Sublingual Immunotherapy

Use only FDA-approved SLIT products for the treatment of allergic rhinitis/rhinoconjunctivitis and not for any other related or unrelated condition. (A/B)

The physician should be aware that SLIT may not be suitable in patients with certain medical conditions, particularly those that may reduce the patient’s ability to survive a systemic reaction or the resultant treatment of the systemic reaction. ( S , D )

Use FDA-approved SLIT products very cautiously in the pregnant or breastfeeding patient because there are insufficient data regarding the safety of initiating or continuing SLIT during either pregnancy or breastfeeding. ( W , C)

Do not assume dosing equivalence between SLIT tablets and extracts of the same allergen. ( W , B/C )

Administer the patient’s first dose of SLIT in a medical facility under the supervision of a physician or other health care professional with experience in the diagnosis and treatment of anaphylaxis. The patient should be observed in the clinic or medical facility for 30 minutes after the administration of the SLIT dose. ( S , D )

Prescribe epinephrine (either an autoinjector or other form for self-injection) to patients receiving SLIT tablets. ( S , D )

Reduce a patient’s SLIT dose if they have missed treatment for more than 7 days. ( W , D )

Schedule patients receiving SLIT therapy for regular follow-up care with a specialist trained in the evaluation of patients with allergic conditions to monitor efficacy and safety and as a strategy for optimizing adherence. ( M , D )

-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 FDACurrently, 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 )