mixed pollens allergen extract

REMS

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.

Contraind./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;
OB: Use during pregnancy only if clearly needed (systemic/local adverse reactions may be poorly tolerated during pregnancy);
Lactation: Use cautiously if breastfeeding;
Pedi: 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.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: urticaria

EENT: throat irritation, ear pruritus, oropharyngeal pain, pharyngeal edema

GI: abdominal pain, dyspepsia, lip pruritus, mouth edema, oral hypoesthesia, oral paraesthesia, oral pruritus, stomatitis, tongue edema, tongue pruritus

Resp: asthma, cough, dysphonia

Misc: allergic reactions including anaphylaxis/laryngopharyngeal restriction

Interactions ⬆ ⬇

Drug-drug:

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 blockersblunt 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.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

SL (Adults 18–65 yr): 300 IR daily, started 4 mos prior to expected onset of grass pollen season, continued throughout season.
SL (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.

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: allergy, cold and cough remedies

Pharmacologic Classification: immunotherapy

Pharmacokinetics ⬆ ⬇

Absorption: Allergen is absorbed and processed from oral mucosa and GI tract.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(decrease in symptoms/need for medications)

ROUTE	ONSET	PEAK	DURATION
SL	4 mo	unknown	maintained throughout pollen season

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.

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Indications ⬇