Asmanex

• Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack and any additional information you are given. These will give you more information about mometasone, and will also provide you with a full list of side-effects which you could experience from using the inhaler.
• Your doctor will tell you how often to use the inhaler, but as a guide, it is usual to use it either once or twice daily. If you are asked to use the inhaler just once a day, use it in the evening; if you are using it twice a day, use it in the morning as well as the evening. Make sure you know how to use your inhaler device properly. If you are not sure, ask your nurse, doctor or pharmacist to show you.
• Some people using steroid inhalers find that the back of their throats can become sore. If you rinse your mouth with water and brush your teeth after using your inhaler, this is less likely to develop.

Along with their useful effects, inhalers like most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the common ones associated with mometasone. You will find a full list in the manufacturer's information leaflet supplied with your inhaler. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

Using high doses of inhaled steroids over a long time may aggravate mental health problems and be a risk factor for other problems such as developing osteoporosis. Also, children who use an inhaled steroid over a long time should have their growth monitored. If you are concerned about any of these rare effects, you should discuss them with your doctor.

If you experience any other symptoms which you think may be due to the inhaler, speak with your doctor or pharmacist for further advice.

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Asmanex Twisthaler, there are no specific foods that you must exclude from your diet when receiving this medication.

Ask your doctor before using Asmanex Twisthaler, if you have an allergy to milk proteins. 

Before you take Asmanex Twisthaler, tell your doctor if you:

• are allergic to Asmanex Twisthaler or any of its ingredients
• need to treat sudden, severe symptoms of asthma
• have an allergy to milk proteins. Ask your health care provider if you are not sure.
• have an immune system problem
• have osteoporosis
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are exposed to chickenpox or measles
• have or had tuberculosis (TB)
• have any other medical problems
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• previous medications you have taken
• your age
• how you respond to this medication
• the severity of the condition being treated

The recommended starting doses of Asmanex Twisthaler based off previous medications and age are as follows:

• Patients 12 years of age and older who have received bronchodilators alone or have received inhaled corticosteroids: 220 mcg once daily in the evening. The highest recommended daily dose is 440 mcg.
• Patients 12 years of age and older who have received oral (by mouth) corticosteroids: 440 mcg twice daily. The highest recommended daily dose is 880 mcg.
• Children 4-11 years of age: 110 mcg once daily in the evening. The highest recommended daily dose is 110 mcg. 

Contraindications

• Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids12 15 ) are required.1

• Known hypersensitivity to mometasone furoate or any ingredient (e.g., lactose) in the formulation.1

Warnings/Precautions

Warnings

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled mometasone furoate.1

Withdraw systemic corticosteroid therapy gradually 1 and monitor for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy.1 Lung function (FEV1 or PEFR), adjunctive β2-adrenergic agonist use, and asthma symptoms also should be carefully monitored.1 In most patients, several months are required for total recovery of HPA function following withdrawal of systemic corticosteroid therapy.1 Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer.1

Monitor for corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression).1

Monitor for acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with acute electrolyte loss.1

Possible unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).1

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.1 Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.1

Take particular care to avoid exposure in susceptible patients.1 If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immunoglobulin (IG), respectively.1 Consider treatment with an antiviral agent if varicella develops.1

Bronchospasm and/or wheezing may occur.1

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, discontinue treatment with mometasone furoate, and institute alternative therapy.1 8

Treat acute asthma symptoms with a short-acting β2-agonist bronchodilator.1 8 12 If symptoms persist, promptly reevaluate and consider initiation of systemic corticosteroids.1 12

Oral inhalation powder contains lactose and should not be used in those with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.1 2

Sensitivity Reactions

Allergic reaction, facial edema, urticaria, hypersensitivity, and throat tightness reported.1

General Precautions

Glaucoma, increased intraocular pressure, and cataracts reported rarely.1 Carefully monitor patients who have a change in vision or those with a history of increased IOP, glaucoma and/or cataracts.1

Administration of higher than recommended dosages of inhaled mometasone furoate over prolonged periods of time, or in particularly sensitive individuals, may result in manifestations of hypercorticism and suppression of HPA function.1 If such changes occur, reduce the dosage of mometasone furoate slowly, consistent with accepted procedures for reducing systemic corticosteroid dosage and management of asthma symptoms.1

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.1

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).1

Monitor patients with major risk factors for decreased BMD (e.g., family history of osteoporosis, prolonged immobilization, chronic use of drugs that can reduce bone mass [e.g., anticonvulsants, corticosteroids]) and treat with established standards of care.1

