Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING RYALTRIS (NDC 59467-700-27) is supplied in a white plastic bottle fitted with a metered‑dose spray nozzle unit. Each bottle contains a net fill weight of 31 g and will deliver 240 metered sprays in addition to six (6) initial priming sprays [see Description ( 11 )] . Each spray delivers a volume of 0.1 mL suspension as a fine mist, containing 665 mcg of olopatadine hydrochloride equivalent to 600 mcg of olopatadine (base) and 25 mcg of mometasone furoate monohydrate (on the anhydrous basis). The bottle should be discarded after 240 sprays have been used. Storage Store RYALTRIS upright with the purple dust cap on at room temperature (see USP Controlled Room Temperature, between 20°C and 25°C, or between 68°F and 77°F, with excursions permitted between 15°C to 30°C or between 59°F to 86°F). Do not store in a freezer or refrigerator.; PRINCIPAL DISPLAY PANEL NDC: 59467-700-27 RYALTRIS – olopatadine hydrochloride and mometasone furoate 240 Metered Sprays Bottle Label image1; PRINCIPAL DISPLAY PANEL NDC: 59467-700-27 RYALTRIS – olopatadine hydrochloride and mometasone furoate 240 Metered Sprays Carton image2
- 16 HOW SUPPLIED/STORAGE AND HANDLING RYALTRIS (NDC 59467-700-27) is supplied in a white plastic bottle fitted with a metered‑dose spray nozzle unit. Each bottle contains a net fill weight of 31 g and will deliver 240 metered sprays in addition to six (6) initial priming sprays [see Description ( 11 )] . Each spray delivers a volume of 0.1 mL suspension as a fine mist, containing 665 mcg of olopatadine hydrochloride equivalent to 600 mcg of olopatadine (base) and 25 mcg of mometasone furoate monohydrate (on the anhydrous basis). The bottle should be discarded after 240 sprays have been used. Storage Store RYALTRIS upright with the purple dust cap on at room temperature (see USP Controlled Room Temperature, between 20°C and 25°C, or between 68°F and 77°F, with excursions permitted between 15°C to 30°C or between 59°F to 86°F). Do not store in a freezer or refrigerator.
- PRINCIPAL DISPLAY PANEL NDC: 59467-700-27 RYALTRIS – olopatadine hydrochloride and mometasone furoate 240 Metered Sprays Bottle Label image1
- PRINCIPAL DISPLAY PANEL NDC: 59467-700-27 RYALTRIS – olopatadine hydrochloride and mometasone furoate 240 Metered Sprays Carton image2
Overview
RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C 21 H 23 NO 3 •HCl with the following chemical structure: Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure: Mometasone furoate monohydrate is a white powder, with an empirical formula of C 27 H 30 C l2 O 6 •H 2 O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling ( 16 )] . structureolopatadine structuremometasone
Indications & 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 & 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 & 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 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 )] .
Contraindications
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 )
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; 81% White, 15% Black/African American and 3% Other). Table 1 lists adverse reactions from the safety population reported with frequencies ≥1% and more frequently than placebo in patients treated with RYALTRIS. Somnolence was reported in <1% (2 of 789) of patients treated with RYALTRIS and no patients treated with placebo. Table 1: Adverse Reactions with ≥1% Incidence that Were Reported More Frequently with RYALTRIS than Placebo in the Safety Population in Adult and Pediatric Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis RYALTRIS N=789 n (%) Olopatadine HCl Nasal Spray * N=751 n (%) Mometasone Furoate Nasal Spray * N=746 n (%) Placebo N=776 n (%) Dysgeusia 24 (3.0) 16 (2.1) 0 (0) 2 (0.3) Epistaxis 8 (1.0) 11 (1.5) 6 (0.8) 5 (0.6) Nasal discomfort 8 (1.0) 4 (0.5) 4 (0.5) 6 (0.8) * Non-US approved drugs
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 impairment of central nervous system performance may occur [see Warnings and Precautions ( 5.2 )] . 7.2 Inhibitors of Cytochrome P450 3A4 Studies have shown that mometasone furoate, a component of RYALTRIS, is primarily and extensively metabolized to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome P450 (CYP) 3A4 in the metabolism of this compound. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the mometasone furoate plasma concentration and potentially increase the risk for adverse reactions. Caution should be exercised when considering the coadministration of RYALTRIS with strong CYP3A4 inhibitors [see Clinical Pharmacology ( 12.3 )] .
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