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RYALTRIS® is a fixed-dose combination therapy that provides relief from both NASAL and OCULAR symptoms of seasonal allergic rhinitis1

RYALTRIS® nasal spray contains 2 active components that provide rapid and sustained relief 1:

OLOPATADINE
HYDROCHLORIDE1

MOMETASONE
FUROATE1

FAST-ACTING ANTIHISTAMINE

 +

ESTABLISHED CORTICOSTEROID

 =

RYALTRIS®
About RYALTRIS™

Study Design1

The efficacy of RYALTRIS® was evaluated in 2 multicenter, randomized, double-blind, placebo- and active-controlled clinical studies of 2 weeks’ duration (Study 1 and Study 2). The 2 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 5 mm, or greater than negative diluent control) to relevant seasonal allergens (tree/grass pollen in Study 1 and ragweed/mountain cedar pollen in Study 2), and nasal symptoms defined as a 12-hour reflective total nasal symptom score (rTNSS) ≥8 out of 12 and a congestion score ≥2 for the morning (AM) assessment at screening.

In Studies 1 and 2, patients were randomized to 1 of 4 treatment groups: RYALTRIS® 2 sprays (665 mcg olopatadine hydrochloride and 25 mcg mometasone furoate per spray) per nostril twice daily; olopatadine hydrochloride nasal spray 2 sprays (665 mcg per spray) per nostril twice daily; mometasone furoate nasal spray 2 sprays (25 mcg per spray) per nostril twice daily; or vehicle placebo for 2 weeks. The olopatadine hydrochloride and mometasone furoate comparators used the same device and vehicle as RYALTRIS® but were non–US-approved drugs.

The primary endpoint for both studies was the change from baseline in average morning (AM) and evening (PM) patient-reported 12-hour rTNSS over the 14-day treatment period. Total nasal symptom score was calculated as the sum of the patient-reported symptom scores of 4 individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe).

Secondary endpoints included change from baseline in average AM and PM subject-reported 12-hour instantaneous total nasal symptom score (iTNSS) over the 14-day treatment period and change from baseline in average AM and PM subject-reported 12-hour reflective total ocular symptom score (rTOSS) over the 14-day treatment period. Similarly, rTOSS and iTOSS were calculated as the sum of patient’s scoring of 3 individual ocular symptoms (itching/burning, tearing/watering, and redness) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe).

Patients were required to record symptom severity daily (morning [AM] and evening [PM]), reflecting over the previous 12 hours (reflective) or at the time of dosing (instantaneous). The primary efficacy endpoint was the mean change from baseline in average AM and PM patient-reported 12-hour rTNSS over the 2-week treatment period. The average AM and PM rTNSS (maximum score of 12) was assessed as the change from baseline for each day and then averaged over a 2-week treatment period.

Reference

  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.
 

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

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CONTRAINDICATIONS

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

CONTRAINDICATIONS

Patients with known hypersensitivity to any ingredients of RYALTRIS, including mometasone furoate. (4)

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)

ADVERSE REACTIONS

The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, and nasal discomfort. (6.1)

INDICATIONS

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.

For more information, please see the Full Prescribing Information.

To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364.

Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

RYALTRIS and the RYALTRIS logo are registered trademarks of Glenmark Specialty SA.

Distributed by: Hikma Specialty USA Inc. Columbus, OH 43228

Reference
  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

Read More...

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION

  • Do not take RYALTRIS if you are allergic to olopatadine hydrochloride, mometasone furoate monohydrate or any of the ingredients in RYALTRIS. Ask your healthcare provider if you are not sure.
  • RYALTRIS can cause sleepiness or drowsiness. Do not drive, operate machinery or do anything that requires alertness until you know how RYALTRIS affects you.
  • Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using RYALTRIS.

RYALTRIS may cause serious side effects, including the following:

  • Sleepiness or drowsiness.
  • Nose and throat problems. Symptoms of nose and throat problems may include: nosebleeds, sores (ulcers) in the nose, hole in the cartilage between your nose (nasal septal perforation). Symptoms of nasal septal perforation may include: crusting in the nose, nosebleeds, runny nose and/or a whistling sound when you breathe.
  • Slow wound healing. You should not use RYALTRIS until your nose has healed if you have a sore in your nose, if you have had surgery on your nose or if your nose has been injured.
  • Fungal infection in your nose and throat (thrush, or Candida). Tell your healthcare provider if you have any redness or white-colored patches in your nose or mouth.
  • Eye problems, including glaucoma or cataracts. You should have regular eye exams when using RYALTRIS.
  • Allergic reactions. Call your healthcare provider or get emergency medical care if you have any of the following signs of a serious allergic reaction: wheezing, rash, hives, swelling of your face, mouth, and tongue and breathing problems.
  • Immune system problems that may increase the risk of infection. Taking medicines that weaken your immune system makes you more likely to get infections. These infections may include tuberculosis (TB), ocular herpes simplex infections, and infections caused by fungi, bacteria, viruses, and parasites. Avoid contact with people who have contagious diseases, such as chickenpox or measles, while using RYALTRIS. If you come in contact with someone who has chickenpox or measles, call your healthcare provider right away. Symptoms of infection may include: fever, aches or pains, chills and tiredness.
  • Adrenal insufficiency. Adrenal insufficiency happens when your adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea, vomiting and low blood pressure.
  • Slowed growth in children. A child’s growth should be checked regularly while using RYALTRIS.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

  • The most common side effects of RYALTRIS include unpleasant taste, nosebleeds and nasal discomfort.
  • Tell your healthcare provider if you have side effects that bother you or do not go away.
  • These are not all of the possible side effects of RYALTRIS. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. RYALTRIS and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

  • Certain medicines for HIV, cobicistat-containing products, certain antifungals, certain antibiotics and/or certain antidepressants. Ask your healthcare provider or pharmacist for a list of your medicines if you are not sure.

Before you use RYALTRIS, tell your healthcare provider about all of your medical conditions, including if you:

  • Have had recent nasal sores, nasal surgery or nasal injury.
  • Have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eyes).
  • Have tuberculosis or any untreated fungal, bacterial or viral infections or eye infections caused by herpes.
  • Have been near someone who has chickenpox or measles.
  • Are not feeling well or have any other symptoms that you do not understand.
  • Are pregnant or plan to become pregnant. It is not known if RYALTRIS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known if RYALTRIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using RYALTRIS.

INDICATIONS

RYALTRIS is a prescription nasal spray that contains 2 medicines, olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid. RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

For more information, please see Full Prescribing Information.

To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364.

Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

RYALTRIS and the RYALTRIS logo are registered trademarks of Glenmark Specialty SA.

Distributed by: Hikma Specialty USA Inc. Columbus, OH 43228

Reference

  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.