Included as part of the PRECAUTIONS section.
Severe Allergic Reactions
ORALAIR can cause systemic allergic reactions including
anaphylaxis which may be life-threatening. In addition, ORALAIR can cause
severe local reactions, including laryngopharyngeal swelling, which can
compromise breathing and be life-threatening.
Patients who have a systemic allergic reaction to ORALAIR
should stop taking ORALAIR.
Patients who have either escalating or persistent local
reactions to ORALAIR should be reevaluated and considered for discontinuation
Administer the initial dose of ORALAIR in a healthcare
setting under the supervision of a physician prepared to manage a severe
systemic or a severe local allergic reaction. Observe patients in the office
for at least 30 minutes following the initial dose of ORALAIR.
Severe and serious allergic reactions may require
treatment with epinephrine [See Epinephrine below].
Prescribe auto-injectable epinephrine to patients
receiving ORALAIR. Instruct patients to recognize the signs and symptoms of a
severe allergic reaction and in the proper use of emergency self-injection of
epinephrine, and instruct patients to seek immediate medical care upon its use
[See PATIENT INFORMATION].
ORALAIR may not be suitable for patients with certain
medical conditions that may reduce the ability to survive a serious allergic
reaction or increase the risk of adverse reactions after epinephrine
administration. Examples of these medical conditions include but are not
limited to: markedly compromised lung function (either chronic or acute),
unstable angina, recent myocardial infarction, significant arrhythmia, and
ORALAIR may not be suitable for patients who are taking
medications that can potentiate or inhibit the effect of epinephrine. These
Beta-adrenergic blockers: Patients taking
beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine
used to treat serious systemic reactions, including anaphylaxis. Specifically,
beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating
effects of epinephrine.
Alpha-adrenergic blockers, ergot alkaloids:
Patients taking alpha-adrenergic blockers may be unresponsive to the usual
doses of epinephrine used to treat serious systemic reactions, including
anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the
vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot
alkaloids may reverse the pressor effects of epinephrine.
Tricyclic antidepressants, levothyroxine sodium,
monoamine oxidase inhibitors and certain antihistamines: The adverse
effects of epinephrine may be potentiated in patients taking tricyclic
antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the
antihistamines chlorpheniramine, and diphenhydramine.
Cardiac glycosides, diuretics: Patients who
receive epinephrine while taking cardiac glycosides or diuretics should be
observed carefully for the development of cardiac arrhythmias.
Eosinophilic esophagitis has been reported in association
with sublingual tablet immunotherapy [see CONTRAINDICATIONS and ADVERSE
REACTIONS]. Discontinue ORALAIR and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent gastro-esophageal
symptoms including dysphagia or chest pain.
ORALAIR has not been studied in subjects with moderate or
severe asthma or any subjects who required daily medication. Page 4/ 13
Immunotherapy with ORALAIR should be withheld if the patient
is experiencing an acute asthma exacerbation. Reevaluate patients who have
recurrent asthma exacerbations and consider discontinuation of ORALAIR.
Concomitant Allergen Immunotherapy
ORALAIR has not been studied in subjects receiving
concomitant allergen immunotherapy. Concomitant dosing with other allergen
immunotherapy may increase the likelihood of local or systemic adverse
reactions to either subcutaneous or sublingual allergen immunotherapy.
Stop treatment with ORALAIR to allow complete healing of
the oral cavity in patients with oral inflammation (e.g., oral lichen planus,
mouth ulcers or thrush) or oral wounds, such as those following oral surgery or
Initiation Of ORALAIR Therapy during Grass Pollen Season
The risk of ORALAIR may be increased when treatment is
initiated during the grass pollen season.
Patient Counseling Information
Advise the patient to read the Medication Guide and to
keep ORALAIR and all medicines out of the reach of children.
Inform patients that ORALAIR is used for sublingual
immunotherapy for the treatment of grass pollen-induced allergic rhinitis with
or without conjunctivitis and is not indicated for the immediate relief of
Severe Allergic Reactions
Advise patients that ORALAIR may cause systemic allergic
reactions, including anaphylactic reactions, and severe local allergic
reactions [See WARNINGS AND PRECAUTIONS].
Educate patients about the signs and symptoms of a severe
systemic allergic reaction and a severe local allergic reaction. The signs and
symptoms of a severe allergic reaction may include: syncope, dizziness,
hypotension, tachycardia, dyspnea, wheezing, bronchospasm, chest discomfort,
cough, abdominal pain, vomiting, diarrhea, rash, pruritus, flushing, and
urticaria [See WARNINGS AND PRECAUTIONS].
Ensure that patients have injectable epinephrine
available and are appropriately trained in its use. Instruct patients who
experience a severe allergic reaction to seek immediate medical care,
discontinue therapy, and resume treatment only at the instruction of a
physician [See WARNINGS AND PRECAUTIONS].
Inform the patient that the first dose of ORALAIR is
administered in a healthcare setting under the supervision of a physician and
s/he will be monitored for at least 30 minutes to watch for signs and symptoms
of a severe systemic or a severe local allergic reaction [See DOSAGE AND
Inform parents/guardians that ORALAIR should be
administered to children only under adult supervision [See DOSAGE AND
Because of the risk of eosinophilic esophagitis, instruct
patients with severe or persistent symptoms of esophagitis to discontinue
ORALAIR and to contact their healthcare professional. [See WARNINGS AND
Instruct patients with asthma that if they have
difficulty breathing or if asthma becomes difficult to control, they are to
stop taking ORALAIR and contact their healthcare professional immediately [See WARNINGS
Instruct patients to carefully remove the ORALAIR tablet
from the blister just prior to dosing and to take the sublingual tablet
immediately by placing it under the tongue where it will dissolve. Also instruct
patients to avoid swallowing for about 1 minute, to wash their hands after
handling the tablet, and to avoid food or beverages for 5 minutes after taking
the tablet [See DOSAGE AND ADMINISTRATION].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No carcinogenicity studies were conducted in animals.
There was no evidence of mutagenic or clastogenic activity in response to
ORALAIR in the in vitro bacterial mutagenesis assay and mouse lymphoma
thymidine kinase cell assay or the in vivo bone marrow micronucleus and
unscheduled DNA synthesis tests in rats.
No fertility study was conducted with ORALAIR.
Use In Specific Populations
Pregnancy Category B: Reproductive and
developmental toxicity studies performed in female rats and rabbits have
revealed no evidence of harm to the fetus due to ORALAIR. In these studies, the
effect of ORALAIR on embryo-fetal development was evaluated. Animals were
administered 1000 IR/kg/day of ORALAIR by oral gavage on days 6-17 of gestation
for rats, and days 6-18 of gestation for rabbits. A dose of 1000 IR/kg/day of
ORALAIR corresponds to approximately 200 fold a human dose on an IR/kg/day
basis. No adverse effects on embryo-fetal development were observed. There are,
however, no adequate and well controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response,
ORALAIR should be used during pregnancy only if clearly needed.
Because systemic and local adverse reactions with
immunotherapy may be poorly tolerated during pregnancy, ORALAIR should be used
during pregnancy only if clearly needed.
Labor And Delivery
Safety and effectiveness of ORALAIR in labor and delivery
have not been established.
It is not known if ORALAIR is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
ORALAIR is administered to a nursing woman.
Efficacy and safety of ORALAIR have been established in
children and adolescents 10 through 17 years of age. ORALAIR is not approved
for use in children younger than 10 years of age because safety has not been
ORALAIR has not been studied in patients over 65 years of