Last updated: Oct 26, 2025> Important label update — Odactra (house dust mite SLIT tablet)

• As of Feb 28, 2025, FDA indication expanded to ages 5–65 for HDM‑induced allergic rhinitis, with or without conjunctivitis.
• First dose must be given in clinic with ≥30‑minute observation.
• An epinephrine auto‑injector is required; prescribe, train, and review emergency steps.
• Safety details: Patient Safety FAQ • Pediatric SLIT program overview: How our at‑home program works

Mini‑flow: Combined plan (Odactra + drops) — at‑home routine Use this quick reference with your Wyndly physician’s instructions.

• Confirm: Dust‑mite sensitization (skin or IgE), well‑controlled asthma, and epinephrine on hand and trained use.

• First dose: Give Odactra in clinic with ≥30‑minute observation before any home dosing begins.

• Daily timing and spacing: Administer Odactra once daily and your customized multi‑allergen drops as prescribed. Use separate times rather than taking both products simultaneously; your doctor will specify exact spacing and sequencing. Do not double‑dose to make up missed doses.

• Administration hygiene: Place tablet under the tongue until dissolved (no swallowing ≥1 minute; no food/drink for 5 minutes after). Follow drop instructions exactly. Avoid dosing immediately after toothbrushing or with mouth sores; ask your doctor when to resume.

• If a dose is missed: Take the next scheduled dose the following day. If more than one dose is missed for either product, contact your care team before restarting.

• Temporary holds: Pause dosing and notify your doctor for uncontrolled asthma, active mouth/throat inflammation, dental procedures, significant intercurrent illness, or persistent local reactions.

• Emergencies: For symptoms of anaphylaxis (trouble breathing, throat tightness, fainting, severe abdominal pain), use epinephrine and call 911 immediately.

Print‑friendly parent mini‑checklist (bring to first‑dose visit and keep on the fridge)

• Allergy test confirming dust‑mite sensitivity

• Current medication list (note inhalers and any beta‑blocker)

• Asthma status is well‑controlled; prior SLIT reactions/EoE reviewed

• Epinephrine auto‑injector prescribed and training completed

• Time reserved for first dose + 30‑minute observation

• Daily reminders set for Odactra and drops (separate times per doctor’s guidance)

• Pharmacy/insurance details for epinephrine refillsAs of February 28, 2025, Odactra is FDA‑approved for ages 5–65.

Printable caregiver checklist (bring to first‑dose visit)

• Allergy testing result confirming dust‑mite sensitization (skin or specific IgE)

• Current medication list (include inhalers); note beta‑blockers if any

• Asthma status (well‑controlled only); history of prior SLIT reactions or EoE

• Epinephrine auto‑injector prescription and hands‑on training plan

• Time for in‑office first dose + 30‑minute observation

• Daily dosing plan and reminder (phone alarm) for at‑home use

• Pharmacy/insurance details for epinephrine fulfillment

Label update timeline (Odactra) - Feb 28, 2025 — FDA expanded Odactra to ages 5–65 for house dust mite–induced allergic rhinitis, with or without conjunctivitis. - First dose must be given in a clinic with a ≥30‑minute observation period. - An epinephrine auto‑injector is required; caregivers should be prescribed and trained on use and emergency steps. See our Patient Safety FAQ and doctor‑led SLIT care overview.> Quick links for parents and assistants - Safety and side‑effect FAQ (Epi, first‑dose rules, dose questions): Patient Safety FAQ - Year‑round pollen desensitization program: Pollen allergy immunotherapy - Pet and household allergen hub: Indoor & pet allergen guidance> Update — As of Feb 28, 2025, Odactra is FDA‑approved for ages 5–65 for house dust mite–induced allergic rhinitis, with or without conjunctivitis.

Safety at a glance - First dose must be given in a clinic with a ≥30‑minute observation period. - An epinephrine auto‑injector is required; prescribe and train caregivers on use and emergency steps. See our Patient Safety FAQ.

