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Ciclesonide (oral inhalation): Drug information

Ciclesonide (oral inhalation): Drug information
(For additional information see "Ciclesonide (oral inhalation): Patient drug information" and see "Ciclesonide (oral inhalation): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Alvesco
Brand Names: Canada
  • Alvesco
Pharmacologic Category
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult
Asthma, maintenance/controller

Asthma, maintenance/controller: Oral inhalation: Note : Product selection: Individualize daily ciclesonide dose based on severity of symptoms, typically as follows: Low doses for mild persistent asthma; low to medium doses for moderate persistent asthma; and medium to high doses for severe persistent asthma. Select a product with a favorable dosage per actuation to improve convenience and adherence (Ref).

Dosage Classification for Ciclesonide Preparations (GINA 2023)

Low dose

Medium dose

High dose

Ciclesonide

80 to 160 mcg/day

>160 to 320 mcg/day

>320 mcg/day

US labeling: Metered-dose inhaler:

Note: Dosing based on previous asthma therapy and asthma severity. May increase dose after 4 weeks of therapy in patients who are not adequately controlled.

Prior therapy with bronchodilators alone: Initial: 80 mcg twice daily (maximum dose: 160 mcg twice daily)

Prior therapy with inhaled corticosteroids: Initial: 80 mcg twice daily (maximum dose: 320 mcg twice daily)

Prior therapy with oral corticosteroids: Initial: 320 mcg twice daily (maximum dose: 320 mcg twice daily)

Canadian labeling: Metered-dose inhaler: Initial: 400 mcg once daily; more severe asthma may require 400 mcg twice daily; maintenance: 100 to 800 mcg/day.

Conversion: Conversion from oral to orally inhaled steroid: Initiation of oral inhalation therapy should begin in patients who have previously been stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin at least 1 week after starting inhaled therapy. Manufacturer's labeling recommends reducing prednisone dose no more rapidly than ≤2.5 mg/day on a weekly basis.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer labeling (has not been studied); however, dose adjustments may not be necessary as ≤20% of drug is eliminated renally.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ciclesonide (oral inhalation): Pediatric drug information")

Asthma

Asthma:

Maintenance therapy: Note: Doses should be titrated to the lowest effective dose once asthma is controlled:

Manufacturer's labeling: Alvesco inhaler: 80 mcg/inhalation and 160 mcg/inhalation:

Children 2 to 11 years: Limited data available: Metered-dose inhaler: Oral inhalation: 40, 80, or 160 mcg once daily. Dosing from studies of childhood asthma (or wheezing in children <5 years). Efficacy results variable in children ≤6 years (Ref).

Children ≥12 years and Adolescents: Metered-dose inhaler: Oral inhalation: Note: Initial dose is based on previous asthma therapy.

Prior therapy with bronchodilators alone: Initial: 80 mcg twice daily, may increase dose after 4 weeks of therapy if response inadequate; maximum daily dose: 320 mcg/day.

Prior therapy with inhaled corticosteroids: Initial: 80 mcg twice daily, may increase dose after 4 weeks of therapy if response inadequate; maximum daily dose: 640 mcg/day.

Prior therapy with oral corticosteroids: Initial: 320 mcg twice daily; maximum daily dose: 640 mcg/day.

Asthma guidelines: Global Initiative for Asthma guidelines (Ref): HFA inhaler (refers to available US products): Oral inhalation: Note: Administer in divided doses twice daily:

Children 6 to 11 years:

"Low" dose: 80 mcg/day.

"Medium" dose: >80 to 160 mcg/day.

"High" dose: >160 mcg/day.

Children ≥12 years and Adolescents:

"Low" dose: 80 to 160 mcg/day.

"Medium" dose: >160 to 320 mcg/day.

"High" dose: >320 mcg/day.

Mild flare, exacerbation: Limited data available:

Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:

It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (Ref). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (Ref). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (Ref).

Conversion from oral systemic corticosteroid to orally-inhaled corticosteroid: Children ≥12 years and Adolescents: Initiation of oral inhalation therapy should begin in patients who have previously been stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin at least 1 week after starting inhaled therapy. Manufacturer's labeling recommends reducing prednisone dose no more rapidly than 2.5 mg/day on a weekly basis. In the presence of withdrawal symptoms, resume previous OCS dose for 1 week before attempting further dose reductions.

Canadian labeling: Maintenance therapy: Alvesco Inhaler 100 mcg/inhalation and 200 mcg/inhalation [Canadian products]: Metered-dose inhaler: Oral inhalation:

Children 6 to 11 years:

Initial: 100 to 200 mcg once daily.

Maintenance: 100 to 200 mcg/day.

