DYMISTA

AbsorptionAfter nasal administration of two sprays per nostril (548 mcg of azelastine hydrochloride and 200 mcg of fluticasone) of DYMISTA, the mean (± standard deviation) peak plasma exposure (C max ) was 194.5 ± 74.4 pg/mL for azelastine and 10.3 ± 3.9 pg/mL for fluticasone propionate and the mean total exposure (AUC) was 4217 ± 2618 pg/mL*hr for azelastine and 97.7 ± 43.1 pg/mL*hr for fluticasone. The median time to peak exposure (t max ) from a single dose was 0.5 hours for azelastine and 1...

Adults and Adolescents 12 Years of Age and Older: The efficacy and safety of DYMISTA in adults and adolescents 12 years of age and older with seasonal allergic rhinitis was evaluated in 3 randomized, multicenter, double-blind, placebo-controlled clinical trials in 853 patients. The population of the trials was 12 to 78 years of age (64% female, 36% male; 80% white, 16% black, 2% Asian, 1% other). Patients were randomized to one of four treatment groups: one spray per nostril twice daily of DYMISTA, azelastine hydrochloride nasal spray, fluticasone propionate nasal spray, and vehicle placebo. T...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Somnolence [see Warnings and Precautions (5.1) ]
• Local nasal effects, including epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, and Candida albicans infection [see Warnings and Precautions (5.2) ]
• Glaucoma and Cataracts [see Warnings and Precautions (5.3) ]
• Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ]
• Hypercorticism and Adrenal...

DYMISTA is contraindicated in patients with hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any other ingredients of DYMISTA. Reactions have included anaphylaxis [see Adverse Reactions (6.2) ] . Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or to any ingredients of DYMISTA. Reactions have included anaphylaxis. ( 4 )

• Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA. ( 5.1 )
• 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. ( 5.1 )
• Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adv...

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with DYMISTA. The drug interactions of the combination are expected to reflect those of the individual components.

• Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.
• Ritonavir: Coadministration is not recommended. ( 5.6 , 7.2 )
• Other potent CYP3A4 inhibitors, such as k...