If you need more information about DULERA, here are some answers to frequently asked questions. However, this does not replace talking to your doctor.

 
 
What is DULERA? How does DULERA work? What are the 2 medicines in DULERA? Is the medicine inside a DULERA inhaler a powder or a spray? Who should use DULERA? Who should not use DULERA? Does DULERA come in different dose strengths? Will DULERA replace my rescue inhaler? What are the side effects of DULERA? How should I use DULERA? What do I do if I miss a dose? How long do I keep taking DULERA? How can I find out if DULERA is right for me? How do I store DULERA? How often do I have to refill DULERA? Do I need to rinse my mouth after using DULERA?
What is DULERA?

DULERA (mometasone furoate and formoterol fumarate dihydrate) is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

How does DULERA work?

In a 6-month clinical research study,* people 12 and over whose asthma was not under control while using a medium-dose inhaler were given DULERA to use twice daily. People using DULERA experienced a significant improvement in lung function, as well as:

  • Reduced use of a rescue inhaler to treat sudden symptoms.
  • Reduced number of nights waking up to use a rescue inhaler.

70% of patients taking DULERA in the same clinical study* had NO flare-ups

Over the 6-month clinical research study,* 70% of people taking DULERA 100 mcg/5 mcg had no asthma flare-ups–compared to 66% taking mometasone furoate 100 mcg, 46% taking formoterol 5 mcg alone, and 44% of patients taking placebo (the contents of the inhaler did not contain medicine).

* The study involved people whose asthma was not under control while using medium-dose inhaled corticosteroids.

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.

What are the 2 medicines in DULERA?

The 2 medicines in DULERA help keep airways open. It is taken twice daily every day.

  • Mometasone furoate is an inhaled corticosteroid. By decreasing swelling in the lungs, it helps open the airways to help you breathe easier.
  • Formoterol fumarate is a long-acting beta2 agonist—LABA for short. It helps relax muscles around the airways to make breathing easier.
Is the medicine inside a DULERA inhaler a powder or a spray?

When you “puff” (inhale) a dose of DULERA, the medicine enters your lungs as a spray. It is not a powder. After you finish taking a dose of DULERA, always rinse your mouth with water.

Who should use DULERA?

You and your doctor can decide on the right daily “controller” medicine for you. DULERA is for people 12 and older whose asthma is not well controlled by another asthma control medicine. DULERA is NOT a rescue inhaler. If your asthma is under control and you need a rescue inhaler only once in a while, DULERA is not right for you.

Who should not use DULERA?

Do not use DULERA to treat sudden severe symptoms of asthma or if you are allergic to any of the ingredients in DULERA. See the end of the Patient Information for a list of ingredients in DULERA.

Does DULERA come in different dose strengths?

Yes. DULERA is available in 2 dose strengths. Your doctor will decide which dose strength is right for you.

Will DULERA replace my rescue inhaler?

No, DULERA is not a rescue inhaler and should not be used to treat sudden asthma symptoms.

What are the side effects of DULERA?

DULERA may cause serious side effects. To learn more please see Possible Side Effects.

Get emergency care if breathing problems worsen and you use your rescue inhaler medicine, but it does not relieve your breathing problems.

How should I use DULERA?

Do not use DULERA unless your healthcare provider has taught you how to use it properly. Ask your healthcare provider or pharmacist if you have any questions.

Use DULERA exactly as prescribed. Do not use DULERA more often than prescribed. DULERA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between DULERA and your other inhaled medications, including the differences in prescribed use and physical appearance. DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening. For a step-by-step guide see Using Your DULERA Inhaler.

What do I do if I miss a dose?

If you miss a dose of DULERA, skip your missed dose and take your next dose at your regular time. Do not take DULERA more often or use more puffs than you have been prescribed.

How long do I keep taking DULERA?

Do not change or stop using DULERA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.

How can I find out if DULERA is right for me?

Only your doctor can decide if DULERA is right for you. Completing the Asthma Control Checklist is a great way to give your doctor a detailed picture of your asthma symptoms over the past 6 months to help determine which prescription medicines are right for you.

How do I store DULERA?

The 120-actuation inhaler can be stored in any position. For the 60-actuation inhaler, after priming, store the inhaler with the mouthpiece down or sideways. Store DULERA at room temperature between 68°F to 77°F (20°C to 25°C). The contents of your DULERA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst. Do not throw container into fire or incinerator. Keep DULERA and all medicines out of the reach of children.

How often do I have to refill DULERA (120-puff inhaler)?

Your DULERA inhaler will last about 1 month of regular use. It contains 120 doses, enough for 2 puffs in the morning and 2 puffs at night for 30 days. When the counter reads 20, you should refill your prescription or ask your doctor if you need a new prescription for DULERA. Throw away DULERA after the counter reaches 0, indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.

Do I need to rinse my mouth after using DULERA?

Yes. Rinse your mouth with water after each dose (2 puffs) of DULERA. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat. Spit out the water. Do not swallow it.

 
 

DULERA Special Offers & Support

*Not all patients are eligible. Terms and conditions apply.
 

 
What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 

 
Selected Important Safety Information about DULERA
  • DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
    • 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.
  • 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, seizures and electrocardiogram (ECG) changes. 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, cataracts, and blurred vision. 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.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.
 

What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?
 

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 
 
 
 
Selected Important Safety Information about DULERA
 
  • DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
    • 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.
  • 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, seizures and electrocardiogram (ECG) changes. 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, cataracts, and blurred vision. 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.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.