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    DYMISTA®
    (azelastine hydrochloride and fluticasone propionate) nasal spray
    overview
  • clinical information
  • drug monograph
Full prescribing information
  • Onset
  • Efficacy
  • Safety

DYMISTA® (azelastine hydrochloride and
fluticasone propionate) nasal spray offers
Seasonal Allergic Rhinitis (SAR) patients
fast reliefa and inflammation
control — with every dose.1,2

aAs demonstrated in patients 12 and older, fast relief is defined as the first timepoint (30 minutes) at which DYMISTA® was significantly superior to placebo in the mean change from baseline in instantaneous total nasal symptom score (iTNSS) and was sustained thereafter.1
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Onset of Relief

DYMISTA® offers fast reliefa and inflammation control — with every dose1,2

aAs demonstrated in patients 12 and older, fast relief is defined as the first timepoint (30 minutes) at which DYMISTA® was significantly superior to placebo in the mean change from baseline in instantaneous total nasal symptom score (iTNSS) and was sustained thereafter.1

In a pivotal trial with symptomatic adolescent and adult patients having moderate to severe allergic rhinitis (SAR), the reduction in nasal symptom scores with DYMISTA® was statistically significant vs placebo within 30 minutes, and that significant difference was maintained throughout the 4-hour observation period1

RAPID SYMPTOM RELIEF WITHIN 30 MINUTES WITH DYMISTA® VS PLACEBOb

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3
2
1
0
0
15
30
45
Reduction in TNSSc
Minutes
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P=.032
DYMISTA® (n=193)
Placebo (n=200)
onset in as early as30minutes1
bIn patients 12 years of age and older, onset of action was defined as the first timepoint at which DYMISTA® was statistically superior to placebo in mean change from baseline in instantaneous TNSS and was sustained thereafter.1
cChange from baseline in instantaneous TNSS following administration.
TNSS = Total Nasal Symptom Score.
Source: Dymista [package insert].1

In a survey, 85% of patients identified rapid relief of symptoms as one of the most important attributes of SAR treatment.3

Significant Improvement of Nasal Symptoms Over 2 Weeks

DYMISTA® demonstrated significantly greater improvement in total nasal symptom relief vs azelastine HCl or generic fluticasone propionate COMPARATORSd

dThe azelastine hydrochloride and fluticasone propionate comparators used the same device and vehicle as DYMISTA and are not commercially marketed.1

Across 3 pivotal clinical trials, involving patients 12 and older, DYMISTA® provided statistically significant (P≤.038) improvement in placebo-subtracted reflective Total Nasal Symptom Scores (rTNSS) ranging from 43% to 67% greater than that of azelastine HCI or fluticasone propionate, over a 14-day study period1

  • DYMISTA® also showed consistent, statistically significant (P<.001) improvement in rTNSS regardless of the allergy season when compared with placebo1

IMPROVEMENT IN REFLECTIVE TOTAL NASAL SYMPTOM SCORES

Mean Change in rTNSS

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3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
LS Mean Change From
Baseline in rTNSSe
DYMISTA®
FP
AZE
DYMISTA®
FP
AZE
DYMISTA®
FP
AZE
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f
g
h
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SPRING
MP 4002 (N=831)
FALL
MP 4004 (N=776)
SPRING AND SUMMER
MP 4006 (N=1791)
ePlacebo subtracted. fP<.034 vs FP; P=.001 vs AZE. gP<.038 vs FP; P=.032 vs AZE. hP<.029 vs FP; P=.016 vs AZE.
AZE = azelastine HCl; FP = fluticasone propionate; LS = least-squares; rTNSS = reflective Total Nasal Symptom Score.
Source: DYMISTA [package insert].1

In a supportive Phase III, randomized, double-blind, parallel-group study of patients 12 years and older, DYMISTA® achieved 90% greater improvement in placebo-subtracted TNSS vs generic Flonase® (fluticasone propionate), which represents a 1.47 numerical difference in TNSS2,4

  • DYMISTA® was significantly different from both fluticasone propionate and azelastine HCl (P<.05)4

MAGNITUDE OF NASAL SYMPTOM RELIEF

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3.5
3.0
2.5
2.0
1.5
1.0
0.5
0
Mean Reduction From
Baseline in TNSS
Astelin®
(n=152)
Generic Flonase®
(n=151)
DYMISTA®
(n=153)
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i
j
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90% Greater Improvement vs generic Flonase®
(fluticasone propionate)
-1.05
-1.64
-3.11
Change from baseline in the placebo-subtracted mean TNSS for each day (maximum score 24), averaged over the 14-day study period.2 Percent difference represents the improvement in TNSS with DYMISTA® relative to commercially available generic Flonase® (fluticasone propionate) comparator.2,4
iP =.003 vs generic Flonase®.   jP<.001 vs Astelin®
TNSS = Total Nasal Symptom Score.
Sources: Hampel 20102; Data on file.4

The most common adverse events in this trial for DYMISTA® were dysgeusia (7.2%), epistaxis (3.9%), and headache (2.6%)2

A Supportive SAR Trial Shows Sustained Improvement Over 2 Weeks

DYMISTA® demonstrated significantly greater improvement in total nasal symptom relief vs active comparators and placebo over 2 weeks (P<.001), in a supportive study involving patients 12 and older2

SUSTAINED IMPROVEMENT OVER TIME

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7
6
5
4
3
2
1
0
0
2
3
4
5
6
7
8
9
10
11
12
13
14
TNSS LS Mean Change
From Baseline
Study Day
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placebo (n=151)
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Astelin® (n=152)
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generic Flonase® (n=151)
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DYMISTA® (n=153)
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kP≤.01 vs Astelin®, generic Flonase®, and placebo.2   lP<.01 vs Astelin® and placebo.2
LS = least-squares; TNSS = Total Nasal Symptom Score.
Source: Hampel 2010.2

