"(Reuters) - Mylan NV said on Friday it would start selling a generic version of its life-saving EpiPen allergy treatment at a more than 50 percent discount, a day after 20 U.S. states filed a lawsuit against generic drugmakers including Mylan ove"...
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.
Adults and Adolescents Aged 12 Years and Older
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
|Adverse Event||Adult and Adolescent Patients Aged 12 Years and Older|
(n = 774)
|VERAMYST Nasal Spray 110 mcg Once Daily
(n = 768)
|Headache||54 (7%)||72 (9%)|
|Epistaxis||32 (4%)||45 (6%)|
|Pharyngolaryngeal pain||8 (1%)||15 (2%)|
|Nasal ulceration||3 ( < 1%)||11 (1%)|
|Back pain||7 ( < 1%)||9 (1%)|
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.
Pediatric Patients Aged 2 to 11 Years
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
|Adverse Event||Pediatric Patients Aged 2 to < 12 Years|
(n = 429)
|VERAMYST Nasal Spray 55 mcg Once Daily
(n = 369)
|VERAMYST Nasal Spray 110 mcg Once Daily
(n = 426)
|Headache||31 (7%)||28 (8%)||33 (8%)|
|Nasopharyngitis||21 (5%)||20 (5%)||21 (5%)|
|Epistaxis||19 (4%)||17 (5%)||17 (4%)|
|Pyrexia||7 (2%)||17 (5%)||19 (4%)|
|Pharyngolaryngeal pain||14 (3%)||16 (4%)||12 (3%)|
|Cough||12 (3%)||12 (3%)||16 (4%)|
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.
Long-term (52-Week) Safety Trial
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.
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.
Immune System Disorders
Respiratory, Thoracic, and Mediastinal Disorders
Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.
Read the Veramyst (fluticasone furoate) Side Effects Center for a complete guide to possible side effects
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/10/2015
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