Version May 2024
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 Bioequivalent Allergy Units (BAU). Note: Initiate treatment ≥12 weeks before expected onset of each pollen season and continue throughout pollen season. May be taken daily for 3 consecutive years (including intervals between grass pollen seasons). Safety and efficacy of initiating treatment during grass pollen season or restarting treatment after missing a dose have not been established. In clinical trials, treatment interruptions ≤7 days were allowed.
Grass pollen-induced allergic rhinitis: Adults ≤65 years: Sublingual: One tablet (2,800 BAU) once daily
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Not indicated for patients >65 years of age.
(For additional information see "Timothy grass pollen sublingual tablet: Pediatric drug information")
Note: Dosage strength expressed in Bioequivalent Allergy Units (BAU). Initiate treatment ≥12 weeks before expected onset of each grass pollen season and continue throughout pollen season. May be taken daily for 3 consecutive years (including intervals between grass pollen seasons). Safety and efficacy of initiating treatment during grass pollen season or restarting treatment after missing a dose have not been established. In clinical trials, treatment interruptions ≤7 days were allowed.
Grass pollen-induced allergic rhinitis: Children ≥5 years and Adolescents: Sublingual: 1 tablet (2,800 BAU) once daily. First dose should be administered in a health care setting due to the potential for allergic reactions.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics, unless otherwise noted.
>10%:
Dermatologic: Pruritus of ear (7% to 13%)
Gastrointestinal: Oral itching (24% to 27%)
Hypersensitivity: Mouth edema (10% to 11%)
Respiratory: Throat irritation (21% to 23%)
1% to 10%:
Cardiovascular: Chest discomfort (2%)
Dermatologic: Lip pruritus (children and adolescents: 3%), pruritus (adults: 2%), urticaria (2%)
Gastrointestinal: Abdominal pain (adults: ≤1%), dyspepsia (adults: 2%), dysphagia (1% to 2%), gastroesophageal reflux disease (adults: ≤1%), glossalgia (1%), glossitis (adults: 1%), nausea (2%), oral discomfort (2%), oral hypoesthesia (1% to 2%), oral mucosa erythema (2% to 5%), oral paresthesia (5% to 10%), palatal edema (adults: 1%), stomatitis (1%), tongue disease (adults: 1%), tongue pruritus (6% to 9%)
Hypersensitivity: Lip edema (adults: 1%), swelling of lips (4% to 7%), swollen tongue (3%), tongue edema (adults: 1%)
Nervous system: Fatigue (adults: 1%), headache (2% to 3%)
Ophthalmic: Eye pruritus (children and adolescents: 3%)
Respiratory: Constriction of the pharynx (adults: 1%), cough (children and adolescents: 3%), dry throat (adults: 2%), dyspnea (1% to 2%), nasal congestion (children and adolescents: 2%), nasal discomfort (2%), oropharyngeal pain (2% to 4%), pharyngeal edema (3%, including enlarged uvula), pharyngeal erythema (children and adolescents: 4%), sneezing (children and adolescents: 2%)
Postmarketing:
Cardiovascular: Cardiac rate disturbance, chest pressure, hypotension, increased heart rate
Dermatologic: Cheilitis, erythema of skin, facial erythema, lip blister, skin rash
Gastrointestinal: Diarrhea, dysgeusia, eosinophilic esophagitis, exacerbation of ulcerative colitis, gastritis, laryngeal discomfort, mouth pain, oral mucosa ulcer, sialorrhea, vomiting, xerostomia
Hypersensitivity: Angioedema, facial edema, hypersensitivity reaction (including anaphylactic shock, anaphylaxis, and severe hypersensitivity reaction)
Local: Local pruritus (throat)
Nervous system: Dizziness, drowsiness, dysarthria, foreign body sensation, impaired consciousness, paresthesia (including burning sensation [in extremities] and hypoesthesia), tremor
Ophthalmic: Swelling of eye
Otic: Otalgia (discomfort), swelling of the ear
Respiratory: Bronchospasm, exacerbation of asthma, exercise-induced asthma, hoarseness, hyperventilation, laryngitis, oxygen saturation decreased, peak expiratory flow rate decreased, pneumonia, respiratory distress, status asthmaticus, stridor, wheezing
Miscellaneous: Neck edema
Hypersensitivity to any of the inactive ingredients (gelatin, mannitol, and sodium hydroxide) contained in this product or any other 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 US labeling): Unstable, severe chronic, or severe seasonal asthma (FEV1 <70% of predicted value in adults; <80% in children); concomitant beta-blocker therapy; oral inflammation (eg, oral lichen planus, oral ulcerations, severe oral candidiasis, or dental extraction).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Esophagitis: Eosinophilic esophagitis has been reported with sublingual tablet immunotherapy; discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms (eg, dysphagia, chest pain). Use is contraindicated in patients with a history of eosinophilic esophagitis.
• Hypersensitivity reactions [US Boxed Warning]: Severe, life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restrictions, may occur. Local reactions in the mouth or throat may occur; consider discontinuation in patients experiencing escalating and persistent adverse reactions in the mouth or throat. Increased risk of local or systemic adverse reactions may occur when given with concomitant allergen immunotherapy.
Disease-related concerns:
• Respiratory disease: [US 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.
Other warnings/precautions:
• Administration: [US 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: [US 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: [US 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.
• Monitoring: [US Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a health care setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. Each subsequent dose in pediatric patients should be done under direct adult supervision.
• 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Generic: 10,000 bau/mL (10 mL); 100,000 bau/mL (50 mL)
Tablet Sublingual, Sublingual:
Grastek: 2800 bau [contains gelatin (fish)]
May be product dependent
Solution (Timothy Grass Pollen Allergen Injection)
10000 bau/mL (per mL): $39.15
100000 bau/mL (per mL): $31.81
Sublingual (Grastek Sublingual)
2800 bau (per each): $13.88
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Sublingual, Sublingual:
Grastek: 2800 bau [contains gelatin (fish)]
Sublingual: Administer first dose in a healthcare 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. Remove sublingual tablet from blister unit with dry hands immediately prior to administration. Place tablet 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.
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 unit with dry hands immediately prior to administration. Place tablet 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.
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/biologicsbloodvaccines/allergenics/ucm393188.htm, must be dispensed with this medication.
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 timothy grass or cross-reactive grass pollens in patients 5 through 65 years of age. Not indicated for the immediate relief of allergy symptoms.
Grass Pollen Allergen Extract (Timothy Grass) may be confused with Grass Pollen Allergen Extract (5 Grass Extract)
None known.
There are no known significant interactions.
In general, allergen immunotherapy is not initiated during pregnancy. Sublingual therapy should be held in newly pregnant patients (Cox 2011; Epstein 2017).
It is not known if grass pollen allergen extract is present in breast milk.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose.
Grass pollen allergen extract contains extract from timothy 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).
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