Grazax
Grazax is a sublingual allergen immunotherapy tablet containing a standardised extract of grass pollen allergen (Phleum pratense, 75,000 SQ-T per tablet).
It is used to modify the underlying allergic disease process in adults and children (aged 5 years and over) with grass pollen-induced allergic rhinitis and conjunctivitis (hayfever) who have not responded adequately to conventional antihistamines or nasal corticosteroids.
Grazax is a prescription-only medicine (POM) manufactured by ALK-Abello.
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Grazax is a prescription-only sublingual allergen immunotherapy tablet used to treat grass pollen-induced allergic rhinitis and conjunctivitis (hayfever) in adults and children aged 5 years and over.
It contains a standardised extract of timothy grass pollen (Phleum pratense, 75,000 SQ-T per tablet) and is manufactured by ALK-Abello.
Unlike antihistamines and nasal steroid sprays, which treat only the symptoms of hayfever, Grazax works by modifying the underlying immune response to grass pollen, offering the prospect of long-term disease modification.
This page provides a comprehensive clinical overview of Grazax, including how it works, who it is suitable for, dosing guidance, side effects, safety warnings, and how to access it in the United Kingdom.
Allergic rhinitis caused by grass pollen is one of the most common allergic conditions in the UK, affecting an estimated 10 to 15 million people.
Symptoms include sneezing, nasal congestion, runny nose, itchy and watery eyes, and itching of the throat and palate.
For many people, hayfever is a minor seasonal inconvenience, but for a significant minority, symptoms are severe enough to impair sleep, concentration, productivity at work or school, and overall quality of life.
The grass pollen season in the UK typically runs from late May to July, with peak counts occurring in June.
Conventional treatments (oral antihistamines, intranasal corticosteroids, and eye drops) provide good symptom relief for most patients, but a substantial proportion continue to experience disabling symptoms despite optimal use of these medicines.
Allergen immunotherapy offers a treatment option for this group.
Important safety information about Grazax
Before reading further, note the following essential safety points about Grazax.
- Grazax is a prescription-only medicine and must be initiated by a specialist experienced in the management of allergic diseases.
- The first dose must be taken under medical supervision with access to resuscitation facilities.
- Do not use Grazax if you have severe or unstable asthma.
- Carry your adrenaline auto-injector at all times if one has been prescribed.
- Stop taking Grazax and call 999 if you experience severe throat swelling, difficulty breathing, or signs of anaphylaxis.
Understanding grass pollen allergy
Allergic rhinitis is an IgE-mediated inflammatory condition of the nasal mucosa triggered by exposure to airborne allergens.
In seasonal allergic rhinitis (hayfever), the trigger is pollen from grasses, trees, or weeds. Grass pollen is the most common cause of hayfever in the UK.
When a sensitised individual inhales grass pollen, allergen proteins bind to IgE antibodies on the surface of mast cells in the nasal and conjunctival mucosa.
This triggers degranulation of mast cells, releasing histamine, leukotrienes, prostaglandins, and other inflammatory mediators.
The result is the characteristic symptoms of sneezing, itching, nasal congestion, rhinorrhoea, and conjunctival irritation.
The late-phase allergic response, occurring 4 to 8 hours after initial allergen exposure, involves recruitment of eosinophils, basophils, and T-helper 2 (Th2) lymphocytes to the nasal mucosa.
This sustained inflammation contributes to persistent nasal congestion, mucosal swelling, and heightened sensitivity to further pollen exposure (a phenomenon known as priming).
Over successive days of high pollen counts, symptoms become progressively worse.
Diagnosis of grass pollen allergy is based on a characteristic history of seasonal symptoms coinciding with the grass pollen season, supported by positive skin prick testing or measurement of specific IgE antibodies to grass pollen in the blood.
A clear clinical history is usually sufficient for diagnosis in primary care, but specialist assessment is recommended before starting allergen immunotherapy.
How Grazax works: mechanism of allergen immunotherapy
Allergen immunotherapy is the only treatment that modifies the underlying immunological mechanisms driving allergic disease.
