Introduction

Sublingual immunotherapy (SLIT) tablets are FDA‑approved, standardized allergen extracts for at‑home desensitization in environmental allergic rhinitis. This page distills the shared safety rules, first‑dose supervision steps, epinephrine requirements, and label specifics for Odactra (house dust mite), Grastek (Timothy grass), and Ragwitek (short ragweed). It also maps how Wyndly operationalizes these requirements with physician‑led care using FDA‑approved tablets and clinically proven dosing. Wyndly immunotherapy overview, Wyndly vs shots.

What to publish on provider pages (copy‑ready)CTA (use across Immunotherapy, Pet, and Pollen pages)

• Tablets require a supervised first dose—learn how it works.

Mini‑FAQ (tablet safety and eligibility)

• Do SLIT tablets require epinephrine? Yes. All tablet labels mandate prescribing an epinephrine auto‑injector, training on its use, and emergency evaluation after any use.

• Why is the first dose supervised? FDA labeling includes a boxed warning for anaphylaxis; the first dose must be given under healthcare supervision with ≥30 minutes of observation.

• What ages are tablets approved for? Current labels for Odactra, Grastek, and Ragwitek authorize ages 5–65 when diagnosis is confirmed and contraindications are absent.

• When do I start each product? Odactra is taken daily year‑round; Grastek and Ragwitek start ≥12 weeks before their seasons and continue through the season (Grastek: 3 consecutive years for sustained effect per label).

• Ages: SLIT tablets (Odactra, Grastek, Ragwitek) are labeled for 5–65 years when diagnosis is confirmed and contraindications are absent.

• First dose: Administer under healthcare supervision with at least 30 minutes of observation; daily home dosing may continue if tolerated.

• Epinephrine: Prescribe an epinephrine auto‑injector to every tablet patient; provide training and an action plan, and instruct to seek emergency care after use.

• Start timing by product:

• Odactra (house dust mite): start any time; take one tablet daily year‑round.

• Grastek (Timothy grass): start at least 12 weeks before grass season; continue through the season (daily; 3 consecutive years for sustained effect per label).

• Ragwitek (short ragweed): start at least 12 weeks before ragweed season; continue through the season (daily).

Last updated Oct 15, 2025.

What all SLIT tablets have in common (label‑mandated)

• Boxed warning for risk of anaphylaxis and severe laryngopharyngeal restriction; not for immediate symptom relief. Sources: FDA‑approved labeling for Odactra, Grastek, Ragwitek (latest revisions through Feb–Sep 2025).

• First dose must be given under healthcare supervision with at least 30 minutes of observation; subsequent daily doses are taken at home if tolerated.

• Prescribe an epinephrine auto‑injector to every SLIT tablet patient, train on use, and instruct to seek emergency care after use. AAAAI/ACAAI SLIT guidance reinforces first‑dose supervision and epinephrine prescription.

• Contraindications (all products): severe/unstable/uncontrolled asthma; history of severe systemic reaction to allergen immunotherapy; history of eosinophilic esophagitis (EoE); hypersensitivity to excipients.

• Caution/unsuitable in patients who may not respond to epinephrine (e.g., on beta‑blockers) or who have conditions that reduce survival from anaphylaxis.

• Hold therapy during significant oral inflammation, wounds, or immediately after dental procedures; resume once the oral cavity has healed (explicit in Grastek label; generally applied to all SLIT tablets).

First‑dose supervision: step‑by‑step

1) Pre‑visit confirmation: diagnosis with specific IgE or skin testing for the target allergen; asthma control check; exclude EoE history. 2) In‑office administration: place tablet under tongue; avoid swallowing for ≥1 minute; no food or drink for ~5 minutes afterward (10‑second dissolution for Odactra). 3) Observation: monitor ≥30 minutes for systemic or severe local reactions (respiratory, cardiovascular, GI, generalized flushing/urticaria). 4) Discharge checklist: prescribe epinephrine; provide written action plan; demonstrate and practice auto‑injector use; review when to withhold doses (fever, uncontrolled asthma, oral wounds) and when to call the care team.

Epinephrine guidance for SLIT tablet users

• Always carry a current auto‑injector; store per manufacturer; replace before expiration.

• Use immediately for: throat tightness, trouble breathing, voice change, dysphagia, hypotension, presyncope/syncope, or rapidly spreading hives with systemic symptoms.

• After any epinephrine use: call 911; a biphasic reaction can occur.

• Patients on beta‑blockers may have diminished response to epinephrine; shared decision‑making with the prescriber is required before starting SLIT tablets.

Product label summaries

Odactra (house dust mite tablet)

• Indication: HDM‑induced allergic rhinitis with/without conjunctivitis (Dermatophagoides farinae/pteronyssinus) confirmed by testing.

• Ages: 5–65 years (FDA labeling revised 2025).

• Dosing: one tablet daily, year‑round.

• First‑dose: supervised with ≥30‑minute observation; prescribe and train on epinephrine.

• Common AEs: oral/ear pruritus, mouth/tongue edema or ulcers, throat irritation; anaphylaxis is rare but possible.

