Grazax (Phleum Pratense (225))

Grazax is indicated for patients with confirmed grass‑pollen allergy who experience seasonal symptoms.

• Seasonal allergic rhinitis caused by timothy grass pollen.
• Allergic rhinoconjunctivitis triggered by grass pollen exposure.
• Patients who have a positive skin‑prick test or specific IgE to Phleum pratense.
• Individuals seeking disease‑modifying therapy rather than symptomatic relief alone.
• Use as part of a pre‑seasonal treatment regimen to reduce the need for antihistamines.
• Adults and adolescents (12 years and older) with mild to moderate grass‑pollen allergy.

The safety profile of Grazax includes both frequently observed and rare adverse events.

Common

• Mild oral itching, tingling, or irritation at the tablet site, usually resolving within minutes.
• Transient sore throat, hoarseness, or a feeling of throat tightness that subsides without treatment.
• Nasal irritation, sneezing, or runny nose occurring shortly after the dose.
• Mild gastrointestinal discomfort such as nausea or abdominal fullness that is self‑limited.

Serious

• Anaphylactic reaction characterized by hives, widespread swelling, difficulty breathing, or a drop in blood pressure.
• Angioedema involving swelling of the lips, tongue, or throat that may compromise airway.
• Persistent wheezing, severe shortness of breath, or bronchospasm requiring emergency medical attention.

Before starting Grazax, patients and clinicians should consider several precautionary measures to ensure safe use.

• Confirm diagnosis of grass‑pollen allergy with appropriate testing (skin‑prick or specific IgE).
• Avoid initiating therapy in individuals with uncontrolled asthma or a history of severe allergic reactions.
• Do not use in patients with active oral infections, lesions, or poor oral hygiene.
• Discontinue the tablet and seek medical help if signs of anaphylaxis appear after dosing.
• Pregnant or breastfeeding women should discuss potential risks with a healthcare professional, as safety data are limited.
• Concomitant use of beta‑blockers may mask symptoms of an allergic reaction.
• Keep the medication out of reach of children; accidental ingestion can cause serious effects.

Grazax may interact with other medications or substances that influence immune response or allergic reactions.

Avoid

• Concurrent use of other allergen immunotherapy products (e.g., subcutaneous grass pollen extracts) without medical supervision.
• Simultaneous administration of systemic corticosteroids at high doses that could suppress the intended immunologic effect.

Use with caution

• Beta‑blockers, which can interfere with the treatment of severe allergic reactions.
• ACE inhibitors, as they may increase the risk of angioedema.
• Antihistamines or leukotriene receptor antagonists, which can be continued but may mask mild local reactions.