Fluticasone Furoate (Avamys)

1. Health Canada Product Monograph — Fluticasone Furoate

• Used to treat the nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.
• Used to treat the nasal symptoms of perennial (year-round) allergic rhinitis in patients 2 years of age and older.

• There are no adequate, well-controlled studies of fluticasone furoate in pregnant women.
• It should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.

• It is not known whether fluticasone furoate passes into human breast milk, though other corticosteroids have been detected in milk.
• Because there is no controlled data on its use by nursing mothers, caution is advised, and the decision to use it while breastfeeding should weigh the benefit to the mother against any potential risk to the infant.

• Clinical studies did not include enough patients 65 years and older to determine whether they respond differently than younger adults, and other reported experience has not identified differences in response between older and younger patients.
• Dose selection in older adults should still be cautious, reflecting the greater likelihood of reduced liver, kidney, or heart function, or other illnesses and medications, in this age group.

• Approved for children 2 years of age and older; the usual starting dose in children 2 to under 12 years is one spray per nostril once daily, which may be increased to two sprays per nostril once daily if needed, then stepped back down to one spray per nostril once symptoms are controlled.
• Safety and effectiveness have not been evaluated in children younger than 2 years.
• A one-year study in children found a small reduction in growth velocity compared with placebo, so children should be kept on the lowest dose that controls symptoms and growth should be monitored during long-term treatment.

• The recommended dose for adults and adolescents 12 years and older is two sprays (27.5 mcg each) in each nostril once daily, for a total daily dose of 110 mcg.
• Children 2 to under 12 years usually start with one spray in each nostril once daily and may increase to two sprays per nostril if their response is inadequate, reducing back down once symptoms are controlled.
• The pump must be primed with several test sprays before the first use, after 30 days without use, or if the cap has been left off for more than five days.
• If a dose is missed, take the next dose at its regular scheduled time; do not double up to make up for a missed dose.
• It may take several days of regular use to reach full benefit, and symptoms may not return for several days after stopping, so an absence of immediate effect is expected.

• Headache is common.
• Nosebleed (epistaxis) is common.
• Pain in the back of the throat (pharyngolaryngeal pain) is common.
• Small sores or ulceration inside the nose may occur.
• Nasopharyngitis, meaning common-cold-type symptoms, may occur.
• Back pain may occur.
• Upper respiratory tract infection symptoms may occur.
• Nausea may occur.
• Dryness or irritation inside the nose may occur.
• A hoarse voice (dysphonia) may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Nasal septal perforation, a hole forming in the wall between the nostrils, has been reported, usually with long-term use.
• A fungal infection of the nose with Candida albicans can develop, which may require stopping the spray and treating the infection.
• Impaired wound healing in the nose can occur, so the spray should be avoided after recent nasal surgery, trauma, or ulcers until healing is complete.
• With higher-than-recommended doses or in susceptible individuals, systemic corticosteroid effects such as Cushingoid features and suppression of the body's normal cortisol production can occur.
• Eye problems such as glaucoma, cataracts, or a fluid buildup under the retina (central serous chorioretinopathy) have been associated with nasal and inhaled corticosteroids.
• Serious allergic reactions, including swelling of the face or throat (angioedema), hives, or anaphylaxis, can occur, though rarely.
• Reduced growth velocity has been observed in children using this medication long-term, so growth should be monitored.
• Patients switching from long-term systemic corticosteroids to this nasal spray can experience withdrawal symptoms such as joint or muscle pain, fatigue, and low mood, and rarely adrenal insufficiency requiring temporary systemic steroid treatment.

• Use with caution in patients with active or dormant tuberculosis of the respiratory tract.
• Use with caution in patients with untreated fungal, bacterial, viral, or parasitic infections, or with ocular herpes simplex.
• Use with caution in patients with liver impairment, since systemic exposure to the medication can be increased.
• Use with caution in patients being switched from long-term systemic corticosteroid therapy, who should be monitored closely for adrenal insufficiency.
• Use with caution in patients with a history of increased eye pressure, glaucoma, cataracts, or vision changes, with periodic eye monitoring considered during long-term therapy.
• Patients who are immunosuppressed should take particular care to avoid exposure to chickenpox or measles, as these illnesses can be more severe in this setting.

• Contraindicated in patients with hypersensitivity to fluticasone furoate or to any other ingredient in the formulation.

• Fluticasone furoate is broken down mainly by the liver enzyme CYP3A4, so strong inhibitors of this enzyme, such as ketoconazole, can raise blood levels of the drug and increase the risk of systemic corticosteroid effects.
• Coadministration with ritonavir, a potent CYP3A4 inhibitor, is not recommended due to the risk of increased systemic exposure and effects such as cortisol suppression.
• Caution is advised when this spray is combined with any other strong CYP3A4 inhibitor, since exposure to fluticasone furoate could rise beyond expected levels.

• No food interactions are established for this nasal spray, since it acts locally in the nose with only minimal medication reaching the bloodstream.

• Administered intranasally once daily, at any time of day, and works best with regular, consistent daily use rather than as-needed dosing; benefit may take several days to become apparent.

• Store the nasal spray device between 4 and 30 degrees C, kept upright with the cap in place.
• Do not refrigerate or freeze.

• Avamys is a nasal corticosteroid spray used once daily to relieve nasal symptoms from seasonal or year-round allergies.
• The usual dose is two sprays in each nostril once daily for adults and adolescents, with lower starting doses for younger children; use it regularly, since full benefit can take several days.
• Common effects include headache, nosebleeds, throat discomfort, and nasal dryness or irritation.
• Contact your doctor's office promptly if you notice ongoing nosebleeds, nasal pain or a whistling sound when breathing through the nose, vision changes, or signs of an allergic reaction such as facial swelling or hives.
• Prime the pump before first use or after a period of non-use, spray it into each nostril while breathing in gently, and avoid spraying directly onto the nasal septum, the wall between the nostrils.
• Store the spray upright at room temperature with the cap on, and keep it out of reach of children.