GNH USA

Europe — EMA

Grazax

Grazax is a prescription sublingual tablet containing Phleum pratense allergen extract for grass‑pollen allergic rhinitis prophylaxis in the EU.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains a standardized Phleum pratense (timothy grass) allergen extract, typically supplied as 225 µg of the active component per tablet. The product is formulated for oral administration under the tongue and is marketed in the European Union for the prophylaxis of seasonal allergic rhinitis caused by grass pollen. It is intended to be taken daily throughout the grass pollen season to build tolerance.

What is Phleum Pratense (225) used for?

Grazax is indicated for the prevention of symptoms associated with grass‑pollen induced allergic rhinitis and rhinoconjunctivitis.

- Seasonal allergic rhinitis caused by timothy grass (Phleum pratense) pollen. - Allergic rhinoconjunctivitis triggered by grass pollen exposure. - Patients with confirmed IgE sensitisation to grass pollen. - Use as part of a comprehensive allergy management plan, including avoidance measures. - May be considered for individuals who prefer sublingual immunotherapy over injection.

What are the side effects of Phleum Pratense (225)?

Side effects reported with sublingual grass‑pollen immunotherapy are generally mild and transient, but rare serious reactions can occur.

Common: - Oral itching or mild irritation at the site of tablet placement. - Throat discomfort or mild soreness. - Ear or nasal itching. - Mild gastrointestinal upset such as nausea. - Transient headache.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Angioedema involving the face, lips, or tongue. - Severe bronchospasm or respiratory distress. - Persistent urticaria (hives) lasting more than 24 hours. - Cardiovascular symptoms such as hypotension or syncope.

What precautions apply to Phleum Pratense (225)?

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

- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Do not initiate therapy in individuals with uncontrolled asthma or recent severe asthma exacerbations. - Avoid use in patients with a history of severe systemic allergic reactions to grass pollen or other allergens. - Counsel patients to remain seated for at least 30 minutes after each dose and to have emergency medication available. - Pregnancy and lactation status should be discussed with a healthcare professional. - Regular follow‑up is recommended to monitor tolerance and symptom control.

What does Phleum Pratense (225) interact with?

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

Avoid: - Concurrent use of other allergen immunotherapy products (e.g., subcutaneous grass‑pollen extracts). - Systemic corticosteroids or immunosuppressive agents that could alter the intended immune response. - Beta‑blockers in patients at risk of anaphylaxis, as they may interfere with emergency treatment.

Use with caution: - Antihistamines or mast‑cell stabilisers, which may mask early signs of an allergic reaction. - ACE inhibitors or angiotensin receptor blockers, given the rare risk of angioedema. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) in patients with known NSAID‑exacerbated respiratory disease. - Live vaccines, as immunotherapy may theoretically affect vaccine response.

Frequently asked questions

What is the active ingredient in Grazax and how does it work?+
Grazax contains a standardized extract of Phleum pratense (timothy grass) allergen. Repeated sublingual exposure is intended to shift the immune response from an IgE‑driven allergy toward IgG4 production and regulatory T‑cell activity, promoting tolerance to grass pollen.
Who is a suitable candidate for Grazax therapy?+
Candidates are individuals with confirmed IgE sensitisation to grass pollen who experience seasonal allergic rhinitis or rhinoconjunctivitis and who do not have uncontrolled asthma or a history of severe systemic reactions to grass pollen.
How is Grazax administered and what is the recommended schedule?+
Grazax is taken as a single sublingual tablet placed under the tongue. The usual practice is to start before the grass‑pollen season and continue daily throughout the season, but exact timing should be determined by a healthcare professional.
What are the most common side effects experienced with Grazax?+
Common adverse events include oral itching, mild throat irritation, ear or nasal itching, mild nausea, and transient headache. These effects are typically brief and resolve without intervention.
Can Grazax cause severe allergic reactions?+
Rarely, systemic reactions such as anaphylaxis, angioedema, severe bronchospasm, or persistent urticaria can occur. Patients should be instructed to seek immediate medical attention if signs of a serious reaction develop.
Are there any contraindications for using Grazax?+
Grazax should not be used in individuals with uncontrolled asthma, a recent severe asthma exacerbation, or a known severe systemic reaction to grass pollen. It is also contraindicated in patients receiving other allergen immunotherapy products simultaneously.
How should Grazax be stored before use?+
The tablets should be kept in the original packaging, protected from moisture, and stored at room temperature, typically between 15 °C and 30 °C, away from direct sunlight.
Can Grazax be taken together with antihistamines?+
Antihistamines may be used concurrently, but they can mask early signs of an allergic reaction. Patients should discuss any concomitant use with their clinician.
What should a patient do if they experience oral itching after taking Grazax?+
Mild oral itching is a common reaction. The patient can rinse the mouth with water and remain seated for at least 30 minutes. If the itching persists or worsens, they should contact their healthcare provider.
Is Grazax safe to use during pregnancy or breastfeeding?+
The safety of Grazax during pregnancy or lactation has not been fully established. Women who are pregnant, planning pregnancy, or breastfeeding should discuss potential risks and benefits with their physician.
How long does it typically take to see a reduction in allergy symptoms with Grazax?+
Clinical experience suggests that noticeable improvement may begin after several weeks of daily dosing, but full therapeutic benefit often requires continued use throughout the pollen season.
What monitoring is required while on Grazax therapy?+
Patients should have regular follow‑up visits to assess tolerance, symptom control, and any adverse reactions. Monitoring of asthma status is recommended, especially in those with a history of respiratory disease.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Phleum Pratense (225)
Route
Sublingual Use
Manufacturer
Alk-Abello A/S
Origin
EU

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