ENT - September 2020 - 494

XHANCE® (fluticasone propionate) nasal spray for
intranasal use.
Rx only.
Brief Summary of Prescribing Information (PI) for
XHANCE. See full PI.
IMPORTANT DOSING CONSIDERATIONS:
Use Twice Daily for Best Effect: Inform patients that they should use
XHANCE on a regular basis as directed. XHANCE, like other corticosteroids,
does not have an immediate effect on nasal polyps or symptoms. Individual
patients will experience a variable time to onset and degree of symptom
relief, and the full benefit may not be achieved until treatment has been
administered for up to 16 weeks or longer. Patients should not increase
the prescribed dosage but should contact their healthcare providers if
symptoms do not improve or if the condition worsens. If a patient missed
a dose, the patient should be advised to take the dose as soon as they
remember. The patient should not take more than the recommended
dose for the day.
Keep Spray Out of Eyes and Mouth: Inform patients to avoid spraying
XHANCE in their eyes and mouth.
How to Use XHANCE Nasal Spray: It is important for patients to
understand how to correctly administer XHANCE nasal spray using the
exhalation delivery system. Advise the patient to carefully read the patient
Instructions for Use. The patient should note the difference in appearance
of the cone-shaped, non-flexible nosepiece and the longer flexible
mouthpiece. Patients should be advised not to inhale (e.g., "sniff")
when blowing (exhaling) into the mouthpiece. Patients should be advised
not to block the other nostril because the exhaled breath must pass
around the back of the nasal septum and out the other side of the nose.
CONTRAINDICATIONS: XHANCE should not be administered to
patients with a history of hypersensitivity to any ingredient in XHANCE.
WARNINGS & PRECAUTIONS:
Local Nasal Effects
Epistaxis, Nasal Erosions, and Ulcerations: In placebo-controlled clinical
trials of 16 weeks' duration, epistaxis, nasal erosions, and nasal
ulcerations were reported more frequently in patients treated with
XHANCE than those who received placebo.
Nasal Septal Perforation: Nasal septal perforations have been reported
in patients following the intranasal application of XHANCE. In placebocontrolled clinical trials of 16 weeks' duration, nasal septal perforations
were reported in 1 (0.3%) patient treated with XHANCE compared with none
treated with placebo. The patient had a prior history of nasal/sinus surgery.
Three (0.3%) patients treated with XHANCE in uncontrolled, open-label
trials of 3 to 12 months' duration developed nasal septal perforations.
As with any long-term topical treatment of the nasal cavity, patients using
XHANCE over several months or longer should be examined periodically
for possible changes in the nasal mucosa. If a septal perforation is noted,
discontinue XHANCE. Avoid spraying XHANCE directly on the septum.
Candida Infection: In clinical trials with XHANCE, localized infections
with Candida albicans have been observed. Eight (0.9%) patients in
uncontrolled, open-label trials of 3 to 12 months' duration developed
Candida albicans infections (nasal, pharyngeal, esophageal, or intestinal).
If such an infection develops, it may require treatment with appropriate
local therapy and discontinuation of XHANCE. Patients using XHANCE
should be examined periodically for evidence of Candida infection in the
nasal and oropharyngeal mucosa.
Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on
wound healing, patients who have experienced recent nasal ulcerations, nasal
surgery, or nasal trauma should avoid using XHANCE until healing has occurred.

Glaucoma and Cataracts: Nasal and inhaled corticosteroids, including
fluticasone propionate, may result in the development of glaucoma and/
or cataracts. In placebo-controlled clinical trials of 16 weeks' duration,
cataracts were reported in 4 (1.2%) patients treated with XHANCE,
compared with 3 (1.9%) patients treated with placebo. Among these
patients, 2 patients treated with XHANCE reported subcapsular cataracts
compared with none treated with placebo. Eleven patients (1.2%) in
uncontrolled, open-label trials of 3 to 12 months' duration developed new
or worsening cataracts, of which none were subcapsular. 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.
Hypersensitivity Reactions Including Anaphylaxis: XHANCE
is contraindicated in patients with known hypersensitivity to fluticasone
propionate or any of the ingredients of XHANCE. Discontinue XHANCE
if such reactions (e.g., anaphylaxis, angioedema, urticaria, contact
dermatitis, rash, hypotension, and bronchospasm) occur.
Immunosuppression: Persons who are using drugs that suppress the
immune system are more susceptible to infections than healthy individuals
and may experience a worsening of existing infections. Chickenpox and
measles, for example, can have a more serious or even fatal course in
susceptible adults using corticosteroids. In such adults who have not had
these diseases or been properly immunized, 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 develops,
treatment with antiviral agents may be considered. Corticosteroids
should be used with caution, if at all, in patients with active or quiescent
tuberculosis infections of the respiratory tract; systemic fungal, bacterial,
viral, or parasitic infections; or ocular herpes simplex.
Hypothalamic-Pituitary-Adrenal Axis Effects: Hypercorticism
and adrenal suppression may occur when intranasal corticosteroids,
such as XHANCE, are used at higher-than-recommended dosages or
in susceptible individuals at recommended dosages. Since fluticasone
propionate is absorbed into the circulation and can be systemically
active at higher doses, recommended dosages of XHANCE should not
be exceeded to avoid hypothalamic-pituitary-adrenal (HPA) dysfunction.
A relationship between plasma levels of fluticasone propionate and
inhibitory effects on stimulated cortisol production has been shown after
4 weeks of pulmonary treatment with fluticasone propionate inhalation
aerosol. Since individual sensitivity to effects on cortisol production exists,
physicians should consider this information when prescribing XHANCE.
Patients treated with XHANCE should be observed carefully for any
evidence of systemic corticosteroid effects such as hypercorticism and
adrenal suppression (including adrenal crisis). If such effects occur, the
dosage of XHANCE should be reduced slowly, consistent with accepted
procedures for reducing systemic corticosteroids, and other treatments
for management of nasal symptoms should be considered. Particular
care should be taken in observing patients postoperatively or during
periods of stress for evidence of inadequate adrenal response. 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). After withdrawal
from systemic corticosteroids, a number of months are required for
recovery of HPA function. 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, such as trauma, surgery, infection (particularly gastroenteritis),
or other conditions associated with severe electrolyte loss. In 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.

ENT - September 2020

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