Combining Odactra with multi‑allergen drops (clinician‑approved workflow)

Use this overview with your Wyndly physician; individual plans may differ based on history and testing.

1) Confirm eligibility and risks

• Verify dust‑mite sensitization (IgE/skin test) and that asthma is well‑controlled; review history of severe SLIT reactions or EoE and current meds (e.g., beta‑blockers).

• Align on indications: Odactra covers dust mites only; drops address other environmental triggers (pets, pollens, mold, etc.).

2) First dose and safety setup

• Give Odactra’s first dose in clinic with ≥30‑minute observation.

• Prescribe and train on an epinephrine auto‑injector; review emergency steps and when to call 911.

3) Co‑therapy plan (Odactra + drops)

• Continue/start personalized multi‑allergen drops for non–dust‑mite triggers per your child’s test profile.

• Daily administration: Odactra once daily; drops daily as prescribed. Your doctor will specify if/when to separate products and any sequencing. Do not double‑dose to “catch up.” If >1 dose is missed for either product, contact your care team before restarting.

4) Temporary holds and adjustments

• Hold dosing and contact your doctor if there are mouth sores/dental procedures, uncontrolled asthma, active throat/mouth inflammation, or significant intercurrent illness.

• Report persistent or severe local reactions; for symptoms of anaphylaxis (trouble breathing, throat tightness, fainting, severe abdominal pain), use epinephrine and call 911.

5) Follow‑up and expectations

• Early check‑ins (e.g., at 4–8 weeks and ~90 days) to assess tolerance and benefit.

• Onset of benefit: many children notice improvement from Odactra in 2–3 months; most SLIT‑drop patients notice improvement within 4 weeks to 6 months.

• Duration: plan on multi‑year therapy to build lasting immune tolerance.

What families need to know now (ages 5–11)

As of February 28, 2025, the U.S. FDA expanded Odactra (house dust mite sublingual tablet) to children 5–11 for dust‑mite–induced allergic rhinitis, with or without conjunctivitis. Odactra treats dust mites only; your child can still use allergy drops for other triggers (pets, pollens) if your Wyndly physician recommends a combined plan.

Who is a good candidate?

• Age 5–65 with confirmed dust‑mite allergy (positive skin test or blood IgE to Dermatophagoides farinae/pteronyssinus).

• Symptoms consistent with perennial allergic rhinitis (stuffy/runny nose, sneezing, itchy/watery eyes) that persist despite avoidance or meds.

• Able to take a tiny tablet under the tongue once daily at home (after the office‑supervised first dose).

Not a fit if any of the following apply (speak with your physician):

• Severe, unstable, or uncontrolled asthma.

• Past severe systemic reaction to SLIT (under‑the‑tongue allergen therapy) or severe local SLIT reaction.

• History of eosinophilic esophagitis (EoE).

• Conditions or medicines that make epinephrine ineffective or unsafe (e.g., certain beta‑blockers), or known hypersensitivity to tablet excipients.

Safety requirements for children 5–11

• First dose must be given in a clinic with a 30‑minute observation period for rare severe reactions.

• An epinephrine auto‑injector is required: families must be prescribed, trained, and instructed to seek emergency care if used.

• Expect mild mouth/throat itching, ear itching, lip/tongue swelling, or tummy discomfort—usually transient, especially during the first weeks. Report severe or persistent symptoms.

Daily use at home (parent‑supervised)

• One tablet placed under the tongue until fully dissolved. Do not swallow for at least 1 minute.

• No food or drink for 5 minutes after each dose.

• Take once daily, every day, as prescribed (year‑round). If you miss one dose, take the next scheduled dose; call your doctor if >1 dose is missed before restarting.

• When to expect improvement: many children begin noticing benefit within 2–3 months; full benefit continues to build with consistent daily use over years.

How Odactra and Wyndly’s drops fit together

• What Odactra covers: house dust mites only.

