Learn About a Prescription Medicine That May Be Used To Help Control Asthma SymptomsLearn About a Prescription Medicine That May Be Used To Help Control Asthma Symptoms

“ With my asthma symptoms, I never   pictured myself here! Taking steps to  control them helped.”

A Prescription Medicine That May Be Used to Help Control Symptoms of Asthma and Prevent Symptoms Such as Wheezing in People 5 Years of Age and Older

DULERA is

a prescription medicine that may help control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older.

DULERA combines an inhaled corticosteroid medicine (ICS), mometasone furoate, and a long-acting beta2-adrenergic agonist medicine (LABA), formoterol.

DULERA® (mometasone furoate and formoterol fumarate dihydrate) Is Not Used to Relieve Sudden Breathing Problems and Will Not Replace a Rescue Inhaler

DULERA is not

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

DULERA is not for adults and children 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 children with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

DULERA® (mometasone furoate and formoterol fumarate dihydrate) is Taken Twice Daily Every DayDULERA® (mometasone furoate and formoterol fumarate dihydrate) is Taken Twice Daily Every Day

MEDICINES

IN

The Two Medicines in DULERA® (mometasone furoate and formoterol fumarate dihydrate)The Two Medicines in DULERA® (mometasone furoate and formoterol fumarate dihydrate)

ONE INHALER

DULERA is taken twice daily every day. DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening.

  • Mometasone furoate is an inhaled corticosteroid—ICS for short. Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • Formoterol fumarate is a long-acting beta2-agonist—LABA for short. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

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.

Learn about a Savings Offer & Free Trial Offer

SAVINGS OFFER FOR DULERA* FREE TRIAL OFFER FOR DULERA*

* Not all patients are eligible. Certain restrictions apply. Please see the Terms and Conditions.

Learn about a Savings Offer & Free Trial Offer

SAVINGS OFFER FOR DULERA* FREE TRIAL OFFER FOR DULERA*

* Not all patients are eligible. Certain restrictions apply. Please see the Terms and Conditions.

3 Dosage Strengths Available

50 mcg/5 mcg

Approved in 2019 for pediatric patients aged 5 to less than 12 years

100 mcg/5 mcg

or

200 mcg/5 mcg

Approved in 2010 for adult and adolescent patients aged 12 years and older

Approved Dosage Strengths for DULERA® (mometasone furoate and formoterol fumarate dihydrate)

3 dosage strengths available

50 mcg/5 mcg

Approved in 2019 for pediatric patients aged 5 to less than 12 years

100 mcg/5 mcg

or

200 mcg/5 mcg

Approved in 2010 for adult and adolescent patients aged 12 years and older

For pediatric patients aged 5 to 12 years

DULERA helps significantly improve lung function. Pediatric patients 5 to less than 12 years old taking DULERA had a greater measure of air exhaled during a forced breath in 1 second compared to those taking mometasone furoate alone*.

*The study involved pediatric patients 5 to less than 12 years old whose asthma was previously controlled on an ICS/LABA for at least 4 weeks.

For adult and adolescent patients aged 12 years and older

DULERA helps significantly improve lung function. Fewer adults and adolescents 12 years and older taking DULERA had an asthma flare-up compared to people taking formoterol alone*.

*The study involved patients 12 years of age and older 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.


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, electrocardiogram (ECG) changes, or death. 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.
  • 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. After each dose (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or 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.
  • 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, headache, flu, and upper respiratory infection.

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.


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