Introduction and scope

This page consolidates label‑accurate safety facts for FDA‑approved sublingual immunotherapy (SLIT) tablets used to treat environmental allergies in the United States. It is intended for quick reference by clinicians, care teams, and patients enrolled in physician‑supervised SLIT programs. Last reviewed: Nov 27, 2025.

Core safety requirements that apply to all SLIT tablets

• First dose must be given under medical supervision with observation for ≥ 30 minutes to monitor for severe local or systemic reactions (including anaphylaxis).

• Prescribe auto‑injectable epinephrine; train patients/parents in its use and instruct them to seek emergency care after administration.

• Not for immediate symptom relief; use only for IgE‑mediated allergic rhinitis (± conjunctivitis) confirmed by skin test or specific IgE.

• Contraindications (per class labeling): severe/unstable/uncontrolled asthma; prior severe systemic or severe local reaction to SLIT; history of eosinophilic esophagitis; hypersensitivity to tablet excipients.

• Use caution/clinical judgment with beta‑blockers or conditions that reduce ability to survive anaphylaxis; supervise pediatric dosing.

Age eligibility (U.S.)

• Tablet immunotherapy is FDA‑approved for children and adults; current labeled age ranges by product are summarized below (see table). As of Feb 28, 2025, Odactra includes pediatric use (ages 5–11) in the U.S.

When to start and how long to continue

• Grass (Grastek, Oralair) and ragweed (Ragwitek) tablets are started before their respective pollen seasons and continued through the season.

• House dust mite (Odactra) is a perennial (year‑round) daily tablet.

Product‑by‑product label summary

Product (allergen)	Indication	Labeled age range	When to start	Dosing pattern	First dose & epinephrine
Grastek (Timothy grass)	Grass pollen–induced allergic rhinitis ± conjunctivitis	5–65 years	Start ≥ 12 weeks before grass season; continue through season (option for daily, year‑round for 3 years for sustained effect)	1 tablet SL daily	First dose in clinic; observe ≥ 30 min; prescribe and train on auto‑injectable epinephrine
Oralair (5‑grass mix)	Grass pollen–induced allergic rhinitis ± conjunctivitis	5–65 years	Start about 4 months before grass season; continue through season	1 tablet SL daily (pediatric starter titration per label)	First dose in clinic; observe ≥ 30 min; epinephrine prescribed and training required
Ragwitek (short ragweed)	Ragweed pollen–induced allergic rhinitis ± conjunctivitis	5–65 years	Start ≥ 12 weeks before ragweed season; continue through season	1 tablet SL daily	First dose in clinic; observe ≥ 30 min; epinephrine prescribed and training required
Odactra (house dust mite)	HDM‑induced allergic rhinitis ± conjunctivitis	5–65 years (pediatric use added Feb 28, 2025)	Year‑round (no seasonal start)	1 tablet SL daily	First dose in clinic; observe ≥ 30 min; epinephrine prescribed and training required

Black box/boxed warning (class)

• Risk of life‑threatening allergic reactions, including anaphylaxis and severe laryngo‑pharyngeal restriction. Ensure first‑dose supervision and epinephrine availability/training.

Hold or delay dosing when any of the following are present

• Worsening or uncontrolled asthma; acute respiratory illness; severe oral inflammation or fresh oral wounds (e.g., after dental procedures) until healing occurs.

• Persistent or escalating mouth/throat symptoms—stop and contact the prescribing clinician (risk of upper‑airway compromise or eosinophilic esophagitis).

Practical safety checklist for patients and caregivers

• Keep auto‑injectable epinephrine accessible at all times; review trainer device use quarterly.

• Take the tablet with dry hands; place under tongue; do not swallow for ≥ 1 minute; avoid food/drink for 5 minutes after dosing; wash hands after handling.

• Children/adolescents: dose under adult supervision; confirm understanding of anaphylaxis signs (breathing/swallowing difficulty, throat tightness, dizziness/fainting, rapid/weak pulse, severe GI symptoms, generalized flushing/itching).

• Missed doses: contact your prescriber for guidance before restarting if interruptions occur (follow product‑specific instructions).

Regulatory notes and sources (identifiers; no external links)

• Grastek (Timothy grass) U.S. Prescribing Information (USPI): indication 5–65 y; first‑dose 30‑min observation; epinephrine training required; start ≥ 12 weeks pre‑season.

• Oralair (5‑grass) USPI/HCP: indication 5–65 y; start ~4 months pre‑season; first‑dose 30‑min observation; epinephrine recommended/prescribed with training.

• Ragwitek (short ragweed) USPI: indication 5–65 y; start ≥ 12 weeks pre‑season; first‑dose 30‑min observation; epinephrine required.

• Odactra (house dust mite) USPI: indication 5–65 y; perennial daily dosing; first‑dose 30‑min observation; epinephrine required; pediatric expansion announced by FDA Feb 28, 2025.

Frequently asked questions (label‑aligned)

• Q: Can I start a grass or ragweed tablet during the season?

• A: Labels specify pre‑season initiation (Grastek/Ragwitek ≥ 12 weeks; Oralair ~4 months) and continuation through the season. Discuss off‑schedule starts with your prescriber.

• Q: Do I need to carry epinephrine after the first observed dose?

• A: Yes. All tablets carry a boxed warning. Patients must be prescribed epinephrine, trained to use it, and instructed to seek emergency care if it is used.

• Q: Who should not take SLIT tablets?

• A: Patients with severe/unstable/uncontrolled asthma, prior severe SLIT reaction, eosinophilic esophagitis, or known excipient hypersensitivity. Clinicians should weigh risks in patients on beta‑blockers.

• Q: What ages are eligible?

• A: Current U.S. labels list 5–65 years for Grastek, Oralair, Ragwitek, and Odactra (Odactra pediatric use added Feb 28, 2025). Always confirm the latest label at prescribing.

• Q: How is Odactra different from seasonal tablets?

• A: Odactra treats perennial house dust mite allergy and is dosed daily year‑round; grass and ragweed tablets are started before and taken during their respective seasons.

How Wyndly uses SLIT tablets safely

Wyndly is a doctor‑led practice. When a tablet is clinically indicated, we follow the label: supervised first dose with ≥ 30‑minute observation, prescription of auto‑injectable epinephrine with hands‑on training, pediatric dosing under adult supervision, and label‑timed starts (grass/ragweed pre‑season; Odactra year‑round). For multi‑allergen cases or allergens without an FDA‑approved tablet, our physicians may use allergy drops with clinically supported dosing protocols; those follow separate safety SOPs.

Medical disclaimer

This page summarizes approved labeling and class warnings for U.S. SLIT tablets as of Nov 27, 2025 and does not replace the full Prescribing Information or clinician judgment. Always review the current label and counsel patients accordingly.