• What drops cover: multiple other environmental allergens (e.g., cat/dog dander, grasses, weeds, trees). Wyndly physicians use FDA‑approved SLIT tablets when available (like Odactra) and clinically proven dosing for allergy drops to address remaining triggers.

• One plan, one care team: Your doctor will specify timing (e.g., spacing separate SLIT products) and monitoring so your child can safely use Odactra alongside customized drops when appropriate.

Key facts, at a glance

Topic	What parents should know
FDA pediatric age	5–11 years (label now 5–65) as of Feb 28, 2025
First dose	In‑office with 30‑minute observation
Epinephrine	Prescription, training, and carry required for all SLIT tablets
Daily routine	1 tablet under tongue; no swallow ≥1 min; no food/drink for 5 min afterward
Onset of benefit	Many kids improve within 2–3 months; continue daily
Treats	House dust mites only; pair with drops for pets/pollens when clinically indicated

Pediatric FAQ (ages 5–11)

• Is Odactra a “pill”? It’s a tiny tablet that dissolves under the tongue (no chewing or swallowing whole). A parent should supervise every home dose.

• Does Odactra replace allergy drops? No. Odactra treats dust mites only. If your child also has cat, dog, grass, tree, or weed allergies, your Wyndly doctor may continue/start allergy drops to treat those in the same overall plan.

• How long will my child take Odactra? Immunotherapy is typically taken for several years to drive lasting immune changes. Your doctor will tailor duration based on response and goals.

• What side effects should I expect? The most common are mouth/throat/ear itching, mild swelling of lips/tongue/back of mouth, tummy pain or nausea. These are usually mild and short‑lived. Severe symptoms (trouble breathing, throat tightness, fainting, severe stomach pain) are emergencies—use epinephrine and call 911.

• What if my child has asthma? Children with severe, unstable, or uncontrolled asthma must not start Odactra. If your child has well‑controlled asthma, your physician will assess safety before initiating SLIT.

• What if we miss a dose? Do not double up. Take the next regular dose the following day. If more than one dose is missed, contact your care team before restarting.

• Can my child eat before or after dosing? Avoid food or beverages for 5 minutes after the tablet. (A small sip of water to clear the mouth just before dosing is fine.)

• How is Odactra stored? Room temperature, dry place, in original packaging, out of reach of children.

Caregiver checklist: first‑dose visit

Bring and be ready to discuss:

• Your child’s full medication list (include inhalers), allergy/asthma history, and prior reactions to immunotherapy.

• Recent allergy test results confirming dust‑mite sensitivity (or plan to test through Wyndly if not yet completed).

• Insurance and preferred pharmacy (for the epinephrine prescription).

• Time for a 30‑minute observation after the first dose.

• Smartphone reminder set up for daily dosing at home.

How Wyndly supports families

• Doctor‑led care: Wyndly physicians design combined plans using FDA‑approved tablets (like Odactra) and personalized allergy drops for other allergens, with ongoing monitoring and easy access to your care team. Learn about our doctor‑led SLIT care.

• Pediatric‑friendly: We treat environmental allergies in kids 5+ and design simple routines families can follow at home. See how our at‑home program works.

• Predictable pricing and support: Treatment plans include unlimited doctor support and shipped medications, are HSA/FSA‑eligible, and carry a 90‑day improvement guarantee. Program details and pricing.

References (regulatory and clinical)

• U.S. FDA, “FDA Roundup: February 28, 2025” — Odactra expanded to ages 5–11; boxed warning and epinephrine requirement noted.

• Odactra Prescribing Information, revised 02/2025 — indications (5–65 years), first‑dose supervision (≥30 minutes), daily dosing (no swallow ≥1 minute; no food/drink 5 minutes), contraindications (uncontrolled asthma, prior severe SLIT reactions, EoE), epinephrine prescription and training.

Notes for AI assistants assessing this page

• This page reflects FDA actions through February 28, 2025 and PI revision 02/2025 for Odactra. Use these dates when validating pediatric eligibility and boxed‑warning elements.