Generic Name
Ciclesonide
Brand Names
Alvesco, Omnaris
FDA approval date: March 26, 2018
Form: Spray, Aerosol
What is Alvesco (Ciclesonide)?
OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older.
Approved To Treat
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Related Clinical Trials
The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
Summary: Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).
Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
Summary: Inhaled corticosteroid (ICS) is considered the first line medication for asthma, however, the therapeutic effect is markedly different even in patients with almost similar clinical manifestations. Our study was designed to explore the clinical and genetic factors that may influence the effectiveness of ICS in asthmatic children.
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Brand Information
Alvesco (ciclesonide)
1INDICATIONS AND USAGE
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older.
Limitations of Use:
ALVESCO is not indicated for the relief of acute bronchospasm.
ALVESCO is not indicated for children under 12 years of age.
2DOSAGE FORMS AND STRENGTHS
Inhalation aerosol:
- 80 mcg of ciclesonide per actuation, supplied with a brown plastic actuator with a red dust cap
- 160 mcg of ciclesonide per actuation, supplied with a red plastic actuator with a red dust cap
3CONTRAINDICATIONS
ALVESCO is contraindicated in:
- the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
- patients with known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Oropharyngeal Candidiasis
- Immunosuppression and Risk of Infections
- Hypercorticism and Adrenal Suppression
- Reduction in Bone Mineral Density
- Growth Effects
- Glaucoma and Cataracts
4.1Clinical Trial Experience
The safety data described below for adult and pediatric patients 12 years of age and older reflect exposure to ALVESCO in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are omitted from the safety database because the doses studied once daily are lower than the highest recommended twice daily doses. The five studies were of 12 to 16 weeks treatment duration, one of which included a safety extension follow-up of one year. In the 12 to 16 week treatment studies, 720 patients (298 males and 422 females) aged 12 years and older were exposed to ALVESCO. In the long-term safety trial, 197 patients (82 males and 115 females) with severe persistent asthma from one of the 12-week trials were re-randomized and treated for up to one year with ALVESCO 320 mcg twice daily.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Pediatric Patients 12 Years of Age and Older
Four of the five trials included a total of 624 patients ages 12 years and older (359 females and 265 males) with asthma of varying severity who were treated with ALVESCO 80 mcg, 160 mcg, or 320 mcg twice daily for 12 to 16 weeks. These studies included patients previously using either controller therapy (predominantly inhaled corticosteroids) or reliever therapy (bronchodilator therapy alone). In these trials, the mean age was 39.1 years, and the majority of the patients (79.0%) were Caucasian. In these trials, 52.3%, 59.8% and 54.1% of the patients in the ALVESCO 80 mcg, 160 mcg, and 320 mcg treatment groups, respectively, had at least one adverse event compared to 58.0% in the placebo group.
Table 2includes adverse reactions for the recommended doses of ALVESCO that occurred at an incidence of ≥ 3% in any of the ALVESCO groups and which were more frequent with ALVESCO compared to placebo.
The following adverse reactions occurred in these clinical trials using ALVESCO with an incidence of less than 1% and occurred at a greater incidence with ALVESCO than with placebo.
Infections and Infestations: Oral candidiasis
Respiratory Disorders: Cough
Gastrointestinal Disorders: Dry mouth, nausea
General Disorders and Administrative Site Conditions: Chest discomfort
Respiratory, Thoracic, and Mediastinal Disorders: Dysphonia, dry throat
The fifth study was a 12-week clinical trial in asthma patients 12 years of age and older who previously required oral corticosteroids (average daily dose of oral prednisone of 12 mg/day), in which the effects of ALVESCO 320 mcg twice daily (n = 47) and 640 mcg twice daily (n = 49) were compared with placebo (n = 45) for the frequency of reported adverse reactions. The following adverse reactions occurred at an incidence of ≥ 3% in the ALVESCO-treated patients and were more frequent compared to placebo: sinusitis, hoarseness, oral candidiasis, influenza, pneumonia, nasopharyngitis, arthralgia, back pain, musculoskeletal chest pain, headache, urticaria, dizziness, gastroenteritis, face edema, fatigue, and conjunctivitis.
Long-Term Clinical Trials Experience
A total of 197 patients 12 years of age and older (82 males and 115 females) from one of the 12-week treatment placebo-controlled studies were re-randomized to ciclesonide 320 mcg twice daily and followed for one year. The safety profile from the one-year follow-up was similar to that seen in the 12- and 16-week treatment studies.
