Dosing & Uses
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 on proper use of emergency self-injection of epinephrine
Safety and efficacy of initiating treatment during ragweed season not established
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
<5 years: Safety and efficacy not established
5-17 years: 1 tablet SL qDay; give 1st dose in physician’s office and observe for 30 min for allergic reactions
Dosing Considerations
Prescribe autoinjectable epinephrine to patients prescribed ragweed allergen extract and instruct on proper use of emergency self-injection of epinephrine
Safety and efficacy of initiating treatment during ragweed season not established
Not approved for persons older than 65 years
Adverse Effects
>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
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)
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.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)
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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