GNH USA

Europe — EMA

Grazax

Learn about Grazax sublingual tablet (225 µg Phleum pratense) for grass‑pollen allergic rhinitis, its uses, side effects, precautions, and FAQs.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains 225 µg of the grass pollen allergen Phleum pratense. It is formulated for oral administration under the tongue and is marketed in the European Union for allergen immunotherapy. The product is designed to help patients develop tolerance to grass pollen and reduce symptoms of seasonal allergic rhinitis. It is taken daily before and during the grass pollen season under medical supervision.

What is Phleum Pratense (225) used for?

Grazax is indicated for patients with grass‑pollen induced seasonal allergic rhinitis who require immunotherapy to modify their allergic response.

- Reduces nasal congestion, sneezing, and itchy eyes caused by grass pollen exposure. - Improves quality of life by decreasing reliance on symptomatic antihistamines or nasal corticosteroids. - Can be used in adults and adolescents with confirmed grass‑pollen allergy, as determined by skin‑prick testing or specific IgE. - May be considered when allergen avoidance alone is insufficient to control symptoms. - Supports long‑term disease modification when administered according to the recommended treatment schedule.

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

Side effects of Grazax vary in frequency and severity; most are mild and transient, while rare reactions may require medical attention.

Common: - Mild oral itching or tingling at the site of tablet placement. - Transient throat irritation or mild sore throat. - Brief nasal itching or sneezing shortly after dosing. - Minor gastrointestinal discomfort such as nausea. - Ear fullness or mild ear pressure. - Temporary hoarseness or voice change.

Serious: - Persistent or worsening oral swelling that interferes with breathing. - Anaphylactic reaction characterized by hives, difficulty breathing, or low blood pressure.

What precautions apply to Phleum Pratense (225)?

Before starting Grazax, patients and healthcare providers should consider several precautions to ensure safe and effective use.

- Perform a confirmed diagnosis of grass‑pollen allergy using skin‑prick testing or specific IgE measurement. - Initiate therapy under medical supervision, especially the first dose, to monitor for adverse reactions. - Avoid use in individuals with uncontrolled asthma or a history of severe allergic reactions to grass pollen. - Do not administer if the patient has an active oral infection, ulcer, or severe dental disease. - Counsel patients to keep the tablet under the tongue until it dissolves completely; swallowing may reduce efficacy. - Pregnant or breastfeeding women should discuss potential risks with their clinician, as safety data are limited. - Discontinue the tablet and seek medical help if persistent oral swelling or systemic symptoms develop.

What does Phleum Pratense (225) interact with?

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

Avoid: - Concurrent use of systemic corticosteroids or immunosuppressive agents without physician guidance. - Other allergen immunotherapy products targeting grass pollen administered simultaneously.

Use with caution: - Antihistamines or leukotriene receptor antagonists, as they may mask early signs of an allergic reaction. - Beta‑blockers, which can interfere with the treatment of severe allergic reactions. - ACE inhibitors, due to the potential for enhanced angioedema risk. - Live vaccines, because immunotherapy may alter immune response.

Frequently asked questions

What is the active ingredient in Grazax and how much does each tablet contain?+
Each Grazax tablet contains 225 µg of the grass pollen allergen Phleum pratense, which is the standardized active ingredient used for sublingual immunotherapy.
How does Grazax work to reduce allergy symptoms?+
Grazax works by repeatedly exposing the immune system to small amounts of grass pollen allergen under the tongue, promoting a shift from IgE‑mediated responses toward IgG4 production and regulatory T‑cell activation, which together build tolerance to grass pollen.
Who is eligible to receive Grazax treatment?+
Grazax is prescribed for adults and adolescents with a confirmed diagnosis of grass‑pollen induced seasonal allergic rhinitis, typically verified by skin‑prick testing or specific IgE testing.
Can pregnant or breastfeeding women use Grazax?+
Safety data for Grazax during pregnancy and lactation are limited; women who are pregnant, planning pregnancy, or breastfeeding should discuss potential risks and benefits with their healthcare provider.
What are the most common side effects experienced with Grazax?+
Common side effects include mild oral itching or tingling, throat irritation, brief nasal itching or sneezing, mild gastrointestinal discomfort, ear fullness, and temporary hoarseness.
What signs indicate a serious allergic reaction to Grazax?+
Serious reactions may present as persistent oral swelling that interferes with breathing, hives, difficulty breathing, or a drop in blood pressure, all of which require immediate medical attention.
Do I need to take Grazax every day throughout the pollen season?+
Grazax is typically taken daily starting before the grass pollen season and continued throughout the season, following the dosing schedule prescribed by a healthcare professional.
Are there any medications that should be avoided while using Grazax?+
Patients should avoid taking other grass‑pollen allergen immunotherapy products at the same time and should discuss the use of systemic corticosteroids or immunosuppressants with their doctor.
How should I administer the Grazax tablet?+
Place the tablet under the tongue, allow it to dissolve completely without swallowing, and avoid eating or drinking for at least 10 minutes after administration.
What monitoring is required when starting Grazax?+
The first dose is usually administered under medical supervision to observe for any immediate adverse reactions; subsequent doses can be taken at home if no severe reactions occur.
Can Grazax be used together with antihistamines?+
Antihistamines can be used with Grazax, but they may mask early signs of an allergic reaction, so patients should be aware and discuss timing with their clinician.
Is Grazax available over the counter in the EU?+
No, Grazax is a prescription‑only medication in the European Union and must be prescribed by a qualified healthcare professional.
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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