House Dust Mite Allergen Extract

(house dust mite al er juhn EK strakt)

House dust mite-induced allergic rhinitis: Treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or D. pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts in adults ≤65 years.

Limitations of use: Not indicated for the immediate relief of allergic symptoms.

Hypersensitivity to any component of the formulation; severe, unstable, or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction after taking any sublingual allergen immunotherapy; history of eosinophilic esophagitis.

Canadian labeling: Additional contraindications (not in the US labeling): Coadministration with beta-blockers; active oral cavity inflammatory conditions (eg, oral lichen planus with ulcerations, severe oral candidiasis, dental extraction).

There are no dosage adjustments provided in the manufacturer's labeling.

There are no known significant interactions.

>10%:

Gastrointestinal: Oral itching (61%), swelling of lips (18%), swollen tongue (16%), glossalgia (14%), nausea (14%), tongue ulcer (12%), stomach pain (11%)

Hypersensitivity: Mouth edema (20%, uvula)

Local: Local pruritus (in the ear; 52%), local swelling (uvula/back of the mouth; 20%)

Respiratory: Throat irritation (67%), pharyngeal edema (14%)

1% to 10%:

Cardiovascular: Chest discomfort (1%)

Central nervous system: Mouth pain (3%)

Dermatologic: Urticaria (1%)

Gastrointestinal: Dysgeusia (10%), oral mucosa ulcer (10%), oral paresthesia (9%), diarrhea (7%), tongue pruritus (5%), stomatitis (3%), vomiting (3%), dyspepsia (2% to 3%), gastroesophageal reflux disease (2%), oral mucosa erythema (2%), dysphagia (1%), lip pruritus (1%)

Ophthalmic: Eye pruritus (2%)

Respiratory: Pharyngeal erythema (2%), sneezing (2%), upper respiratory tract infection (2%), dry throat (1%), oropharyngeal pain (1%)

Frequency not defined: Hypersensitivity: Anaphylaxis

You should not use house dust mite allergen extract if you've had an allergic reaction to similar allergen or pollen extract medicines, or if:

• you have severe or uncontrolled asthma;

• you have had an allergic reaction that affected your esophagus (the tube that connects your mouth and stomach) and caused heartburn or trouble swallowing; or

• you are younger than 18 years or older than 65 years.

Tell your doctor if you have ever had:

• mouth sores, swollen gums, or other wounds or irritations inside your mouth;

• breathing problems;

• heart disease;

• uncontrolled high blood pressure;

• if you take an antidepressant or migraine headache medicine; or

• if you take medicine to treat heart problems, high blood pressure, or a prostate disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Your doctor may perform an allergy skin test or blood test to make sure you are allergic to the specific pollen contained in this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will give you the first dose and watch you closely for at least 30 minutes, to make sure you do not have an allergic reaction.

House dust mite allergen extract is a sublingual tablet that dissolves under your tongue. Do not chew this tablet or swallow it whole.

To take the sublingual tablet:

• Remove a tablet from the package only when you are ready to take the medicine.

• Use dry hands to remove the tablet and place it in your mouth.

• Place the sublingual tablet under your tongue and allow it to dissolve completely.

• Do not swallow for at least 1 minute. Do not eat or drink anything for at least 5 minutes.

Wash your hands after handling the sublingual tablet.

A child using house dust mite allergen extract should be supervised by an adult while taking this medicine.

Your doctor may also prescribe epinephrine (Epi-Pen) to keep with you in case you ever have an allergic reaction to house dust mite allergen extract.

If you need oral surgery or dental work, or if you have a mouth injury or infection, you may need to stop using this medicine until your mouth heals. Tell your doctor if the sublingual tablets cause any mouth irritation.

Store tablets in the blister pack at room temperature, away from moisture and heat.