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 sublingual tablet containing 225 S.U. of Phleum pratense (timothy grass) allergen extract, marketed for the treatment of grass pollen allergy. It is an immunotherapy product approved in the EU. The tablet is placed under the tongue daily to induce immune tolerance to grass pollen, helping reduce symptoms of seasonal allergic rhinitis in patients with confirmed grass‑pollen sensitivity through a structured dosing schedule.

Manufacturer / TM Owner

Alk-Abello A/S

1
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Indications & Clinical Uses

Grazax is indicated for the management of grass‑pollen–related allergic conditions.

  • Seasonal allergic rhinitis (hay fever) caused by grass pollen.
  • Allergic conjunctivitis triggered by grass pollen exposure.
  • Prevention of symptom recurrence during the grass pollen season.
  • Use as part of a comprehensive allergy management plan in patients with confirmed grass‑pollen sensitivity.

Side Effects

Side effects reported with sublingual grass pollen immunotherapy vary in frequency and severity.

Common

  • Mild itching or irritation of the mouth or throat.
  • Transient oral swelling or tingling sensation.
  • Mild gastrointestinal discomfort such as nausea.
  • Localized ear or nasal itching.

Serious

  • Persistent or severe oral swelling that interferes with breathing.
  • Anaphylactic reaction requiring emergency medical attention.
  • Severe asthma exacerbation triggered by the tablet.

Precautions & Warnings

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

  • Confirmed diagnosis of grass‑pollen allergy by skin test or specific IgE.
  • Not recommended for patients with uncontrolled asthma or severe respiratory disease.
  • Use under medical supervision, especially during the first dose.
  • Avoid if you have a history of severe allergic reactions to any component of the tablet.
  • Discuss use during pregnancy or breastfeeding with a healthcare professional.
  • Keep the tablet out of reach of children.

Avoid Interactions

Grazax may interact with other medications or substances that affect the immune system or allergic response.

Avoid

  • Concurrent use of other allergen immunotherapy products without medical guidance.
  • Systemic corticosteroids at high doses during the treatment period.

Use with caution

  • Beta‑agonist inhalers for asthma; monitor symptoms closely.
  • Antihistamines may mask early signs of an allergic reaction.
  • ACE inhibitors or NSAIDs if they have a known propensity to cause angio‑edema.

Frequently Asked Questions

Grazax contains Phleum pratense (timothy grass) allergen extract standardized to 225 S.U. per sublingual tablet.

The tablet is placed under the tongue and allowed to dissolve completely without swallowing, typically once daily as directed by a healthcare professional.

Grazax is prescribed for patients with confirmed grass‑pollen sensitivity; age‑specific recommendations should be discussed with a physician.

Common side effects include mild itching or irritation of the mouth or throat, transient oral swelling, tingling sensations, mild nausea, and localized ear or nasal itching.

If persistent or severe oral swelling occurs, or if signs of anaphylaxis such as difficulty breathing, hives, or rapid pulse develop, emergency medical attention is required.

The safety of Grazax during pregnancy or lactation has not been established; patients should consult their healthcare provider before use.

Antihistamines can be used, but they may mask early signs of an allergic reaction; it is advisable to discuss concurrent use with a doctor.

Mild upper‑respiratory infections do not usually require stopping Grazax, but any worsening of symptoms should be evaluated by a clinician.

Treatment is usually continued throughout the grass pollen season each year, as part of a long‑term immunotherapy plan prescribed by a specialist.

Patients should be observed during the first dose and regularly reviewed for symptom control, side effects, and any changes in asthma status.

Published by GNH India Pharmaceuticals Limited

Last updated:

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