Dosing & Uses
Dosage Forms & Strengths
- 12 SQ-HDM
- SQ is a method of standardization of biological potency, major allergen content, and complexity of allergen extract; HDM is abbreviation for house dust mite
Sublingual allergy immunotherapy (SLIT) tablet indicated for dust mite-induced allergic rhinitis with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts, in people aged 18-65 years
1 tablet SL qDay
<18 years: Safety and efficacy not established
>65 years: Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Itching in the ear (51.7%)
Itching in the mouth (61.3%)
Swelling of the uvula/back of the mouth (19.8%)
Swelling of the lips (18%)
Swelling of the tongue (15.8%)
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%)
Taste alteration/food tastes different (10%)
Black Box Warnings
Life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restriction, may occur
Not for administration to patients with severe, unstable, or uncontrolled asthma
Observe patients for at least 30 min following initial dose
Prescribe patients autoinjectable epinephrine; instruct and train patients on appropriate use and instruct patients to seek immediate care upon use
Administration may not be suitable for patients with certain underlying medical conditions that may reduce the ability to survive serious allergic reactions or for patients unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers
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
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
Available data on pregnant women are insufficient to inform associated risks in pregnancy
- In a fetal/embryo developmental toxicity study performed in mice, administration during gestation did not reveal adverse developmental outcomes in fetuses
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
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
Remove foil from blister with dry hands
Place the tablet under the 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
Store at controlled room temperature, 20-25 °C (68-77 °F); store in original package until use to protect from moisture
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.