Grazax (Phleum Pratense (225))

Grazax is indicated for the management of symptoms caused by grass pollen exposure in patients with allergic rhinitis or rhinoconjunctivitis.

• Grass‑pollen‑induced allergic rhinitis (seasonal)
• Allergic rhinoconjunctivitis triggered by timothy grass
• Patients who require a disease‑modifying approach rather than symptomatic relief
• Use as part of a seasonal immunotherapy regimen under medical supervision
• Adults and adolescents for whom sublingual immunotherapy is appropriate
• Individuals seeking an alternative to injection‑based allergy shots

Side effects of sublingual grass pollen immunotherapy with Grazax are generally mild, but some patients may experience more significant reactions. These reactions are usually self‑limiting and resolve without specific treatment.

Common

• Mild itching or tingling in the mouth or throat
• Transient oral discomfort or swelling
• Nasal irritation or sneezing shortly after dosing
• Gastrointestinal upset such as nausea
• Mild headache or fatigue after the first few doses

Serious

• Severe allergic reaction (anaphylaxis) requiring immediate medical attention
• Persistent swelling of the lips, tongue, or throat that interferes with breathing
• Systemic allergic symptoms such as hives, wheezing, or dizziness
• Rapid drop in blood pressure (hypotension) associated with an allergic reaction

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

• Confirm diagnosis of grass‑pollen allergy with appropriate testing
• Assess for uncontrolled asthma or severe respiratory disease
• Review history of severe allergic reactions or anaphylaxis
• Avoid use in individuals with active oral infections or lesions
• Discuss pregnancy or breastfeeding status, as safety data are limited
• Ensure the patient can adhere to daily sublingual administration
• Keep the tablet out of reach of children

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

Avoid

• Concurrent use of other allergen immunotherapy products without medical guidance
• Simultaneous administration of beta‑blockers during a severe allergic reaction
• Use of monoamine oxidase inhibitors (MAOIs) is not recommended due to limited data

Use with caution

• Antihistamines or corticosteroids may mask early signs of an allergic response
• ACE inhibitors or angiotensin receptor blockers, as they can influence airway reactivity
• Immunosuppressive drugs that could alter the intended immune tolerance effect
• Non‑steroidal anti‑inflammatory drugs (NSAIDs) may exacerbate nasal symptoms
• Any medication that may cause oral irritation should be monitored closely