Timothy grass pollen allergen extract (Rx)

Brand and Other Names:Grastek
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

sublingual tablet

  • 2800 BAU (bioequivalent allergy units)/tablet

Allergic Rhinitis

Indicated as immunotherapy for grass pollen-induced allergic rhinitis (with or without conjunctivitis) confirmed by positive skin test or in vitro testing for Timothy grass pollen-specific IgE antibodies

Initiate treatment at least 12 weeks before the expected onset of grass pollen season and maintain it throughout the season

5-65 years: 1 tablet SL qDay; give 1st dose in physician's office and observe for 30 min

>65 years: Not approved

Dosing Considerations

Not indicated for the immediate relief of allergic symptoms

Allergen contents: Timothy grass (Phleum pratense)

Administration

Instruct patients to avoid swallowing for about 1 minute following SL administration

Wash hands after handling the tablet

Do not take with food or beverage; avoid food or beverages for 5 minutes after taking the SL tablet

Dosage Forms & Strengths

sublingual tablet

  • 2800 BAU (bioequivalent allergy units)/tablet

Allergic Rhinitis

Indicated as immunotherapy for grass pollen-induced allergic rhinitis (with or without conjunctivitis) confirmed by positive skin test or in vitro testing for Timothy grass pollen-specific IgE antibodies

Initiate treatment at least 12 weeks before the expected onset of grass pollen season and maintain it throughout the season

<5 years: Safety and efficacy not established

≥5 years: 1 tablet SL qDay; give 1st dose in physician’s office and observe for 30 min

Dosing Considerations

Not indicated for the immediate relief of allergic symptoms

Allergen contents: Timothy grass (Phleum pratense)

Administration

Administer only under adult supervision

Instruct patients to avoid swallowing for about 1 minute following SL administration

Wash hands after handling the tablet

Do not take with food or beverage; avoid food or beverages for 5 minutes after taking the SL tablet

Not approved for persons older than 65 years

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Adverse Effects

>10% (Adults)

Oral pruritus (26.7%)

Throat irritation (22.5%)

Ear pruritus (12.5%)

Mouth edema (11.1%)

>10% (Children)

Oral pruritus (24.4%)

Throat irritation (21.3%)

1-10% (Adults)

Paraesthesia oral (9.8%)

Tongue pruritus (5.7%)

Lip swelling (4%)

Pharyngeal edema (3.4%)

Swollen tongue (2.8%)

Skin pruritus (2.4%)

Dyspepsia (2.3%)

Hypoesthesia oral (2.3%)

Headache (2.1%)

Nausea (1.9%)

Dry throat (1.7%)

Skin urticaria (1.7%)

Oropharyngeal pain (1.6%)

Nasal discomfort (1.6%)

Oral discomfort (1.6%)

Chest discomfort (1.6%)

Oral mucosal erythema (1.5%)

Throat tightness (1.4%)

Fatigue (1.4%)

Lip edema (1.3%)

Glossitis (1.3%)

Dyspnea (1.1%)

Stomatitis (1.1%)

Tongue disorder (1.1%)

Tongue edema (1.1%)

Glossodynia (1%)

Dysphagia (1%)

Palatal edema (1%)

1-10% (Children)

Mouth edema (9.8%)

Tongue pruritus (9.2%)

Ear pruritus (7.2%)

Lip swelling (7.2%)

Paraesthesia oral (5.4%)

Oral mucosal erythema (4.9%)

Oropharyngeal pain (4%)

Pharyngeal erythema (3.6%)

Eye pruritus (3.4%)

Headache (3.4%)

Pharyngeal edema (2.9%)

Lip pruritus (2.9%)

Cough (2.7%)

Swollen tongue (2.5%)

Dysphagia (2%)

Dyspnea (2%)

Chest discomfort (2%)

Skin urticaria (1.8%)

Nasal discomfort (1.6%)

Nasal congestion (1.6%)

Sneezing (1.6%)

Nausea (1.6%)

Oral discomfort (1.6%)

Stomatitis (1.3%)

Hypoesthesia oral (1.1%)

Glossodynia (1.1%)

Postmarketing Reports

Altered state of consciousness, drowsiness

Anaphylactic shock, angioedema, face edema, facial erythema, difficulty speaking, laryngeal discomfort, swelling of neck, throat pruritus

Asthma exercise induced, status asthmaticus, hyperventilation, forced expiratory volume decreased, oxygen saturation decreased, peak expiratory flow rate decreased, pneumonia, respiratory distress, vital capacity decreased, wheezing

Chest pressure, heart rate increased, heart rate irregular, hypotension

Diarrhea, vomiting

Dizziness

Eosinophilic esophagitis

Oral pain

Rash

Sensation of foreign body

Tremor

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Warnings

Black Box Warnings

Can cause life-threatening allergic reactions (eg, anaphylaxis, severe laryngopharyngeal edema)

Do not administer to patients with severe, unstable, or uncontrolled asthma

Administer 1st dose in a doctor’s office and observe patient for at least 30 minutes

Patients should be prescribed autoinjectable epinephrine, trained on its appropriate use, and instructed to seek immediate medical care upon its use

May not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction (eg, markedly compromised lung function [either chronic or acute], unstable angina, recent MI, significant arrhythmia, uncontrolled hypertension)

May not be suitable for patients taking drugs that inhibit bronchodilator or epinephrine effects (eg, beta-blockers, alpha-blockers, ergot alkaloids)

Patients taking drugs that potentiate epinephrine effect (eg, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine) may be unresponsive to the usual doses of epinephrine

Carefully observe patients who receive epinephrine while taking cardiac glycosides or diuretics for the development of cardiac arrhythmias

Contraindications

Severe, unstable, or uncontrolled asthma

History of any severe systemic or local reaction to SL allergen immunotherapy

History of eosinophilic esophagitis

Hypersensitivity to inactive ingredients (gelatin, mannitol, and sodium hydroxide)

Cautions

Potential for severe allergic reaction (see Black Box Warnings and Contraindications)

Must be prescribed with autoinjectable epinephrine (see Black Box Warnings)

Can cause local reaction in the mouth or throat that could compromise the upper airway

Eosinophilic esophagitis has been reported in association with SL tablet immunotherapy

Not studied with moderate or severe asthma or any subjects who required daily medication

Withhold dose if patient experiencing an acute asthma exacerbation; re-evaluate patients with recurrent asthma exacerbations and consider discontinuing

Not studied in individuals receiving concomitant allergen immunotherapy

Stop treatment and allow complete healing of the oral cavity in patients with oral inflammation (eg, oral lichen planus, mouth ulcers or thrush) or oral wounds (eg, oral surgery, dental extraction)

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if distributed in human breast milk; caution advised

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Precise mechanism of allergen immunotherapy is not known

Allergen immunotherapy SL tablet consisting of purified and calibrated pollen extract of Timothy grass (Phleum pratense)

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Code Definition
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.