Ciclesonide

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;
• bronchospasm (wheezing, chest tightness, trouble breathing);
• sores or white patches in your mouth or throat;
• vision problems, such as tunnel vision or blurred vision; or
• worsening asthma symptoms.

Common side effects may include:

• unpleasant taste in your mouth;
• dry mouth, burning or irritation in your mouth;
• runny or stuffy nose, sore throat;
• hoarse voice;
• mild itching or skin rash;
• joint pain, back pain; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Forms And Strengths

ZETONNA Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.

Storage And Handling

ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose.

The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient's instructions for proper use accompany each package of ZETONNA.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.

Contents under Pressure

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.

Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.

ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.

NDC Number 63402-737-60

Manufactured for: Sunovion Pharmaceuticals Inc.,  Marlborough, MA 01752 USA. Revised: Oct 2014

Systemic and local corticosteroid use may result in the following:

• Epistaxis, ulcerations, nasal septal perforations, Candida albicans infection, impaired wound healing [see WARNINGS AND PRECAUTIONS]
• Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]

Clinical Trials Experience

The safety data described below for adults and adolescents 12 years of age and older are based on 4 clinical trials evaluating doses of ciclesonide nasal aerosol from 74 to 282 mcg. Three of the clinical trials were 2 to 6 weeks in duration and one trial was 26 weeks in duration with an additional 26-week open-label extension. Data from the first 6 weeks of the 26-week trial were pooled with data from the three 2-week trials. Short-term data (2 to 6 weeks) included 3001 patients with seasonal and perennial allergic rhinitis, of these, 884 received ZETONNA 74 mcg once daily and 892 received placebo. The short-term data included 1098 (36.6%) males, 1903 (63.4%) females, 2587 (86.2%) Caucasians, 320 (10.7%) Blacks, 49 (1.6%) Asians, and 45 (1.5%) patients classified as Other. The 26-week trial was conducted in 1110 patients with perennial allergic rhinitis [394 (35.5%) males and 716 (64.5%) females, ages 12 to 78 years old] treated with ZETONNA 74 mcg, 148 mcg or placebo once daily. Of these patients, 298 were treated with 74 mcg ZETONNA, 505 with 148 mcg, and 307 with placebo. The racial distribution in this trial included 922 (83.1%) Caucasians, 146 (13.2%) Blacks, 18 (1.6%) Asians, and 24 (2.2%) patients classified as Other. The 26-week open-label extension included 824 patients [295 (35.8%) males and 529 (64.2%) females, ages 12 to 79 years old] given ZETONNA 148 mcg once daily. The racial distribution in the open-label extension included 690 (83.7%) Caucasians, 104 (12.6%) Blacks, 15 (1.8%) Asians, and 15 (1.8%) patients classified as Other.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In three short-term trials and the first 6 weeks of one long-term trial, conducted in the US, 884 patients with a history of seasonal or perennial allergic rhinitis were treated with ZETONNA 74 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. The table below displays reactions that occurred with an incidence of at least 2.0% and more frequently with ZETONNA 74 mcg than with placebo in seasonal or perennial allergic rhinitis clinical trials of 2 to 6 weeks duration.

Table 1: Adverse Reactions Occurring with a Frequency of at least 2.0% and Greater than Placebo from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis

When considering the data from higher doses evaluated in the short-term trials, epistaxis demonstrated a dose response. In addition, two patients treated with ZETONNA 74 mcg experienced nasal septal perforations in the short-term trials compared to no patients treated with placebo.

Approximately 1.2% of patients treated with ZETONNA 74 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo. Discontinuations due to local adverse reactions were similar in ZETONNA 74 mcg treated patients (0.8%) compared to placebo treated patients (0.8%). Local adverse reactions leading to discontinuation that occurred only in ZETONNA treated patients included ear infection, nasal discomfort, nasal dryness, nasal mucosal/septum disorders, pharyngitis, streptococcal pharyngitis, sinus headache, and tonsillitis.

In one 26-week double-blind, placebo-controlled safety trial that included 1110 adult and adolescent patients with perennial allergic rhinitis, additional adverse reactions, with an incidence of at least 2%, that occurred more frequently with ZETONNA than with placebo were upper respiratory tract infection, urinary tract infection, oropharyngeal pain, nasal mucosal/septum disorders, viral upper respiratory tract infection, cough, influenza, bronchitis, streptococcal pharyngitis, muscle strain, and nausea. Nasal discomfort (5.7%) and epistaxis (11.4%) were also more frequent in the 26-week safety trial compared to clinical trials 2 to 6 weeks in duration. Nasal mucosal/septum disorders and cough demonstrated a dose response.

Discontinuations due to adverse reactions were higher in ZETONNA treated patients compared to placebo treated patients and demonstrated a dose response. Local adverse reactions leading to discontinuation were also higher in ZETONNA 74 mcg treated patients (1.7%) compared to placebo treated patients (0.7%). The only local adverse reaction leading to discontinuation that occurred in ZETONNA treated patients and was not observed in the 2-to 6-week trials was upper respiratory tract infection.

A total of 824 patients with perennial allergic rhinitis who completed the 26-week double-blind trial enrolled into an open-label extension and received ZETONNA 148 mcg for 26 weeks. Additional adverse reactions, observed with an incidence of at least 2% were sinusitis, nasopharyngitis, and back pain.

A total of 4 nasal septal ulcerations were also reported in the 26-week open-label extension.

There were no reports of nasal septal perforations in the long-term safety trial.

Nasal and ocular safety was evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial, in adult and adolescent patients 12-74 years of age with a history of perennial allergic rhinitis. A total of 737 patients were treated with ZETONNA 74 mcg or ciclesonide nasal spray 200 mcg once daily. The combined incidence of nasal mucosal or septum disorders, including erosions and ulcerations, was 3 (0.8%) for ZETONNA 74 mcg and 4 (1.1%) for ciclesonide nasal spray 200 mcg treated patients. There were no nasal septal perforations reported with either treatment. Ocular findings, including the development or worsening of lens opacities, increase in intraocular pressure, and worsening visual acuity, were also evaluated over the 26-week treatment period. The occurrence of ocular safety events was similar for the ZETONNA 74 mcg and ciclesonide nasal spray 200 mcg treatment groups.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of other formulations of ciclesonide, ALVESCO® Inhalation Aerosol and OMNARIS® Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

ALVESCO® Inhalation Aerosol: immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue, and pharynx.

OMNARIS® Nasal Spray: nasal congestion, nasal ulcer, and dizziness. Localized infections of the nose or mouth with Candida albicans have also occurred with OMNARIS® Nasal Spray.

Chronic overdosage may result in signs or symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. There are no data on the effects of acute or chronic overdosage with ZETONNA.

Ciclesonide may be found in some form under the following brand names:

• Alvesco

• Omnaris

• Zetonna

Ciclesonide is part of the drug class:

• Respiratory Glucocorticoids

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Ciclesonide nasal spray:

• Use 1 time each day, 2 sprays in each nostril.
• Do not use more than a total of 2 sprays in each nostril each day.

Ciclesonide inhalation:

• Use inhaler twice daily, one or two inhalations at a time depending on the dose prescribed.

If you take too much ciclesonide call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If ciclesonide is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.