ragweed allergen extract (Rx)

Brand and Other Names:Ambrosia artemisiifolia, Ragwitek
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

sublingual tablet

  • 12 Amb a 1-U (~12mcg/tablet)

Allergic Rhinitis

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

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

18-65 years: 1 tablet SL qDay; give 1st dose in physician’s office and observe for 30 min for allergic reactions

>65 years: Not approved

Dosing Considerations

Prescribe autoinjectable epinephrine to patients prescribed ragweed allergen extract and instruct them in the proper use of emergency self-injection of epinephrine

Safety and efficacy of initiating treatment during ragweed season not established

<18 years: Safety and efficacy not established

Not approved for persons older than 65 years

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Adverse Effects

>10%

Throat irritation (16.6%)

Oral pruritus (10.9%)

Ear pruritus (10.4%)

1-10%

Oral paraesthesia (10%)

Mouth edema (6.1%)

Tongue pruritus (5.1%)

Lip swelling (3%)

Swollen tongue (2.9%)

Skin pruritus (1.8%)

Lip pruritus (1.5%)

Dry mouth (1.4%)

Tongue edema (1.3%)

Oropharyngeal pain (1.5%)

Throat tightness (1.3%)

Nausea (1.1%)

Palatal edema (1.1%)

Dysphagia (1%)

Chest discomfort (1%)

Postmarking Reports

Gastrointestinal disorders: Glossodynia

Skin and subcutaneous tissue disorders: Angioedema

Respiratory, thoracic and mediastinal disorders: Dysphonia

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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)

Patients taking drugs that inhibit bronchodilator or epinephrine effects (eg, beta-blockers, alpha-blockers, ergot alkaloids) may be unresponsive to the usual doses of epinephrine

May not be suitable for patients taking drugs that potentiate epinephrine effect (eg, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine)

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 sublingual allergen immunotherapy

History of eosinophilic esophagitis

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

Cautions

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

Must be prescribed with autoinjectable epinephrine

Eosinophilic esophagitis reported; consider discontinuing if severe or persistent gastroesophageal symptoms (including dysphagia or chest pain) occur

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

Can cause local reaction in the mouth or throat that could compromise the upper airway; consider discontinuing if persistent and escalating adverse reactions of mouth or throat occur

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

Available human data do not establish the presence or absence of ragweed allergen extract-associated risks during pregnancy

Animal studies

  • In an embryo/fetal developmental toxicity study, ragweed allergen extract SC administered to mice during gestation at doses up to ~3 times the human sublingual dose did not reveal adverse developmental outcomes in fetuses

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 extract of ragweed allergen (Ambrosia artemisiifolia)

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Administration

SL Administration

Remove tablet from foil blister unit with dry hands

Immediately place table under the tongue; allow it to remain there until completely dissolved

Do not swallow for at least 1 minute

Wash hands after handling tablet

Do not take tablet with food or beverage; do not take food or beverage for the following 5 minutes after table dissolved

Storage

Store at controlled room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

Store in original package until use to protect from moisture

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Formulary

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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.