GNH USA

Europe — EMA

Grazax

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

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a sublingual tablet that contains 225 µg of Phleum pratense (timothy grass) allergen extract. It is a prescription‑only product marketed in the European Union for allergen immunotherapy. The tablet is placed under the tongue, delivering a standardized dose of grass pollen allergen to help induce immune tolerance in patients with grass‑pollen‑induced allergic rhinitis. It is taken once daily and continued through the season, typically.

What is Phleum Pratense (225) used for?

Grazax is indicated for the management of symptoms caused by grass pollen exposure in patients with allergic rhinitis or rhinoconjunctivitis.

- Grass‑pollen‑induced allergic rhinitis (seasonal) - Allergic rhinoconjunctivitis triggered by timothy grass - Patients who require a disease‑modifying approach rather than symptomatic relief - Use as part of a seasonal immunotherapy regimen under medical supervision - Adults and adolescents for whom sublingual immunotherapy is appropriate - Individuals seeking an alternative to injection‑based allergy shots

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

Side effects of sublingual grass pollen immunotherapy with Grazax are generally mild, but some patients may experience more significant reactions. These reactions are usually self‑limiting and resolve without specific treatment.

Common: - Mild itching or tingling in the mouth or throat - Transient oral discomfort or swelling - Nasal irritation or sneezing shortly after dosing - Gastrointestinal upset such as nausea - Mild headache or fatigue after the first few doses

Serious: - Severe allergic reaction (anaphylaxis) requiring immediate medical attention - Persistent swelling of the lips, tongue, or throat that interferes with breathing - Systemic allergic symptoms such as hives, wheezing, or dizziness - Rapid drop in blood pressure (hypotension) associated with an allergic reaction

What precautions apply to Phleum Pratense (225)?

Before starting Grazax, patients and clinicians should consider several precautionary measures to ensure safe and effective use.

- Confirm diagnosis of grass‑pollen allergy with appropriate testing - Assess for uncontrolled asthma or severe respiratory disease - Review history of severe allergic reactions or anaphylaxis - Avoid use in individuals with active oral infections or lesions - Discuss pregnancy or breastfeeding status, as safety data are limited - Ensure the patient can adhere to daily sublingual administration - Keep the tablet out of reach of children

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 other allergen immunotherapy products without medical guidance - Simultaneous administration of beta‑blockers during a severe allergic reaction - Use of monoamine oxidase inhibitors (MAOIs) is not recommended due to limited data

Use with caution: - Antihistamines or corticosteroids may mask early signs of an allergic response - ACE inhibitors or angiotensin receptor blockers, as they can influence airway reactivity - Immunosuppressive drugs that could alter the intended immune tolerance effect - Non‑steroidal anti‑inflammatory drugs (NSAIDs) may exacerbate nasal symptoms - Any medication that may cause oral irritation should be monitored closely

Frequently asked questions

What is the active ingredient in Grazax and how does it work?+
Grazax contains Phleum pratense (timothy grass) allergen extract. When placed under the tongue, it exposes the immune system to a small, controlled amount of grass pollen, encouraging a shift from a Th2‑dominant response to a Th1‑dominant response and increasing IgG4 production, which together promote immune tolerance.
Who is a suitable candidate for Grazax therapy?+
Suitable candidates are individuals diagnosed with grass‑pollen‑induced allergic rhinitis or allergic rhinoconjunctivitis who need a disease‑modifying treatment, have no uncontrolled asthma, and can adhere to daily sublingual dosing under medical supervision.
How is Grazax administered?+
Grazax is taken as a single tablet placed under the tongue. The tablet should be allowed to dissolve completely without swallowing, and the patient should avoid eating or drinking for a short period after dosing as instructed by a healthcare professional.
Can Grazax be used during pregnancy or breastfeeding?+
Safety data for Grazax during pregnancy or lactation are limited, so the decision to use it should be made jointly by the patient and her healthcare provider after weighing potential benefits and risks.
What are the most common side effects of Grazax?+
Common side effects include mild itching or tingling in the mouth or throat, transient oral swelling, nasal irritation or sneezing, mild gastrointestinal upset, and occasional headache or fatigue after the first few doses.
What signs indicate a serious allergic reaction to Grazax?+
Serious reactions may present as anaphylaxis, persistent swelling of the lips, tongue, or throat that impairs breathing, widespread hives, wheezing, dizziness, or a sudden drop in blood pressure. Immediate medical attention is required if these occur.
How long does a typical Grazax treatment course last?+
Treatment usually begins before the grass pollen season and continues daily throughout the season, often for several years, to maintain immune tolerance. The exact duration is determined by the prescribing physician based on individual response.
Is it safe to take other allergy medications while using Grazax?+
Antihistamines or corticosteroids can be used, but they may mask early signs of an allergic reaction. Patients should discuss any concurrent allergy medications with their healthcare provider to ensure appropriate monitoring.
What should I do if I miss a dose of Grazax?+
If a dose is missed, the patient should take the missed tablet as soon as they remember, provided it is still the same day. If it is close to the time of the next scheduled dose, they should skip the missed dose and resume the regular schedule. They should not double‑dose.
Can children use Grazax?+
Grazax is prescribed for adolescents and adults; use in younger children should be considered only under specialist guidance, taking into account the child's ability to follow sublingual administration and safety monitoring.
How should Grazax be stored?+
The tablets should be stored at room temperature, protected from moisture and direct sunlight, and kept out of reach of children. Do not refrigerate unless instructed by the pharmacist.
Are there any dietary restrictions while taking Grazax?+
There are no specific dietary restrictions, but patients should avoid eating or drinking for a short period after placing the tablet under the tongue, as recommended by 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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