GNH USA

Europe — EMA

Grazax

Grazax sublingual tablet (225 µg Phleum pratense) for grass pollen allergy in the EU – uses, side effects, precautions and interactions.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a sublingual tablet that contains 225 µg of the grass pollen allergen Phleum pratense. It is marketed in the European Union as an allergen immunotherapy product designed to modify the immune response to grass pollen exposure. The tablet is taken orally under the tongue and is intended for use in individuals with confirmed grass pollen allergy, following medical evaluation.

What is Phleum Pratense (225) used for?

Grazax is indicated for the treatment of allergic rhinitis caused by grass pollen. Clinical use focuses on long‑term reduction of symptoms and medication need.

- Reduces seasonal nasal congestion, sneezing, and itchy eyes associated with grass pollen. - Decreases reliance on antihistamines and nasal corticosteroids during grass season. - Suitable for adults and children with a confirmed grass pollen allergy. - Administered daily throughout the grass pollen season to maintain tolerance. - May be considered as part of a broader allergy management plan.

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

Side effects of Grazax vary in frequency and severity. Most users experience mild, transient reactions, while rare serious events require medical attention.

Common: - Oral itching or mild throat irritation. - Ear or nasal itching. - Mild gastrointestinal discomfort. - Transient swelling of the lips or tongue. - Localized rash at the site of tablet placement.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent swelling of the throat that interferes with breathing. - Severe urticaria (hives) covering large body areas. - Acute bronchospasm or wheezing. - Rapid onset of cardiovascular symptoms such as hypotension.

What precautions apply to Phleum Pratense (225)?

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

- Confirm diagnosis of grass pollen allergy through skin testing or specific IgE measurement. - Avoid use in individuals with uncontrolled asthma or recent asthma exacerbations. - Do not initiate therapy in patients who have experienced anaphylaxis to grass pollen extracts. - Monitor for local oral reactions during the first weeks of treatment. - Discuss any history of cardiovascular disease with a healthcare professional. - Pregnant or breastfeeding individuals should consult a physician before use.

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 sublingual or subcutaneous grass pollen immunotherapy products. - Administration of systemic antihistamines or corticosteroids immediately before the tablet, as they may mask early reactions.

Use with caution: - Beta‑blockers, which can interfere with treatment of anaphylaxis. - ACE inhibitors, due to potential for increased angioedema risk. - Immunosuppressive agents that may alter the intended immune response. - Herbal supplements that have known allergenic potential.

Frequently asked questions

What is the active ingredient in Grazax and how does it work?+
Grazax contains the grass pollen allergen Phleum pratense (225 µg). It is administered sublingually to expose the immune system to small, controlled amounts of the allergen, promoting tolerance and reducing allergic symptoms over time.
Who is eligible to use Grazax for grass pollen allergy?+
Grazax is intended for individuals with a confirmed diagnosis of grass pollen‑induced allergic rhinitis, typically adults and children who have demonstrated sensitivity through skin prick testing or specific IgE testing.
How should Grazax be taken for optimal effect?+
The tablet is placed under the tongue and allowed to dissolve without chewing. It is usually taken once daily, preferably at the same time each day, throughout the grass pollen season as advised by a healthcare professional.
Can Grazax be used together with antihistamines?+
Antihistamines can be taken, but using them immediately before the tablet may mask early local reactions. Patients should discuss timing with their physician.
What are the most common side effects of Grazax?+
Common side effects include mild oral itching, throat irritation, ear itching, transient lip or tongue swelling, and mild gastrointestinal discomfort.
When should a patient seek medical help while using Grazax?+
Medical attention is needed if the patient experiences signs of anaphylaxis such as difficulty breathing, persistent throat swelling, severe hives, wheezing, or a sudden drop in blood pressure.
Is Grazax safe for people with asthma?+
Grazax can be used in patients with well‑controlled asthma, but it is not recommended for those with uncontrolled asthma or recent severe exacerbations.
Should pregnant or breastfeeding women use Grazax?+
Pregnant or nursing individuals should consult their healthcare provider before starting Grazax to weigh potential benefits and risks.
What medications should be avoided while on Grazax?+
Patients should avoid other grass pollen immunotherapy products and be cautious with systemic antihistamines or corticosteroids taken immediately before the tablet.
How long does treatment with Grazax typically last?+
Treatment duration is usually a full grass pollen season, with some protocols extending for multiple years to achieve sustained tolerance; exact length should be determined by a physician.
Can Grazax cause interactions with beta‑blockers?+
Beta‑blockers do not interact directly with Grazax, but they can complicate the management of severe allergic reactions, so use with caution and under medical supervision.
What should be done if a dose of Grazax is missed?+
If a dose is missed, the patient should take the missed tablet as soon as they remember, unless it is close to the time of the next scheduled dose. They should not double‑dose and should follow the guidance of their healthcare provider.
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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