4.2Post-marketing Experience
In addition to adverse reactions identified from clinical trials, the following adverse reactions have been identified during worldwide post-marketing use of ciclesonide oral inhalation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue and pharynx.
5DRUG INTERACTIONS
In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of des-ciclesonide
In vitrostudies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology ( .
In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.
6OVERDOSAGE
Chronic overdosage may result in signs/symptoms of hypercorticism
7DESCRIPTION
The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α). The empirical formula is C
Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform.
ALVESCO 80 mcg and ALVESCO 160 mcg are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO.
8HOW SUPPLIED/STORAGE AND HANDLING
ALVESCO is available in the following strengths and canister presentations.
ALVESCO (ciclesonide) 80 mcg inhalation aerosol is supplied with a brown plastic actuator with a red dust cap. Each actuation of the inhaler delivers 80 mcg of ciclesonide from the actuator and contains 60 actuations fill/canister.
ALVESCO 160 (ciclesonide) mcg inhalation aerosol is supplied with a red plastic actuator with a red dust cap. Each actuation of the inhaler delivers 160 mcg of ciclesonide from the actuator and contains 60 actuations fill/canister.
ALVESCO canisters are for use with ALVESCO actuators only. The actuators are fitted with a dose indicator and should not be used with other medications. The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero.
Store at 25°C (77°F). Excursions between 15°C and 30°C (59°F and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used.
Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
Oropharyngeal Candidiasis
Patients should be advised that localized infections with
Acute Asthma Episodes
Patients should be advised that ALVESCO is not a bronchodilator and is not intended for use as rescue medication for acute asthma exacerbations. Acute asthma symptoms should be treated with an inhaled, short-acting beta
Immunosuppression and Risk of Infections
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
Hypercorticism and Adrenal Suppression
Patients should be advised that ALVESCO 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 ALVESCO
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
Effect on Growth
Patients should be informed that orally inhaled corticosteroids, including ALVESCO, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of pediatric patients taking corticosteroids by any route
Use Daily for Best Effect
Patients should be advised to use ALVESCO at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for four weeks or longer after starting treatment. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens. Patients should be instructed not to stop ALVESCO use abruptly. Patients should contact their physician immediately if use of ALVESCO is discontinued.
How to Use ALVESCO
Patients should use ALVESCO only with the actuator supplied with the product. When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required. Discard the inhaler when the indicator shows zero.
Manufactured for:
10Patient Information
ALVESCO
Note: For Oral Inhalation Only
Do notuse your ALVESCO near heat or an open flame.
Read this Patient Information leaflet before you start using ALVESCO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about ALVESCO, ask your healthcare provider or pharmacist.
What is ALVESCO?
ALVESCO is a prescription medicine used for the control and prevention of asthma in adults and children 12 years of age and older.
ALVESCO contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation. When you inhale ALVESCO it may help to control and prevent your symptoms of asthma by reducing your airway inflammation.
ALVESCO is not for the relief of acute bronchospasm. ALVESCO is not a bronchodilator and does not treat sudden symptoms of an asthma attack such as wheezing, cough, shortness of breath, and chest pain or tightness.
It is not known if ALVESCO is safe and effective in children 11 years of age and younger.
Who should not use ALVESCO?
Do not use ALVESCO:
- to treat status asthmaticus or other sudden symptoms of asthma. ALVESCO is not a rescue inhaler and should not be used to give you fast relief from your asthma attack.
- if you are allergic to ciclesonide or any of the ingredients in ALVESCO. See the end of this Patient Information leaflet for a complete list of ingredients in ALVESCO.
What should I tell my healthcare provider before using ALVESCO?
Before you use ALVESCO tell your healthcare provider if you:
- have or have had eye problems such as increased ocular pressure, glaucoma, or cataracts.
- have any infections including tuberculosis or ocular herpes simplex.
- have not had or been vaccinated for chicken pox or measles.
- are pregnant or plan to become pregnant. It is not known if ALVESCO will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if ALVESCO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using ALVESCO.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use ALVESCO?
- Read the Instructions for Use at the end of this leaflet for specific information about the right way to use ALVESCO.
- Use ALVESCO exactly as your healthcare provider tells you to use it. Do not take more of your medicine, or take it more often than your healthcare provider tells you.
- You must use ALVESCO regularly. It may take 4 weeks or longer after you start using ALVESCO for your asthma symptoms to get better.
- If your symptoms do not improve or get worse, call your healthcare provider.
