Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children (5 years or older), with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.

Children should be carefully selected for treatment

Adult Dosage

The recommended dose for adults and children (5 years or older) is one oral lyophilisate (75,000 SQ-T) daily. Clinical experience on immunotherapy with Grazax in children (younger than 5 years) and the elderly (65 years or older) is lacking.

Grazax treatment should only be initiated by physicians with experience in treatment of allergic diseases and the capability to treat allergic reactions.

Child Dosage

For treatment of children, physicians should be experienced in treating allergic diseases in children and the patients should be carefully selected considering the expected level of efficacy in this age group

Contra Indications

Hypersensitivity to any of the excipients. Malignancy or systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases.

Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis.

Patients with uncontrolled or severe asthma (in adults: FEV₁ < 70% of predicted value after adequate pharmacologic treatment, in children: FEV₁ < 80% of predicted value after adequate pharmacologic treatment) should not be treated with Grazax immunotherapy

Special Precautions

In case of oral surgery, including dental extraction, and shedding of a deciduous tooth in children, treatment with Grazax should be stopped for 7 days to allow healing of the oral cavity.

In children with concomitant asthma and experiencing an acute upper respiratory tract infection Grazax treatment should be temporarily discontinued until the infection has resolved.

When treated with Grazax the patient is exposed to the allergen that causes the allergic symptoms. Therefore, primarily mild or moderate local allergic reactions are to be expected during the treatment period. If the patient experiences significant local adverse reactions from the treatment, anti-allergic medication (e.g. antihistamines) should be considered.

In post marketing experience, rare cases of severe systemic allergic reactions have been reported and therefore the medical supervision at start of treatment is an important precaution.

The onset of systemic symptoms may include flushing, intensive itching in palms of hand and soles of the feet, and other areas of the body (like a nettle rash). Sense of heat, general discomfort and agitation/anxiety may also occur. In case of severe systemic reactions, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat a physician should be contacted immediately. In such cases treatment should be discontinued permanently or until otherwise advised by the physician. If patients with concomitant asthma experience symptoms and signs indicating asthma deterioration, treatment should be discontinued and a physician consulted immediately in order to evaluate the continuation of treatment.

In patients who have previously had a systemic reaction to grass subcutaneous immunotherapy, the risk of experiencing a severe reaction with Grazax may be increased. Initiation of Grazax should be carefully considered and measures to treat reactions should be available.

Severe allergic reactions may be treated with adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants and mono amino oxidase inhibitors (MAOIs) with possible fatal consequences; this should be taken into consideration prior to initiating specific immunotherapy.

Clinical experience in relation to simultaneous vaccination and treatment with Grazax is missing. Vaccination may be given without interrupting treatment with Grazax after medical evaluation of the general condition of the patient.

Grazax contains fish-derived gelatine. The available data have not indicated an increased risk of allergic reactions in severe fish allergic patients. However, awareness is suggested when initiating treatment with Grazax in these patients.

Interactions

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 no data available on possible risks of simultaneous immunotherapy with other allergens during treatment with Grazax.

Adverse Reactions

In studies investigating treatment with Grazax 75,000 SQ-T daily in adult patients, 70% of the patients receiving Grazax reported side effects during the first treatment year. This number decreased markedly in the second year of continuous treatment.

Very commonly reported adverse reactions in adult patients, with seasonal grass pollen induced allergic rhinoconjunctivitis, treated with Grazax were local allergic reactions in the mouth which mostly were mild to moderate. In the majority of patients these reactions started early in therapy, lasted from minutes to hours after each intake of Grazax and tended to subside spontaneously within 1 to 7 days.

The following table of undesirable effects is based on data from controlled clinical trials investigating Grazax in adult and paediatric patients with seasonal grass-pollen induced rhinoconjunctivitis including patients with mild to moderate co-existing grass-pollen induced asthma, during the first treatment year.

Adverse reactions are divided into groups according to the MedDRA convention frequencies: Very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000).

If the patient experiences significant adverse events from the treatment, anti-allergic medication should be considered.

In post marketing experience, rare cases of severe systemic allergic reactions have been reported and therefore the medical supervision at start of treatment is an important precaution, please refer to Dosage Information and Precautions.

In case of severe systemic reactions, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat a physician should be contacted immediately. In such cases treatment should be discontinued permanently or until otherwise advised by the physician.

Experience in children

Overall, the adverse events profile in children and adolescents treated with Grazax was similar to that observed in adults. Upper respiratory tract infections, abdominal pain, and vomiting were reported more frequently in the paediatric population than in the adult population (all common).

Manufacturer

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