Significant separation was demonstrated by the DYMISTA® group as early as Day 2

Safety and Tolerability in Patients 6 Years of Age and Older

Safety and tolerability of DYMISTA® has been widely studied in >4000 patients (including children, adolescents, and adults)

Children 6 to 11 Years of Age

Safety results from a 2-week, double-blind, placebo-controlled clinical trial in children 6 to 11 years of age with SAR found that children treated with DYMISTA® for 2 weeks (N=302) experienced more adverse reactions than those receiving placebo: overall incidence of adverse reactions (16% vs 12%), dysgeusia (4% vs 0%), and epistaxis (4% vs 3%)1

  • In both treatment groups, 1% of patients discontinued use due to adverse reactions
  • Somnolence was not reported

A 3-month, open-label safety trial conducted in children 6 to 11 years old (N=353) found that more treatment-emergent adverse events occurred in children receiving combination therapy with DYMISTA® (n=264) compared to fluticasone propionate (n=89) (1 spray in each nostril twice daily)4

  • No nasal ulcerations or septal perforations were observed
  • 2% of patients in the DYMISTA® group and 3% in the fluticasone group discontinued use because of adverse events
  • There were two reports of somnolence, one severe, among children taking DYMISTA®

Adolescents and Adults

The safety data described below in adults and adolescents 12 years of age and older reflect exposure to DYMISTA in patients with seasonal allergic rhinitis in 3 double-blind, placebo-controlled clinical trials of 2-week duration.1

Adverse Reactions ≥2% Incidence in 2-week Seasonal Allergic Rhinitis Pivotal Trials
(Studies MP 4002, MP 4004, and MP 4006)

1 spray per nostril twice daily
DYMISTA(N=853)m Azelastine Hydrochloride Nasal Sprayn(N=851) Fluticasone Propionate
Nasal Sprayn (N=846)		 Vehicle Placebo(N=861)
Dysgeusia 30 (4%) 44 (5%) 4 (1%) 2 (<1%)
Headache 18 (2%) 20 (2%) 20 (2%) 10 (1%)
Epistaxis 16 (2%) 14 (2%) 14 (2%) 15 (2%)
mSafety population N=853, intent-to-treat population N=848
nNot commercially marketed
Source: DYMISTA [package insert].1

In a separate 12-month, open-label safety trial (N=611), the overall rate of any adverse reaction was 47% with DYMISTA® and 44% with fluticasone propionate4,0

  • Of patients treated with DYMISTA®:
      – None had severe epistaxis, 2% had mild epistaxis, and <1% had moderate epistaxis
      – No nasal ulcerations or septal perforations were observed
  • In both treatment groups, 3% of patients discontinued use because of adverse reactions
oAs listed in the Full Prescribing Information, this trial was an open-label, active-controlled study in which 404 patients (12 years of age and older) with chronic allergic or nonallergic vasomotor rhinitis were treated with DYMISTA® 1 spray per nostril twice daily, and 207 patients were treated with fluticasone propionate 2 sprays per nostril once daily.4
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Company:
Meda Pharmaceuticals
Pharmacologic class:
Antihistamine + corticosteroid
Active
IngRedients:
Azelastine HCl, fluticasone propionate 137 mcg/50 mcg; per 0.137 mL metered nasal spray; aqueous suspension
Indications:
DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief
Adults & ADOLESCENTS:
1 spray per nostril twice daily
Children
6-11 YRS:
1 spray per nostril twice daily
Contraindications:
None
Warnings
and Precautions:
  • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA
  • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur
  • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma
  • Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts
  • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly
  • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving DYMISTA
Adverse Reactions:
The most common adverse reactions (≥2% incidence) are: dysgeusia, epistaxis, and headache
Drug Interactions:
  • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate
  • Ritanovir: Coadministration is not recommended
  • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration
use in Specific Populations:
Pregnancy: Based on animal data, may cause fetal harm
How Supplied:
Pump (23 g)—120 sprays
REFERENCES
  1. DYMISTA [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc; 2015.
  2. Hampel FC, Ratner PH, van Bavel J, et al. Double-blind, placebo-controlled study of azelastine and
    fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010;105(2):168-173.
  3. Marple BF, Fornadley JA, Patel AA, et al. Keys to successful management of patients with allergic rhinitis:
    focus on patient confidence, compliance, and satisfaction. Otolaryngol Head Neck Surg. 2007;
    136(suppl 6):S107-S124.
  4. Data on file. Meda Pharmaceuticals Inc.

All trademarks are the property of their respective owners.

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© 2015 Meda Pharmaceuticals Inc. Dymista is a registered trademark of Meda Pharmaceuticals Inc. 05/15   US/DYM/0415/0068j

This MPR Prescribing Alert is produced as a basic reminder of important information for healthcare professionals. Readers are advised to consult manufacturers and specialists if questions arise about specific products, treatments, or diseases. The publisher and editors do not assume liability for any errors or omissions. MPR and MPR Prescribing Alert are registered trademarks of Haymarket Media, Inc.

© 2015 Haymarket Media, Inc.

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Important
Safety Information

INDICATIONS

DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.

Important safety information

  • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA.
  • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur.
  • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
  • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly.
  • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving DYMISTA.
  • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.
  • Ritanovir: Coadministration is not recommended.
  • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.
  • The most common adverse reactions (≥2% incidence) are: dysgeusia, epistaxis, and headache.
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