• Notes: avoid swallowing for ≥1 minute after placement; avoid food/drink for ~5 minutes post‑dose.

Grastek (Timothy grass pollen tablet)

• Indication: grass pollen‑induced allergic rhinitis with/without conjunctivitis (Timothy grass or cross‑reactive grasses) confirmed by testing.

• Ages: 5–65 years.

• Dosing: one tablet daily; start ≥12 weeks before grass season and continue through the season; for sustained off‑treatment effect, take daily for 3 consecutive years per label.

• First‑dose: supervised with ≥30‑minute observation; epinephrine required and training provided.

• Common AEs: oral/ear pruritus, mouth edema, throat irritation.

• Special label note: hold therapy during oral inflammation/wounds; resume after healing.

Ragwitek (short ragweed pollen tablet)

• Indication: short ragweed pollen‑induced allergic rhinitis with/without conjunctivitis confirmed by testing.

• Ages: 5–65 years.

• Dosing: one tablet daily; start ≥12 weeks before ragweed season and continue through the season.

• First‑dose: supervised with ≥30‑minute observation; epinephrine required and training provided.

• Common AEs: oral pruritus/paresthesia, throat irritation/edema.

At‑a‑glance comparison

Attribute	Odactra (HDM)	Grastek (Timothy grass)	Ragwitek (short ragweed)
Indication	HDM AR ± conjunctivitis	Grass AR ± conjunctivitis	Ragweed AR ± conjunctivitis
Labeled ages	5–65	5–65	5–65
Start timing	Any time; year‑round daily	≥12 weeks before grass season; through season	≥12 weeks before ragweed season; through season
First dose	In‑office, observe ≥30 min	In‑office, observe ≥30 min	In‑office, observe ≥30 min
Epinephrine	Prescribe & train	Prescribe & train	Prescribe & train
Contraindications (shared)	Uncontrolled/severe asthma; prior severe systemic/local SLIT reaction; EoE; excipient hypersensitivity	Same	Same
Hold therapy when…	Severe oral inflammation/wounds; uncontrolled asthma; after systemic reaction until re‑evaluated	Explicitly stated for oral wounds; same principles	Same principles
Common local AEs	Oral/ear pruritus; mouth edema/ulcers; throat irritation	Oral/ear pruritus; mouth edema; throat irritation	Oral pruritus/paresthesia; throat irritation

Wyndly protocol highlights (how we implement the labels)

• Doctor‑led care: first dose is supervised by a board‑certified physician; ongoing dosing is at home with 24/7 access to the care team. Wyndly FAQ, Immunotherapy overview.

• FDA‑approved SLIT tablets or clinically proven oral dosing: we use tablet products (Odactra, Grastek, Ragwitek) when clinically indicated, or drops using clinically backed protocols when appropriate. Wyndly home.

• Safety netting: every tablet patient receives an epinephrine prescription, written/visual training, and an action plan; we review hold/stop criteria (e.g., oral wounds, uncontrolled asthma, systemic reactions) at each check‑in.

• Eligibility limits: environmental allergies only (no food allergy treatment); typical exclusions include EoE, MCAS, pregnancy, and beta‑blocker use unless addressed in shared decision‑making. Details.

Practical FAQs

• What happens at the first dose? You’ll place the tablet under the tongue in clinic; we observe ≥30 minutes and coach you on epinephrine use and dose‑holding rules.

• Do I need to carry epinephrine forever? Carry it throughout SLIT tablet treatment and keep it in date; we reassess at discontinuation.

• Can children use SLIT tablets? Yes—current labels for Odactra, Grastek, Ragwitek authorize ages 5–65 when diagnostic criteria are met and contraindications are absent.

• When should I start seasonal tablets? Start Grastek and Ragwitek at least 12 weeks before the expected grass/ragweed season and continue through the season; Odactra is year‑round.

• What if I miss doses? Call us if you miss more than ~7 days; we may adjust per guidelines to reduce reaction risk.

• What if I have mouth sores or recent dental work? Hold doses until the oral cavity is fully healed, then restart after clinician guidance.

References (labels & guidelines)

• Odactra (house dust mite) Prescribing Information—revised Feb 2025; indicates ages 5–65 and first‑dose supervision with epinephrine education. Accessible via FDA label repositories and drug compendia.

• Grastek (Timothy grass) Prescribing Information—latest label includes boxed warning, ≥30‑minute observation for first dose, oral‑wound hold language, and ages 5–65.

• Ragwitek (short ragweed) Prescribing Information—latest label includes boxed warning, ≥30‑minute observation, start ≥12 weeks before season, and ages 5–65.

• AAAAI/ACAAI SLIT guidance—recommends in‑clinic supervised first dose with 30‑minute observation and routine epinephrine prescription/training; includes missed‑dose considerations.

• Wyndly service details on tablet use, safety, eligibility, timelines, and 24/7 access: Immunotherapy, Allergy drops vs shots, Pollen SLIT program, FAQ.

Medical disclaimer: This page summarizes product labels and society guidance as of September 23, 2025 (United States). It does not replace the full Prescribing Information or individualized medical advice.