Side Effects of Veramyst (fluticasone)

Veramyst (fluticasone) is a synthetic steroid of the glucocorticoid family used to treat symptoms of seasonal or perennial allergic and non-allergic rhinitis.Veramyst mimics the naturally-occurring hormone produced by the adrenal glands, cortisol or hydrocortisone. The exact mechanism of action of fluticasone is unknown.

Veramyst has potent anti-inflammatory actions. It is believed Veramyst exerts its beneficial effects by inhibiting several types of cells and chemicals involved in allergic, immune and inflammatory responses. When used as a nasal inhaler or spray, the medication goes directly to the lining within the nose, and very little is absorbed into the rest of the body. 

Common side effects of Veramyst include

• headache,
• throat infection,
• nasal irritation,
• sneezing,
• cough,
• nausea, and
• vomiting. 

Serious side effects of Veramyst include

• hypersensitivity reactions (such as skin rash, itching, facial swelling, and anaphylaxis),
• growth suppression in some children,
• nosebleed,
• septum perforation,
• fungal infection of the nose and throat,
• glaucoma, and
• cataracts.

High doses, and rarely normal doses, may suppress the adrenal glands and impair their ability to make natural cortisone. 

Drug interactions of Veramyst include ritonavir and ketoconazole, which may increase the blood concentrations of Veramyst and potentially increase its side effects.

Drugs that reduce the action of liver enzymes that breakdown Veramyst should not be combined with Veramyst.

There are no adequate and well-controlled studies of Veramyst in pregnant women. Veramyst should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is unknown if Veramyst is secreted in breast milk. Other medications in the same class as Veramyst are secreted into breast milk. Veramyst should be used only while breastfeeding if it is absolutely necessary.

The most common side effects associated with fluticasone are

• headache,
• throat infection,
• nasal irritation,
• sneezing,
• cough,
• nausea,
• vomiting.

Hypersensitivity reactions such as

• skin rash,
• itching,
• facial swelling, and
• anaphylaxis may occur.

Some children may experience growth suppression when using fluticasone. A bloody nasal discharge (nosebleed) and septum perforation may occur. Fungal infection of the nose and throat, glaucoma, and cataracts are also associated with intranasal fluticasone.

High doses, and rarely normal doses, may suppress the adrenal glands and impair their ability to make natural cortisone. People with such suppression (which can be identified by testing) need increased amounts of cortisone orally or by the intravenous route during periods of high physical stress since higher amounts of cortisone are naturally needed by the body to fight physical stress.

Systemic and local corticosteroid use may result in the following:

• Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation
• Cataracts and glaucoma
• Immunosuppression
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction

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

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 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.

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.

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.

Immune System Disorders

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

Respiratory, Thoracic, and Mediastinal Disorders

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

• 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.