Grazax

Grazax is a sublingual allergen immunotherapy tablet containing a standardised extract of Timothy grass pollen (Phleum pratense).

It is used for the treatment of grass pollen-induced allergic rhinitis and conjunctivitis (hay fever) in patients who have not responded adequately to conventional antihistamine and corticosteroid treatments.

Grazax works by modifying the underlying immune response to grass pollen allergen.

Regular daily administration delivers controlled doses of the allergen sublingually, inducing immune tolerance through the production of blocking antibodies, regulatory T-cells, and a shift from a Th2 to a Th1 immune profile.

This desensitisation reduces both the immediate and late-phase allergic responses.

Treatment should ideally be started at least 4 months before the grass pollen season and continued for 3 consecutive years to achieve sustained benefit.

Clinical trials have demonstrated that Grazax reduces hay fever symptoms by approximately 30% and the need for rescue medication by a similar margin, with benefits persisting for several years after completing the 3-year course.

Place one tablet under the tongue each day and allow it to dissolve completely — do not swallow for at least one minute. Do not eat or drink for 5 minutes after administration.

The first dose should be taken under medical supervision (in the clinic) so that any allergic reaction can be managed.

Continue daily throughout the year, including outside the pollen season, for a recommended 3-year course.

One tablet (75,000 SQ-T) sublingually once daily. Treatment should begin at least 4 months before the expected start of the grass pollen season.

Continue daily for 3 consecutive years for optimal long-term benefit. If a dose is missed, resume the next day as normal. Do not take a double dose.

Very common (more than 1 in 10): oral pruritus (itching in the mouth), throat irritation, and mouth oedema — these local allergic reactions are expected and usually diminish within the first 1-2 weeks of treatment.

Common (1 in 10 to 1 in 100): ear itching, lip swelling, tongue swelling, and sneezing. Uncommon (1 in 100 to 1 in 1,000): dysphagia, chest tightness, urticaria, and nausea.

Rare: severe systemic allergic reactions including anaphylaxis, though this is extremely uncommon with sublingual immunotherapy.

The first dose must be administered under medical supervision with the patient observed for at least 30 minutes. Adrenaline auto-injector should be available at the clinic.

Do not start during a respiratory infection or asthma exacerbation. Patients with severe or unstable asthma should not use Grazax.

Discontinue temporarily after oral surgery or dental extraction until the oral mucosa has healed.

Severe or uncontrolled asthma (FEV1 below 70% predicted). Severe immune deficiency. Active malignancy. Oral inflammation or infection (e.g., oral lichen planus, oral ulcers).

Known hypersensitivity to any excipient. Previous severe systemic reaction to allergen immunotherapy. Not recommended for children under 5 years.