mono amino oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers. Other immunotherapy products The EU RMP (v3.0) includes use in This is acceptable contraindicate use in patients patients with severe immune from an RMP with severe immune deficiency deficiency or autoimmune disease. perspective. PI or autoimmune disease. It is Given this and given the amendments are recommended that a similar evaluator’s comment, the proposed subject to final contraindication is applied or at PI has been amended as follows: determination by least advice regarding use in the Delegate. Acarizax is contraindicated: these groups is added. in patients with a known hypersensitivity to the any of the excipients in patients with forced expiratory volume in one second (FEV1) < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment in patients who have experienced a severe asthma exacerbation within the last 3 months in patients with active or poorly controlled autoimmune diseases, immune defects, immunodeficiency’s, immunosuppression or malignant neoplastic disease Concurrently, the following amendment is also proposed to the section of the AU PI ‘precautions for alignment with the current EU SPC (approved late 2015): Limited data is available on treatment with allergy immunotherapy in patients with autoimmune diseases in remission. Acarizax should therefore be prescribed with caution in these patients. The contraindications Asthma is a known risk factor for The sponsor’s define some asthma parameters anaphylaxis, , and has previously response is but should specifically been known to constitute a risk in acceptable from contraindicate use in patients AIT despite AIT having also been an RMP with and/or severe used to treat asthma. perspective ‘unstable asthma’ as well as patients with however this The safety profile of the population defined FEV1 < 70% and in recommendation of subjects not well controlled by
mono amino oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers. Other immunotherapy products contraindicate use in patients with severe immune deficiency or autoimmune disease. It is recommended that a similar contraindication is applied or at least advice regarding use in these groups is added. The EU RMP (v3.0) includes use in patients with severe immune deficiency or autoimmune disease. Given this and given the evaluator’s comment, the proposed PI has been amended as follows: Acarizax is contraindicated: in patients with a known hypersensitivity to the any of the excipients in patients with forced expiratory volume in one second (FEV1) < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment in patients who have experienced a severe asthma exacerbation within the last 3 months in patients with active or poorly controlled autoimmune diseases, immune defects, immunodeficiency’s, immunosuppression or malignant neoplastic disease Concurrently, the following amendment is also proposed to the ‘precautions section of the AU PI for alignment with the current EU SPC (approved late 2015): Limited data is available on treatment with allergy immunotherapy in patients with autoimmune diseases in remission. Acarizax should therefore be prescribed with caution in these patients. This is acceptable from an RMP perspective. PI amendments are subject to final determination by the Delegate. The contraindications define some asthma parameters but should specifically contraindicate use in patients with ‘unstable and/or severe asthma’ as well as patients with defined FEV1 < 70% and in Asthma is a known risk factor for anaphylaxis, , and has previously been known to constitute a risk in AIT despite AIT having also been used to treat asthma. The safety profile of the population of subjects not well controlled by The sponsor’s response is acceptable from an RMP perspective however this recommendation
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