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)