| 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).| | | System Organ Class | Frequency | Adverse Drug Reaction | | Cardiac disorders
| Uncommon | Palpitations
| | Infections and infestations
| Uncommon | Upper respiratory tract infection, laryngitis
| | Blood and lymphatic system disorders
| Uncommon | Lymphadenopathy
| | Nervous system disorders
| Common | Headache, oral paraesthesia
| | | Uncommon | Dizziness
| | Eye disorders
| Common | Eye pruritus, conjunctivitis, redness of eyes or tearflow
| | | Uncommon | Eye swelling
| | Ear and labyrinth disorders
| Very common | Ear pruritus
| | Respiratory, thoracic and mediastinal disorders
| Very common | Throat irritation, sneezing
| | Common | Cough, asthma, pharyngitis, rhinorrhoea, nasal congestion, nasal passage irritation, rhinitis, throat tightness, dyspnoea, pharyngeal oedema
| | | Uncommon | Nasopharyngitis, bronchospasm, wheezing, hoarseness, laryngeal discomfort,
| | Immune system disorders
| Uncommon | Systemic allergic reaction
| | Gastrointestinal disorders
| Very common | Oedema mouth, oral pruritus
| | | Common | Swelling, pain or blistering of oropharynx, dyspepsia and nausea, oral hypoaesthesia or oral discomfort, oral mucosal blistering, swollen tongue or glossodynia. Lip swelling, stomatitis, gastritis, gastro-esophageal reflux, vomiting, diarrhoea
| | | Uncommon | Lip blister, mouth ulceration, odynophagia, oral pain, , dry mouth and dry throat, tongue disorders, salivary gland disorders, abdominal pain, dysphagia, epigastric discomfort,
| | Skin and subcutaneous tissue disorders
| Common | Pruritus, urticaria,
| | | Uncommon | Angioneurotic oedema such as swollen face
| | General disorders and administration site conditions
| Common | Fatigue
| | Uncommon | Chest discomfort, chest pain, chest tightness, feeling hot, malaise, pyrexia, sensation of foreign body
|
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 section 4.2 and 4.4. 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). | |
