(GRAS POL uhn al er juhn EK strakt five GRAS EK strakt)
Grass pollen-induced allergic rhinitis: Immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the 5 grass species contained in this product in patients 10 through 65 years of age. Not indicated for the immediate relief of allergy symptoms.
Canadian labeling: Treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis in patients 5 through 50 years of age who have a positive skin test and positive titer of IgE specific to Poaceae grass pollen; symptoms for ≥2 pollen seasons; and patients who are not tolerant or responsive to conventional therapy.
Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product or any component of the formulation; severe, unstable or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis
Canadian labeling: Additional contraindications (not in U.S. labeling): Immunotherapy is not indicated if a patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing; concomitant therapy with beta-blockers or ACE inhibitors; severe and/or unstable asthma (FEV1 <70% of predicted value); severe immune deficiency or autoimmune disease; any malignant disease (eg, cancer); oral inflammation (eg, oral lichen planus, oral ulcerations, or oral mycosis)
Grass pollen allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer to patients with severe, unstable, or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Grass pollen allergen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Grass pollen allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
Dosage strength expressed in Index of Reactivity (IR). Note: Initiate treatment 4 months before expected onset of each grass pollen season and continue throughout pollen season. Safety of initiating treatment during grass pollen season or restarting treatment after missing a dose have not been established.
Grass pollen-induced allergic rhinitis: Sublingual:
U.S. labeling: Adults ≤65 years: 300 IR once daily
Canadian labeling: Adults ≤50 years: Day 1: 100 IR once daily; Day 2: 200 IR once daily; Maintenance (Day 3 and thereafter): 300 IR once daily
Dosage strength expressed in Index of Reactivity (IR). Note: Initiate treatment 4 months before expected onset of each grass pollen season and continue throughout pollen season. Safety of initiating treatment during grass pollen season or restarting treatment after missing a dose have not been established.
Grass pollen-induced allergic rhinitis: Sublingual:
U.S. labeling: Children ≥10 years and Adolescents: Initial: Day 1: 100 IR once daily; Day 2: 200 IR once daily; Maintenance (Day 3 and thereafter): 300 IR once daily
Canadian labeling: Children ≥5 years and Adolescents: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer 's labeling.
There are no dosage adjustments provided in the manufacturer 's labeling.
Sublingual:
Administer first dose in a health care setting due to the potential for allergic reactions; monitor patient for 30 minutes after first dose. If well tolerated, subsequent doses may be taken at home; subsequent pediatric doses should be done under adult supervision. Remove sublingual tablet from blister immediately prior to administration. Place tablet(s) under tongue until completely dissolved ( ≥1 minute) and then swallow. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following dissolution of tablet (to prevent the swallowing of allergen extract). Auto-injectable epinephrine should be made available to patients.
Canadian labeling recommends taking dose in the morning; in the event a dose is missed, patients should resume with the next regularly scheduled dose (do not double dose). If therapy is interrupted for >7 days, restart therapy under medical supervision.
Store between 20 ‚ °C and 25 ‚ °C (68 ‚ °F and 77 ‚ °F); excursions are permitted between15 ‚ °C and 30 ‚ °C (59 ‚ °F and 86 ‚ °F). Protect from moisture.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Sublingual [preservative free]:
Oralair: 300 IR (30s)
Oralair Adult Sample Kit: 300 IR (9s)
Oralair Childrens and Adolescents Sample Kit: 100 IR (3s) & 300 IR (6s)
ACE Inhibitors: May enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). Specifically, ACE inhibitors may increase the risk of severe allergic reaction to Grass Pollen Allergen Extract (5 Grass Extract). Consider therapy modification
Beta-Blockers: May enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Consider therapy modification
Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose. Canadian labeling recommends monitoring pediatric patients for at least 30 minutes after administration of each dose.
Frequency of adverse reactions similar in adult and pediatric patients, unless otherwise noted.
>10%:
Gastrointestinal: Oral itching (25%)
Respiratory: Throat irritation (22%)
1% to 10%:
Cardiovascular: Lip edema (4%)
Central nervous system: Oral paresthesia (4%), voice disorder (children and adolescents 5 to 17 years: 3%), oral hypoesthesia (2%)
Dermatologic: Pruritus of ear (8%), tongue pruritus (8%), atopic dermatitis (children and adolescents 5 to 17 years: 3%), lip pruritus (children and adolescents 5 to 17 years: 3%)
Gastrointestinal: Abdominal pain (4%), dyspepsia (4%), stomatitis (2%), dysphagia (<2%), esophageal pain (<2%), gastritis (<2%), gastroesophageal reflux disease (<2%), nausea (<2%), vomiting (<2%)
Hypersensitivity: Mouth edema (8%), tongue edema (3%)
Respiratory: Asthma (children and adolescents 5 to 17 years: 7%), cough (7%), tonsillitis (children and adolescents 5 to 17 years: 6%), oropharyngeal pain (5%), pharyngeal edema (4%), upper respiratory tract infection (children and adolescents 5 to 17 years: 4%)
<1% (Limited to important or life-threatening): Acanthoma, allergic myocarditis, aphonia, chest pain, chronic lymphocytic thyroiditis, Crohns disease, enlargement of salivary glands, eosinophilia, eosinophilic esophagitis, extrinsic asthma (analgesic asthma syndrome), eyelid injury, food allergy (oral allergy syndrome), gastroenteritis, headache, hypersensitivity reaction, loss of consciousness, lymphadenopathy, neoplasm (plasmacytoma), oropharyngeal blistering, peripheral vascular disease, stridor, tachycardia, vascular disease, weight loss
Concerns related to adverse effects:
- Eosinophilic esophagitis: Eosinophilic esophagitis has been reported with use. Discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms (including dysphagia or chest pain) and consider a diagnosis of eosinophilic esophagitis.
