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Sublingual Immunotherapy

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Table 3. Suggested Guidelines for the Practicing Allergist Regarding the Use of FDA-Approved SLIT Products Question or concern Expert suggestion and rationale Late administration: missed days 1–7 Based on the experience obtained with the SLIT trials, the lack of dose escalation, in general, and the experience with SCIT, no dose reduction is recommended. Late administration: missed days 8–14 Follow the above guidelines except for those SLIT products that have a dose escalation. For products with a dose escalation, it is recommended to restart from dose 1 and escalate as indicated in the package insert. Late administration: missed days >14 It is suggested that the patient return to the physician's office for the next dose to be administered under supervision. Delay in the administration of epinephrine by the patient Although local and GI symptoms are very common adverse effects, the patient should be educated to have a low threshold for use of their epinephrine autoinjector and for calling 911 when experiencing a systemic reaction. Consider the use of epinephrine for the rapid onset (<15 minutes) of any of the following : (1) symptoms beyond the local oral and mild GI symptoms, (2) moderate to severe tongue or throat swelling, (3) wheezing or respiratory distress, (4) generalized urticaria and/or angioedema, and (5) any serious, potentially life-threatening symptom. Aer the administration of epinephrine for SLIT-induced anaphylaxis, it is strongly suggested to discontinue treatment e patient should discontinue SLIT and schedule an office visit with the prescribing allergist. Once the allergist has confirmed that the patient experienced anaphylaxis, most patients should be advised to permanently discontinue SLIT when administered in a medically nonsupervised setting (eg, at home). e final decision must be made on a case-by-case basis, balancing the potential for benefit with the potential for harm and involving the patient in the decision-making process. ➤ SS9: Currently, the only FDA-approved products for SLIT in the United States are the 5-grass (Oralair ® ), Timothy grass (Grastek ® ), ragweed (Ragwitek ® ) and house dust mite (Odactra™) tablets, indicated for the treatment of allergic rhinitis. Although alternative regimens and preparations for SLIT have been proposed and may be used off-label in the United States (eg, use of liquid subcutaneous immunotherapy [SCIT] extract for sublingual delivery or use of specific sublingual drops or other sublingual tablets), these products and formulations do not have FDA approval at present and have not been systematically studied in a rigorous manner in US populations. Use of such products or formulations as prescribed SLIT therapy is currently off-label, at a practitioner's discretion and liability, and is without recommendation for any current particular indication in the US populations. Therefore, off-label use of aqueous SLIT extracts or any other non–FDA-approved SLIT formulation is not endorsed. (S-D)

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