house dust mite immunotherapy (Rx)

>10%

18-65 years

• Itching in the mouth (61.3%)
• Itching in the ear (51.7%)
• Swelling of the uvula/back of the mouth (19.8%)
• Swelling of the lips (18%)
• Swelling of the tongue (15.8%)
• Nausea (14.2%)
• Tongue pain (14.2%)
• Tongue ulcer/sore on the tongue (11.6%)
• Stomach pain (11.3%
• Mouth ulcer/sore in the mouth (10.3%)
• Throat irritation/tickle (67%)
• Throat swelling (13.6%)

12-17 years

• Throat irritation/tickle (73.4%)
• Itching in mouth (73.4%)
• Itching in ear (50%)
• Tongue pain (24.5%)
• Stomach pain (23.4%)
• Swelling of uvula/back of mouth (20.2%)
• Swelling of lips (20.2%)
• Swelling of tongue (19.1%)
• Throat swelling (18.1%)
• Nausea (17%)
• Tongue ulcer/sore on tongue (12.8%)
• Mouth ulcer/sore in mouth (10.6%)

1-10%

18-65 years

• Taste alteration/food tastes different (10%)
• Diarrhea (6.9%)

12-17 years

• Diarrhea (7.7% )
• Paresthesia oral (5.3%)
• Oral pain (4.3%)
• Vomiting (4.3%)
• Taste alteration/food tastes different (4.3%)
• Tongue pruritus (3.2%)
• Stomatitis (2.1%)
• Chest discomfort (2.1%)
• Pruritus (2.1%)
• Flushing (1.1%)
• Chest pain (1.1%)
• Noncardiac chest pain (1.1%)
• Acute sinusitis (1.1%)
• Arthralgia (1.1%)
• Neck pain (1.1%)
• Oropharyngeal pain (1.1%)
• Rhinorrhea (1.1%)
• Throat tightness (1.1%)
• Tonsillar hypertrophy (1.1%)
• Aphthous ulcer (1.1%)
• Dysphagia (1.1%)
• Eosinophilic esophagitis (1.1%)
• Salivary gland enlargement (1.1%)
• Tongue discomfort (1.1%)
• Ear discomfort (1.1%)
• Ear pain (1.1%)
• Eye pruritus (1.1%)
• Eye swelling (1.1%)

Postmarketing Reports

Skin and subcutaneous tissue disorders: Erythema

Immune system disorders: Serious systemic allergic reactions, including anaphylaxis

Respiratory, thoracic, and mediastinal disorders: Cough

Contraindications

Severe, unstable, or uncontrolled asthma

History of severe systemic allergic reaction

History of severe local reaction after taking sublingual allergen immunotherapy

History of eosinophilic esophagitis

Hypersensitivity to product or components

Cautions

Therapy may cause systemic allergic reactions, including anaphylaxis, which may be life-threatening (see Black Box warning)

May cause local reaction in mouth or throat that could compromise upper airway; discontinue therapy if patient experiences persistent and escalating adverse reactions in mouth or throat

Eosinophilic esophagitis may occur; discontinue therapy and consider diagnosis of eosinophilic esophagitis in patients who experience persistent gastroesophageal symptoms including dysphagia or chest pain

Withhold immunotherapy if patient experiences acute asthma exacerbation; reevaluate patients who experience recurrent asthma exacerbations; discontinue therapy if necessary

Concomitant dosing with other allergen immunotherapy may increase likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy

Stop therapy and allow complete healing of oral cavity in patients with oral inflammation, including oral lichen planus, mouth ulcers or thrush, or oral wounds such as those following oral surgery or dental extraction

Drug interactions overview

• Patients taking beta-adrenergic blockers may be unresponsive to usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis; beta-adrenergic blockers may antagonize cardiostimulating and bronchodilating effects of epinephrine
• Patients taking alpha-adrenergic blockers may be unresponsive to usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis; alpha-adrenergic blockers may antagonize vasoconstricting and hypertensive effects of epinephrine; ergot alkaloids may also reverse pressor effects of epinephrine
• Adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine and diphenhydramine
• Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for development of cardiac arrhythmias

Pregnancy

Available data on pregnant women are insufficient to inform associated risks in pregnancy

Animal studies

• In a fetal/embryo developmental toxicity study performed in mice, administration during gestation did not reveal adverse developmental outcomes in fetuses

Lactation

Data are not available to assess effects on breastfed children or on milk production and excretion in nursing women

Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

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

Mechanisms of action of allergen immunotherapy have not been fully established

Sublingual Administration

Remove foil from blister with dry hands

Place tablet under tongue; it will dissolve within 10 sec; do not swallow for at least 1 min

Wash hands after handling tablet

Not for administration with food or beverage; do not take food or beverage for 5 min after taking tablet

Administer first dose under the supervision of a physician with experience in the diagnosis and treatment of allergic reactions; observe patient for at least 30 minutes following initial dose; if patient tolerates first dose, subsequent doses may be taken at home

Prescribe autoinjectable epinephrine to patients and instruct them in proper use of emergency self-injection of epinephrine

Missed dose

• Limited data are available regarding the safety of restarting treatment after a missed dose
• In clinical studies, treatment interruptions for up to 7 days were allowed

Storage

Store at controlled room temperature, 20-25ºC (68-77ºF); store in original package until use to protect from moisture