GNH USA

Europe — EMA

Grazax

Grazax sublingual tablet (225 µg Phleum pratense) is a prescription allergen immunotherapy for seasonal grass‑pollen allergic rhinitis in the EU.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains 225 µg of the timothy grass allergen Phleum pratense. It is classified as an allergen immunotherapy product and is marketed in the European Union for the treatment of grass‑pollen‑induced allergic rhinitis. The tablet is placed under the tongue, where it delivers a controlled dose of allergen to promote immune tolerance. It is taken daily before the grass season to build tolerance.

What is Phleum Pratense (225) used for?

Grazax is indicated for patients with seasonal allergic rhinitis or allergic rhinoconjunctivitis caused by timothy grass pollen, and it is prescribed as a disease‑modifying therapy.

- Pre‑seasonal treatment to reduce symptoms when grass pollen exposure begins. - Adjunct to standard antihistamine or intranasal corticosteroid therapy. - Long‑term immunotherapy aimed at modifying the underlying allergic response. - Suitable for adults and children aged 5 years and older with confirmed grass‑pollen allergy. - Can be used in patients who have experienced inadequate relief from conventional allergy medications.

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

Side effects of sublingual grass‑pollen immunotherapy are generally mild, but some reactions may require medical attention.

Common: - Mild oral itching or tingling at the site of tablet placement. - Transient sore throat or mild irritation of the mouth. - Nasal congestion or runny nose shortly after dosing. - Mild gastrointestinal discomfort such as nausea. - Mild headache or feeling of fatigue after the first few doses. - Temporary increase in eye itching or watery eyes.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Swelling of the lips, tongue, or throat that impairs breathing. - Urticaria (hives) covering large areas of the body. - Bronchospasm or wheezing requiring emergency care.

What precautions apply to Phleum Pratense (225)?

Before starting Grazax, clinicians should evaluate patient history and consider specific safety considerations to minimize risk.

- Confirm a documented allergy to timothy grass pollen through skin testing or specific IgE measurement. - Avoid initiating therapy in patients with uncontrolled asthma or a history of severe allergic reactions. - Do not use in individuals taking beta‑blockers, as they may interfere with emergency treatment of anaphylaxis. - Pregnancy and breastfeeding status should be assessed, as safety data are limited. - Patients should be observed for at least 30 minutes after the first dose to monitor for systemic reactions. - Discontinue the tablet if signs of anaphylaxis, severe swelling, or bronchospasm develop.

What does Phleum Pratense (225) interact with?

Grazax may interact with other medications or substances that affect immune response or allergic reaction management.

Avoid: - Concurrent use of omalizumab or other biologic agents targeting IgE without specialist supervision. - Simultaneous administration of high‑dose systemic corticosteroids that could suppress the intended immunologic effect. - Live vaccines administered within two weeks of starting therapy, as immune modulation may affect vaccine response.

Use with caution: - Beta‑blockers, because they can reduce the effectiveness of epinephrine in treating anaphylaxis. - ACE inhibitors or ARBs, which may increase the risk of angio‑edema in susceptible individuals. - Antihistamines, which can mask early signs of an allergic reaction during dose escalation. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) may exacerbate gastrointestinal irritation when combined with sublingual tablets.

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 timothy grass allergen Phleum pratense, which is the standardized active ingredient.
For which condition is Grazax prescribed in the European Union?+
Grazax is prescribed for seasonal allergic rhinitis or allergic rhinoconjunctivitis caused by timothy grass pollen.
How is Grazax administered to patients?+
The tablet is placed under the tongue (sublingual) and allowed to dissolve without swallowing, usually once daily.
Can children use Grazax, and if so, what is the minimum age?+
Grazax may be used in children aged 5 years and older who have a confirmed allergy to timothy grass pollen.
What are the most common side effects reported with Grazax?+
Common side effects include mild oral itching, sore throat, nasal congestion, mild gastrointestinal discomfort, headache, and temporary eye irritation.
What serious adverse reactions require immediate medical attention?+
Serious reactions such as anaphylaxis, swelling of the lips, tongue or throat, widespread hives, or bronchospasm should be treated as emergencies.
Should patients be observed after taking the first dose of Grazax?+
Yes, patients are typically observed for at least 30 minutes after the initial dose to monitor for systemic allergic reactions.
Is it safe to take Grazax while pregnant or breastfeeding?+
Safety data for use during pregnancy and lactation are limited; clinicians should assess the risk‑benefit ratio before prescribing.
Can Grazax be taken together with antihistamines?+
Antihistamines can be used with Grazax, but they may mask early signs of an allergic reaction during dose escalation, so monitoring is advised.
What medications should be avoided while undergoing Grazax therapy?+
Concurrent use of omalizumab, high‑dose systemic corticosteroids, and live vaccines within two weeks of starting therapy should be avoided.
How does Grazax work to reduce allergy symptoms?+
Repeated sublingual exposure to timothy grass pollen induces immune tolerance, shifting the response from a Th2‑dominant profile toward Th1/regulatory pathways and lowering IgE‑mediated reactions.
Is Grazax available over the counter or is a prescription required?+
Grazax is a prescription‑only medication (Rx) in the EU.
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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