Relevant medical history, including specification of Allergic rhinitis Allergic conjunctivitis Asthma Verified allergies ALK contend that the standard case report used for collection of spontaneous post marketing data sufficiently captures information relevant for cases of severe allergic reactions including severe acute exacerbation of asthma. Consequently, ALK maintains that additional targeted questionnaires are unnecessary. Other immunotherapy products Concomitant administration of The sponsor’s contraindicate use in patients beta-blockers and immunotherapy response is noted. treated with beta-blockers due are contraindicated in There is no to their potential to interfere immunotherapy guidelines objection from an with treatment for anaphylaxis. because blockage of RMP perspective It is recommended a similar receptors is undesirable to the proposed PI βadreno contraindication is applied to during adrenaline administration statement Acarizax. which may be indicated in the regarding event of a serious systemic allergic betablockers. reaction. However the ALK does not agree that recommendation concomitant treatment with regarding the is an absolute related contraindication as the risk is contraindication associated with the use of is maintained for adrenaline and not directly related final to the HDM SLIT-tablet. The determination by recently published European the Delegate. Academy of Allergy and Clinical Immunology (EAACI) position paper on contraindications furthermore supports that is considered a relative contraindication. Subsequently, Seqirus proposes to describe concomitant treatment with beta-blockers in the PI under specifically: ‘precautions’, Severe systemic allergic reactions may be treated with adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants,
Relevant medical history, including specification of Allergic rhinitis Allergic conjunctivitis Asthma Verified allergies ALK contend that the standard case report used for collection of spontaneous post marketing data sufficiently captures information relevant for cases of severe allergic reactions including severe acute exacerbation of asthma. Consequently, ALK maintains that additional targeted questionnaires are unnecessary. Other immunotherapy products contraindicate use in patients treated with beta-blockers due to their potential to interfere with treatment for anaphylaxis. It is recommended a similar contraindication is applied to Acarizax. Concomitant administration of beta-blockers and immunotherapy are contraindicated in immunotherapy guidelines because blockage of βadreno receptors is undesirable during adrenaline administration which may be indicated in the event of a serious systemic allergic reaction. ALK does not agree that concomitant treatment with is an absolute contraindication as the risk is associated with the use of adrenaline and not directly related to the HDM SLIT-tablet. The recently published European Academy of Allergy and Clinical Immunology (EAACI) position paper on contraindications furthermore supports that is considered a relative contraindication. Subsequently, Seqirus proposes to describe concomitant treatment with beta-blockers in the PI under ‘precautions’, specifically: Severe systemic allergic reactions may be treated with adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, The sponsor’s response is noted. There is no objection from an RMP perspective to the proposed PI statement regarding betablockers. However the recommendation regarding the related contraindication is maintained for final determination by the Delegate.