Grazax delivers a precisely controlled dose of grass pollen allergen to the sublingual mucosa (the tissue under the tongue) every day.
The sublingual route targets a network of antigen-presenting cells, particularly dendritic cells, that reside in the oral mucosa.
These cells process the allergen and present it to the immune system in a way that promotes tolerance rather than allergy.
Over weeks and months of daily treatment, several immunological changes occur. Regulatory T cells (Tregs) are induced, which suppress the Th2-driven allergic response.
Production of allergen-specific IgG4 increases; this blocking antibody competes with IgE for allergen binding and prevents mast cell activation.
Over time, allergen-specific IgE decreases, reducing the sensitivity of mast cells and basophils to grass pollen.
The ratio of Th1 to Th2 cytokines shifts towards Th1 dominance, dampening the eosinophilic inflammation that drives chronic allergic symptoms.
These changes are gradual and cumulative. Symptomatic improvement is usually noticeable during the first grass pollen season after starting treatment, with further improvement in subsequent seasons.
A full three-year course is recommended to achieve sustained disease modification that persists after treatment is stopped.
Clinical evidence for Grazax
Grazax has been evaluated in multiple randomised, double-blind, placebo-controlled clinical trials.
The pivotal GT-08 trial, which enrolled 634 adults with moderate to severe grass pollen-induced allergic rhinoconjunctivitis, demonstrated a 30% reduction in the combined rhinoconjunctivitis symptom and medication score compared with placebo during the first grass pollen season.
Benefits were sustained over three years of treatment.
The GT-14 trial extended follow-up to two years after completion of a three-year course and confirmed that the clinical effect was maintained for at least two years post-treatment.
A paediatric trial (GT-21) in children aged 5 to 16 years with grass pollen allergy demonstrated similar efficacy and safety to adult studies.
Meta-analyses of sublingual immunotherapy for grass pollen allergy, including Cochrane reviews, support a clinically meaningful reduction in symptoms and rescue medication use compared with placebo.
NICE technology appraisal TA246 recommends Grazax as an option for treating grass pollen-induced allergic rhinoconjunctivitis in adults and children aged 5 years and over who have failed to respond adequately to anti-allergy medicines.
The decision to start treatment should be made by a clinician with specialist expertise in allergy.
Grazax compared with other hayfever treatments
Conventional hayfever treatments include oral non-sedating antihistamines (such as cetirizine, loratadine, and fexofenadine), intranasal corticosteroids (such as fluticasone, mometasone, and beclometasone), antihistamine eye drops (such as olopatadine and azelastine), and leukotriene receptor antagonists (montelukast).
These medicines are effective at controlling symptoms but do not alter the underlying allergic disease process. Symptoms return as soon as treatment is stopped.
Subcutaneous allergen immunotherapy (SCIT), administered as a course of injections, is an alternative form of immunotherapy with a longer track record.
It requires regular clinic visits for injections and carries a higher risk of systemic allergic reactions than sublingual immunotherapy.
Grazax offers the convenience of home administration (after the supervised first dose) and a more favourable safety profile than injection-based immunotherapy, making it more practical for many patients.
The key advantage of allergen immunotherapy over conventional treatments is the potential for sustained disease modification.
After completing a three-year course of Grazax, many patients experience several years of reduced symptoms and reduced need for rescue medication, even without ongoing treatment.
Some patients achieve long-term remission.
Dosage and administration
One Grazax tablet (75,000 SQ-T) is taken daily. Place the tablet under the tongue and allow it to dissolve completely without chewing or swallowing.
Keep the tablet in position for at least one minute. Do not eat or drink for at least five minutes after taking the tablet.
The first dose must be given under medical supervision with at least 30 minutes of observation. All subsequent doses are taken at home.
Treatment should begin at least 4 months before the expected start of the grass pollen season to allow sufficient time for the immune system to develop tolerance.
Continue treatment daily throughout the year for three consecutive years. Consistent daily dosing is important for efficacy.
Side effects of Grazax
Local oral reactions
Local reactions are the most common side effects and occur in the majority of patients.
