Fluticasone furoate

Fluticasone furoate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone furoate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone furoate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The recommended starting dosage in children is 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, dosage reduction to 55 mcg once daily is recommended.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone furoate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone furoate in pediatric patients.

Contraindications

Fluticasone furoate is contraindicated in patients with hypersensitivity to any of its ingredients

Warnings

Warnings, precautions and adverse reactions associated with Fluticasone furoate should be taken into account.

Local Nasal Effects

• Epistaxis and Nasal Ulceration.
• In clinical trials of 2 to 52 weeks’ duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with VERAMYST Nasal Spray than those who received placebo.

Candida Infection

• Evidence of localized infection.
• Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use VERAMYST Nasal Spray until healing has occurred.

Glaucoma and Cataracts

• Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts.
• Glaucoma and cataract formation was evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month trial in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week trial in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either VERAMYST Nasal Spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (<21 mmHg) in ≥98% of the patients in any treatment group in both trials. However, in the 12-month trial in adolescents and adults, 12 patients, all treated with VERAMYST Nasal Spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (≥21 mmHg). In the same trial, 7 patients (6 treated with VERAMYST Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the trial that were not present at baseline.

Hypersensitivity Reactions

• Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. Discontinue VERAMYST Nasal Spray if such reactions occur.

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 children or adults who have not had these diseases or have not 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 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.
• If chickenpox or measles develops, treatment with antiviral agents may be considered.
• Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, 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 Effects

• Hypercorticism and Adrenal Suppression
• When intranasal steroids 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 VERAMYST Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid 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/or muscular pain, lassitude, 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.

Use of Cytochrome P450 3A4 Inhibitors

• Coadministration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. Use caution with the coadministration of VERAMYST Nasal Spray and other potent cytochrome P450 3A4(CYP3A4) inhibitors, such as ketoconazole.

Effect on Growth

• Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving VERAMYST Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including VERAMYST Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fluticasone furoate Clinical Trials Experience in the drug label.

Postmarketing Experience

• Systemic and local corticosteroid use may result in the following:
• Epistaxis.
• Ulceration.
• Candida albicans infection.
• Impaired wound healing.
• Nasal septal perforation.
• Cataracts and glaucoma.
• Immunosuppression.
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction

Drug Interactions

• Fluticasone furoate is cleared by extensive first-pass metabolism mediated by CYP3A4. In a drug interaction trial of intranasal fluticasone furoate and the CYP3A4 inhibitor ketoconazole given as a 200-mg once-daily dose for 7 days, 6 of 20 subjects receiving fluticasone furoate and ketoconazole had measurable but low levels of fluticasone furoate compared with 1 of 20 receiving fluticasone furoate and placebo. Based on this trial and the low systemic exposure, there was a 5% reduction in 24-hour serum cortisol levels with ketoconazole compared with placebo. The data from this trial should be carefully interpreted because the trial was conducted with ketoconazole 200 mg once daily rather than 400 mg, which is the maximum recommended dosage. Therefore, caution is required with the coadministration of VERAMYST Nasal Spray and ketoconazole or other potent CYP3A4 inhibitors.

• Based on data with another glucocorticoid, fluticasone propionate, metabolized by CYP3A4, coadministration of VERAMYST Nasal Spray with the potent CYP3A4 inhibitor ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. High exposure to corticosteroids increases the potential for systemic side effects, such as cortisol suppression.

• Enzyme induction and inhibition data suggest that fluticasone furoate is unlikely to significantly alter the cytochrome P450-mediated metabolism of other compounds at clinically relevant intranasal dosages.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

Teratogenic Effects

• Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
• There were no teratogenic effects in rats and rabbits at inhaled fluticasone furoate dosages of up to 91 and 8 mcg/kg/day, respectively (approximately 7 and 1 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There was also no effect on pre- or post-natal development in rats treated with up to 27 mcg/kg/day by inhalation during gestation and lactation (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis).
• There are no adequate and well-controlled studies in pregnant women. VERAMYST Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

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

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluticasone furoate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluticasone furoate during labor and delivery.

Nursing Mothers

• It is not known whether fluticasone furoate is excreted in human breast milk. However, other corticosteroids have been detected in human milk.
• Since there are no data from controlled trials on the use of intranasal fluticasone furoate by nursing mothers, caution should be exercised when VERAMYST Nasal Spray is administered to a nursing woman.

Pediatric Use

• Controlled clinical trials with VERAMYST Nasal Spray included 1,224 patients aged 2 to 11 years and 344 adolescent patients aged 12 to 17 years. * The safety and effectiveness of VERAMYST Nasal Spray in children younger than 2 years 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 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 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 VERAMYST Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including VERAMYST Nasal Spray, each patient’s dose should be titrated to the lowest dosage that effectively controls his/her symptoms.
• A randomized, double-blind, parallel-group, multicenter, 1-year placebo-controlled clinical growth trial evaluated the effect of 110 mcg of VERAMYST Nasal Spray once daily on growth velocity in 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years) with stadiometry. Mean growth velocity over the 52-week treatment period was lower in the patients receiving VERAMYST Nasal Spray (5.19 cm/year compared with placebo (5.46 cm/year). The mean treatment difference was -0.27 cm/year [95% CI: -0.48 to -0.06].

Geriatic Use

There is no FDA guidance on the use of Fluticasone furoate in geriatric settings.

Gender

There is no FDA guidance on the use of Fluticasone furoate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluticasone furoate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluticasone furoate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluticasone furoate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluticasone furoate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluticasone furoate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fluticasone furoate Administration in the drug label.

Monitoring

There is limited information regarding Fluticasone furoate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fluticasone furoate and IV administrations.

Overdosage

There is limited information regarding Fluticasone furoate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Fluticasone furoate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fluticasone furoate Mechanism of Action in the drug label.

Structure

There is limited information regarding Fluticasone furoate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fluticasone furoate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fluticasone furoate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fluticasone furoate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fluticasone furoate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fluticasone furoate How Supplied in the drug label.

Storage

There is limited information regarding Fluticasone furoate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Fluticasone furoate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fluticasone furoate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fluticasone furoate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Fluticasone furoate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.