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.
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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?+
Who is eligible to receive Grazax therapy?+
When should treatment with Grazax be started?+
How is Grazax administered?+
Can Grazax be used as a rescue medication for hay fever attacks?+
What are the most common side effects of Grazax?+
What serious adverse reactions require immediate medical attention?+
Is Grazax safe for use during pregnancy or breastfeeding?+
Can Grazax be taken together with other allergy medications?+
How long does a typical course of Grazax last?+
What monitoring is required while on Grazax therapy?+
Is there a risk of cross‑reactivity with other grass pollens?+
Product details
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