Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.4 )] • Effect on Growth [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, and nasal discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Specialty USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared with rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adults and Pediatric Patients 12 Years of Age and Older The pooled RYALTRIS safety population reflects exposure to RYALTRIS at 2 sprays (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate) in each nostril twice daily in a total of 1189 patients from Studies 1 and 2 [see Clinical Studies (14)] and from three additional placebo and/or active-controlled studies in patients with allergic rhinitis.
One placebo controlled study was a 52-week safety study.
In this study, 393 patients were exposed to RYALTRIS for one year, and no new safety signals were observed.
The RYALTRIS safety population described below reflects exposure to RYALTRIS at 2 sprays (2 sprays deliver a total of 1,330 mcg of olopatadine hydrochloride and 50 mcg of mometasone furoate) in each nostril twice daily for two weeks duration in a total of 789 patients, including 596 patients from Studies 1 and 2 [see Clinical Studies (14)], and 36 and 157 from two additional placebo and active-controlled studies in patients with seasonal allergic rhinitis.
The demographics of the RYALTRIS-treated patients were 12 to 81 years of age (mean age of 40 years;
67% female;
5 WARNINGS AND PRECAUTIONS • 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 additional reductions in alertness and additional impairment of CNS performance may occur.
( 5.2 ) • Glaucoma and cataracts: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
( 5.3 ) • Hypersensitivity Reactions: Hypersensitivity reactions can occur with RYALTRIS.
Like all medications, Ryaltris can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: