may require dosage adjustment.tazemetostatMonitor Closely (1)tazemetostat will decrease the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.tucatinibSerious - Use Alternative (1)tucatinib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.voriconazoleMonitor Closely (1)voriconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. >10% Headache (11%) Nasopharyngitis (11%) 1-10% Epistaxis (4.9%) Ear pain (2.2%) Facial edema (3%) Urticaria (3%) Oral candidiasis (3%) Back pain (3%) Extremety pain (3%) Conjunctivitis (3%) Upper respiratory infection (9%) Gastroenteritis (3%) Sinusitis (3%) Contraindications Documented hypersensitivity Treatment of acute asthma or status asthmaticus Cautions Development of Kaposi's sarcoma associated with prolonged use of corticosteroids Psychiatric disturbances reported with corticosteroid use Mild to moderate oropharyngeal candidiasis reported; treat with appropriate local or systemic (eg, oral antifungal) therapy and discontinue therapy when symptoms occur; patients should rinse mouth after inhalation of medication Not a bronchodilator and not indicated for rapid relief of bronchospasm or other acute episodes of asthma; patients should be instructed to contact their physician immediately if episodes of asthma not responsive to usual doses of bronchodilators occur during the course of treatment; during such episodes, patients may require therapy with oral corticosteroids Glaucoma, increased intraocular pressure, and cataracts reported following administration of inhaled corticosteroids; close monitoring warranted in patients with a change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing; if bronchospasm occurs following dosing, treat immediately with a fast-acting inhaled bronchodilator; treatment should be discontinued and alternative treatment should be instituted Reduction in bone mineral density Decreases in bone mineral density (BMD) observed with long-term administration of products containing inhaled corticosteroids; the clinical significance of small changes in BMD with regard to long-term outcomes is unknown Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants and oral corticosteroids) should be monitored and treated with established standards of care Immune suppression and risk of infections Persons using drugs that suppress immune system are more susceptible to infections than healthy individuals; chickenpox and measles, can have a more serious or even fatal course in susceptible children or adults using corticosteroids; take particular care with patients who have not had these diseases or been properly immunized, How the dose, route, and duration of corticosteroid administration affect risk of developing a disseminated infection is not known; the safety and effectiveness of this medication have not been established in pediatric patients <12 years of age and this medication is not indicated for use in this population; the contribution of underlying disease and/or prior corticosteroid treatment to the risk is also not known If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated; if exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated; if chickenpox develops, treatment with antiviral agents may be considered Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex Transferring patients from systemic corticosteroid therapy Use caution in patients transferred from systemically active corticosteroids to this therapy because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function Transfer of patients from systemic steroid therapy to this therapy may unmask allergic conditions previously suppressed by the systemic steroid therapy, eg, rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function Hypercorticism and adrenal suppression This medication will often help control asthma symptoms with less suppression of HPA function than therapeutically similar oral doses of prednisone; since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing therapy; take particular care in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response Hypercorticism and adrenal suppression may occur when corticosteroids, including this medication, are used at higher-than-recommended dosages or patients at risk for such effects Effect on growth Orally inhaled corticosteroids, including this medication, may cause a reduction in growth velocity when administered to pediatric patients; the safety and effectiveness of this therapy have not been established in pediatric patients <12 years of age; this medication is not indicated for use in this population Monitor growth of pediatric patients receiving this medication routinely (eg, via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, including this medication, titrate each patient’s dose to lowest dosage that effectively controls his/her symptoms Pregnancy There are no available data on use in pregnant women to assess drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there is low systemic exposure following administration at recommended dose In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Animal data In animal reproduction studies, drug administered by oral route to pregnant rats during period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times maximum recommended human daily oral inhalation dose (MRHDOID) Teratogenicity, characteristic of corticosteroids, decreased body weight, and/or skeletal variations were observed in rabbit fetuses following administration of ciclesonide to pregnant rabbits by subcutaneous route during period of organogenesis at doses 0.15 times MRHDOID and higher on mcg/m2 basis; no evidence of fetal harm observed in rabbits at doses of 0.03 times MRHDOID Lactation There are no data on presence of the drug or its metabolite in human milk, effects on breastfed infant, or milk production; not known whether oral inhalation administration of this drug at recommended dose could result in sufficient systemic absorption to produce detectable quantities in human milk The molecular weight of the prodrug ciclesonide (approximately 541 g/mol) is small enough to be excreted into breast milk; however, its high plasma protein binding affinity and very short half-life suggests that minimal amounts will be present within the milk Conversely, the half-life of the active metabolite des-ciclesonide (approximately 471 g/mol) suggests that exposure to the nursing infant will be greater than that of the prodrug ciclesonide; although ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1% for each) due to low gastrointestinal absorption and high first-pass metabolism, the relative anti-inflammatory activity of des-ciclesonide is 120 times greater than that of ciclesonide and 12 times greater than that of dexamethasone; the effects of this exposure on a nursing infant are unknown, however, like all corticosteroids, suppression of HPA function is a potential complication Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from therapy, or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Glucocorticoid prodrug, converted to active ingredient des-ciclesonide; has immunosuppressive properties, anti-inflammatory activity, and anti-inflammatory effects. Distribution Bioavailability: 63% (active metabolite) Absorption: 52% Protein Bound: 99% (IV) Vd: 2.9 L/kg (ciclesonide); 12.1 L/kg (des-ciclesonide) following IV administration Metabolism Metabolized to active des-ciclesonide by esterases, then further metabolized by liver CYP3A4 and to a lesser extent, CYP2D6 Eliminiation Following IV administration Half-life: 0.71 hr (ciclesonide); 6-7 hr (des-ciclesonide) Clearance: 152 L/L/hr (ciclesonide); 228 L/L/hr (des-ciclesonide) Excretion: Feces (66%); urine (20%) BRAND FORM. UNIT PRICE PILL IMAGE Alvesco inhalation- 160 mcg/actuation aerosolAlvesco inhalation- 80 mcg/actuation aerosolCopyright © 2010 First DataBank, Inc.Select a drug:ciclesonide inhalationciclesonide nasalPrint Patient Educationciclesonide inhalation CICLESONIDE HFA INHALER - ORAL INHALATION (sye-KLES-oh-nide) COMMON BRAND NAME(S): Alvesco USES: Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier.This medication must be taken regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, get medical help right away. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using ciclesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Inhale this medication by mouth as directed by your doctor. No shaking of the inhaler is necessary before use. If the inhaler is new or has not been used for 1 week or more, prime the inhaler for use by spraying 3 puffs into the air. Remove the cover on the mouthpiece. Breathe out as much as you comfortably can. Place the mouthpiece into your mouth and close your lips tightly around it. While breathing in slowly and deeply, press down on the canister with your finger. After inhaling, try to hold your breath for at least 10 seconds to get this medication into your lungs and allow it to work properly.Dosage is based on your medical condition and response to treatment.A spacer device may be used with this medication if you find it difficult to use this inhaler. Ask your doctor or pharmacist for more information.If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last.To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.Clean the mouthpiece once a week with a dry tissue. Do not wet the mouthpiece to clean it.Use this medication regularly to get the most benefit from it. This medication works best when used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this inhaler more often, or stop using it without first consulting your doctor.Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when