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Veramyst

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Veramyst

Veramyst

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Nasal Effects

Epistaxis and Nasal Ulceration

In clinical studies 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 [see ADVERSE REACTIONS].

Candida Infection

Evidence of localized infections of the nose with Candida albicans was seen on nasal exams in 7 of 2,745 patients treated with VERAMYST Nasal Spray during clinical trials and was reported as an adverse event in 3 patients. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of VERAMYST Nasal Spray. Therefore, patients using VERAMYST Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Nasal Septal Perforation

Postmarketing cases of nasal septal perforation have been reported in patients following the intranasal application of VERAMYST Nasal Spray [see ADVERSE REACTIONS].

Impaired Wound Healing

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 were evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month study in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week study 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 studies. However, in the 12-month study 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 study, 7 patients (6 treated with VERAMYST Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the study that were not present at baseline.

Hypersensitivity Reactions, Including Anaphylaxis

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

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. (See the respective package inserts for complete VZIG and IG prescribing information.) 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 [see DRUG INTERACTIONS].

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 [see Use In Specific Populations].

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).

Local Nasal Effects

Patients should be informed that treatment with VERAMYST Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with VERAMYST Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use VERAMYST Nasal Spray until healing has occurred [see WARNINGS AND PRECAUTIONS].

Cataracts and Glaucoma

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 VERAMYST Nasal Spray [see WARNINGS AND PRECAUTIONS].

Hypersensitivity Reactions, Including Anaphylaxis

Patients should be aware that hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. If such reactions occur, patients should discontinue use of VERAMYST Nasal Spray [see WARNINGS AND PRECAUTIONS].

Immunosuppression

Patients who are on immunosuppressant 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 [see WARNINGS AND PRECAUTIONS].

Effect on Growth

Parents should be advised that VERAMYST Nasal Spray may slow growth in children. A child taking VERAMYST Nasal Spray should have his/her growth checked regularly [see WARNINGS AND PRECAUTIONS and Pediatric Use].

Use Daily for Best Effect

Patients should use VERAMYST Nasal Spray on a regular once-daily basis for optimal effect. VERAMYST Nasal Spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms. Although significant improvement is usually achieved within 24 hours in patients with seasonal allergic rhinitis and 4 days in patients with perennial allergic rhinitis, maximum benefit may not be reached for several days. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

Keep Spray Out of Eyes

Patients should be informed to avoid spraying VERAMYST Nasal Spray in their eyes.

Potential Drug Interactions

Patients should be advised that coadministration of VERAMYST Nasal Spray and ritonavir is not recommended and to be cautious if coadministrating with ketoconazole.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at doses of up to 9 and 19 mcg/kg/day, respectively (less than the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis).

Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats.

No evidence of impairment of fertility was observed in reproductive studies conducted in male and female rats at inhaled fluticasone furoate doses of up to 24 and 91 mcg/kg/day, respectively (approximately 2 and 7 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m² basis).

Use In Specific Populations

Pregnancy

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.

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 [see Clinical Studies]. The safety and effectiveness of VERAMYST Nasal Spray in children younger than 2 years have not been established.

Controlled clinical studies 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 study 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] [see WARNINGS AND PRECAUTIONS].

Geriatric Use

Clinical studies of VERAMYST Nasal Spray did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. 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, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment

Use VERAMYST Nasal Spray with caution in patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY].

Renal Impairment

No dosage adjustment is required in patients with renal impairment [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.

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