Localized candidal infections of the mouth and pharynx reported.1 If infection occurs, appropriate local or systemic treatment and/or discontinuance of therapy may be required.1

Use with extreme caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.1

Specific Populations

Category C.1

Not known whether mometasone is distributed into milk;1 however, other corticosteroids are distributed into milk.1 Caution advised if used in nursing women.1

Safety and efficacy of mometasone oral inhalation powder not established in children <4 years of age.1

With prolonged use, may slow growth rate in children and adolescents.1 Monitor routinely (e.g., via stadiometry) the growth and development of pediatric patients receiving corticosteroid therapy.1 Weigh benefits of corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies.1 Use the lowest possible dosage that effectively controls asthma.1

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Common Adverse Effects

Adults and children ≥12 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Headache,1 3 4 7 8 allergic rhinitis,1 8 pharyngitis,1 3 4 5 7 upper respiratory tract infection,1 8 sinusitis,1 oral candidiasis,1 3 4 5 7 dysmenorrhea,1 8 musculoskeletal pain,1 8 back pain,1 8 dyspepsia.1 7

Adults and children ≥12 years of age previously receiving oral corticosteroids: Musculoskeletal pain, oral candidiasis, sinusitis, allergic rhinitis, upper respiratory infection, arthralgia, fatigue, depression, sinus congestion.1

Children 4–11 years of age previously receiving bronchodilators and/or inhaled corticosteroids: Fever,1 headache,11 allergic rhinitis,1 pharyngitis,11 upper respiratory tract infection,11 abdominal pain.1 11

Treatment of Asthma

Asmanex® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Important Limitations of Use

Asmanex TWISTHALER is NOT indicated for the relief of acute bronchospasm.

Asmanex TWISTHALER is NOT indicated in children less than 4 years of age.

See FDA-Approved Patient Labeling (Patient Information).

Oral Candidiasis

Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with Asmanex TWISTHALER therapy, but at times therapy with Asmanex TWISTHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1)].

Acute Asthma Episodes

Patients should be advised that Asmanex TWISTHALER is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Acute asthma symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction have been reported with use of Asmanex TWISTHALER. Discontinue Asmanex TWISTHALER if such reactions occur [see Contraindications (4.2), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].

Asmanex TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with Asmanex TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4.2) and Adverse Reactions (6.2)].

Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

Hypercorticism and Adrenal Suppression

Patients should be advised that Asmanex TWISTHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to Asmanex TWISTHALER [see Warnings and Precautions (5.6)].

Reduction in Bone Mineral Density

Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition [see Warnings and Precautions (5.7)].

Reduced Growth Velocity

Patients should be informed that orally inhaled corticosteroids, including mometasone furoate inhalation powder, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.8)].

Use Daily for Best Effect

Patients should be advised to use Asmanex TWISTHALER at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. If symptoms do not improve in that time frame or if the condition worsens, patients should be instructed to contact their physician.

Instructions for Use

Patients should be instructed to record the date of pouch opening on the cap label and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads "00" and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation and rotated fully until the click is heard. Rinsing of mouth after inhalation is advised. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
MSD International GmbH (Singapore Branch)
Singapore 638030, Singapore

For patent information: www.merck.com/product/patent/home.html

Copyright © 2008, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0887-pwih-1409r015

Patient Information

Asmanex® TWISTHALER® 220 mcg (mometasone furoate inhalation powder)
Asmanex® TWISTHALER® 110 mcg (mometasone furoate inhalation powder)

FOR ORAL INHALATION ONLY

Please read this leaflet carefully before taking Asmanex® TWISTHALER®.

This leaflet does not contain the complete information about this medication. If you have any questions about Asmanex TWISTHALER, ask your health care provider or pharmacist.

