mixed pollens allergen extract

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mixed pollens allergen extract

(miks-ed po-lenz a-ler-jenex-trakt),

Oralair

(trade name)

Classification

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

Indications

Treatment of grass pollen-induced allergic rhinitis with/without conjunctivitis, confirmed by testing to be associated with the presence of pollen-specific IgE antibodies for the following grasses: sweet vernal, orchard, perenniel rye, timothy and Kentucky Blue.

Action

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.

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
SL4 mounknownmaintained throughout pollen season

Contraindications/Precautions

Contraindicated in: Severe/unstable/uncontrolled asthma; History of severe allergic or other reaction to sublingual immunotherapy; 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 <10 yr has not been established.
Exercise Extreme Caution in: Any medical condition that may preclude surviving a serious allergic reaction.

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • throat irritation (most frequent)
  • ear pruritus
  • oropharyngeal pain
  • pharyngeal edema

Respiratory

  • asthma
  • cough
  • dysphonia

Gastrointestinal

  • abdominal pain (most frequent)
  • dyspepsia
  • oral hypoesthesia
  • oral pruritus
  • lip pruritus
  • mouth edema
  • oral paraesthesia
  • stomatitis
  • tongue edema
  • tongue pruritus

Dermatologic

  • urticaria

Miscellaneous

  • allergic reactions including anaphylaxis/laryngopharyngeal restriction

Interactions

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.

Route/Dosage

Sublingual (Adults 18–65 yr) 300 IR daily, started 4 mos prior to expected onset of grass pollen season, continued throughout season.
Sublingual (Children 10–17 yr) Day 1—100 IR, day 2—200 IR (Two 100 IR tablets), day 3 and following —300 IR started 4 mo prior to expected onset of grass pollen season, continued throughout season.

Availability

Sublingual tablets: 100 index of reactivity (IR), 300 IR

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 speaking, 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)

Implementation

  • Therapy should be started at least 4 mo 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 Oralair; 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 ?
Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years.
The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider s office.
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.
Stallergenes recommends starting Oralair a few months before the start of grass allergy season and stopping when the pollen season is over.
The study was sponsored by Stallergenes, which markets the tablet as Oralair in Europe.
The sublingual tablet based grass allergens Grazax and Oralair continue to roll-out in the EU, and hope remains for their US approval.
Two sublingual grass tablets, Grazax (ALK-Abello) and Oralair (Stallergenes) forecast to have sales of $250m in the US and EU by 2019.
Two sublingual grass tablets, Grazax (ALK-Abell) and Oralair (Stallergnes) forecast to have sales of $250m in the US and EU by 2019.
Since 2003, Stallergenes has been running the Oralair program, which addresses these unmet medical needs with EBM-documented, registered allergen tablets that are safe and easy-to-use.
2009 will also feature a number of significant clinical test results as part of the Oralair programme.
In order to reinforce our attractiveness as we look forward to the prospect of a US partnership for marketing Oralair(R), we are naturally conducting this development with Quintiles, our longstanding partner for all the post-phase I development of the Oralair program, i.
We expect the Oralair programme to bring in a steady flow of product licenses in the next few years," says Albert Saporta, Chairman and CEO of Stallergenes.