- Hypersensitivity reactions: [U.S. Boxed Warning]: Severe, life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restrictions, may occur. Discontinue use if systemic allergic reactions occur. Re-evaluate patients with escalating or persistent local reactions; consider discontinuation. Increased risk of local or systemic adverse reactions may occur when given with concomitant allergen immunotherapy; the initiation of therapy during grass pollen season may increase the risk of adverse reactions. The Canadian labeling reports that diarrhea and angioneurotic edema were observed in clinical trials within the first year of treatment; use of antihistamines may be considered if moderate local adverse reactions occur.
Disease-related concerns:
- Respiratory disease: [U.S. Boxed Warning]: Do not administer to patients with severe, unstable, or uncontrolled asthma; use has not been studied in patients with moderate or severe asthma or in patients requiring daily medication. Withhold treatment if patient is experiencing an acute asthma exacerbation. Re-evaluate patients with recurrent asthma exacerbations and consider discontinuation.
Concurrent drug therapy issues:
- Vaccines: Effect of vaccination during therapy has not been evaluated; Canadian labeling suggests that vaccines may be administered during therapy if deemed appropriate after clinical assessment of patient.
Dosage form specific issues:
- Lactose: May contain lactose; Canadian labeling recommends avoiding use in patients with hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or significant lactose allergies.
Other warnings/precautions:
- Administration: [U.S. Boxed Warning]: Auto-injectable epinephrine should be prescribed to patients; instruct patients on appropriate use and to obtain immediate medical care upon its use.
- Appropriate patient selection: [U.S. Boxed Warning]: Use may not be suitable for patients with conditions that may reduce their ability to survive a serious allergic reaction, including but not limited to compromised lung function (either chronic or acute) and cardiovascular conditions (eg, unstable angina, recent MI, arrhythmia, and uncontrolled hypertension).
- Appropriate use: [U.S. Boxed Warning]: Use may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators due to concomitant drug therapy. The effect of epinephrine may be potentiated or inhibited by the following medications: beta blockers, alpha blockers, ergot alkaloids, tricyclic antidepressants, levothyroxine, monoamine oxidase inhibitors, antihistamines, cardiac glycosides, and diuretics.
- Experienced physician: Canadian labeling recommends that only physicians experienced in the treatment of adult or pediatric respiratory allergic diseases should prescribe and initiate treatment.
- Monitoring: [U.S. Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a health care setting. Each subsequent dose in pediatric patients should be done under direct adult supervision. Canadian labeling recommends monitoring pediatric patients for at least 30 minutes after each dose.
- Oral inflammation/wounds: Discontinue therapy to allow for complete healing of the oral cavity due to oral inflammation (eg, oral lichen planus, mouth ulcers, or thrush) or oral wounds following oral surgery or dental extraction. After healing is complete, the Canadian labeling recommends that therapy be resumed at dose used prior to procedure; if interruption >7 days, resume therapy under medical supervision.
B
Adverse events have not been observed in animal reproduction studies.
Grass pollen allergen extract is a mix of the following 5 pollens: Sweet vernal, orchard, perennial rye, timothy, and Kentucky blue grass. While the exact mechanism has not been fully elucidated, specific immunotherapy (SIT) may act by inducing a switch from T helper 2 cell response (Th2) to T helper 1 cell (Th1) response resulting in decreased interleukin-4 (IL-4) and interleukin-5 (IL-5) and increased interleukin-10 (IL-10), production of IgG-blocking antibodies that compete with IgE antibodies for allergen binding, proliferation of regulatory T lymphocytes and cytokines, and decreases in mast cells, eosinophils, and early- and late-phase allergic responses (Leith, 2006).
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience ear, mouth, or throat irritation. Have patient report immediately to prescriber dysphagia, difficulty speaking, heartburn, angina, tachycardia, passing out, dizziness, flushing, shortness of breath, cough that will not go away, severe diarrhea, severe nausea, vomiting, abdominal cramps, or severe abdominal pain (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.