Zetonna

ZETONNA- ciclesonide aerosol, metered
Covis Pharma US, Inc

1 INDICATIONS AND USAGE

1.1 Treatment of Seasonal Allergic Rhinitis

ZETONNA® (ciclesonide) is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

1.2 Treatment of Perennial Allergic Rhinitis

ZETONNA® (ciclesonide) is indicated for the treatment of symptoms associated with perennial allergic rhinitis in adult and pediatric patients 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Information

Administer ZETONNA by the nasal route only. Avoid spraying in eyes or directly onto the nasal septum.

Priming:

Prior to initial use, ZETONNA must be primed by actuating 3 times.
If ZETONNA is not used for 10 consecutive days, it must be primed by actuating 3 times.
If ZETONNA is dropped, the canister and actuator may become separated. If this happens, reassemble ZETONNA and spray 1 test spray into the air before using.

Cleaning:

Clean outside of nose piece with a clean, dry tissue or cloth weekly; do not wash or put in water. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.

2.2 Recommend Dosage for Seasonal and Perennial Allergic Rhinitis

The recommended dosage of ZETONNA is 1 actuation (37 mcg of ciclesonide) per nostril once daily. The maximum total daily dosage should not exceed 1 actuation in each nostril per day (74 mcg per day).

3 DOSAGE FORMS AND STRENGTHS

Nasal aerosol: 37 mcg of ciclesonide per actuation

4 CONTRAINDICATIONS

ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Adverse Reactions

Epistaxis and Nasal Ulceration: In clinical trials of 2 to 26 weeks in duration, epistaxis was observed more frequently in patients treated with ZETONNA 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 (148 mcg) [see Adverse Reactions (6)].

The occurrence of local nasal adverse events was further evaluated in a separate, postmarketing 26-week randomized, open-label, active-controlled nasal and ocular safety trial conducted in patients with perennial allergic rhinitis. In this study epistaxis was observed in 6% of patients treated with ZETONNA and nasal ulceration was identified in 3 of 367 patients administered ZETONNA [see Adverse Reactions (6)].

Nasal Septal Perforation: Nasal septal perforation has been reported in patients following the nasal application of ZETONNA. 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 patients treated with ZETONNA compared with none of 892 patients treated with placebo. No nasal septal perforations were reported in 367 patients treated with ZETONNA in a postmarketing 26-week, open-label, active-controlled trial in patients with perennial allergic rhinitis [see Adverse Reactions (6)].

Before starting ZETONNA 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. Avoid spraying ZETONNA directly onto the nasal septum.

Candida Infection: Localized infections of the nose or pharynx with Candida albicans has occurred from the use of ciclesonide. If such an infection occurs with ZETONNA, treat it with appropriate local therapy and discontinue ZETONNA.

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 until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal and inhaled corticosteroids, including ZETONNA, can 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.

5.3 Hypersensitivity Reactions

ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA. Hypersensitivity reactions including angioedema, with swelling of the lips, tongue and pharynx, have occurred after nasal administration of ZETONNA. Discontinue ZETONNA if such reactions occur.

5.4 Immunosuppression and Risk of Infections

Patients 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 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 safety and effectiveness of ZETONNA have not been established in pediatric patients less than 12 years of age and ZETONNA is not indicated for use in this population. The contribution of the underlying disease or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, 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 Prescribing Information for VZIG and IG). 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.

5.5 Hypercorticism and Adrenal Suppression

Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including ZETONNA, are used at higher-than-recommended dosages [see Dosage and Administration (2)] or patients at risk for such effects.

5.6 Effect on Growth

Corticosteroids, including ZETONNA, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of ZETONNA have not been established in pediatric patients less than 12 years of age and ZETONNA is not indicated for use in this population. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving ZETONNA [see Pediatric Use (8.4)].

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Epistaxis, Ulcerations, Nasal Septal Perforations, Candida albicans Infection, Impaired Wound Healing [see Warnings and Precautions (5.1)]
Glaucoma and Cataracts [see Warnings and Precautions (5.2)]
Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4)]
Hypercorticism and Adrenal Suppression, including Growth Reduction [see Warnings and Precautions (5.5, 5.6), Use in Specific Populations (8.4)]

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