GNH USA

Europe — EMA

Grazax

Learn about Grazax sublingual tablet, its uses for grass‑pollen allergic rhinitis, side effects, precautions, and drug interactions.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains 225 SQ‑U of Phleum pratense (timothy grass) allergen extract. It is designed for allergen immunotherapy and is taken daily before and during the pollen season as directed.

What is Phleum Pratense (225) used for?

Grazax is indicated for the treatment of grass‑pollen–induced allergic conditions in patients with confirmed sensitivity.

- Seasonal allergic rhinitis (hay fever) caused by timothy grass pollen. - Allergic conjunctivitis associated with grass pollen exposure. - Adjunct therapy for patients seeking disease‑modifying treatment rather than symptomatic relief alone. - Use in individuals aged 5 years and older, as prescribed by a physician. - May be considered for patients who have not achieved adequate control with antihistamines or nasal corticosteroids.

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

Side effects reported with sublingual grass‑pollen immunotherapy are generally mild and related to local exposure, but rare systemic reactions can occur.

Common: - Itching or mild irritation of the mouth and throat. - Swelling of the tongue or lips. - Transient gastrointestinal discomfort such as nausea. - Mild headache or fatigue.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Respiratory distress, including wheezing or bronchospasm. - Rapid onset of hives or angioedema beyond the oral cavity.

What precautions apply to Phleum Pratense (225)?

Before prescribing Grazax, clinicians should evaluate patient history and consider specific safety considerations.

- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Avoid use in patients with uncontrolled asthma or severe chronic respiratory disease. - Do not initiate therapy in individuals with a history of severe systemic allergic reactions to allergen extracts. - Monitor patients for at least 30 minutes after the first dose to detect possible systemic reactions. - Counsel patients to keep the tablet under the tongue until it dissolves completely; do not swallow immediately. - Discontinue treatment if persistent oral swelling or systemic symptoms develop. - Use with caution in pregnant or breastfeeding women; safety data are limited.

What does Phleum Pratense (225) interact with?

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

Avoid: - Concurrent use of other allergen immunotherapy products (subcutaneous or sublingual) without medical supervision. - Beta‑blockers, which can interfere with the treatment of severe allergic reactions. - ACE inhibitors in patients with a history of angioedema.

Use with caution: - Antihistamines or nasal corticosteroids, which may mask early signs of systemic reactions. - Immunosuppressive agents that could alter the intended immune‑modulating effect. - Live vaccines, as immune response may be affected during active immunotherapy.

Frequently asked questions

What is the mechanism of action of Grazax sublingual tablets?+
Grazax delivers a low dose of timothy grass pollen allergen under the tongue, which over time induces immune tolerance by shifting the response from IgE‑mediated allergy toward regulatory pathways.
Who can be treated with Grazax?+
Grazax is approved for patients aged 5 years and older who have a confirmed sensitivity to grass pollen and who require disease‑modifying therapy for allergic rhinitis or conjunctivitis.
How is Grazax administered?+
The tablet is placed under the tongue and allowed to dissolve completely without swallowing. It is usually taken once daily, starting before the grass‑pollen season and continued throughout the season as directed by a healthcare professional.
What are the most common side effects of Grazax?+
Common side effects include mild itching or irritation of the mouth and throat, swelling of the tongue or lips, transient nausea, and occasional headache or fatigue.
Can Grazax cause severe allergic reactions?+
Rarely, systemic reactions such as anaphylaxis, respiratory distress, or widespread hives can occur. Patients should be observed after the first dose and instructed to seek immediate medical help if severe symptoms develop.
Should Grazax be used in patients with asthma?+
Grazax can be used in patients with mild, well‑controlled asthma, but it should be avoided in individuals with uncontrolled or severe asthma due to an increased risk of respiratory reactions.
Is it safe to take Grazax while pregnant or breastfeeding?+
Safety data for use during pregnancy or lactation are limited. The medication should be used only if the potential benefit justifies the potential risk, and the decision should be made by a physician.
Can I take antihistamines together with Grazax?+
Antihistamines and nasal corticosteroids can be used alongside Grazax, but they may mask early signs of systemic allergic reactions, so patients should be monitored closely.
What should I do if I miss a dose of Grazax?+
If a dose is missed, take it as soon as you remember on the same day. Do not take a double dose the next day; simply continue with the regular schedule.
Are there any medications that should be avoided while on Grazax?+
Beta‑blockers and ACE inhibitors should be avoided because they can interfere with the management of severe allergic reactions. Other allergen immunotherapy products should not be combined without medical supervision.
How long does treatment with Grazax typically last?+
Treatment usually begins several months before the grass‑pollen season and continues throughout the season. Some clinicians recommend a course of three consecutive years to achieve lasting tolerance.
Do I need a prescription to obtain Grazax?+
Yes, 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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