Children ≥12 years and Adolescents:

Initial: 400 mcg once daily; more severe asthma may require 400 mcg twice daily.

Maintenance: 100 to 800 mcg/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, dose adjustments may not be necessary as ≤20% of drug is eliminated renally.

Dosing: Hepatic Impairment: Pediatric

No dosage adjustment necessary.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (≤11%)

Respiratory: Nasopharyngitis (≤11%)

1% to 10%:

Cardiovascular: Facial edema (≥3%)

Central nervous system: Dizziness (≥3%), fatigue (≥3%), voice disorder (1%)

Dermatologic: Urticaria (≥3%)

Gastrointestinal: Gastroenteritis (≥3%), oral candidiasis (≥3%)

Infection: Influenza (≥3%)

Neuromuscular & skeletal: Arthralgia (≥3%), back pain (≥3%), limb pain (≥3%), musculoskeletal chest pain (≥3%)

Ophthalmic: Conjunctivitis (≥3%)

Otic: Otalgia (2%)

Respiratory: Upper respiratory tract infection (≤9%), nasal congestion (≤6%), pharyngolaryngeal pain (≤5%), hoarseness (≥3%), pneumonia (≥3%), sinusitis (≥3%), paradoxical bronchospasm (2%)

<1%, postmarketing, and/or case reports: Angioedema (with swelling of lip/pharynx/tongue), cataract, chest discomfort, increased gamma-glutamyl transferase, increased intraocular pressure, increased serum ALT, nausea, palpitations, pharyngeal candidiasis, skin rash, weight gain, xerostomia

Contraindications

Hypersensitivity to ciclesonide or any component of the formulation; status asthmaticus or other acute asthma episodes requiring intensive measures

Canadian labeling: Additional contraindications (not in US labeling): Untreated fungal, bacterial, or tuberculosis infections of the respiratory tract; moderate to severe bronchiectasis

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue ciclesonide and institute alternative therapy.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (eg, angioedema, bronchospasm, rash, urticaria) may occur; discontinue use if reaction occurs.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes, respiratory tuberculosis (TB) disease (active TB) or infection (latent TB), or untreated viral, fungal, parasitic, or bacterial systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

• Oral candidiasis: Local oropharyngeal Candida albicans infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other eosinophilic conditions (eg, vasculitic rash, decreased pulmonary function, cardiac complications) can occur.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute asthma episodes requiring intensive measures.

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, antiseizure medications or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; blurred vision, increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

Special populations:

• Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 cm per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.

• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.

Warnings: Additional Pediatric Considerations

Relative to other inhaled corticosteroids, ciclesonide may exhibit less effect on HPA function due to it being a prodrug which is activated in the lungs; in four pediatric patients, resolution of HPA suppression was reported after switching from fluticasone to ciclesonide therapy (Heller 2010).

Although recommended in children ≥12 years and adolescents, using higher doses (quintupled) in children <12 years of age has not shown efficacy and may be associated with a higher risk of adverse effects. A study in children 5 to 11 years of age with mild to moderate persistent asthma evaluated quintupling the dose of the inhaled corticosteroid (fluticasone) following the early signs of decreased asthma control; results showed that quintupled fluticasone dosages did not reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (Jackson 2018).

Dosage Forms Considerations

Alvesco 6.1 g canisters contain 60 inhalations.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Alvesco: 80 mcg/actuation (6.1 g); 160 mcg/actuation (6.1 g)

Generic Equivalent Available: US

No

Pricing: US

Aerosol solution (Alvesco Inhalation)

80 mcg/ACT (per gram): $5.31

160 mcg/ACT (per gram): $5.31

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Alvesco: 100 mcg/actuation (1 ea); 200 mcg/actuation (1 ea) [contains alcohol, usp]

Administration: Adult

Metered-dose inhaler: Prime inhaler by actuating 3 times before the first use or when the inhaler has not been used for >10 consecutive days; do not shake before use. Rinse mouth with water (and spit out) after inhalation. Do not wash or place inhaler in water. Clean mouthpiece using a dry cloth or tissue once weekly. Discard after the "discard by" date or when dose indicator display window reads "0", even if canister is not completely empty.

