ryaltris

Important safety information

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 warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. 5.4 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 [see Contraindications ( 4 )] . 5.5 Immunosuppression and Risk of Infections Persons who are using drugs that suppress the immune system, such as corticosteroids, including RYALTRIS, are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of RYALTRIS have not been established in pediatric patients less than 12 years of age and RYALTRIS is not indicated for use in this population. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective Prescribing Information for VZIG and IG). If chickenpox develops, treatment with antiviral agents may be considered. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections. 5.6 Hypercorticism and Adrenal Suppression Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including RYALTRIS, are misused by taking higher-than-recommended dosages [see Dosage and Administration ( 2 )] or in patients at risk for such effects. 5.7 Effect on Growth Nasal corticosteroids, including RYALTRIS, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of RYALTRIS have not been established in pediatric patients less than 12 years of age and RYALTRIS is not indicated for use in this population. Routinely monitor the growth of pediatric patients receiving RYALTRIS [see Use in Specific Populations ( 8.4 )] .