Sublingual Immunotherapy

Publication Date: March 1, 2017
Last Updated: December 16, 2022

Treatment

Use only FDA-approved SLIT products for the treatment of allergic rhinitis/rhinoconjunctivitis and not for any other related or unrelated condition. (A/B)
560
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 )
560
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)
560
Do not assume dosing equivalence between SLIT tablets and extracts of the same allergen. ( W , B/C )
Notes: There are no direct comparisons between the same allergen extract administered as a SLIT tablet vs. as an aqueous SLIT extract, and it is unknown whether equal efficacy and/or safety exists when using similar doses of the 2 preparations. Each formulation has to have its own safety profile established.
560
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 )
560
Prescribe epinephrine (either an autoinjector or other form for self-injection) to patients receiving SLIT tablets. ( S , D )

Notes: Patients should be trained how to use the device, instructed on how to recognize and manage adverse reactions and missed doses, and advised on when to contact their physician or other health care professional. Recommendations for when to withhold the SLIT tablet dose to avoid potential situations when systemic allergic reactions may be more likely should also be provided.

560
Reduce a patient’s SLIT dose if they have missed treatment for more than 7 days. ( W , D )
560
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 )
560
-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 )
560

Recommendation Grading

Overview

Title

Sublingual Immunotherapy

Authoring Organizations

American College of Allergy, Asthma, and Immunology

American Academy of Allergy, Asthma & Immunology

Publication Month/Year

March 1, 2017

Last Updated Month/Year

October 16, 2024

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Document Objectives

The focus of the SLIT practice parameter is to provide guidance for effective, safe, and appropriate administration of the FDA-approved sublingual immunotherapy (SLIT) formulations.

Inclusion Criteria

Male, Female, Adult, Child, Older adult

Health Care Settings

Ambulatory

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Management

Diseases/Conditions (MeSH)

D063729 - Sublingual Immunotherapy

Keywords

sublingual immunotherapy, ragweed, allergen, allergic rhinitis immunotherapy, SLIT, allergy drops, grassweed

Source Citation

Greenhawt M, Oppenheimer J, Nelson MN, et al. Sublingual immunotherapy. Ann Allergy Asthma Immunol. 2017;118(3):276-282.e2.

Supplemental Methodology Resources

Data Supplement

Methodology

Number of Source Documents
59
Literature Search Start Date
December 1, 2012
Literature Search End Date
April 1, 2015