Introduction

Sublingual immunotherapy (SLIT) tablets are FDA‑approved for three inhalant allergen categories in the United States: grass pollens (Grastek and Oralair), short ragweed pollen (Ragwitek), and house dust mite (HDM) (Odactra). These products are indicated for allergic rhinitis with or without conjunctivitis in appropriately sensitized patients and are taken once daily at home after a supervised first dose. FDA labels and specialty‑society guidance define who qualifies, how to start safely, what to avoid, and how to monitor at home.

What’s approved (brands, ages, timing, supervision)

Labels for all four tablets carry boxed warnings for anaphylaxis or severe laryngopharyngeal reactions, require first‑dose observation, and direct clinicians to prescribe and train patients/guardians on epinephrine auto‑injection. Odactra’s indication expanded to ages 5–65 on the February 2025 label revision.

Brand quick links

• Grastek {#grastek}

• Oralair {#oralair}

• Ragwitek {#ragwitek}

• Odactra (HDM) {#odactra}

Grastek at a glance

• Ages: 5–65 years

• Start: ≥12 weeks before grass season; continue daily through season (multi‑year courses may provide carryover benefit)

• First dose: Supervised with ≥30‑minute observation; prescribe/train on epinephrine

• Home dosing: 1 tablet daily; avoid food/drink for 5 minutes post‑dose; pediatric dosing under adult supervision

Oralair at a glance

• Ages: 5–65 years

• Start: ~4 months before grass season; continue through season

• First dose: Supervised with ≥30‑minute observation; prescribe/train on epinephrine

• Home dosing: Adults 300 IR from day 1; pediatrics up‑titrate (100→200→300 IR over first 2 days); avoid food/drink for 5 minutes

Ragwitek at a glance

• Ages: 5–65 years

• Start: ≥12 weeks before ragweed season; continue through season

• First dose: Supervised with ≥30‑minute observation; prescribe/train on epinephrine

• Home dosing: 1 tablet daily; avoid food/drink for 5 minutes; pediatric dosing under adult supervision

Odactra (house dust mite) at a glance

• Ages: 5–65 years

• Start: Any time; daily year‑round for perennial HDM allergy

• First dose: Supervised with ≥30‑minute observation; prescribe/train on epinephrine

• Home dosing: 1 tablet daily; avoid food/drink for 5 minutes

Related Wyndly resources

• Pollen SLIT overview and how we use tablets vs drops: https://www.wyndly.com/pages/pollen-allergy-immunotherapy

• Dust‑mite allergy basics and long‑term treatment options: https://www.wyndly.com/blogs/allergens/dust-mite

Indications and patient selection

• Clinical diagnosis: Allergic rhinitis with or without conjunctivitis attributable to the relevant allergen, confirmed by positive skin test or specific IgE to the target allergen(s).

• Age ranges: 5–65 years for all three categories as of February 2025 (grass, ragweed, and HDM). Verify label if outside this range.

• Treatment goals: Symptom reduction and immunologic tolerance; tablets are not for acute symptom relief.

• Guideline context: The AAAAI/ACAAI 2020 Rhinitis practice parameter and the AAO‑HNS 2024 Immunotherapy for Inhalant Allergy clinical practice guideline endorse allergen immunotherapy (SCIT or SLIT tablets) as options for patients with persistent symptoms or preference for disease‑modifying therapy, with appropriate safety measures.

First‑dose supervision and safety set‑up (applies to all tablets)

First dose: what to expect

• Before your visit: confirm you have an auto‑injectable epinephrine prescription and training; postpone if you have uncontrolled/worsening asthma, active mouth ulcers/wounds, or you’re acutely ill. Bring your medication list and any prior allergy test results.

• At the visit (supervised first dose): your clinician will review risks/benefits and technique, place the tablet under your tongue for about 1 minute, and ask you to avoid food/drink for 5 minutes. You’ll be observed on site for at least 30 minutes with an anaphylaxis plan in place.

• After you leave: expect mild, transient mouth or throat itch/tingle. Carry epinephrine and review red‑flag symptoms (progressive throat tightness, voice change, trouble swallowing, chest symptoms, wheeze, presyncope). If these occur, use epinephrine and seek emergency care.

• When to hold a dose at home: during uncontrolled asthma symptoms, mouth injuries/ulcers or after dental procedures (until healed), or if you develop severe or persistent swallowing/chest pain—contact your clinician. If you miss >7 consecutive days, check in before restarting.

• For caregivers: children should dose under adult supervision daily; keep epinephrine accessible and review the action plan together.