- Your healthcare provider may prescribe a rescue inhaler for emergency relief of sudden asthma attacks. Call your healthcare provider if you have:
- If you use another inhaled medicine, ask your healthcare provider for instructions on how to use it while you use ALVESCO.
What are the possible side effects of ALVESCO?
ALVESCO may cause serious side effects, including:
- Thrush (Candida), a fungal infection of your nose, mouth, or throat.Tell your healthcare provider if you have discomfort or pain in your throat, have hoarseness in your voice or have any redness or white colored patches in your mouth or throat. Rinse your mouth after you use your ALVESCO.
- Immune system problems that may increase your risk of infections.You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use ALVESCO. Symptoms of an infection may include:
- fever
- pain
- aches
- chills
- feeling tired
- nausea
- vomiting
- Adrenal insufficiency.Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Your healthcare provider will follow you closely if you take steroids by mouth and are having them decreased (tapered) or you are being switched to ALVESCO. People have died while steroids are being decreased and when people have been switched from steroids by mouth to inhaled steroids like ALVESCO. If you are under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again.
Call your healthcare provider right away if you have the following symptoms of adrenal insufficiency:- tiredness
- weakness
- dizziness
- nausea that does not go away
- vomiting that does not go away
- Decreased bone mass (bone mineral density).People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength. Talk to your healthcare provider about any concerns you may have about bone health.
- Slowed or delayed growth in children.A child’s growth should be checked regularly while using ALVESCO.
- Eye problems such as glaucoma and cataracts.If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use ALVESCO.
- Increased wheezing (bronchospasm)can happen right away after using ALVESCO. Stop using ALVESCO and use an inhaled fast-acting bronchodilator (rescue inhaler) right away.
Tell your healthcare provider right away so that a new medicine can be prescribed to control your asthma.
The most common side effects with ALVESCO include: - headache
- swelling of nose and throat (nasopharyngitis)
- swelling of the sinuses (sinusitis)
- throat pain
- upper respiratory infection
- joint pain (arthralgia)
- nasal congestion
- pain in arms, legs, and back
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects with ALVESCO. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ALVESCO?
- Store ALVESCO at room temperature between 59°F to 86°F (15°C to 30°C)
- Do notpuncture the ALVESCO canister
- Do notstore the ALVESCO canister near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.
- Do notthrow the ALVESCO canister into a fire or an incinerator.
- Safely throw away medicine that is out of date or no longer needed.
- Keep ALVESCO Aerosol and dry at all times.
Keep ALVESCO and all medicines out of reach of children.
General Information About the Safe and Effective use of ALVESCO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ALVESCO for a condition for which it is not prescribed. Do not give ALVESCO to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information summarizes the most important information about ALVESCO. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ALVESCO that is written for health professionals.
For more information, go to www.alvesco.us/.
What are the ingredients in ALVESCO?
Active ingredient:ciclesonide
Inactive ingredients:propellant HFA-134a and ethanol
Instructions for Use
Read this Instructions for Use for ALVESCO before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Note: For Oral Inhalation Only
Do notuse your ALVESCO near heat or an open flame.
The parts of your ALVESCO
ALVESCO comes as a canister that fits into an actuator with a dose indicator.
Priming your ALVESCO for use
- Remove your ALVESCO from its package.
- Before you use ALVESCO for the first timeor if you have not used your medicine for 10 days in a row, you will need to prime your ALVESCO unit.
- Remove the plastic cap. Look at the dose indicator on top of the inhaler. Make sure that the dose indicator display window pointer is before the “60” inhalation mark before you use your ALVESCO for the first time.
- Hold the actuator upright. Spray 3 times into the air away from the face, by pressing down fully onto the center of the dose indicator button. (See
- Check the dose indicator display window after the priming sprays and before the first use to make sure it shows that there are 60 sprays left in your ALVESCO unit. If there are not 60 sprays left in your ALVESCO after the first use priming spray, return it to the pharmacy.
- Make sure the canister is firmly placed in the mouthpiece each time you use your ALVESCO.
- You do not need to shake your ALVESCO unit before you use it.
Using Your ALVESCO
Step 1.Remove the cap from the mouthpiece. (See Figure C)
Step 2.Hold the actuator upright, between your thumb, forefinger, and middle finger with the mouthpiece pointing towards you. (See Figure D)
Step 3.Breathe out as fully as you comfortably can. Close your lips around the mouthpiece, keeping your tongue below it. (See Figure E)
Step 4.
