.
DULERA is not a rescue inhaler and should not be used as a treatment for sudden asthma symptoms.
DULERA is not for people who are well controlled on a long-term asthma control medicine like a low to medium dose of an inhaled corticosteroid medicine, or who only need a rescue inhaler once in a while.
Click here for additional Selected Important Safety Information About DULERA.
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.
