Product image of Grazax (Phleum Pratense (225)) supplied by GNH India

Grazax

Active Ingredient:
Phleum Pratense (225)
Origin:
EU

Grazax (Phleum Pratense (225))

Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (timothy grass) allergen extract. It is used for allergen immunotherapy and is placed properly under the tongue to help people with seasonal allergic rhinitis caused by grass pollen. Marketed in the European Union, Grazax is intended for daily, regularly use during the grass pollen season under the guidance of a qualified healthcare professional.

Manufacturer / TM Owner

Alk-Abello A/S

1
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Indications & Clinical Uses

Grazax is indicated for the treatment of seasonal allergic rhinitis that is triggered by grass pollen, particularly timothy grass.

  • Reduces symptoms such as sneezing, nasal congestion, and itchy eyes during the grass pollen season.
  • Provides a disease‑modifying approach by gradually inducing immune tolerance to the grass allergen.
  • Can be used as a monotherapy for patients who have not responded adequately to antihistamines or nasal corticosteroids.
  • May be prescribed for adults and adolescents with confirmed grass‑pollen allergy, as determined by skin‑prick testing or specific IgE testing.
  • Intended for daily administration throughout the grass pollen season, typically starting before the onset of pollen exposure.

Side Effects

Side effects of Grazax may occur, ranging from mild local reactions to rare systemic events.

Common

  • Mild itching or tingling in the mouth shortly after the tablet is placed under the tongue.
  • Transient sore throat or mild irritation of the oral mucosa.
  • Temporary increase in nasal congestion or sneezing during the first weeks of therapy.
  • Minor gastrointestinal discomfort such as nausea or abdominal fullness.
  • Mild headache or fatigue that usually resolves without intervention.

Serious

  • Anaphylaxis or severe systemic allergic reaction requiring immediate medical attention.
  • Persistent or worsening asthma symptoms, including wheezing or shortness of breath.

Precautions & Warnings

Before starting Grazax, certain precautions and warnings should be considered to ensure safe use.

  • Do not use if you have a known severe allergy to timothy grass or any tablet component.
  • Avoid starting therapy if you have uncontrolled asthma or a recent asthma exacerbation.
  • Tell your healthcare provider about any history of anaphylaxis, especially to allergens or medicines.
  • Use caution during pregnancy or breastfeeding; safety has not been fully established.
  • Stop the tablet and seek medical help if you develop swelling, hives, or breathing difficulty.
  • Store at room temperature, protected from moisture, and keep out of reach of children.

Avoid Interactions

Grazax may interact with certain medications or conditions; consider the following guidance.

Avoid

  • Concurrent use of beta‑blockers, which can mask symptoms of anaphylaxis and complicate emergency treatment.
  • Simultaneous administration of other allergen immunotherapy products targeting grass pollen.

Use with caution

  • Antihistamines or nasal corticosteroids, as they may affect the perception of local side effects.
  • Asthma medications, especially leukotriene modifiers, requiring close monitoring of respiratory status.
  • Immunosuppressive drugs, which could alter the immune response to the sublingual tablet.
  • Vaccinations, particularly live vaccines, should be scheduled at least two weeks before or after starting Grazax.

Frequently Asked Questions

Each Grazax tablet contains 225 µg of Phleum pratense (timothy grass) allergen extract, which is the active ingredient used for sublingual immunotherapy.

Grazax induces immune tolerance by exposing the immune system to small, controlled amounts of grass pollen allergen under the tongue, shifting the response from IgE‑mediated allergy toward a regulatory T‑cell mediated pathway.

Grazax is prescribed for adults and adolescents with confirmed seasonal allergic rhinitis caused by grass pollen, as verified by skin‑prick testing or specific IgE testing, and who do not have uncontrolled asthma.

Treatment is typically initiated several weeks before the expected start of the grass pollen season and continued daily throughout the season.

Antihistamines may be used alongside Grazax, but they can mask local side effects; patients should discuss timing and dosing with their healthcare provider.

Common side effects include mild itching or tingling in the mouth, transient sore throat, temporary increase in nasal congestion or sneezing, mild gastrointestinal discomfort, and occasional headache or fatigue.

Signs of a serious reaction include anaphylaxis, such as swelling of the face or throat, hives, difficulty breathing, or a sudden drop in blood pressure, and they require immediate medical attention.

The safety of Grazax during pregnancy or lactation has not been fully established; patients should consult their healthcare provider before starting treatment in these situations.

If asthma symptoms worsen or new respiratory difficulties arise, the tablet should be discontinued and medical advice sought promptly.

Grazax should be stored at room temperature, protected from moisture, and kept out of reach of children.

Concurrent use of beta‑blockers should be avoided because they can mask anaphylaxis symptoms; other allergen immunotherapy products targeting grass pollen should also not be used simultaneously.

Patients should be monitored for local oral reactions, signs of systemic allergy, and any changes in asthma control throughout the treatment period.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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