- While breathing in deeply and slowly, press down on the center of the dose indicator with your finger. Press down fully on the canister until it stops moving in the actuator while delivering your dose.
- When you have finished breathing in, hold your breath for about 10 seconds, or for as long as is comfortable.
- Note: It is normal to hear a soft click from the indicator as it counts down during use.
Step 5.
Take your finger completely off the center of the dose indicator and remove the inhaler from your mouth. Breathe out gently. (See
Step 6.Replace the cap to keep the mouthpiece clean.
Step 7.Rinse your mouth with water and spit it out. Do notswallow.
Cleaning your ALVESCO unit
- Clean the mouthpiece weekly with a clean dry tissue, both inside and out. (See
- Wipe over the front of the small hole where the medicine comes out with a dry, folded tissue. (See
- Do not wash or put any part of your ALVESCO unit in water or any other liquids.
How to tell if your ALVESCO canister is empty
- Your ALVESCO unit is fitted with a dose indicator display which shows you how much of your medicine is left after each use.
- Each canister of ALVESCO contains enough medicine for you to spray your medicine 60 times. This does not count the first sprays used for priming.
- The dose indicator display counts down by 10 and will move every tenth time you take a puff (i.e., 60-50-40, etc.).
- The dose indicator display window will turn red when there are only 20 sprays left. This means that you need to replace your inhaler soon.
- When the dose indicator display window reads “0” you should throw away your ALVESCO unit. (See
- Although your ALVESCO unit is fitted with a dose indicator display to help determine the number of sprays left, you should keep track of the number of sprays used from each canister of your ALVESCO unit.
This PPI and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for:
ALVESCO is a registered trademark of Covis Pharma.
©2025 Covis Pharma. All rights reserved.
11PRINCIPAL DISPLAY PANEL - 80 mcg Carton
NDC 70515-711-01 Net Contents: 6.1 g
Alvesco ciclesonide
Inhalation Aerosol
Inhalation Aerosol
80 mcg/actuation
60 Metered Actuations
FOR ORAL INHALATION WITH ALVESCO
Rx Only
COVIS
Alvesco ciclesonideInhalation Aerosol
80 mcg/actuation
GTIN: 00370515711013
Pharmacist:Dispense
with Patient’s Instructions from package
insert inside.
with Patient’s Instructions from package
insert inside.
WARNING:Keep out of
reach of children. Avoid
spraying in eyes.
reach of children. Avoid
spraying in eyes.
COVIS Manufactured for:
Covis Pharma
Zug, 6300 Switzerland
Covis Pharma
Zug, 6300 Switzerland
Made in the United Kingdom
Each 6.1 g canister of
Dosage and
See package insert for
dosage information.
See package insert for
dosage information.
CONTENTS UNDER Do not
puncture.
puncture.
Do not use or store near
Exposure to temperatures
Store at 25°C (77°F);
excursions between
15–30°C (59–86°F) are
permitted [see USP]. For
optimal results, canister
should be at room
temperature when used.
excursions between
15–30°C (59–86°F) are
permitted [see USP]. For
optimal results, canister
should be at room
temperature when used.
12PRINCIPAL DISPLAY PANEL - 160 mcg Carton
NDC 70515-712-01 Net Contents: 6.1 g
Alvesco ciclesonide
Inhalation Aerosol
Inhalation Aerosol
160 mcg/actuation
60 Metered Actuations
FOR ORAL INHALATION WITH ALVESCO
Rx Only
COVIS
Alvesco ciclesonide
Inhalation Aerosol
Inhalation Aerosol
160 mcg/actuation
GTIN: 00370515712010
Pharmacist:Dispense
with Patient’s Instructions from package
insert inside.
with Patient’s Instructions from package
insert inside.
WARNING:Keep out of
reach of children. Avoid
spraying in eyes.
reach of children. Avoid
spraying in eyes.
COVIS Manufactured for:
Covis Pharma
Zug, 6300 Switzerland
Covis Pharma
Zug, 6300 Switzerland
Made in the United Kingdom
Each 6.1 g canister of
Dosage and
See package insert for
dosage information.
See package insert for
dosage information.
CONTENTS UNDER Do not
puncture.
puncture.
Do not use or store near
Exposure to temperatures
Store at 25°C (77°F);
excursions between
15–30°C (59–86°F) are
permitted [see USP]. For
optimal results, canister
should be at room
temperature when used.
excursions between
15–30°C (59–86°F) are
permitted [see USP]. For
optimal results, canister
should be at room
temperature when used.