ALK-Abello Ltd

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 common (≥>1/100 to, <1/10), Uncommon uncommon (≥>1/1,000 to, <≤<1/100),  and Rrare (≥>1/10,.000, to <≤<1/1,000), very rare (<≤1/10,.000).

 It is recommended to continue treatment with Grazax for a period of 3 years. Data is available for 3 years of treatment and 1 year of follow-up in adults. No data on treatment with Grazax in children beyond one grass pollen season is available.

Section 4.8 has been amended to update side effects for immune system disorders

Section 5.1 has been amended to include reference to sustained effects after completion of treatment.

§         In section 4.4 (special warnings and precautions for use), the following information have been added:

“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.”

“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 of Grazax should be carefully considered and measures to treat reactions should be available.”

Hypotension has also been added as a reaction where a physician should be contacted immediately.

§         In section 4.8 (undesirable effects), palpitations has been added as a rare adverse drug reaction. The following paragraph has also been added:

“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.”

Hypotension has also been added as a reaction where a physician should be contacted immediately.

4.2     Posology and method of administration

The recommended dose for adults is one oral lyophilisate (75,000 SQ-T) daily. Clinical experience on immunotherapy with Grazax in children and adolescents (<18 years) and the elderly (>65 years) is lacking.

Grazax treatment should only be initiated by physicians with experience in treatment of allergic diseases.

In order to enable patient and physician to discuss any side effects and possible actions it is recommended that the first oral lyophilisate is taken under medical supervision (20-30 minutes).

No eEfficacy data on treatment with Grazax beyond one grass pollen season is available yetfor two years of continuous treatment is available. If no relevant improvement of symptoms is observed during the first pollen season, there is no indication for continuing the treatment during the second year.

Clinical effect in the first treatment grass pollen season is obtained if treatment is initiated at least 4 months prior to the expected start of the grass pollen season. and continued throughout the whole grass pollen season. If treatment is initiated 2-3 months before the season some efficacy may be obtained. To obtain progressive immunoemodulatory effect, treatment with Grazax should continue all year round.

The overall aim of specific immunotherapy is a long-lasting immunomodulation resulting in a maintained effect after termination of the therapy. According to International guidelines immunotherapy should be continued for 3-5 years.

Grazax is an oral lyophilisate. The oral lyophilisate should be taken from the blister unit with dry fingers, and placed under the tongue, where it will disperse.

Swallowing should be avoided for about 1 minute. Food and beverage should not be taken for the following 5 minutes.