IMPORTANT POINTS TO REMEMBER ABOUT Asmanex TWISTHALER

• Your health care provider has prescribed Asmanex TWISTHALER for you or your child. It contains a medicine called mometasone furoate, which is a man-made corticosteroid. This medicine is used as maintenance treatment that helps prevent and control asthma symptoms.
• Asmanex TWISTHALER is not a bronchodilator and should not be used for sudden symptoms of shortness of breath. Use an inhaled short-acting bronchodilator such as albuterol to relieve sudden symptoms of shortness of breath.
• Your health care provider may prescribe bronchodilators such as albuterol for emergency relief if an acute asthma attack occurs.
• Use your Asmanex TWISTHALER regularly and at the same time each day, as prescribed by your health care provider. You or your child may not get the most benefit for 1 to 2 weeks or longer after starting Asmanex. If you or your child's symptoms do not improve in that time frame or if your condition gets worse, contact your health care provider.
• The cap is needed to use the Asmanex TWISTHALER. Do not twist the mouthpiece with your hand. When the cap is removed from the TWISTHALER, the dose counter will count down by one, and show the number of doses available after this use.
• The inhaler delivers your medicine as a very fine powder that you or your child may not taste, smell, or feel. Do not take or give extra doses unless your health care provider has told you to.
• It is important to replace the cap after each inhalation to protect the inhaler from moisture.
• Do not use the inhaler if you notice that it is not working correctly. Take it to your health care provider or pharmacist.

WHO SHOULD NOT USE Asmanex TWISTHALER

Do not use Asmanex TWISTHALER:

• To treat sudden, severe symptoms of asthma.
• If you have an allergy to milk proteins. Ask your health care provider if you are not sure.

HOW TO USE Asmanex TWISTHALER OR GIVE TO YOUR CHILD

• Remove the Asmanex TWISTHALER from its foil pouch and write the date on the cap label.
• Throw away the inhaler 45 days after this date or when the dose counter reads "00", indicating the final dose has been inhaled, whichever comes first.
• Follow steps 1 and 2 below each time you inhale a dose from your Asmanex TWISTHALER.

Inhaler Parts:

See Figures 1 and 2 below to become familiar with the inhaler parts.

Step 1: Open inhaler

Hold the inhaler straight up (upright position) with the colored portion (the base) on the bottom (see Figure 3 below). It is important that you remove the cap of the TWISTHALER while it is in this upright position to make sure that you get the right amount of medicine with each dose.

Holding the colored base, twist the cap in a counterclockwise direction to remove it (see Figure 3 below). As you lift off the cap, the dose counter on the base will count down by one. Removing the cap loads the TWISTHALER with the medicine that you are now ready to inhale.

IT IS IMPORTANT TO NOTE that the indented arrow (located on the white portion of the TWISTHALER, directly above the colored base) is pointing to the dose counter (see Figure 2).

Step 2: Inhale dose

Breathe out fully. Then bring the TWISTHALER up to your mouth or your child's mouth with the mouthpiece facing toward you or your child. Place the mouthpiece in your mouth or your child's mouth, holding it in a horizontal (on its side) position as shown below (see Figure 4). Firmly close your lips around the mouthpiece and take in a fast, deep breath. Since the medicine is a very fine powder, you may not be able to taste, smell, or feel it after inhalation. Do not cover the ventilation holes while inhaling the dose.

Remove the TWISTHALER from your mouth and hold your breath for about 10 seconds, or as long as you comfortably can.

IMPORTANT: DO NOT BREATHE OUT (EXHALE) INTO THE INHALER.

After you take your medicine, it is important that you wipe the mouthpiece dry, if needed, and then REPLACE THE CAP, firmly closing the TWISTHALER right away (see Figures 5 and 6 below).

Be sure that the indented arrow is in line with the dose counter. Put the cap back onto the inhaler and turn it in a clockwise direction, as you gently press down. You'll hear a "click" to let you know that the cap is fully closed. This is the only way to be sure that your next dose is loaded the right way.

IT IS IMPORTANT TO REPEAT STEPS 1 AND 2 EACH TIME YOU INHALE.

Rinse your mouth after using.

STORING YOUR INHALER

• Keep your inhaler clean and dry at all times. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash the inhaler. Avoid contact with any liquids.
• Store in a dry place at 25°C (77°F) [may range between 15–30°C (59–86°F)].
• Keep your inhaler out of the reach of children.

HOW TO KNOW WHEN YOUR INHALER IS EMPTY

The inhaler has a dose counter on the colored base, which shows the number of doses left to use. As you lift off the cap to take your dose, the dose counter on the base will count down by one (if you began with the dose counter reading "30" this will cause the dose counter to now read "29"). Read the numbers from top to bottom.

When the unit reads "01" this indicates the last remaining dose. After dose "01" the counter will read "00". When you replace the cap, the unit will lock and then must be thrown away. Start using a new Asmanex TWISTHALER as instructed by your health care provider.

