Ryaltris

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION For nasal use only. The recommended dosage of RYALTRIS is 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. • Shake the bottle well before each use. • Prime RYALTRIS before initial use by releasing 6 sprays or until a fine mist appears. When RYALTRIS has not been used for 14 or more days, re-prime by releasing 2 sprays or until a fine mist appears. • Avoid spraying RYALTRIS into the eyes or mouth. • For nasal use only ( 2 ) • Recommended dosage: 2 sprays in each nostril twice daily ( 2 ) • Prime before initial use by releasing 6 sprays or until a fine mist appears and when it has not been used for 14 or more days by releasing 2 sprays or until a fine mist appears. ( 2 ) Warnings and cautions 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. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue RYALTRIS if such reactions occur. ( 5.4 ) • Immunosuppression and Risk of Infections: 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. ( 5.5 ) • Hypercorticism and adrenal suppression with misuse or use of higher-than-recommended dosages or at the regular dosage in susceptible patients at risk for such effects ( 5.6 ) • Potential reduction in growth velocity in children: Routinely monitor the growth in pediatric patients receiving RYALTRIS. ( 5.7 , 8.4 ) 5.1 Local Nasal Adverse Reactions Epistaxis Epistaxis was observed in 1% of patients treated with RYALTRIS and 0.6% of patients who received placebo in 2-week studies in patients with seasonal allergic rhinitis [see Adverse Reactions ( 6.1 )]. Nasal Ulceration and Nasal Septal Perforation Instances of nasal ulceration and nasal septal perforation have occurred in patients following the nasal application of antihistamines such as RYALTRIS. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Impaired Nasal Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should avoid use of RYALTRIS until healing has occurred. Local Candida Infection Localized infections of the nose and pharynx with Candida albicans have occurred from nasal administration of mometasone furoate. When such an infection occurs, discontinue RYALTRIS and institute appropriate local or systemic therapy. Patients using RYALTRIS over several months or longer should be examined periodically for evidence of Candida infection. 5.2 Somnolence and Impaired Mental Alertness Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after administration of RYALTRIS. Concurrent use of RYALTRIS with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur. Somnolence was reported in 0.3% of patients treated with RYALTRIS and none of the patients who received placebo in 2-week studies in patients with seasonal allergic rhinitis [see Adverse Reactions ( 6.1 )] . 5.3 Glaucoma and Cataracts Nasal and inhaled corticosteroids including RYALTRIS can result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warrante