RYALTRIS

AbsorptionAfter repeated nasal administration of 2 sprays per nostril of RYALTRIS (2660 mcg of olopatadine hydrochloride and 100 mcg of mometasone furoate) twice daily in patients with seasonal allergic rhinitis, the mean (± standard deviation) peak plasma exposure (C max ) was 19.80 ± 7.01 ng/mL for olopatadine and 9.92 ± 3.74 pg/mL for mometasone furoate, and the mean exposure over the dosing regimen (AUC tau ) was 88.77 ± 23.87 ng/mL*hr for olopatadine and 58.40 ± 27.00 pg/mL*hr for mometaso...

The efficacy of RYALTRIS was evaluated in two multicenter, randomized, double-blind, placebo-and active-controlled clinical studies of 2-week duration in

Study 1(NCT02631551) and

Study 2(NCT02870205). The two studies were of similar design, including a single blind, placebo run-in period for 7 to 10 days, and enrolled a total of 2352 patients 12 years of age and older with seasonal allergic rhinitis. Patients had a history of seasonal allergic rhinitis for at least 2 years prior to screening, a positive skin prick test (wheal diameter 5mm or greater than negative diluent control) to relevant...

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

• Local Nasal Adverse Reactions [see Warnings and Precautions ( 5.1 )]
• Somnolence and Impaired Mental Alertness [see Warnings and Precautions ( 5.2 )]
• Glaucoma and Cataracts [see Warnings and Precautions ( 5.3 )]
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )]
• Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.5 )]
• Hypercorticism and Adrenal Suppression ...

RYALTRIS is contraindicated in patients with known hypersensitivity to any ingredients of RYALTRIS. Hypersensitivity reactions, including wheezing, has occurred after nasal administration of mometasone furoate [see Warnings and Precautions ( 5.4 )]. Patients with known hypersensitivity to any ingredients of RYALTRIS, including mometasone furoate. ( 4 )

• Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa. ( 5.1 )
• Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery when taking RYALTRIS. ( 5.2 )
• Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with RYALTRIS because additio...

7 DRUG INTERACTIONS No formal drug-drug interaction studies have been performed with RYALTRIS. The drug interactions of the combination are expected to reflect those of the individual components [see Clinical Pharmacology ( 12.3 )] . 7.1 Central Nervous System Depressants Concurrent use of RYALTRIS with alcohol or other central nervous system depressants should be avoided because somnolence and im...