PRESCRIBING INFORMATION – UK ONLY

GRAZAX^® Prescribing Information. Please refer to the Summary of Product Characteristics before prescribing.
Pharmaceutical Form and Composition: GRAZAX^® are sublingual lyophilisates (tablets) for specific immunotherapy that contain SQ standardised allergen extract of Timothy grass pollen (Phleum pratense) at a strength of 75,000 SQ-T this equates to 6mcg on average per tablet.
Therapeutic Indications: Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children (5 years or older) with clinically significant symptoms and a positive skin prick test and/or specific IgE test to grass pollen.
Posology and Method of Administration: The daily dose is one tablet to be placed under the tongue. Avoid swallowing for about 1 minute. It is recommended that the first tablet is taken under medical supervision (20 30 minutes). Clinical effect in the first grass pollen season is expected when treatment is initiated at least 4 months prior to the expected start of the grass pollen season. If treatment is initiated 2-3 months before the season some efficacy may also be obtained. For long term efficacy and disease modifying effect, it is recommended to continue daily treatment for 3 consecutive years. should be initiated by physicians with experience in treatment of allergic diseases and the capability to treat allergic reactions.
Clinical Efficacy: In adults continuous daily treatment with GRAZAX^®resulted ina statistically significant improvement in symptoms and medication scores for 3 treatment years and 2 follow up years compared to placebo. Disease modification in adults and children is demonstrated by sustained post-treatment effect on rhinoconjunctivitis observed 2 years after 3 years of treatment with Grazax.
Contraindications: Hypersensitivity to excipients, malignancy or systemic diseases affecting the immune system, inflammatory conditions in the oral cavity with severe symptoms. Uncontrolled or severe asthma (Adults: FEV1 < 70% of predicted value, children: FEV1 < 80% of predicted value, after adequate pharmacologic treatment).
Special Warnings and Precautions for Use: Oral conditions, asthma deterioration, children with concomitant asthma and experiencing an acute upper respiratory tract infection. Oral surgery such as, shedding of a deciduous tooth in children and dental extraction treatment, should stop treatment with Grazax for 7 days. Rare cases of severe systemic allergic reactions have been reported therefore medical supervision at start of treatment is an important precaution. In patients who have previously had a systemic reaction to grass pollen subcutaneous immunotherapy, the risk of experiencing a severe reaction with GRAZAX^® may be increased. Initiation ofGRAZAX^® should be carefully considered and measures to treat reactions should be available. Severe allergic reactions maybe treated with adrenaline. Serious anaphylactic reactions may be treated with adrenaline. Consider whether your patient would be able to tolerate adrenaline (e.g. treatment with tricyclic antidrepressants, MAOIs, COMTIs and/or beta-blockers) in the rare case of a severe systemic allergic reaction.
Interaction with other Medicinal Products and other forms of Interaction: Concomitant therapy with symptomatic anti-allergic agents (e.g. antihistamines, corticosteroids and mast cell stabilisers) may increase the tolerance level of the patient to immunotherapy. There are limited data available on possible risks of simultaneous immunotherapy with other allergens during treatment with Grazax.
Pregnancy and Lactation: No clinical data are available for the use of Grazax during lactation. No effects on the breastfed infants are anticipated. Animal studies do not indicate increased risk to foetus. Treatment should not be initiated during pregnancy.
Undesirable Effects: Subjects taking Grazax should primarily expect mild to moderate local allergic reactions to occur early in therapy that tend to subside spontaneously within 1 to 7 days. The most commonly reported adverse reactions are oral pruritus, throat irritation and oedema mouth. For the majority of events, the reaction should be expected to start within 5 minutes after intake of Grazax on each day of occurrence and abate after minutes to hours. More severe local or systemic allergic reactions may occur within 1 to 7 days. If the patient experiences significant adverse events, anti- allergic medication should be considered. In case of severe systemic reactions, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, feeling of fullness in the throat or asthma deterioration, a physician should be contacted immediately. Overall, the adverse events profile in paediatric patients treated with Grazax was similar to that observed in adults, though eye irritation, ear pain, ear swelling, pharyngeal erythema and oral mucosal blistering are seen at a higher frequency. The events were primarily mild to moderate in severity.
Overdose: In adults doses up to 1,000,000 SQ-T have been tolerated. No data is available in children regarding exposure to doses above the recommended daily dose of 75,000 SQ-T.
Excipients: Gelatin (fish source), mannitol, sodium hydroxide.
Shelf Life: 5 years.
Content of Container: Aluminium blister cards with 30 tablets.
Legal Category: POM.
Marketing Authorisation Holder: ALK-Abelló A/S, Bøge Alle 6 8, DK-2970 Hørsholm, Denmark. UK Office: ALK-Abelló Ltd, The Place, Bridge Avenue, Maidenhead, SL6 1AF .
Telephone: 01189 037940.
Marketing Authorisation Number: PL10085/0039.
Price: £94.73.
Updated: July 2026.
Item Code: GB-GZX-200003