Odactra (dermatophagoides farinae / dermatophagoides pteronyssinus)
Acarizax
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Fact Table
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| Formula | Not applicable; standardized biologic allergen extract mixture of house dust mite proteins/allergens |
| License | U.S. FDA licensed biologic, STN/BLA 125592; initial U.S. approval 2017; indication updated for ages 5–65 in 2025 |
| Bioavailability | Not established; sublingual allergen immunotherapy with local immune exposure rather than conventional systemic bioavailability |
| Legal status | Prescription only |
| Chemical Name | House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract |
| Elimination half-life | Not established; not applicable to standardized allergen extract mixture |
| Dosage (Strength) | 12 SQ-HDM sublingual tablet once daily; contains 6 SQ-HDM D. farinae and 6 SQ-HDM D. pteronyssinus |
| Pregnancy | Insufficient human data; mouse developmental study showed no adverse developmental outcomes at up to 5 times the human sublingual dose |
| Brands | Odactra (ALK-Abelló A/S) |
| Protein binding | Not established; not applicable to allergen extract mixture |
| PubChem CID | Not assigned as a single chemical entity |
| MedlinePlus | Not listed as a dedicated MedlinePlus drug monograph |
| ChEBI | Not assigned |
| ATC code | V01AA03 |
| DrugBank | DB10400 (Dermatophagoides farinae); DB10401 (Dermatophagoides pteronyssinus) |
| KEGG | Not assigned |
| Routes of administration | Sublingual tablet; placed under the tongue |
Odactra (house dust mite allergen extract) is an immunotherapy tablet used to treat dust mite allergies. Instead of just masking symptoms, it works by gradually training the immune system to become less sensitive to dust mite allergens over time. It’s a sublingual tablet that is placed under the tongue until it dissolves. It is available by prescription for adults and children ages 5 to 65.
Directions
The first dose of Odactra must always be taken in a doctor's office or clinic, where you will be monitored for at least 30 minutes for signs of an allergic reaction. Place one tablet under your tongue and allow it to dissolve for at least 10 seconds before swallowing. Do not eat or drink for 5 minutes before or after taking the tablet. After the first dose, take one tablet under the tongue once daily. If you miss a dose, skip it and resume your regular schedule with the next dose.
Ingredients
The active ingredient in Odactra is an extract of Dermatophagoides pteronyssinus (house dust mite) 6 SQ-HDM and Dermatophagoides farinae (house dust mite) 6 SQ-HDM. Inactive ingredients include marine gelatin (fish), mannitol, sodium hydroxide.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Always carry an epinephrine auto-injector and know how to use it in case of a severe allergic reaction.
Do not take Odactra if you have open sores or wounds in your mouth. Wait until the area has fully healed before resuming treatment.
Tell your doctor if you are currently receiving any other allergen immunotherapy.
Inform your doctor if you develop new or worsening asthma symptoms while taking Odactra.
Seek medical attention immediately if you experience difficulty swallowing, throat tightening, or other signs of a severe allergic reaction after taking a dose.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Severe, unstable, or uncontrolled asthma
- History of severe systemic allergic reactions, including anaphylaxis
- History of severe local allergic reactions to sublingual allergen immunotherapy
- History of eosinophilic esophagitis
- Hypersensitivity to any of the inactive ingredients in Odactra
Side Effects
Common side effects of Odactra include:
- Throat irritation
- Itching of the mouth or ears
- Swelling of the lips or tongue
- Tongue pain
- Nausea
- Altered taste
Odactra may cause serious allergic reactions, including hives, swelling of the face or throat, and trouble breathing, which can be life-threatening. It may also trigger worsening asthma symptoms and inflammation of the esophagus, also known as eosinophilic esophagitis.
Seek emergency medical help if you experience difficulty breathing, throat tightening, chest pain, or swelling of the face, lips, or throat after taking Odactra.
Frequently Asked Questions about Odactra
What is Odactra used for, and who can use it?
Odactra is a prescription sublingual immunotherapy tablet used to treat house dust mite–induced allergic rhinitis, with or without conjunctivitis, after allergy has been confirmed by blood or skin testing. It is approved for people 5 through 65 years of age and is not meant for immediate relief of allergy symptoms.
How does Odactra work?
Odactra contains small amounts of house dust mite allergen from Dermatophagoides farinae and Dermatophagoides pteronyssinus. Over time, this immunotherapy is intended to make the immune system less reactive to those allergens, although the label says the exact mechanism is not fully established.
How do you take Odactra?
The first dose must be given in a healthcare setting, with observation for at least 30 minutes. After that, it is taken at home by placing the tablet under the tongue, letting it dissolve, not swallowing for at least 1 minute, avoiding food or drink for 5 minutes afterward, and washing hands after handling the tablet.
What is the usual dose?
The usual dose is one Odactra tablet once daily. Children should have each dose given by an adult who can watch for signs of a serious allergic reaction.
How long does it take to start helping?
Odactra does not work right away. The Medication Guide says symptom relief may begin within about 2 to 3 months of starting treatment, and the manufacturer also notes that symptoms lessen over time with daily use.
What are the most common side effects?
The most commonly reported side effects include throat irritation or tickling, itching in the mouth or ears, swelling in the back of the mouth, lips, or tongue, tongue pain, nausea, throat swelling, stomach pain, mouth or tongue sores, diarrhea, vomiting, and altered taste. These effects often begin early in treatment and are usually local reactions in the mouth or throat.
What serious warnings should patients know about?
Odactra carries a boxed warning because it can cause life-threatening allergic reactions, including anaphylaxis and severe throat swelling. For home use, the prescriber should also prescribe epinephrine and teach the patient or caregiver how to use it.
Who should not take Odactra?
Odactra should not be used in people with severe, unstable, or uncontrolled asthma, a history of severe systemic allergic reaction, a history of severe local reaction to sublingual allergen immunotherapy, or a history of eosinophilic esophagitis. It also should not be used by someone allergic to its inactive ingredients.
What should you do if you miss a dose or have mouth problems?
If one dose is missed, do not take two tablets; just take the next tablet at the usual scheduled time the next day. If more than one dose is missed, contact the healthcare provider before restarting. Treatment should also be stopped temporarily after mouth surgery, tooth removal, or when there are mouth ulcers, cuts, or infections until healing is complete.
Can Odactra be used during pregnancy or breastfeeding, and how should it be stored?
Available pregnancy data are insufficient to define drug-related risk, and it is not known whether Odactra passes into human milk, so those situations should be discussed with the prescriber. Store Odactra in the original package at room temperature in a dry place, protected from moisture, and keep it out of reach of children.
