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RYALTRIS™ is Well Tolerated

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 (SAR).1

3%

Dysgeusia

1%

Epistaxis

1%

Nasal Discomfort

WARNINGS AND PRECAUTIONS

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 SAR.

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.

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.

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.

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 SAR.

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.

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.

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.

Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including RYALTRIS™, are misused by taking higher-than-recommended dosages or in patients at risk for such effects.

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™.

Adverse reactions With ≥1% Incidence That Were Reported More Frequently with RYALTRIS™ than Placebo in 2-Week Placebo-Controlled Studies in Adult and Adolescent Patients with SAR
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.

Reference

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

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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CONTRAINDICATIONS

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

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

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

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

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IMPORTANT SAFETY INFORMATION1

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION1

  • 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.

INDICATIONS1

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

RYALTRIS and the RYALTRIS logo are 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.