Grazax (Phleum Pratense (225))

Grazax is indicated for the prevention of symptoms associated with seasonal allergic rhinitis that are triggered by grass pollen exposure.

• Seasonal allergic rhinitis caused by timothy grass pollen.
• Adults and adolescents with confirmed grass pollen allergy.
• Patients who require a disease‑modifying approach rather than symptomatic relief.
• Use as part of a comprehensive allergy management plan, including avoidance measures.
• May be considered when immunotherapy is preferred over daily antihistamines.
• Suitable for patients seeking a convenient, once‑daily dosing regimen.

The safety profile of Grazax includes both common, generally mild reactions and rare, potentially serious events that may require medical attention.

Common

• Itchy or sore mouth and throat after tablet placement.
• Mild oral swelling or tingling sensation.
• Nasal congestion or runny nose.
• Sneezing or mild eye irritation.
• Mild headache or fatigue.
• Transient increase in nasal itching.

Serious

• Severe allergic reaction (anaphylaxis) with difficulty breathing, hives, or swelling of the face.
• Persistent gastrointestinal symptoms such as vomiting or severe abdominal pain.
• Uncontrolled asthma exacerbation triggered by the tablet.

Most reactions occur within the first few weeks of therapy and often diminish with continued use.

When prescribing Grazax, clinicians should consider several precautions to ensure safe use and to identify patients who may be at higher risk for adverse events.

• Avoid use in individuals with a history of severe systemic allergic reactions to grass pollen.
• Not recommended for patients with uncontrolled asthma or recent asthma exacerbations.
• Caution in patients taking beta‑blockers, as they may mask anaphylaxis symptoms.
• Pregnant or breastfeeding women should discuss potential risks with their healthcare provider.
• Patients should be observed for at least 30 minutes after the first dose.
• Do not administer to children under the age approved in the local labeling.
• Discontinue if severe oral itching or swelling persists.

Grazax may interact with certain medications or conditions; understanding these interactions helps minimize risk and maintain therapeutic effectiveness.

Avoid

• Concomitant use of omalizumab or other monoclonal antibodies targeting IgE, as they may alter the immunologic response.
• Simultaneous administration of high‑dose systemic corticosteroids during the initial treatment phase.

Use with caution

• Beta‑blockers, because they can interfere with the treatment of anaphylaxis if it occurs.
• ACE inhibitors or ARBs, which have been associated with rare cases of angio‑edema.
• Antihistamines, which may mask early signs of an allergic reaction but generally do not require dose adjustment.
• Vaccines administered within two weeks of starting therapy should be discussed with a physician, as immune modulation may affect response.