ragweed allergen extract (Rx)

>10%

Adults (28-day analysis)

• Throat irritation (16.6%)
• Oral pruritus (10.9%)
• Ear pruritus (10.4%)

Children/adolescents (28-day analysis)

• Throat irritation/tickle (48.3%)
• Oral pruritus (47.8%)
• Ear pruritus (33.9%)
• Mouth pain (18.9%)
• Lip swelling (13.8%)
• Nausea (11.5%)
• Swollen tongue (11.3%)
• Throat swelling (10.7%)
• Stomach pain (10.1%)

1-10%

Adults (28-day analysis)

• Oral paresthesia (10%)
• Mouth edema (6.1%)
• Tongue pruritus (5.1%)
• Lip swelling (3%)
• Swollen tongue (2.9%)
• Skin pruritus (1.8%)
• Lip pruritus (1.5%)
• Oropharyngeal pain (1.5%)
• Dry mouth (1.4%)
• Tongue edema (1.3%)
• Throat tightness (1.3%)
• Nausea (1.1%)
• Palatal edema (1.1%)
• Dysphagia (1%)
• Chest discomfort (1%)

Children/adolescents (28-day analysis)

• Uvula/back of mouth swelling (9.9%)
• Oral ulcers (8.4%)
• Tongue ulcers (6.8%)
• Taste alteration (3.9%)
• Diarrhea (2.7%)
• Vomiting (1.2%)

Postmarking Reports

• Ear and labyrinth disorders: Ear discomfort, ear pain
• Gastrointestinal disorders: Glossodynia. GERD, dyspepsia, oral hypoesthesia
• General disorder and administration site conditions: Sensation of foreign body
• Immune system disorders: Serious systemic allergic reactions, including anaphylaxis
• Nervous system disorders: Paresthesia
• Respiratory, thoracic and mediastinal disorders: Dysphonia, asthma exacerbation, cough, dry throat, pharyngeal erythema
• Skin and subcutaneous tissue disorders: Angioedema, urticaria

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)

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.

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)

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