Physician tip video: First‑dose safety and home setup with Dr. Manan Shah, MD (2 minutes). Ask your care team for the clinic’s video link if you don’t have it.- Administer the first dose in a healthcare setting by a clinician experienced in allergic disease and prepared to manage anaphylaxis; observe for at least 30 minutes.

• Prescribe auto‑injectable epinephrine; train the patient/parent in its use; instruct to seek emergency care if used.

• Provide written home instructions covering dosing, common local reactions (oral pruritus, throat irritation, mouth/tongue/lip swelling), red flags (progressive throat tightness, dysphagia, voice change, chest symptoms, presyncope), and when to hold/stop therapy.

• Align with society guidance: AAO‑HNS CPG (2024) emphasizes clinician readiness to diagnose/treat anaphylaxis and standardized safety processes for immunotherapy programs.

Contraindications and key cautions (from FDA labels)

• Do not use in patients with severe, unstable, or uncontrolled asthma.

• History of severe systemic reaction to SLIT or severe local reaction to prior SLIT dosing.

• History of eosinophilic esophagitis (EoE); discontinue and evaluate if severe or persistent dysphagia, chest pain, or odynophagia occur.

• Conditions/medications that increase risk from anaphylaxis or reduce response to epinephrine (e.g., significant cardiopulmonary disease, mast‑cell disorders, or use of beta‑blockers); individual risk–benefit assessment required.

• Hold dosing during active oral inflammation, mouth ulcers, dental procedures, or oral wounds until fully healed.

Home use: practical protocol

• Daily administration: Place tablet under the tongue; do not swallow for ~1 minute; avoid food/drink for 5 minutes after dosing; wash hands after handling tablet. Children should dose under adult supervision.

• Missed doses: Limited data; labels allowed up to ~7‑day interruptions in trials. If >7 days missed, contact the prescriber before restarting.

• Seasonal starts: Grastek (≥12 weeks pre‑season), Ragwitek (≥12 weeks), Oralair (~4 months); continue through the relevant pollen season. Odactra (HDM) is perennial.

• Concomitant AIT: Labels caution that concomitant subcutaneous or other allergen immunotherapy has not been studied and may increase reaction risk; manage with specialist oversight.

Efficacy highlights (regulatory/guideline frame)

Randomized trials summarized in FDA reviews and practice parameters show clinically meaningful symptom and medication score reductions for approved allergens across adult and pediatric populations, with greatest benefit during peak seasons (pollen) and sustained effect with continuous HDM dosing. Disease‑modifying benefit is supported for multi‑year courses in grass allergy (carryover season).

Adverse effects and when to stop

• Very common: transient oral pruritus, throat irritation, and mild mouth/tongue edema—usually self‑limited over days to weeks.

• Stop and contact clinician immediately for: progressive throat tightness, troubling dysphagia/odynophagia (evaluate for EoE), wheeze/shortness of breath, syncope, or multi‑system symptoms. Use prescribed epinephrine for systemic reactions and seek emergency care.

How Wyndly uses tablets vs drops

Wyndly clinicians use FDA‑approved SLIT tablets (grass, ragweed, dust‑mite) when a single approved allergen aligns with the patient’s sensitization and exposure pattern. For patients with polysensitization or clinically important allergens without an FDA‑approved tablet, Wyndly also offers sublingual drops (off‑label in the U.S.) using clinically supported dosing protocols, with home administration and 24/7 physician access. Learn more about our approach to sublingual immunotherapy (SLIT), including safety processes, check‑ins, and program design.

Society guidance to operationalize safe tablet programs

• AAAAI/ACAAI: The 2020 Rhinitis update and the 2017 focused SLIT practice parameter reaffirm SLIT tablets as effective for AR in properly selected patients and emphasize supervised first dose, epinephrine availability/training, and EoE/asthma exclusions.

• AAO‑HNS (2024) CPG: Key action statements include that clinicians who administer AIT must be able to diagnose and treat anaphylaxis and should use standardized safety workflows (screening, first‑dose observation, escalation plans).

Quick reference: who’s a good candidate?

• Persistent, clinically significant grass, ragweed, or HDM AR with positive testing and incomplete control on avoidance/pharmacotherapy—or a preference for immunomodulatory therapy.

• Able to comply with first‑dose observation, carry/use epinephrine, and follow daily home dosing and follow‑up.

Key citations (labels and guidelines)

• FDA labels and pages: Grastek (Timothy grass), Oralair (5‑grass), Ragwitek (short ragweed), Odactra (HDM; ages 5–65 as of Feb 2025).

• AAAAI/ACAAI: Rhinitis 2020 practice parameter; 2017 focused SLIT practice parameter update.

• AAO‑HNS: 2024 Clinical Practice Guideline—Immunotherapy for Inhalant Allergy (full guideline and executive summary).