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Odactra (house dust mite SLIT tablet): label summary for indications, ages, first‑dose supervision, and epinephrine

Update: March 3, 2025 — What changed? - FDA expanded Odactra’s indication to include children 5–11 years (previously ≥12 years). Current U.S. PI now lists ages 5–65. - No changes to boxed warning, first‑dose supervision, or epinephrine prescription/training requirements.

Summary (label‑aligned)

  • Indication: House dust mite–induced allergic rhinitis ± conjunctivitis, confirmed by skin test or specific IgE; not for immediate symptom relief (per current U.S. Prescribing Information).

  • Age range: 5–65 years (U.S. label).

  • First dose: Administer under supervision of a clinician experienced in allergic diseases; observe ≥30 minutes; setting equipped to manage severe reactions.

  • Epinephrine: Prescribe and train patient/parents in use; seek immediate medical care if used.

  • Daily home dosing: 1 tablet sublingually once daily; allow to dissolve under the tongue; avoid swallowing for ≥1 minute and food/drink for 5 minutes afterward.

Where to start care (tablets + drops, hybrid model)

  • Start with a consult: Meet a board‑certified Wyndly doctor online to confirm candidacy and coordinate supervised first dosing when needed: Schedule a consult.

  • Learn how FDA‑approved tablets (e.g., dust‑mite) and custom drops work together in our hybrid approach: Tablets + drops overview.

Indication and who qualifies

Odactra is an allergen extract tablet for sublingual immunotherapy (SLIT) indicated to treat house dust mite–induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro specific IgE to Dermatophagoides farinae or D. pteronyssinus. It is not indicated for immediate symptom relief. Approved use is for individuals 5 through 65 years of age.

Dosing and administration

  • Dose: one tablet once daily, placed under the tongue until dissolved (≈10 seconds). Do not swallow for at least 1 minute. Avoid food or drink for 5 minutes after dosing.

  • After the first dose is tolerated in clinic (see below), subsequent doses may be taken at home.

First‑dose supervision and epinephrine requirement

  • Boxed warning: Odactra can cause life‑threatening allergic reactions (e.g., anaphylaxis, severe laryngopharyngeal restriction).

  • First dose must be administered under supervision of a clinician experienced in allergic diseases, with the patient observed in the office for at least 30 minutes and the setting prepared to manage severe reactions.

  • Prescribe epinephrine, instruct and train patients/parents in its use, and instruct them to seek immediate medical care if epinephrine is administered.

Contraindications and key precautions

  • Contraindications: severe, unstable, or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis; or hypersensitivity to excipients.

  • Temporarily withhold dosing during oral inflammation/wounds; reevaluate patients with recurrent asthma exacerbations.

Pediatric use and 2025 label change

On February 28, 2025, FDA expanded Odactra’s indication to include children 5–11 years (previously ≥12 years). The current U.S. Prescribing Information reflects the 5–65‑year age range.

Quick‑reference table

Item Odactra label details
Indication HDM‑induced allergic rhinitis ± conjunctivitis; confirm by skin test or specific IgE
Age range 5–65 years (U.S.)
Daily dose 1 tablet SL daily; do not swallow for ≥1 min; no food/drink ×5 min after
First dose Give under medical supervision; observe ≥30 min
Epinephrine Must prescribe and train patient/parent; seek urgent care if used
Boxed warning Risk of life‑threatening allergic reactions (e.g., anaphylaxis, severe laryngopharyngeal restriction)
Contraindications Severe/unstable/uncontrolled asthma; prior severe systemic or severe local SLIT reaction; eosinophilic esophagitis; hypersensitivity to excipients
Home use Allowed after supervised first dose if tolerated
All items above are summarized from the current U.S. Prescribing Information unless otherwise noted.

Practical counseling points (label‑aligned)

  • Carry the prescribed epinephrine autoinjector at all times while on therapy; ensure you and/or caregivers know how and when to use it.

  • If a severe reaction occurs and epinephrine is used, stop Odactra and seek emergency care immediately.

  • If doses are interrupted for more than a few days, consult the prescriber before resuming (clinical trials allowed up to 7 days off).

Related SLIT tablet pages

For comparison of other FDA‑approved SLIT tablets used at Wyndly, see product label summaries for Grastek (Timothy grass) and Ragwitek (short ragweed), which follow the same first‑dose supervision and epinephrine rules and have their own age ranges and seasonal start guidance (e.g., ≥12 weeks pre‑season for Grastek/Ragwitek).

Tablet vs. multi‑allergen drops (quick compare)

Feature HDM tablet (Odactra) Multi‑allergen SLIT drops (Wyndly)
What it treats House dust mite only (D. farinae, D. pteronyssinus) Multiple environmental allergens at once (e.g., dust mites, pets, pollens, mold)
Age range 5–65 years (U.S. label) Typically 5+ (doctor‑directed)
First dose Must be given under medical supervision with ≥30‑minute observation; epinephrine prescribed/training required Taken at home; no routine in‑office observation required per SLIT safety profile used at Wyndly
Daily use 1 tablet under the tongue once daily Custom daily drops under the tongue
Best fit Confirmed dust‑mite–driven AR ± conjunctivitis; prefer a single FDA‑labeled tablet Mixed or multi‑trigger allergies; prefer one plan covering several allergens

How we help you choose

  • If dust mites are your only (or dominant) trigger and you want an FDA‑labeled tablet, we can coordinate supervised first dosing and ongoing home use of Odactra.

  • If you have multiple triggers (e.g., dust mites + cats/dogs + pollens) or want one regimen for all, our doctor‑directed multi‑allergen drops may be a better fit.

Explore related care and FAQs