timothy grass pollen allergen extract

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timothy grass pollen allergen extract

(ti-moe-thee grass po-len al-ler-gen ex-trakt),


(trade name)


Therapeutic: allergy cold cough remedies
Pharmacologic: temporary class
Pregnancy Category: B


Treatment of timothy grass-induced allergic rhinitis with/without conjunctivitis, confirmed by testing to be associated with the presence of pollen-specific IgE antibodies.


Small doses of antigen produce T-cell activation and downregulation of mucosal mast cells; additional effects include ↓ IgE production, ↑ specific immunoglobulin G4 (IgG4) production and changes in interleukin and eosinophil activity.

Therapeutic effects

Decreased symptoms (rhinitis/conjunctivitis) and need for daily medication to control symptoms.


Absorption: Allergen is absorbed and processed from oral mucosa and GI tract.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (decrease in symptoms/need for medications)

SL12 wkunknownmaintained throughout pollen season†
†Effect may persist for more than one year following discontinuation.


Contraindicated in: Severe/unstable/uncontrolled asthma; History of severe allergic or other reaction to sublingual immunotherapy; History of eosinophilic esophagitis; History of hypersensitivity to inactive ingredients.
Use Cautiously in: Oral inflammation/wounds including oral surgery/dental extraction, oral lichan planus, mouth ulcers or thrush (discontinue temporarily); Patients who may not respond to epinephrine/bronchodilators including those taking beta-blockers; Obstetric: Use during pregnancy only if clearly needed (systemic/local adverse reactions may be poorly tolerated during pregnancy); Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in children <5 yr has not been estblished.
Exercise Extreme Caution in: Any medical condition that may preclude surviving a serious allergic reaction.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue
  • headache

Ear, Eye, Nose, Throat

  • ear pruritus (most frequent)
  • throat irritation (most frequent)
  • dry throat
  • eye pruritus
  • nasal discomfort
  • oropharyngeal pain
  • pharyngeal edema
  • sneezing
  • throat tightness


  • dyspnea


  • chest discomfort


  • mouth edema (most frequent)
  • oral pruritus (most frequent)
  • dyspepsia
  • dysphagia
  • glossitis
  • glossodynia
  • lip swelling
  • oral hypoesthesia
  • oral mucosal erythema
  • oral paraesthesia
  • stomatitis
  • swollen tongue
  • palatal edema
  • tongue pruritus


  • pruritus
  • urticaria


  • allergic reactions including anaphylaxis/laryngopharyngeal restriction (life-threatening)


Drug-Drug interaction

Concurrent allergen immunotherapy may ↑ risk of adverse reactions.Concurrent beta blockers may ↓ response to bronchodilators or parenteral epinephrine if required for severe allergic reactions to pollen extract.Alpha blockers and beta blockers blunt the beneficial effects of epinephrine which may be required to treat anaphylaxis (↑ dose of epinephrine may be required).Ergot alkaloids may reverse the pressor effects of epinephrine.Effects of epinephrine may be ↑ by tricyclic antidepressants, levothyroxine, MAO inhibitors and some antihistamines including chlorpheniramine and diphenhyramine.Cardiac glycosides may ↑ risk of adverse cardiovascular events with epineprine.


Sublingual (Adults and Children 5–65 yr) One tablet daily, started at least 12 wk prior to onset of timothy grass pollen season, continued throughout season (has been taken daily for three consecutive years).


