Xhance

Last updated on RxList: 5/14/2021
Xhance Side Effects Center

What Is Xhance?

Xhance (fluticasone propionate) nasal spray is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

What Are Side Effects of Xhance?

Common side effects of Xhance include:

Dosage for Xhance

The recommended adult dosage of Xhance is one spray per nostril twice daily (total daily dose of 372 mcg). Two sprays per nostril twice daily may also be effective in some patients (total daily dose of 744 mcg).

What Drugs, Substances, or Supplements Interact with Xhance?

Xhance may interact with ritonavir and other antiviral drugs, ketoconazole and other azole antifungals, macrolide antibiotics, nefazodone, and conivaptan. Tell your doctor all medications and supplements you use.

Xhance During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xhance; it is unknown how it would affect a fetus. It is unknown if Xhance passes into breast milk. Other corticosteroids pass into breast milk. Fluticasone propionate concentrations in blood after orally inhaled therapeutic doses are low, and concentrations in breast milk are likely to be low. Consult your doctor before breastfeeding.

Additional Information

Our Xhance (fluticasone propionate) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Xhance Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, rash; feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe or ongoing nosebleeds;
  • noisy breathing, runny nose, or crusting around your nostrils;
  • redness, sores, or white patches in your mouth or throat;
  • fever, chills, body aches;
  • blurred vision, eye pain, or seeing halos around lights;
  • any wound that will not heal; or
  • signs of a hormonal disorder--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • minor nosebleed, burning or itching in your nose;
  • sores or white patches inside or around your nose;
  • cough, trouble breathing;
  • headache, back pain;
  • sinus pain, sore throat, fever; or
  • nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xhance (Fluticasone Propionate Nasal Spray, for Intranasal Use)

Xhance Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

  • Local nasal effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing [see WARNINGS AND PRECAUTIONS]
  • Cataracts and glaucoma [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • HPA axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Effect on Growth [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

The safety data described below are based on two placebo-controlled clinical trials evaluating doses of a fluticasone propionate nasal spray with an exhalation delivery system from 93 mcg twice daily to 372 mcg twice daily. Both trials were 16-weeks in duration with an additional 8-week open-label extension. The trials included a total of 643 adult subjects with bilateral nasal polyps and associated moderate or severe nasal congestion of which 161 received 93 mcg twice daily, 160 received 186 mcg twice daily, 161 received 372 mcg twice daily and 161 received placebo. The overall pooled safety data included 296 (46.0%) Female, 347 (54.0%) Male, 584 (90.8%) White, 39 (6.1%) Black, 9 (1.4%) Asian, and 11 (1.7%) subjects classified as Other. Of these patients, 45 (7%) were 65 years of age or older.

Table 1 displays adverse reactions with an incidence of ≥ 3% in the XHANCE 186 mcg and 372 mcg twice daily subjects, and more common than placebo.

Table 1. Summary of Adverse Reactions with XHANCE Reported in ≥ 3% of Subjects with Nasal Polyps and More Common Than Placebo in Placebo-Controlled Studies

Adverse Reaction Placebo
(N = 161)
n (%)
XHANCE
186 mcg bid
(N = 160)
n (%)
372 mcg bid
(N = 161)
n (%)
Epistaxis1 4 (2.5) 19 (11.9) 16 (9.9)
Nasopharyngitis 8 (5.0) 3 (1.9) 12 (7.5)
Nasal septal ulceration2 3 (1.9) 11 (6.9) 12 (7.5)
Nasal congestion 6 (3.7) 7 (4.4) 9 (5.6)
Acute sinusitis 6 (3.7) 7 (4.4) 8 (5.0)
Headache 5 (3.1) 8 (5.0) 6 (3.7)
Pharyngitis 2 (1.2) 2 (1.3) 5 (3.1)
Nasal mucosal ulceration2 2 (1.3) 6 (3.8) 4 (2.5)
Nasal mucosal erythema 6 (3.7) 9 (5.6) 8 (5.0)
Nasal septal erythema 3 (1.9) 6 (3.8) 7 (4.3)
bid = twice daily.
1Includes spontaneous adverse reaction reports
2Include ulcerations and erosions

Other adverse reactions with XHANCE observed with an incidence < 3% but ≥ 1% and more common than placebo included: nasal dryness, sinusitis, oropharyngeal pain, toothache, intraocular pressure increase, dizziness, abdominal discomfort, and weight increase.

5.0% of subjects treated with XHANCE 186 mcg twice daily and 1.2% of subjects treated with 372 mcg twice daily discontinued from the clinical trials prior to the open-label extension because of adverse reactions compared to 4.3% of subjects treated with placebo.

There were no clinically relevant differences in the incidence of adverse reactions based on gender. Clinical trials did not include sufficient numbers of non-Caucasian patients or patients aged 65 years and older to determine whether they respond differently from Caucasian or younger patients, respectively.

The adverse reactions observed during uncontrolled, open-label trials of 3 to 12 months duration in subjects with chronic sinusitis with and without nasal polyps receiving XHANCE 372 mcg twice daily were similar to the adverse reactions reported in clinical trials in patients with nasal polyps.

DRUG INTERACTIONS

Inhibitors Of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole) with XHANCE is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir

A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see CLINICAL PHARMACOLOGY]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole

Coadministration of orally inhaled fluticasone propionate (1000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Read the entire FDA prescribing information for Xhance (Fluticasone Propionate Nasal Spray, for Intranasal Use)

© Xhance Patient Information is supplied by Cerner Multum, Inc. and Xhance Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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