GNH USA

Europe — EMA

Grazax

Grazax sublingual tablet (225 SQ-U Phleum pratense) is a prescription allergen immunotherapy for grass pollen‑induced allergic rhinoconjunctivitis in the EU.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet containing 225 SQ-U of Phleum pratense (grass pollen) extract. It is formulated for allergen immunotherapy and is marketed in the European Union for the treatment of grass pollen‑induced allergic rhinoconjunctivitis (hay fever). The tablet is taken under the tongue, allowing direct exposure to the allergen to promote immune tolerance.

What is Phleum Pratense (225) used for?

Grazax is indicated for the prevention of symptoms associated with grass pollen‑induced allergic rhinoconjunctivitis. It is used as a disease‑modifying therapy that aims to reduce the need for symptomatic medications over time.

- Initiated before the start of the grass pollen season. - Administered daily as a sublingual tablet. - Intended for patients with confirmed grass pollen allergy. - May be continued for several years to achieve long‑term tolerance. - Used under medical supervision with periodic follow‑up. - Not a rescue medication for acute allergy attacks.

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

Side effects of Grazax are generally mild to moderate and reflect local or systemic immune responses to the allergen exposure.

Common: - Oral itching or mild irritation at the site of administration. - Throat irritation or mild soreness. - Transient ear or nasal itching. - Mild gastrointestinal discomfort. - Headache. - Localized swelling of the lips or tongue.

Serious: - Severe oral or throat swelling that may affect breathing. - Anaphylactic reaction requiring emergency care. - Persistent wheezing or shortness of breath. - Rapid onset of hives or widespread rash.

What precautions apply to Phleum Pratense (225)?

Patients should consider several precautions before starting Grazax therapy. The medication is not suitable for everyone and requires careful monitoring.

- Confirmed diagnosis of grass pollen allergy by a qualified clinician. - Not recommended for individuals with uncontrolled asthma. - Use with caution in patients with a history of severe allergic reactions. - Avoid initiating treatment during an active allergic episode. - Pregnant or breastfeeding women should discuss potential risks with their healthcare provider. - Keep the tablet out of reach of children; accidental ingestion can cause serious reactions. - Ensure regular follow‑up appointments to assess tolerance development.

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: - Systemic antihistamines taken within 24 hours before the first dose, as they may mask early reactions. - Immunosuppressive drugs that could alter the intended immune response. - ACE inhibitors that may exacerbate angioedema.

Use with caution: - Beta‑blockers, which can make treatment of anaphylaxis more difficult. - Other allergen immunotherapy products administered concurrently. - Medications that cause dry mouth, potentially affecting tablet dissolution. - Over‑the‑counter cold or flu remedies that contain antihistamines.

Frequently asked questions

What is the active ingredient in Grazax and how does it work?+
Grazax contains a standardized extract of Phleum pratense (grass pollen) at 225 SQ-U. When taken sublingually, it exposes the immune system to low doses of the allergen, encouraging a shift from a Th2‑dominant response to regulatory T‑cell activity and increasing IgG4 production, which helps build tolerance.
Who is eligible to receive Grazax therapy?+
Grazax is prescribed for patients with a confirmed diagnosis of grass pollen‑induced allergic rhinoconjunctivitis who are not adequately controlled with standard symptomatic medications. A healthcare professional should assess suitability, especially regarding asthma control and prior severe allergic reactions.
When should treatment with Grazax be started?+
Treatment is typically initiated several weeks to months before the anticipated start of the grass pollen season, allowing the immune system to develop tolerance before exposure peaks.
How is Grazax administered?+
The tablet is placed under the tongue and allowed to dissolve completely without swallowing. Patients should remain upright and avoid eating or drinking for at least 30 minutes after the dose.
Can Grazax be used as a rescue medication for hay fever attacks?+
No. Grazax is a disease‑modifying therapy and does not provide immediate relief of acute allergy symptoms. Patients may still need rescue antihistamines or nasal corticosteroids during the season.
What are the most common side effects of Grazax?+
Common side effects include mild oral itching, throat irritation, transient ear or nasal itching, mild gastrointestinal discomfort, headache, and localized swelling of the lips or tongue.
What serious adverse reactions require immediate medical attention?+
Signs of a severe reaction such as significant swelling of the throat or tongue, difficulty breathing, wheezing, widespread hives, or any symptoms of anaphylaxis should be treated as an emergency and medical help should be sought immediately.
Is Grazax safe for use during pregnancy or breastfeeding?+
The safety of Grazax during pregnancy or lactation has not been established. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider.
Can Grazax be taken together with other allergy medications?+
Grazax can be used alongside symptomatic treatments such as antihistamines or nasal corticosteroids, but systemic antihistamines should be avoided shortly before the first dose to not mask early reactions.
How long does a typical course of Grazax last?+
A full course usually spans three to five years of daily administration, depending on the individual’s response and the prescribing physician’s recommendation.
What monitoring is required while on Grazax therapy?+
Patients should have regular follow‑up visits to assess tolerance development, review any adverse reactions, and adjust the treatment plan as needed.
Is there a risk of cross‑reactivity with other grass pollens?+
Phleum pratense extract may provide some cross‑protection against related grass species, but the degree of cross‑reactivity varies. Specific testing can determine the extent of benefit for other grass pollens.
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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