Administration: Pediatric

Oral inhalation: Metered-dose inhaler: Shaking inhaler before use is not necessary since drug is formulated as a solution aerosol. Prime inhaler by releasing 3 puffs into the air before the first use or when the inhaler has not been used for ≥10 consecutive days. Do not spray into eyes or face while priming. Do not use near heat or open flame. Remove mouthpiece cover, place inhaler in mouth, close lips around mouthpiece, and inhale slowly and deeply. Press down on top of inhaler after slow inhalation has begun. Remove inhaler while holding breath for approximately 10 seconds. Breathe out slowly and replace mouthpiece on inhaler. Rinse mouth with water (and spit out) after use to reduce incidence of oral candidiasis. Do not wash any part of inhaler in water; clean mouthpiece using a dry cloth or tissue once weekly. Discard after the "discard by" date or when dose indicator display window reads "0," even if container is not completely empty. Dose indicator will turn red when 20 puffs remain; if inhaler dropped, dose indicator may be inaccurate; manual tracking of inhaler actuations recommended.

Use: Labeled Indications

Asthma, maintenance/controller: Maintenance treatment of asthma as prophylactic therapy in patients ≥12 years of age.

Limitations of use: Not indicated for relief of acute bronchospasm.

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Ciclesonide (Oral Inhalation). Risk C: Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Reproductive Considerations

Uncontrolled asthma may negatively affect fertility by increasing time to pregnancy and reducing birth rate. Fertility may be improved in patients adequately treated with inhaled corticosteroids (Couillard 2021; ERS/TSANZ [Middleton 2020]). Inhaled corticosteroids used for the treatment of asthma should not be discontinued in patients planning to become pregnant (GINA 2023). The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]).

Pregnancy Considerations

Maternal use of inhaled corticosteroids in usual doses are not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following high maternal doses of an alternative inhaled corticosteroid (ERS/TSANZ [Middleton 2020]). Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy.

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2023).

Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy. Due to the risk of exacerbations, stepping down or stopping ICS should not be done during pregnancy (GINA 2023). Ciclesonide oral inhalation is considered probably acceptable for use during pregnancy. Pregnant patients adequately controlled on ciclesonide for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant patients may be preferred. The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if sufficient quantities of ciclesonide are absorbed following oral inhalation to produce detectable amounts in breast milk; however, oral absorption is limited (<1%).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Ciclesonide oral inhalation is considered probably acceptable with breastfeeding (ERS/TSANZ [Middleton 2020]).

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density; growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts

Mechanism of Action

Ciclesonide is a nonhalogenated, glucocorticoid prodrug that is hydrolyzed to the pharmacologically active metabolite des-ciclesonide following administration. Des-ciclesonide has a high affinity for the glucocorticoid receptor and exhibits anti-inflammatory activity. The mechanism of action for corticosteroids is believed to be a combination of three important properties − anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: >4 weeks for maximum benefit

Absorption: 52% (lung deposition)

Distribution: Vd: Ciclesonide: 2.9 L/kg; des-ciclesonide: 12.1 L/kg

Protein binding: ≥99%

Metabolism: Ciclesonide hydrolyzed to its active metabolite, des-ciclesonide via esterases in nasal mucosa and lungs; des-ciclesonide undergoes further hepatic metabolism primarily via CYP3A4 and to a lesser extent via CYP2D6

Bioavailability: Oral inhalation: 63% (active metabolite); oral: negligible

Half-life elimination: Ciclesonide: 0.7 hours; des-ciclesonide: 6 to 7 hours

Time to peak: ~1 hour (des-ciclesonide)

