Alvesco

Common side effects with Alvesco inhalation include:

• headache
• swelling of nose and throat 
• swelling of the sinuses 
• throat pain
• upper respiratory infection
• joint pain (arthralgia)
• nasal congestion
• pain in arms, legs, and back

See "Drug Precautions" section for other risks of using Alvesco.

These are not all the possible side effects of Alvesco. Tell your healthcare provider about any side effects that bother you or do not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take ketoconazole (Nizoral).

Contraindications

• Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids)5 are required.1

• Known hypersensitivity to ciclesonide or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions, including angioedema with swelling of the lips, tongue, and pharynx, reported.1

Infections

Localized candidal infections of the mouth and/or pharynx reported.1

If infection occurs, initiate appropriate local or systemic antifungal treatment while still continuing with inhaled ciclesonide therapy.1 May require interruption of ciclesonide therapy in some patients.1

Use with 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

Acute Exacerbations of Asthma

Treat acute asthma symptoms with a short-acting β2-agonist bronchodilator.1 5 6 If symptoms persist, promptly reevaluate asthma therapy and consider initiating systemic corticosteroids.1 5

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressive drugs compared with healthy individuals.1 12 Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.1 12

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 immune globulin (IG), respectively.1 Consider treatment with an antiviral agent if varicella develops.1

Withdrawal of Systemic Corticosteroid Therapy

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

Withdraw systemic corticosteroid therapy gradually1 and monitor carefully for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy.1 Lung function (FEV1 or morning peak expiratory flow rate [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 (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)

Corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression) may occur; carefully monitor during and for a number of months after withdrawal of systemic corticosteroids.1

Acute adrenal insufficiency may occur during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.1

Possible unmasking of allergic conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).1 12

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of inhaled ciclesonide over prolonged periods may result in manifestations of hypercorticism and suppression of HPA function.1 12 If such changes occur, reduce the dosage of ciclesonide 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 Supplemental therapy with a systemic corticosteroid required during stress or severe asthma attacks.1 12

Musculoskeletal Effects

Long-term use of orally inhaled corticosteroids 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 12

Ocular Effects

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

Respiratory Effects

Bronchospasm and wheezing may occur with oral inhalation therapy.1

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with ciclesonide and institute alternate therapy.1

Specific Populations

Category C.1

Distributed into milk in rats; not known whether distributed into human milk.1 Caution if used in nursing women.1

Safety and efficacy not established in children <12 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 12 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

Insufficient experience with oral inhalation in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 (See Geriatric Patients under Dosage and Administration.)

Increased systemic exposure in patients with moderate to severe hepatic impairment; however, dosage adjustments not necessary.1

Pharmacokinetics not evaluated but impact of renal impairment should be minimal.1

Common Adverse Effects

Headache,1 nasopharyngitis,1 sinusitis,1 pharyngolaryngeal pain,1 upper respiratory infection,1 arthralgia,1 nasal congestion,1 extremity pain,1 back pain,1 hoarseness,1 2 oral candidiasis,1 2 influenza,1 pneumonia,1 musculoskeletal chest pain,1 urticaria,1 dizziness,1 gastroenteritis,1 facial edema,1 fatigue,1 conjunctivitis.1

Ciclesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled ciclesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started .

Ciclesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe .

This medicine is available only with your doctor's prescription .

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

This medicine may weaken your immune system. Avoid being around people who are sick or have infections such as chickenpox or measles. Tell your doctor right away if you think you have been exposed to chickenpox or measles .

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you notice any signs of a throat infection .

This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem .

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while taking this medicine .

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine .

If your symptoms do not improve within four weeks, or if they become worse, check with your doctor .

Local Effects

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 32 of 3038 patients treated with Alvesco. Of the 32 reported cases, 20 occurred in 1394 patients treated with a total daily dose of 320 mcg of Alvesco or higher. Most cases of Candida infection were mild to moderate. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while remaining on treatment with Alvesco, but at times therapy with Alvesco may need to be interrupted. Patients should rinse the mouth after inhalation of Alvesco.

