Veramyst

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.

Veramyst is a prescription medicine used to treat seasonal and year-round allergy symptoms in adults and children 2 years old and older.  Veramyst may also help red, itchy, and watery eyes in adults and teenagers with seasonal allergic rhinitis. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• GlaxoSmithKline LLC

If you take too much Veramyst, call your doctor or local Poison Control Center right away.

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Fluticasone nasal (for the nose) is used to treat nasal congestion, sneezing, runny nose, and itchy or watery eyes caused by seasonal or year-round allergies.

The Flonase brand of this medicine for use in adults and children who are at least 4 years old. Veramyst may be used in children as young as 2 years old. Flonase is available without a prescription.

Fluticasone nasal may also be used for purposes not listed in this medication guide.

• If you have an allergy to fluticasone or any other part of Veramyst (fluticasone (nasal)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Veramyst with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Veramyst Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3)].

Fluticasone furoate, the active component of Veramyst Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:

Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water.

Veramyst Nasal Spray is an aqueous suspension of micronized fluticasone furoate for topical administration to the nasal mucosa by means of a metering (50 microliters), atomizing spray pump. After initial priming [see Dosage and Administration (2)], each actuation delivers 27.5 mcg of fluticasone furoate in a volume of 50 microliters of nasal spray suspension. Veramyst Nasal Spray also contains 0.015% w/w benzalkonium chloride, dextrose anhydrous, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, and purified water. It has a pH of approximately 6.

Before using Veramyst, 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 Veramyst nasal spray before your symptoms improve. Tell your doctor if your symptoms do not improve after a week of treatment.

Veramyst 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 Veramyst.

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

Do not administer Veramyst 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 Veramyst.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Avoid getting the spray in your eyes or mouth. If this does happen, rinse with water.

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 Veramyst.

Common side effects of Veramyst include: epistaxis. Other side effects include: fever. See below for a comprehensive list of adverse effects.

Applies to fluticasone nasal: nasal spray

Along with its needed effects, fluticasone nasal (the active ingredient contained in Veramyst) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluticasone nasal:

• Bloody nose

• Cough
• fever
• headache
• muscle aches
• sore throat
• sores inside the nose
• stuffy or runny nose
• unusual tiredness or weakness

• Difficulty with swallowing
• dizziness
• fast heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash, itching, hives or welts
• tightness in the chest

Some side effects of fluticasone nasal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain