NASONEX®

mometasone furoate (as monohydrate)

NASONEX®

mometasone furoate (as monohydrate)

About NASONEX®

Nasonex® 50 micrograms actuation nasal spray, suspension

Nasonex is a intranasal corticosteroid indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.1

Containing mometasone furoate (as monohydrate)

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About seasonal allergies

Seasonal Allergies (Hayfever) occur when the immune system identifies’ a certain substance (allergen) as harmful, even though it isn’t 2

The immune system then produces antibodies to this harmless substance and the next time a person encounters the substance, the antibodies signal the release of histamine into the blood stream, which causes the signs and symptoms of hayfever or perennial rhinitis2

Seasonal allergic rhinitis can occur in spring, summer and early autumn. And they could usually occur due to allergic sensitivity to airborne mould spores or to pollen from grass, trees and weeds.3

Seasonal allergies or Hayfever refers to common outdoor and indoor allergens including:2

Tree pollen

Common in early spring

Grass pollen

Common in late spring/summer

Ragweed pollen

Common in autumn

NASONEX: Demonstrated efficacy
in the relief of seasonal allergic rhinitis (SAR) symptoms4

In a US-based, multicentre, phase III randomised, 15 day, double blind clinical study, patients ≥12 years old (n=429) with moderate-to-severe baseline symptoms of SAR rated the severity of their symptoms daily before using Nasonex or a placebo.

Subjects were scheduled to receive Nasonex with 200ug once daily (two 50ug sprays per nostril at approximately the same time each morning) or matching vehicle placebo spray for 15 days. 

Co-primary endpoints were reduction from baseline in instantaneous TOSS and instantaneous TNSS.

Symptoms scored included rhinorrhoea, nasal congestion, nasal itching, sneezing, redness of eyes, itching/ burning eyes and tearing/ watering eyes.4

Nasonex showed a greater reduction from baseline in total nasal and ocular symptom scores over days 2 to 15 versus placebo4

  • Instantaneous TOSS reduction: Nasonex: -1.71 (-25.1%); placebo: -1.37 (-20.1%); treatment difference: -0.34 (95% CI: -0.65 to -0.04); p=0.026
  • Instantaneous TNSS reduction: Nasonex: -2.54 (-26.4%); placebo: -1.66 (-16.9%); treatment difference: -0.88 (95% CI: -1.27 to -0.51); p<0.001

TNSS: total nasal symptom score; TOSS: total ocular symptom score

The British Society for Allergy and Clinical Immunology (BSACI) guidelines recommend an intranasal corticosteroid for the first-line treatment of SAR if the patient is experiencing at least 1 moderate-to-severe persistent symptoms5

Nasonex is easy to use6

In a US-based, Nasonex users’ survey (n=1,544):


98%

said Nasonex nasal spray is easy to use6



96%

said Nasonex nasal spray is easy to press/pump6


How to use Nasonex® 5,7

For full information on how to use Nasonex please refer to summary of product characteristics (reference 1) and the patient information leaflet (reference 7)

Shake

Look Down



Aim

Aim towards the outside wall, just inside the nostril.

Spray

Spray once or twice in different directions. Do not sniff hard

Repeat

Repeat in other nostril

Important Safety Information

Do not use Nasonex if:7

  • the patient is allergic (hypersensitive) to mometasone furoate or any other ingredients of this medicine
  • the patient has an untreated infection in their nose. Use of Nasonex during an untreated infection in your nose, such as herpes, can worsen the infection. The patient should be advised to wait until the infection is resolved before starting to use the nasal spray
  • the patient has recently had an operation on their nose or has injured their nose. The patient should be advised to wait until their nose has healed

The safety and efficacy of Nasonex nasal spray in children under 3 years of age have not been established.1

PRECAUTIONS1
Immunosuppression: Use with caution, if at all, in patients with active or quiescent pulmonary tuberculosis, or untreated fungal, bacterial or systemic viral infections. Warn patients who are potentially immunosuppressed of the risk of exposure to certain infections (eg chickenpox, measles) and to seek medical advice. Local nasal effects: Monitor for changes in the nasal mucosa with prolonged use. Treat appropriately or discontinue Nasonex treatment if localised fungal infection of the nose or pharynx develops. Nasonex contains benzalkonium chloride which may cause nasal irritation. Consider discontinuing treatment if persistent nasopharyngeal irritation occurs. Do not use in patients with nasal septum perforation. Systemic effects of corticosteroids: Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for long periods. These may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Visual disturbance has also been reported. Consider referral to an ophthalmologist if blurred vision or other visual disturbances occur to evaluate possible causes, which may include cataract, glaucoma or central serous chorioretinopathy. Patients transferred from long-term administration of systemically active corticosteroids may exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal and systemic corticosteroid administration may need to be resumed. Such transfer may also unmask pre-existing allergic conditions. If there is evidence of use of higher than recommended doses that could result in clinically significant adrenal suppression, consider additional systemic corticosteroid cover during periods of stress or elective surgery. Nasal polyps: Safety and efficacy has not been studied for the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities. Effects on growth in paediatric population: Regularly monitor the height of children receiving prolonged treatment with nasal corticosteroids. If growth is slowed, therapy should be reviewed with the aim of identifying the lowest effective dose and consider referral to a paediatric specialist. Non-nasal symptoms: Concomitant use of additional therapy may provide additional relief of other symptoms, particularly ocular symptoms. Drug interactions: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side effects. The combination should be avoided, unless the benefit outweighs the risk.

For full safety information, please see the Summary of product characteristics1

Adverse effects of Nasonex commonly reported in clinical trials in adult and adolescent patients include headache, epistaxis, pharyngitis, upper respiratory tract infection, nasal burning, nasal irritation, nasal ulceration and throat irritation.1

Refer to Summary of Product Characteristics for complete information on adverse effects

Recorded at uncommon frequency for twice-daily dosing for nasal polyposis.
Recorded for twice-daily dosing for nasal polyposis.

KEY
SAR = Seasonal Allergic Rhinitis

References:
  1. Nasonex Summary of Product Characteristics. Available at www.medicines.org.uk. Accessed March 2023.
  2. Mayo Clinic Staff. Hay fever: symptoms and causes. Mayo Clinic. July 16, 2020. Accessed March 2023. https://www.mayoclinic.org/diseases-conditions/hay-fever/symptoms-causes/syc-20373039?p=1 Symptoms and causes – Mayo Clinic
  3. American College of Allergy. Asthma and immunology. Hay fever. Available at https://acaai.org/allergies/allergic-conditions/hay-fever/ Accessed March 2023
  4. Prenner B M,Lanier B Q et al. Mometasone furoate nasal spray reduces the ocular symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2010;125:1247-1253
  5. Scadding G K Kariyawasam H H et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (revised edition 2017; first edition 2007). Clin Exp Allergy 2017;47;856-889
  6. Fromer L M, Otriz G R, Dowdee A M. Assessment of patient attitudes about mometasone furoate nasal spray: the ease-of-use patient survey. World allergy Organ K 2008;1;156-159
  7. Nasonex Patient Information Leaflet Available at: http://www.medicines.org.uk. Accessed March 2023.
GB-XFY-110025 Date of Prep: March 2023