These include itching in the mouth, throat irritation, tingling or swelling of the lips, tongue, and palate, and ear itching.
These reactions reflect the local immune response to the allergen and are expected during the early phase of treatment.
They typically begin within minutes of taking the tablet, resolve within 30 minutes to an hour, and diminish significantly within the first 1 to 3 months of daily treatment.
Pre-medication with an oral antihistamine may help reduce local reactions during the initiation phase.
Systemic reactions
Systemic allergic reactions are uncommon but may include generalised urticaria (hives), worsening of asthma, angioedema (swelling away from the site of application), and very rarely, anaphylaxis.
Patients at higher risk of systemic reactions include those with a history of previous systemic reactions to allergen immunotherapy, poorly controlled asthma, or concomitant use of beta-blockers.
If you experience sudden difficulty breathing, widespread hives, throat tightness, dizziness, or feel faint, stop taking Grazax and seek emergency medical attention immediately.
Use your adrenaline auto-injector if one has been prescribed.
When to seek urgent medical advice
Contact your GP or call NHS 111 if local oral reactions are severe or do not improve within the first few months of treatment.
Call 999 or attend A&E if you experience signs of anaphylaxis, severe angioedema, or acute worsening of asthma.
Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .
Warnings and precautions
Contraindications
Grazax must not be used in patients with severe, unstable, or uncontrolled asthma, severe immunodeficiency, active malignant disease, oral ulceration or inflammation, or hypersensitivity to any excipient (including fish gelatin). It must not be started during pregnancy.
Asthma
Patients with mild to moderate, well-controlled asthma may use Grazax, but their asthma must be stable before treatment begins.
Spirometry should be performed at baseline and periodically during treatment. If a significant worsening of asthma occurs, Grazax should be temporarily discontinued and the prescriber consulted.
Adrenaline auto-injectors
Patients who have experienced previous systemic allergic reactions to immunotherapy, or who are considered at increased risk, should be prescribed and trained to use an adrenaline auto-injector. They should carry it at all times during the course of treatment.
Drug interactions
Patients taking beta-blockers should be aware that these drugs may reduce the effectiveness of adrenaline in treating anaphylaxis.
Patients on ACE inhibitors may have an increased risk of angioedema. These interactions do not absolutely contraindicate Grazax but require careful clinical assessment.
Pregnancy and breastfeeding
Do not start Grazax during pregnancy. If pregnancy occurs during an established course of treatment that has been well tolerated, continuation may be considered on an individual basis by the specialist. There are limited data on use during breastfeeding.
How to get Grazax in the UK
Grazax is a prescription-only medicine, typically prescribed by an allergy specialist or immunologist.
Referral to a specialist allergy service is usually required, either through your GP or through a secondary care clinic.
NICE TA246 recommends Grazax as an option for patients who have not responded adequately to standard hayfever treatments. Treatment is available on the NHS.
The standard NHS prescription charge in England is currently 9.90 pounds per item (each monthly supply counts as one item); prescriptions are free in Scotland, Wales, and Northern Ireland.
Living with grass pollen allergy: practical advice
Alongside Grazax, practical measures can help reduce pollen exposure during the season.
These include keeping windows closed during peak pollen times (typically early morning and evening), wearing wraparound sunglasses outdoors, showering and changing clothes after spending time outside, drying laundry indoors rather than on the washing line, applying a barrier balm around the nostrils to trap pollen, and monitoring daily pollen forecasts from the Met Office.
During high pollen counts, try to stay indoors between 11 a.m. and 7 p.m. when pollen levels are typically highest at ground level.
Sources
- Grazax 75,000 SQ-T Oral Lyophilisate, Summary of Product Characteristics (EMC)
- Grass pollen extract, British National Formulary (BNF)
- NICE TA246: Pharmalgen for the treatment of bee and wasp venom allergy (cross-reference: allergen immunotherapy)
- Hay fever, NHS
- BSACI guidelines on allergen immunotherapy
- MHRA Yellow Card Scheme
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