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Zetonna

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Zetonna

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Nasal Effects

Epistaxis and Nasal Ulceration

In clinical trials of 2 to 26 weeks in duration, epistaxis was observed more frequently in patients treated with ZETONNA Nasal Aerosol than those who received placebo. In the 26-week open-label extension of the perennial allergic rhinitis trial, nasal ulceration was identified in 4 of 824 patients administered ZETONNA Nasal Aerosol (148 mcg). [see ADVERSE REACTIONS]

Nasal Septal Perforation

Nasal septal perforation has been reported in patients following the intranasal application of ZETONNA Nasal Aerosol. Three short-term placebo-controlled trials (2 weeks) and one long-term (26 weeks with placebo control and 26 weeks open-label extension without placebo control) trial were conducted in patients with seasonal and perennial allergic rhinitis. Nasal septal perforations were reported in 2 patients out of 2335 treated with ZETONNA Nasal Aerosol compared with none of 892 treated with placebo.

Before starting ZETONNA Nasal Aerosol conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically monitor patients with nasal examinations during treatment for adverse effects in the nasal cavity. If an adverse reaction (e.g. erosion, ulceration, perforation) is noted, discontinue ZETONNA Nasal Aerosol. Avoid spraying ZETONNA Nasal Aerosol directly onto the nasal septum.

Candida Infection

In clinical trials with another formulation of ciclesonide, the development of localized infections of the nose or pharynx with Candida albicans has occurred. If such an infection develops with ZETONNA Nasal Aerosol, it may require treatment with appropriate local therapy and discontinuation of ZETONNA Nasal Aerosol.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use ZETONNA Nasal Aerosol until healing has occurred.

Glaucoma and Cataracts

Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

Hypersensitivity

ZETONNA Nasal Aerosol is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA Nasal Aerosol. Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.

Immunosuppression

Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In 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 or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is 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.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

Hypothalamic-Pituitary-Adrenal Axis Effect

Hypercorticism and Adrenal Suppression

When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of ZETONNA Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving ZETONNA Nasal Aerosol. [see Pediatric Use]

Patient Counseling Information

See FDA-Approved Patient Labeling accompanying the product.

Local Nasal Effects

Patients should be informed that treatment with ZETONNA Nasal Aerosol may lead to adverse reactions, which include nasal septal perforation, epistaxis, and nasal ulceration. In addition, ciclesonide is associated with candidal infection, and nasal corticosteroids are associated with impaired wound healing. Do not spray ZETONNA Nasal Aerosol directly onto the nasal septum. Patients who have experienced recent nasal septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma should not use ZETONNA Nasal Aerosol until healing has occurred.

Glaucoma and Cataracts

Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform his/her health care provider if a change in vision is noted while using ZETONNA Nasal Aerosol.

Immunosuppression

Patients who are on immunosuppressive 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.

Use Daily

Patients should use ZETONNA Nasal Aerosol on a regular, once daily basis since its effectiveness depends on its regular use. In clinical trials, the onset of effect was seen after 36 hours following the first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Initial assessment of response should be made during this timeframe and periodically until the patient's symptoms are stabilized. The patient should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve by a reasonable time or if the condition worsens.

Keep Spray Out of Eyes and Off Nasal Septum

Patients should be informed to avoid spraying ZETONNA Nasal Aerosol in their eyes or directly on the nasal septum.

Storage and Handling

Patients should use the ZETONNA Nasal Aerosol canister only with the ZETONNA Nasal Aerosol actuator supplied with the product. The dose indicator display window will show a red zone when it is about time to replace the ZETONNA Nasal Aerosol. Replace ZETONNA Nasal Aerosol when the indicator shows zero.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ciclesonide demonstrated no carcinogenic potential in mice in a study of oral doses up to 900 mcg/kg (approximately 60 times the maximum recommended human daily intranasal dose (MRHDID) in adults based on mcg/m²/day) in mice for 104 weeks, nor in a study in rats of inhalation doses up to 193 mcg/kg (approximately 25 times the maximum human daily intranasal dose in adults and adolescents 12 years of age or older based on mcg/m²/day) for 104 weeks.

Ciclesonide was not mutagenic in an Ames test or in a forward mutation assay and was not clastogenic in a human lymphocyte assay or in an in vitro micronucleus test. However, ciclesonide was clastogenic in the in vivo mouse micronucleus test. The concurrent reference corticosteroid (dexamethasone) in this study showed similar findings.

No evidence of impairment of fertility was observed in a reproductive study conducted in male and female rats both dosed orally up to 900 mcg/kg/day (approximately 120 times MRHDID in adults based on mcg/m²/day).

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

There are no adequate and well-controlled trials in pregnant women. ZETONNA Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

Oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mcg/m² basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal effects. However, subcutaneous administration of ciclesonide in rabbits at similar to MRHDID (on a mcg/m² basis at a maternal dose of 5 mcg/kg/day) produced fetal toxicity. This included fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects. No toxicity was observed at H of the MRHDID in adults (on a mcg/m² basis at a maternal dose of 1 mcg/kg/day).

Nonteratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

It is not known if ciclesonide is excreted in human milk. However, other corticosteroids are excreted in human milk. In a study with lactating rats, minimal but detectable levels of radiolabeled ciclesonide were recovered in milk. Caution should be used when ZETONNA Nasal Aerosol is administered to nursing women.

Pediatric Use

The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established. The safety and efficacy of ZETONNA Nasal Aerosol for treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 11 years of age and younger have not been established.

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including ZETONNA Nasal Aerosol, should be monitored routinely (e.g., via stadiometry). A 52-week, multi-center, double-blind, randomized, placebo-controlled parallel-group trial was conducted to assess the effect of orally inhaled ciclesonide (ALVESCO® Inhalation Aerosol) on growth rate in 609 pediatric patients with mild persistent asthma, aged 5 to 8.5 years. Treatment groups included orally inhaled ciclesonide 40 mcg or 160 mcg or placebo given once daily. Growth was measured by stadiometer height during the baseline, treatment and follow-up periods. The primary comparison was the difference in growth rates between ciclesonide 40 and 160 mcg and placebo groups. Conclusions cannot be drawn from this trial because compliance could not be assured. Ciclesonide blood levels were also not measured during the one-year treatment period. There was no difference in efficacy measures between the placebo and the orally inhaled ciclesonide (ALVESCO® Inhalation Aerosol) groups.

The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

The potential for ZETONNA Nasal Aerosol to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

Geriatric Use

Clinical trials of ZETONNA Nasal Aerosol did not include sufficient numbers of patients age 65 and over to determine whether they responded differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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