Fluticasone Furoate

Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. There are no data on the effects of acute or chronic overdosage with VERAMYST Nasal Spray. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical trials (with dosages of up to 440 mcg/day for 2 weeks [4 times the maximum recommended daily dose]), overdose is unlikely to require any therapy other than observation.

Intranasal administration of up to 2,640 mcg/day (24 times the recommended adult dose) of fluticasone furoate was administered to healthy human volunteers for 3 days. Single-and repeat-dose trials with orally inhaled fluticasone furoate doses of 50 to 4,000 mcg have shown decreased mean serum cortisol at doses of 500 mcg or higher. The oral median lethal dose in mice and rats was > 2,000 mg/kg (approximately 74,000 and 147,000 times, respectively, the maximum recommended daily intranasal dose in adults and 52,000 and 105,000 times, respectively, the maximum recommended daily intranasal dose in children, on a mcg/m² basis).

Acute overdosage with the intranasal dosage form is unlikely since 1 bottle of VERAMYST Nasal Spray contains approximately 3 mg of fluticasone furoate, and the bioavailability of fluticasone furoate is < 1% for 2.64 mg/day given intranasally and 1% for 2 mg/day given as an oral solution.

Fluticasone furoate is a prescription medication used to prevent symptoms of asthma. Fluticasone furoate can also treat the symptoms of allergic and non-allergic rhinitis. Fluticasone furoate is in a class of medications called corticosteroids. These works by decreasing swelling and irritation in the airways to allow for easier breathing.

Fluticasone furoate for oral inhalation is typically used once daily to prevent asthma-related symptoms. Fluticasone furoate intranasal spray is sprayed into each nostril once daily to treat symptoms of allergic rhinitis.

Common side effects of fluticasone furoate for inhalation include upper airway infection or inflammation, throat irritation, and cough. Common side effects of fluticasone furoate for intranasal administration include headache, nose bleeds, throat pain, and nasal burning or irritation.

Fluticasone furoate nasal spray can cause dizziness. Do not drive or operate machinery until you know how fluticasone furoate nasal spray affects you.

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

• Arnuity Ellipta

• Breo Ellipta

• Veramyst

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluticasone furoate, there are no specific foods that you must exclude from your diet when receiving this medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Inhalational:

The recommended adult dose of fluticasone furoate oral inhalation for the prevention of asthma symptoms is 1 inhalation (containing 100 mcg) of fluticasone furoate every 24 hours. If symptoms are not controlled at this dose, the dose may be increased to 1 inhalation (containing 200 mcg) every 24 hours.

Topical:

The recommended dose of fluticasone furoate oral inhalation for the treatment of allergic rhinitis symptoms is 2 sprays per nostril (for a total of 110 mcg) of fluticasone furoate every 24 hours. Once symptoms are controlled at this dose, the dose may be decreased to 1 spray per nostril (for a total dose of 55 mcg) every 24 hours.

You should not use fluticasone nasal if you are allergic to it, or if you are also taking ritonavir (Norvir, Kaletra).

Before using fluticasone nasal, tell your doctor if you have glaucoma or cataracts, liver disease, diabetes, herpes simplex virus of your eyes, tuberculosis or any other infection, sores or ulcers inside your nose, or if you have recently had injury of or surgery on your nose.

It may take up to several days of using this medicine before your symptoms improve. Tell your doctor if your symptoms do not improve after a week of treatment.

Fluticasone nasal can lower blood cells that help your body fight infections. 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 fluticasone nasal.

Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.

Do not give this medicine to a child younger than 2 years old without medical advice. Steroid medication can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Systemic and local corticosteroid use may result in the following:

• Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation [see WARNINGS AND PRECAUTIONS]
• Cataracts and glaucoma [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 reflect exposure to VERAMYST Nasal Spray in 1,563 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 to 12 weeks' duration. The data from adults and adolescents are based upon 6 clinical trials in which 768 patients with seasonal or perennial allergic rhinitis (473 females and 295 males aged 12 years and older) were treated with VERAMYST Nasal Spray 110 mcg once daily for 2 to 6 weeks. The racial distribution of adult and adolescent patients receiving VERAMYST Nasal Spray was 82% white, 5% black, and 13% other. The data from pediatric patients are based upon 3 clinical trials in which 795 children with seasonal or perennial rhinitis (352 females and 443 males aged 2 to 11 years) were treated with VERAMYST Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks. The racial distribution of pediatric patients receiving VERAMYST Nasal Spray was 75% white, 11% black, and 14% other.

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

Overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Less than 3% of patients in clinical trials discontinued treatment because of adverse reactions. The rate of withdrawal among patients receiving VERAMYST Nasal Spray was similar or lower than the rate among patients receiving placebo.

Table 1 displays the common adverse reactions ( > 1% in any patient group receiving VERAMYST Nasal Spray) that occurred more frequently in patients aged 12 years and older treated with VERAMYST Nasal Spray compared with placebo-treated patients.

Table 1: Adverse Reactions with > 1% Incidence in Controlled Clinical Trials of 2 to 6 Weeks' Duration with VERAMYST Nasal Spray in Adult and Adolescent Patients with Seasonal or Perennial Allergic Rhinitis

There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.

In the 3 clinical trials in pediatric patients aged 2 to < 12 years, overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Table 2 displays the common adverse reactions ( > 3% in any patient group receiving VERAMYST Nasal Spray), that occurred more frequently in patients aged 2 to 11 years treated with VERAMYST Nasal Spray compared with placebo-treated patients.

Table 2: Adverse Reactions with > 3% Incidence in Controlled Clinical Trials of 2 to 12 Weeks' Duration with VERAMYST Nasal Spray in Pediatric Patients with Seasonal or Perennial Allergic Rhinitis

There were no differences in the incidence of adverse reactions based on gender or race. Pyrexia occurred more frequently in children aged 2 to < 6 years compared with children aged 6 to < 12 years.

In a 52-week, placebo-controlled, long-term safety trial, 605 patients (307 females and 298 males aged 12 years and older) with perennial allergic rhinitis were treated with VERAMYST Nasal Spray 110 mcg once daily for 12 months and 201 were treated with placebo nasal spray. While most adverse reactions were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received VERAMYST Nasal Spray (123/605, 20%) than in patients who received placebo (17/201, 8%). Epistaxis tended to be more severe in patients treated with VERAMYST Nasal Spray. All 17 reports of epistaxis that occurred in patients who received placebo were of mild intensity, while 83, 39, and 1 of the total 123 epistaxis events in patients treated with VERAMYST Nasal Spray were of mild, moderate, and severe intensity, respectively. No patient experienced a nasal septal perforation during this trial.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of VERAMYST 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone furoate or a combination of these factors.

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.

Read the entire FDA prescribing information for Veramyst (Fluticasone Furoate)