Excretion: Feces (66%); urine (≤20% as active metabolite)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Cmax of des-ciclesonide in patients with moderate to severe liver impairment increased 1.4- to 2.7-fold after oral inhalation.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Cicletex;
  • (AT) Austria: Alvesco;
  • (BD) Bangladesh: Cesonide;
  • (BE) Belgium: Alvesco;
  • (BG) Bulgaria: Alvesco;
  • (BR) Brazil: Alvesco;
  • (CL) Chile: Alvesco | Disbronc;
  • (CN) China: Xian ding;
  • (CO) Colombia: Berosynt | Cicleson | Ciclovent;
  • (CZ) Czech Republic: Alvesco;
  • (DE) Germany: Alvesco;
  • (EC) Ecuador: Alvesco;
  • (EG) Egypt: Alvesco | Tentavir;
  • (ES) Spain: Alvesco;
  • (FR) France: Alvesco;
  • (GB) United Kingdom: Alvesco;
  • (HR) Croatia: Alvesco;
  • (HU) Hungary: Alvesco;
  • (IE) Ireland: Alvesco;
  • (IN) India: Ciclez | Ciclohale | Osonase | Osonide;
  • (IT) Italy: Alvesco;
  • (JP) Japan: Alvesco;
  • (KE) Kenya: Alvesco | Ciclohale;
  • (KR) Korea, Republic of: Alvesco;
  • (LB) Lebanon: Alvesco | Ciclohale;
  • (LT) Lithuania: Alvesco;
  • (LV) Latvia: Alvesco;
  • (MX) Mexico: Alvesco;
  • (MY) Malaysia: Alvesco;
  • (NL) Netherlands: Alvesco;
  • (NO) Norway: Alvesco;
  • (NZ) New Zealand: Alvesco;
  • (PE) Peru: Alvesco;
  • (PL) Poland: Alvesco;
  • (PR) Puerto Rico: Zetonna;
  • (RO) Romania: Alvesco;
  • (RU) Russian Federation: Alvesco;
  • (SA) Saudi Arabia: Alvesco;
  • (SE) Sweden: Alvesco;
  • (SG) Singapore: Alvesco;
  • (SI) Slovenia: Alvesco;
  • (SK) Slovakia: Alvesco;
  • (TR) Turkey: Alvesco | Lasecon;
  • (TW) Taiwan: Alvesco;
  • (ZA) South Africa: Ciclovent
  1. Alvesco (ciclesonide) [prescribing information]. Zug, Switzerland: Covis Pharmaceuticals; February 2023.
  2. Alvesco (ciclesonide) [product monograph]. Oakville, Ontario, Canada: Innomar Strategies Inc; March 2021.
  3. Bakhireva LN, Jones KL, Schatz M, et al, “Asthma Medication Use in Pregnancy and Fetal Growth,” J Allergy Clin Immunol, 2005, 116(3):503-9. [PubMed 16159616]
  4. Bateman E, Karpel J, Casale T, et al, “Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma,” Chest, 2006, 129(5):1176-87. [PubMed 16685007]
  5. Brand PL, Luz García-García M, Morison A, et al. Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy. Respir Med. 2011;105:1588-1595. [PubMed 21839625]
  6. Chmielewska M, Akst LM. Dysphonia associated with the use of inhaled corticosteroids. Curr Opin Otolaryngol Head Neck Surg. 2015; 23(3):255-259. [PubMed 25887975]
  7. Couillard S, Connolly C, Borg C, Pavord I. Asthma in pregnancy: an update. Obstet Med. 2021;14(3):135-144. doi:10.1177/1753495X20965072 [PubMed 34646341]
  8. Derendorf H, “Pharmacokinetic and Pharmacodynamic Properties of Inhaled Ciclesonide,” J Clin Pharmacol, 2007, 47(6):782-9 [PubMed 17412829]
  9. Gelfand EW, Georgitis JW, Noonan M, et al, "Once-Daily Ciclesonide in Children: Efficacy and Safety in Asthma," J Pediatr, 2006, 148(3):377-83. [PubMed 16615971]
  10. Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org. Updated 2018.
  11. Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Updated 2019. Accessed April 7, 2020.
  12. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
  13. Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8. [PubMed 12441327]
  14. Heller MK, Laks J, Kovesi TA, et al. Reversal of adrenal suppression with ciclesonide. J Asthma. 2010;47:337-339. [PubMed 20394520]
  15. Jackson DJ, Bacharier LB, Mauger DT, et al. Quintupling inhaled glucocorticoids to prevent childhood asthma exacerbations. N Engl J Med. 2018;378(10):891-901. [PubMed 29504498]
  16. McKeever T, Mortimer K, Wilson A, et al. Quadrupiling inhaled glucocorticoid dose to abort asthma exacerbations. N Engl J Med. 2018;378(10):902-910. doi: 10.1056/NEJMoa1714257. [PubMed 29504499]
  17. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2);1901208. doi:10.1183/13993003.01208-2019 [PubMed 31699837]
  18. National Asthma Education and Prevention Program (NAEPP), Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
  19. Pearlman DS, Berger WE, Kerwin E, et al, “Once-Daily Ciclesonide Improves Lung Function and is Well Tolerated by Patients With Mild-to-Moderate Persistent Asthma,” J Allergy Clin Immunol, 2005, 116(6):1206-12. [PubMed 16337447]
  20. Pedersen S, Engelstätter R, Weber HJ, et al, “Efficacy and Safety of Ciclesonide Once Daily and Fluticasone Propionate Twice Daily in Children With Asthma,” Pulm Pharmacol Ther, 2009, 22(3):214-20. [PubMed 19141327]
  21. Pedersen S, Garcia Garcia ML, Manjra A, et al, “A Comparative Study of Inhaled Ciclesonide 160 mcg/day and Fluticasone Propionate 176 mcg/day in Children With Asthma,” Pediatr Pulmonol, 2006, 41(10):954-61. [PubMed 16868976]
  22. Pedersen S, Potter P, Dachev S, et al, "Efficacy and Safety of Three Ciclesonide Doses vs Placebo in Children With Asthma: The RAINBOW Study," Respir Med, 2010, 104(11):1618-28. [PubMed 20619624]
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