"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
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 of ORALAIR.
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 uncontrolled hypertension.
ORALAIR may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:
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 dental extraction.
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 allergy symptoms.
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 ADMINISTRATION].
Inform parents/guardians that ORALAIR should be administered to children only under adult supervision [See DOSAGE AND ADMINISTRATION].
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 PRECAUTIONS]
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 AND PRECAUTIONS].
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 established.
ORALAIR has not been studied in patients over 65 years of age.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/2/2016
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