Sublingual tablets: 2800 bioequivalent allergy units (BAUs)

Nursing implications

Nursing assessment

  • Assess for signs and symptoms of allergy (sneezing; runny or itchy nose; nasal congestion; itchy, watery eyes) before and periodically during therapy.
  • Monitor for signs and symptoms of allergic reactions (trouble breathing, throat tightness or swelling, trouble swallowing or sleaking, dizziness or fainting, rapid or weak heartbeat, severe stomach cramps or pain, vomiting, diarrhea, severe flushing or itching) for at least 30 min after initial dose. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction. Discontinue therapy of severe allergic reaction occurs. If persistent or escalating reactions occur, re-evaluate therapy and consider discontinuation.
  • Monitor for signs and symptoms of eosinophilic esophagitis (severe or persistent gastro-esophageal symptoms, dysphagia, chest pain). Discontinue therapy and consider diagnosis if symptoms occur.
  • Monitor for signs and symptoms of asthma attack (wheezing, coughing, dyspnea) before administering. Withhold if patient experiencing acute asthma exacerbation. If recurrent asthma exacerbations occur, consider discontinuation of therapy.
  • Assess for oral inflammation (oral lichen planus, mouth ulcers, thrush) prior to administration. Allow healing before administration.

Potential Nursing Diagnoses

Ineffective breathing pattern (Indications)


  • Therapy should be started at least 12 wks prior to onset and throughout grass pollen season. Administer first dose in health care setting and monitor patient for allergic reactions for at least 30 min. If no reactions occur, patient may administer subsequent doses at home.
  • Sublingual: Remove tablet from blister just prior to dosing. Immediately place tablet under tongue until complete dissolution for at least 1 min before swallowing. Wash hands after handling tablet.

Patient/Family Teaching

  • Instruct patient in correct method of taking Grastek; avoid swallowing tablet until dissolved. Avoid food or beverage for 5 min after dissolution of tablet. If dose is missed, omit and take next scheduled dose next day; do not double doses. If more than 1 dose is missed, notify health care professional before restarting. Explain to patient that therapy does not give immediate relief of allergy symptoms. Instruct patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Instruct patient in how and when to use autoinjectable epinephrine and to seek immediate medical care if used.
  • Advise patient to stop therapy notify health care professional if signs and symptoms of allergic reactions, asthma attack, oral inflammation, or eosinophilic esophagitis occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decreased symptoms or allergic rhinitis and/or conjunctivitis.
References in periodicals archive ?
GRAZAX is currently marketed in Europe and Australia and is available in North America under the brand name GRASTEK.
In 2014, the FDA approved 3 sublingual tablets, 1 containing 5 grass pollen extracts (Oralair) and another containing 1 grass (Timothy) pollen extract (Grastek).
The approved minimum age for use is 5, 10, 18, and 18 years of age, respectively, for Grastek, Oralair, Ragwitek, and Odactra.
* The main driver of growth in the AR market will be the introduction of several AIT tablets: Merck's Grastek (grass), Ragwitek (ragweed), and Mitizax (house dust mite [HDM]) tablets, as well as Greer's Oralair (grass) in the US.
Merck's Timothy grass SLIT, marketed as Grastek, is FDA-approved for treatment of allergic rhinitis in adults and children as young as 5 years of age.
These are the multipollen allergen tablet Oralair (Stallergenes), the Timothy grass pollen tablet Grastek (Merck), and the ragweed tablet Ragwitek (Merck).
The medicines' indications differ in terms of minimum age for prescription, ranging from 5 to 18 years, and the timing of treatment, with Grastek indicated as a year-round treatment, and the others as seasonal treatments.
The three standardized SLIT products under FDA review, all of which have been approved in Europe for years, are Grastek, a Timothy grass extract, and Ragwitek, both developed by Merck in partnership with ALK of Denmark, and Oralair, a five-grass product developed by the French company Stallergenes.
ALK recommends taking Grastek continuously year-round.
* A major driver to the US market will be the introduction of several allergen immunotherapy tablets (AITs): Merck's Grastek (grass), Ragwitek (ragweed), and Mitizax (HDM) tablets, as well as Greer's Oralair (grass).
A second sublingual immunotherapy for grass pollen-induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years, Grastek, was approved by the FDA on April 14.
Like Oralair, Grastek (Timothy Grass Pollen Allergen Extract) has a black box warning of the potential for severe allergic reactions such as anaphylaxis.