GNH USA

Europe — EMA

Grazax

Grazax is a prescription sublingual tablet containing 225 µg Timothy grass extract for treating seasonal allergic rhinitis caused by grass pollen.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (Timothy grass) extract. It is formulated for oral administration under the tongue and is approved in the European Union for allergen immunotherapy. The tablet is designed to gradually desensitize individuals with grass‑pollen‑induced allergic rhinitis by exposing the immune system to a controlled amount of the allergen. over a treatment course that typically spans several months.

What is Phleum Pratense (225) used for?

Grazax is indicated for the management of seasonal allergic rhinitis caused by grass pollen, particularly Timothy grass, and for allergic rhinoconjunctivitis that occurs during the grass pollen season.

- Treatment of grass‑pollen‑induced allergic rhinitis in patients aged 5 years and older. - Prevention of seasonal symptoms such as sneezing, nasal congestion, and itchy eyes. - Use as a disease‑modifying therapy to reduce the need for symptomatic antihistamines or nasal corticosteroids. - Administration before the start of the grass pollen season to establish tolerance. - Option for patients who prefer a sublingual route over injection‑based immunotherapy.

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

The safety profile of Grazax reflects the immune response to sublingual allergen exposure; most reactions are mild and localized, while rare systemic events may occur.

Common: - Itching or mild irritation of the mouth and throat. - Transient oral swelling or tingling sensation. - Mild gastrointestinal discomfort such as nausea. - Localized ear or sinus congestion.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent wheezing or bronchospasm. - Severe swelling of the lips, tongue, or face. - Rapid onset of hives covering large skin areas.

What precautions apply to Phleum Pratense (225)?

Before prescribing Grazax, clinicians should evaluate patient history and consider specific warnings to ensure safe use.

- Not recommended for individuals with uncontrolled asthma or severe chronic obstructive pulmonary disease. - Contraindicated in patients with a known hypersensitivity to Timothy grass pollen or any tablet excipients. - Initiate treatment under medical supervision, especially the first dose, to monitor for adverse reactions. - Advise patients to avoid eating or drinking for at least 10 minutes after tablet placement. - Caution in pregnant or breastfeeding women; safety data are limited. - Regular follow‑up is advised to assess tolerance development and adjust therapy as needed.

What does Phleum Pratense (225) interact with?

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

Avoid: - Concurrent use of systemic corticosteroids or immunosuppressive agents that could blunt the immunotherapy response. - Other allergen immunotherapy products targeting grass pollen, to prevent overlapping exposure.

Use with caution: - Beta‑agonist inhalers for asthma; monitor respiratory status during treatment. - Antihistamines or leukotriene receptor antagonists; they do not interfere but symptom control may mask early reactions. - ACE inhibitors, which can increase the incidence of angio‑edema. - Live vaccines; schedule immunotherapy at least two weeks apart.

Frequently asked questions

What is the mechanism of action of Grazax in treating grass‑pollen allergy?+
Grazax works by repeatedly exposing the immune system to a small, controlled amount of Timothy grass pollen allergen under the tongue. This sublingual exposure shifts the immune response from a Th2‑dominant (allergic) profile toward a Th1 profile and stimulates the production of allergen‑specific IgG4 antibodies, promoting immune tolerance.
Who is eligible to receive Grazax therapy?+
Grazax is approved for patients with seasonal allergic rhinitis or allergic rhinoconjunctivitis caused by grass pollen, typically those aged five years and older who have a confirmed sensitivity to Timothy grass and who can safely take a sublingual tablet under medical supervision.
How should Grazax be taken for optimal effectiveness?+
The tablet should be placed under the tongue and allowed to dissolve completely without chewing. Patients should refrain from eating or drinking for at least 10 minutes after placement and should follow the dosing schedule prescribed by their healthcare professional.
When should treatment with Grazax be started relative to the pollen season?+
Grazax is usually initiated several weeks to a few months before the expected start of the grass pollen season. Starting early allows the immune system to develop tolerance before peak pollen exposure.
Can Grazax be used in children, and what age is recommended?+
Yes, Grazax can be prescribed for children who are at least five years old, provided they have a documented grass‑pollen allergy and can cooperate with the sublingual administration technique.
What are the most common side effects experienced with Grazax?+
Common side effects include mild itching or irritation of the mouth and throat, transient oral swelling or tingling, mild nausea, and localized ear or sinus congestion. These reactions are usually short‑lived and resolve without intervention.
What signs indicate a serious allergic reaction to Grazax?+
Serious reactions may present as anaphylaxis, severe wheezing or bronchospasm, rapid swelling of the lips, tongue, or face, and widespread hives. Any of these symptoms require immediate medical attention.
Are there any medications that should be avoided while taking Grazax?+
Patients should avoid using other grass‑pollen allergen immunotherapy products at the same time and should discuss the use of systemic corticosteroids or other immunosuppressants with their clinician, as these can diminish the intended immune response.
Is it safe to continue using antihistamines while on Grazax?+
Antihistamines and leukotriene receptor antagonists can be used alongside Grazax. They do not interfere with the immunotherapy, but they may mask early mild reactions, so patients should still monitor for any new symptoms.
How long does a typical course of Grazax treatment last?+
A full course of Grazax usually extends for three years of daily administration, which is the period most studies have shown to achieve sustained clinical benefit after discontinuation.
Can pregnant or breastfeeding women use Grazax?+
Safety data for Grazax during pregnancy and lactation are limited. Healthcare providers should weigh potential benefits against unknown risks before prescribing it to pregnant or nursing patients.
What monitoring is required during the first weeks of Grazax therapy?+
The first dose is typically taken under medical supervision to observe for immediate reactions. Subsequent visits may be scheduled to assess tolerance, review any side effects, and confirm adherence to the dosing regimen.
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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