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 containing 225 SQ‑U of Phleum pratense (timothy grass) allergen extract. It is formulated for oral administration under the tongue and is approved in the European Union for the treatment of grass‑pollen‑induced seasonal allergic rhinitis and allergic rhinoconjunctivitis. It belongs to the class of allergen immunotherapy and is supplied as a tablet for use.

Manufacturer / TM Owner

Alk-Abello A/S

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Indications & Clinical Uses

Grazax is indicated for patients with grass‑pollen‑related seasonal allergic rhinitis and allergic rhinoconjunctivitis, typically when symptoms are not adequately controlled by standard pharmacotherapy.

  • Pre‑seasonal treatment to reduce the severity of grass‑pollen allergy symptoms.
  • Adjunct therapy for patients who experience nasal congestion, sneezing, and itchy eyes during the grass pollen season.
  • Long‑term immunotherapy aimed at modifying the underlying allergic response.
  • Use in adults and adolescents with a confirmed diagnosis of grass pollen allergy.
  • May be considered for patients seeking an alternative to daily antihistamines during peak pollen periods.

Side Effects

The safety profile of Grazax includes both frequently observed and less common reactions; most side effects are mild and transient.

Common

  • Mild oral itching or tingling at the site of tablet placement.
  • Transient sore throat or throat irritation.
  • Nasal itching or mild rhinorrhea.
  • Mild gastrointestinal discomfort such as nausea.
  • Mouth swelling or mild lip edema.

Serious

  • Severe allergic reactions, including anaphylaxis, requiring immediate medical attention.
  • Persistent or worsening asthma symptoms in patients with underlying asthma.
  • Swelling of the face, lips, or tongue indicating a systemic reaction.
  • Persistent severe respiratory distress or bronchospasm.

Precautions & Warnings

Before initiating Grazax, clinicians should evaluate patient history and consider specific precautions to ensure safe administration.

  • Confirm a diagnosis of grass pollen allergy through appropriate testing.
  • Avoid use in individuals with uncontrolled or severe asthma.
  • Do not administer to patients with a history of severe systemic allergic reactions to allergen immunotherapy.
  • Pregnancy and lactation status should be assessed, as safety data are limited.
  • Patients should be observed for at least 30 minutes after the first dose for potential reactions.
  • Discontinue treatment if serious adverse events occur and seek medical evaluation.

Avoid Interactions

Grazax may interact with other medications or conditions that affect immune response or increase the risk of allergic reactions.

Avoid

  • Concurrent use of beta‑blockers, which can diminish the effectiveness of emergency epinephrine treatment.
  • Other allergen immunotherapy products targeting the same allergen, to prevent overlapping exposure.

Use with caution

  • Antihistamines or corticosteroids, as they may mask early signs of an allergic reaction.
  • ACE inhibitors, which have been associated with increased incidence of angio‑edema.
  • Biologic agents that modulate immune function, such as omalizumab.
  • Vaccinations, especially live vaccines, should be timed appropriately around immunotherapy.

Frequently Asked Questions

Grazax contains 225 SQ‑U of Phleum pratense (timothy grass) allergen extract. Administered sublingually, it gradually induces immunological tolerance by shifting the immune response from a Th2‑dominant profile to a Th1‑dominant profile and increasing IgG4 production, thereby reducing allergic symptoms.

Grazax is prescribed for patients with confirmed grass‑pollen‑induced seasonal allergic rhinitis or allergic rhinoconjunctivitis, typically adults and adolescents, who have insufficient symptom control with standard antihistamines or nasal corticosteroids.

The tablet is placed under the tongue and allowed to dissolve completely without chewing or swallowing. Patients should avoid eating or drinking for a few minutes after administration.

Treatment is usually initiated several weeks before the expected start of the grass pollen season and continued daily throughout the season to maintain tolerance.

Common side effects include mild oral itching or tingling, transient sore throat, nasal itching, mild rhinorrhea, mild gastrointestinal discomfort, and occasional mild lip or mouth swelling.

In rare cases, Grazax can trigger serious reactions such as anaphylaxis, facial swelling, or worsening asthma. Patients should be observed after the first dose and seek immediate medical care if severe symptoms develop.

Safety data for Grazax use in pregnancy are limited, so the potential risks and benefits should be discussed with a healthcare professional before starting treatment.

Grazax can be used alongside antihistamines or nasal corticosteroids, but these drugs may mask early signs of a reaction. Coordination with a physician is recommended.

If a dose is missed, take it as soon as remembered unless it is close to the time of the next scheduled dose. Do not double‑dose; continue with the regular dosing schedule.

Avoid concurrent use of beta‑blockers and other allergen immunotherapy products. Use caution with antihistamines, corticosteroids, ACE inhibitors, biologic immune modulators, and live vaccines.

Clinical improvement may be observed after several weeks of consistent daily dosing, with maximal benefit typically achieved after several months of therapy.

Grazax is approved for use in adolescents and adults; pediatric use should be evaluated by a specialist based on age, weight, and clinical need.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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