POSSIBLE SIDE EFFECTS WITH Asmanex TWISTHALER

Serious Side Effects may include:

• Fungal infections in the mouth and throat. Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Rinse your mouth after using Asmanex TWISTHALER.
• Worsening asthma or sudden asthma attacks
• Serious allergic reactions. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction, including:
  • Rash
  • Swelling of the face, mouth and tongue
  • Breathing problems
• Possible increased risk of infection due to a weakened immune system with using steroid medicines. Tell your health care provider if you or your child have or had TB, are exposed to anyone with chickenpox or measles, or about any other infections you or your child had before or while using Asmanex TWISTHALER.
• Adrenal insufficiency (your adrenal gland cannot produce enough steroids since you were on oral steroid medicine). If you or your child took steroids by mouth and are having them decreased (tapered) or you are being switched to Asmanex TWISTHALER, you should be followed closely by your health care professional.
  Death can occur. Tell your health care professional 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.
• Decreased bone mass (bone mineral density). Patients who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Talk with your health care provider about any questions about bone health.

The most common side effects with Asmanex TWISTHALER include: headache, nasal allergy symptoms, sore throat, upper respiratory tract infection, sinus infection, fungal infections in the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.

Tell your health care professional about any side effects that bother you or do not go away. These are not all of the possible side effects with Asmanex TWISTHALER. For more information, ask your health care professional.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
MSD International GmbH (Singapore Branch)
Singapore 638030, Singapore

For patent information: www.merck.com/product/patent/home.html

Copyright © 2008, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 09/2014

usppi-mk0887-pwih-1409r010

PRINCIPAL DISPLAY PANEL - 220 mcg - 120 Dose Carton

NDC 0085-1341-01

For Oral Inhalation
Rx only

Asmanex®
Twisthaler®
mometasone furoate inhalation powder
220 mcg per actuation

120 Metered Doses
(For more than 2 inhalations daily)

Discard Twisthaler inhaler 45 days after
opening foil pouch or when dose counter
reads "00", whichever comes first.

Attention Pharmacist: Detach Patient's
Instructions for Use and dispense with inhaler

PRINCIPAL DISPLAY PANEL - 110 mcg - 30 Dose Carton

NDC 0085-1461-02

For Oral Inhalation
Rx only

Asmanex®
Twisthaler®
mometasone furoate inhalation powder
110 mcg per actuation

Usual Dose for 4 to 11 years of age is 110 mcg

30 Metered Doses

Discard Twisthaler inhaler 45 days after
opening foil pouch or when dose counter
reads "00", whichever comes first.

Attention Pharmacist: Detach Patient's
Instructions for Use and dispense with inhaler

Use Asmanex exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Asmanex will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Asmanex comes in a powder form that is preloaded in with a special inhaler device (twisthaler). The device will deliver a measured dose of mometasone as a fine spray of powder each time you use the inhaler.

You may or may not be able to feel or taste this powder in your mouth while using the inhaler. Do not use extra doses if you do not feel or taste the powder. Tell your doctor or pharmacist if you think your inhaler is not working properly.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 weeks of treatment.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using Asmanex. Do not swallow.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you switched to Asmanex from an oral (taken by mouth) steroid, you may need to restart the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

Store Asmanex at room temperature away from moisture and heat. When you first open the foil pouch and remove the inhaler device, write the date on the device. Throw away the inhaler after 45 days, or when the dose counter shows "00."

Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth after each use.

Applies to mometasone: inhalation aerosol, inhalation aerosol powder

Gastrointestinal

Very common (10% or more): Oral candidiasis
Uncommon (0.1% to 1%): Dry mouth and throat, dyspepsia[Ref]

In clinical trials, gastroenteritis and vomiting occurred with an incidence of at least 1% but less than 3%.[Ref]

Nervous system

Very common (10% or more): Headache[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis, allergic rhinitis, upper respiratory infection
Common (1% to 10%): Sinusitis, bronchitis, pharyngitis, dysphonia, epistaxis, nasal irritation, respiratory disorder
Postmarketing reports: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, urinary tract infection (in pediatrics)[Ref]

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain, back pain, myalgia[Ref]

Other

Common (1% to 10%): Fatigue, flu-like symptoms, pain, earache, infection, fever and bruise (in pediatrics)[Ref]

In clinical trials, fatigue, flu-like symptoms, pain, earache, and infection occurred with an incidence of at least 1% but less than 3%.[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations[Ref]

Metabolic

Uncommon (0.1% to 1%): Weight increase[Ref]

Ocular

Rare (less than 0.1%): Glaucoma, cataracts[Ref]

Psychiatric

Frequency not reported: Psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression[Ref]

Hypersensitivity

Postmarketing reports: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction[Ref]

Some side effects of Asmanex Twisthaler may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.