Acute Asthma Episodes

Alvesco is not a bronchodilator and is 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 their usual doses of bronchodilators occur during the course of treatment with Alvesco. During such episodes, patients may require therapy with oral corticosteroids.

Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the 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. (See the respective package inserts for complete VZIG and IG prescribing information.) 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 the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed for patients who are transferred from systemically active corticosteroids to Alvesco 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.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Alvesco may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Alvesco. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during Alvesco therapy [see Dosage and Administration (2)]. Lung function (FEV1 or AM PEFR), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic steroid therapy to Alvesco may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

Hypercorticism and Adrenal Suppression

Alvesco 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 Alvesco. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients particularly when Alvesco is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Alvesco should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma.

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been 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 (e.g., anticonvulsants and oral corticosteroids) should be monitored and treated with established standards of care.

Effect on Growth

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Alvesco routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Alvesco, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids including Alvesco. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

In a comparator control study of one-year treatment duration, 743 patients 18 years of age and older (mean age 43.1 years) with moderate persistent asthma were treated with Alvesco 320 mcg twice daily and 742 were treated with a labeled dose of a comparator-inhaled corticosteroid appropriate for the patient population. Patients had an ophthalmology examination that included visual acuity, intraocular pressure measurement, and a slit lamp examination at baseline, 4, 8 and 12 months. Lens opacities were graded using the Lens Opacification System III. After 52 weeks, CLASS I effects (minimally detected changes) were recorded in 36.1% of the Alvesco-treated patients and in 38.4% of patients treated with the comparator-inhaled corticosteroid. The more severe CLASS III effects were recorded in 8.1% of the Alvesco-treated patients and 9.2% of patients treated with the comparator-inhaled corticosteroid. Of those patients having a CLASS III effect, the incidence of posterior sub-capsular opacities was 0.9% and 0.5% in the Alvesco- and comparator-treated patients, respectively.

Bronchospasm

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with Alvesco, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with Alvesco should be discontinued and alternative treatment should be instituted.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Applies to ciclesonide: inhalation aerosol liquid

Along with its needed effects, ciclesonide (the active ingredient contained in Alvesco) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ciclesonide:

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• nasal congestion
• pain or tenderness around eyes and cheekbones
• shortness of breath or troubled breathing
• sneezing
• sore throat
• stuffy or runny nose
• tightness of chest or wheezing
• unusual tiredness or weakness

• Sore mouth or tongue
• white patches in mouth and/or on tongue

• Blindness
• blurred vision
• creamy white, curd-like patches in mouth or throat
• darkening of skin
• decreased vision
• diarrhea
• dizziness
• eye pain
• fainting
• hoarseness
• lack or slowing of normal growth in children
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• mental depression
• nausea
• pain when eating or swallowing
• painful or difficult urination
• skin rash
• tearing
• vomiting

Some side effects of ciclesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• difficulty in moving
• muscle pain or stiffness
• pain in arms or legs
• pain in joints

• Chest discomfort
• dry mouth or throat
• voice changes

Summary of Use during Lactation

Although not measured, the amounts of inhaled corticosteroids absorbed into the maternal bloodstream and excreted into breastmilk are probably too small to affect a breastfed infant. Reviewers and an expert panel consider inhaled corticosteroids acceptable to use during breastfeeding.[1][2][3]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

None reported with any corticosteroid.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Inhalation) Beclomethasone, Budesonide

References

1. Greenberger PA, Patterson R. The management of asthma during pregnancy and lactation. Clin Rev Allergy. 1987;5:317-24. PMID: 3319123

2. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994;10:39-41. PMID: 7619245

3. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg.htm

Substance Name

Ciclesonide

CAS Registry Number

141845-82-1

Drug Class

Corticosteroids, Inhaled

Glucocorticoids

Anti-Inflammatory Agents

LactMed Record Number

574

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.